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1) extensive partnership with its 2nd largest shareholder, MSD for Diwen Tang
+852-2978-7664 | diwen.tang@gs.com
global market access (2 clinical stage candidates, 7 pre-clinical Goldman Sachs (Asia) L.L.C.
ADC eyeing China NDA and rollout of multiple global pivotal studies
in 2H23; and 3) near-commercial stage of the China franchise. Key Data __________________________________
Initiate at Buy with our 12-m TP of HK$115 implying 59% upside. Market cap: HK$16.9bn / $2.2bn
Enterprise value: HK$15.3bn / $2.0bn
3m ADTV: NA
Preliminary data has been encouraging in breast cancer and lung China
China Pharma, Biotech & Medtech
cancer, particularly the differentiated efficacy in EGFRmut NSCLC M&A Rank: 3
Leases incl. in net debt & EV?: Yes
patients (2023 ASCO), and favorable safety profile (no ILD, no
GS Forecast ________________________________
drop-out). We see SKB264 as a core value driver and expect it to 12/22 12/23E 12/24E 12/25E
Revenue (Rmb mn) 803.9 1,073.0 928.2 1,675.0
explore a broad spectrum of indications for commercialization, EBITDA (Rmb mn) (346.8) (510.3) (909.1) (397.7)
leveraging MSD’s capabilities in clinical development / biomarker EPS (HK$) (5.74) (3.31) (5.16) (2.94)
P/E (X) NM NM NM NM
development and Keytruda as a potential cornerstone for ADC/PD-1 P/B (X) NM 7.4 14.7 10.1
Dividend yield (%) NM 0.0 0.0 0.0
combos. We forecast SKB264 to generate risk-adjusted peak sales N debt/EBITDA (ex lease,X) -- -- -- --
of US$3.6bn by 2033E (contribute 62% of fair value), assuming CROCI (%) 61.4 (141.9) (81.2) (10.2)
1fc9fa9cf8844a388c506688498547c5
FCF yield (%) NM (4.7) (7.8) (4.2)
c.30% market share in TROP2 ADC class. Key catalysts in 2H23: 1)
-- -- 6/23E 12/23E
rollout of key global pivotal studies in TNBC and NSCLC; 2) longer
EPS (HK$) -- -- (3.93) 0.63
follow-up data on HR+/HER2- breast cancer (ESMO) and NSCLC;
GS Factor Profile ____________________________
and 3) first China NDA filing for SKB264. Growth
Financial Returns
Our risk-adjusted DCF based 12-m TP of HK$115 assumes: 1) 13.5%
discount rate/3% terminal growth rate; and 2) probability of success Multiple
(PoS) based on industry average success rates for different stages Integrated
Goldman Sachs does and seeks to do business with companies covered in its research reports. As a result,
investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this
report. Investors should consider this report as only a single factor in making their investment decision. For Reg AC
certification and other important disclosures, see the Disclosure Appendix, or go to
www.gs.com/research/hedge.html. Analysts employed by non-US affiliates are not registered/qualified as research
analysts with FINRA in the U.S.
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12/22 12/23E 12/24E 12/25E Cash & cash equivalents 93.0 1,927.9 571.3 760.6
Total revenue growth NM 33.5 (13.5) 80.4 Accounts receivable 98.7 -- 41.9 121.4
EBITDA growth 56.1 (47.1) (78.1) 56.3 Inventory 52.6 143.8 237.3 281.9
EPS growth 33.3 40.2 (62.3) 43.1 Other current assets 88.1 97.1 97.1 97.1
DPS growth NM NM NM NM Total current assets 332.3 2,168.9 947.6 1,260.9
EBIT margin (51.5) (53.7) (106.9) (29.7) Net PP&E 647.8 892.7 1,131.4 1,363.6
EBITDA margin (43.1) (47.6) (97.9) (23.7) Net intangibles 3.2 6.8 9.7 12.0
Net income margin (76.6) (67.5) (121.9) (38.5) Total investments 0.0 0.0 0.0 0.0
Other long-term assets 9.8 9.8 9.8 9.8
Price Performance _______________________________________ Total assets 993.1 3,078.1 2,098.6 2,646.4
6990.HK (HK$) Hang Seng China Ent. Accounts payable 243.4 287.7 356.0 422.8
Short-term debt 2,890.8 171.9 171.9 171.9
110 7,000
Short-term lease liabilities 82.3 82.3 82.3 82.3
100 6,800 Other current liabilities 950.9 370.9 370.9 370.9
Total current liabilities 4,167.4 912.7 981.0 1,047.8
90 6,600
Long-term debt -- -- -- --
80 6,400 Long-term lease liabilities 41.3 41.3 41.3 41.3
70 6,200 Other long-term liabilities 10.7 10.7 10.7 10.7
Total long-term liabilities 52.0 52.0 52.0 52.0
60 6,000 Total liabilities 4,219.3 964.7 1,033.0 1,099.8
1fc9fa9cf8844a388c506688498547c5
Preferred shares -- -- -- --
Jul-23
Total common equity (3,226.2) 2,113.5 1,065.6 1,546.6
3m 6m 12m Minority interest -- -- -- --
Absolute -- -- -- Total liabilities & equity 993.1 3,078.1 2,098.6 2,646.4
Rel. to the Hang Seng China Ent. -- -- -- Net debt, adjusted 2,797.8 (1,756.1) (399.5) (588.7)
Source: FactSet. Price as of 11 Aug 2023 close.
Cash Flow (Rmb mn) ______________________________________
12/22 12/23E 12/24E 12/25E
Net income (567.4) (724.6) (1,131.9) (644.5)
D&A add-back 67.4 65.5 83.2 100.4
Minority interest add-back -- -- -- --
Net (inc)/dec working capital 34.5 42.7 (67.1) (57.2)
Other operating cash flow 194.6 194.6 223.6 271.9
Cash flow from operations (270.8) (421.8) (892.1) (329.4)
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Table of Contents
PM Summary 4
Key strengths 56
Key risks 61
Financials 62
Valuation 66
Glossary 70
Appendix 71
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Disclosure Appendix 72
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PM Summary
Founded in 2016, Kelun Biotech is an integrated ADC platform that has developed an
ADC-focused pipeline, with 33 candidates that fall into three major categories:
Exhibit 1: Kelun advances a deep pipeline including over ten ADCs as the core
Overview of Kelun Biotech’s key franchises
ADC franchise
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MSD
● A166 (HER2, NDA filed)
ADC is an emerging class of therapeutic modality with the potential to shift the current
treatment paradigm of oncology in front- and late-line settings, growing R&D investment
in the space aims to improve the efficacy and safety profile of ADC products.
We believe Kelun Biotech, as one of the early movers in the ADC field in China, is
well-positioned to grow into a global ADC platform given the following strengths:
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1. Competitive TROP2 ADC as key value driver – Leveraging MSD’s capability, TROP2
ADC SKB264 is targeting global opportunities in the treatment of breast cancer (BC),
non-small cell lung cancer (NSCLC) and broader indications:
n TNBC (c. 11% of breast cancer): In treating Trodelvy validated 3L TNBC, SKB264
showed potentially more favorable safety profile (esp. lower GI tox and no interstitial
lung disease / ILD) vs. Trodelvy and Dato-DXd; preliminary data of SKB264 also
suggested potential to move into earlier lines (ORR of 85.7% in 1L TNBC for PD-L1
combo).
n HR+/HER2- BC (74% of breast cancer): in late-line setting, where Trodolvy secured
approval in early 2023, the early data of SKB-264 showed potentially better response
(ORR of 42.9%, vs. Trodelvy 21% and Dato-Dxd 27%), pending more evidence from
phase II data update at upcoming ESMO. While Enhertu has been recommended in
clinical guideline for HR+/HER2-low (IHC 1+ or IHC2+/ISH-) with robust phase 3
data (DESTINY-Breast04), we see more opportunities lie in treatment of
HR+/HER2-zero (c. 25% of breast cancer) patients for TROP-2 ADCs.
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n NSCLC: the key domain for TROP-2 ADCs, where we have seen:
o Potential differentiated clinical benefits in patients who failed EGFR TKIs:
Per recent data from 2023 ASCO abstract, SKB264 showed ORR of 60% (vs.
Dato-Dxd 35% in TROPION-panTumor01 study and HER3-Dxd 40.2% in phase
1 study) and mPFS of 11.1 months (vs. HER3-Dxd 6.4 months), which looks
even more favorable than PD-1/L1 and VEGF combos (e.g. Atezolizumab +
bevacizumab + chemo) and bispecific antibodies (e.g. AK112) in this setting.
o Comparable early data in late-line EGFRwt; focus on PD-1 combo in 1L:
SKB264 showed ORR of 26% and mPFS of 5.3 months, similar to Trodelvy
17% / 5.2 months, Dato-Dxd 28% / 6.9 months (at 6mg/kg Q3W dose) and
HER3-Dxd 27.7% / 5.4 months. We believe SKB264 / Keytruda combo’s
potential in frontline setting will be key, given Keytruda’s dominant position as
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standard-of-care (SoCs) in NSCLC patients without actionable genetic
alternations; and biomarker-stratified design could play a role in clinical
development differentiation.
3. MSD / Kelun Pharma as long-term partners – With Kelun Pharma (the parent
company) and MSD (2nd largest shareholder) as the top 2 shareholders (68.0%
[includes 13.7% ESOP] /6.1% as of Aug 2023), Kelun Biotech is well placed to leverage
resources from the two leaders in the China market and global oncology space,
respectively:
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4. Robust portfolio strategy that enables synergies – Apart from developing ADCs as
single agent, Kelun Biotech is also expanding its non-ADC franchise as part of its
portfolio strategy to maximize the value of its ADC franchise through 1) synergies in
combination therapies with ADCs, e.g., SKB264 is being studied in combo with PD-1,
Tagrisso and chemotherapy for 1L EGFR-wt and EGFR-mutant NSCLC; 2) sales and
marketing synergies with overlap in target indications, e.g., A400 (RET inhibitor) and
SKB264 in NSCLC; and 3) operational synergies with biologics and small molecule
platforms potentially helping to expand the toolbox of ADC components and
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Exhibit 2: Four approved products and multiple assets at pivotal stage by the end of 2024
Upcoming key revenue catalysts for Kelun Biotech and other competitive products in 2023-2024
Data readout 2024 Data readout from ph2 trial for 1L EGFRwt NSCLC (SKB264+PD-L1) (potentially in 2024 AACR/ASCO)
Trodelvy Data readout Sep-23 Data readout from ph2 EVOKE-02 study (combo w/ Keytruda ± chemo) for 1L a/m NSCLC without AGA
(WCLC oral presentation)
Data readout 2024 Initial data readout from pivotal ph3 EVOKE-01 study for 2/3L a/m NSCLC with or without AGA
Dato-DXd Data readout Sep-23 Data readout from ph1b TROPION-Lung04 (+ Durvalumab ± Carboplatin) for a/m NSCLC without AGA
(WCLC oral presentation)
Regulatory 2H23 NDA submission for 3L a/m NSCLC with or without AGA (ph3 TROPION-Lung01 study)
EGFRmut a/m NSCLC SKB264 Data readout Sep-23 Updated 2023 ASCO data for EGFRmut NSCLC (TKI failure) with longer follow-up (2023 CSCO)
Clinical development 2H24 Completed patient enrollment of pivotal China ph3 trial for EGFRmut advanced NSCLC (TKI failure)
HER3-DXd Data readout Sep-23 Data readout from registrational ph2 HERTHENA-Lung01 for 3L EGFRmut NSCLC (WCLC oral
presentation)
SHR-A2009 Data readout Oct-23 Ph1 data readout of SHR-A2009 (HER3 ADC) for advanced solid tumors (2023 ESMO)
BL-B01D1 Data readout Oct-23 Data update from FIH ph1 study with longer follow-up (2023 ESMO)
Clinical development 2H23 Initiate head-to-head pivotal ph3 trial (vs. platinum based doublets chemo) in 2L EGFRmut NSCLC (TKI
failure)
AK112 Regulatory 2H23 NMPA NDA submission for EGFRmut NSCLC (TKI failure)
Besides catalysts of SKB264, MSD announced at its 2023 ASCO update call that company will initiate a series of ph3 global trials for SKB264 in TNBC, HR+/HER2- BC, and
NSCLC, potentially including combo therapy with Keytruda
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tumors Clinical development 2H24 Conclude dose expansion study of ph1 trial for advanced HER2+ solid tumors
A400 (RET) RET+ NSCLC Clinical development 2H23 Commence pivotal trial for 1L advanced RET+ NSCLC
RET+ MTC Clinical development 1H24 Commence pivotal trial for advanced RET+ MTC
A167 (PD-L1) NPC Clinical development 1H23 Complete patient enrollment of ph3 trial of A167 in combo with chemo in 1L NPC
Regulatory 2H23 Receive conditional marketing approval from the NMPA for 3L+ NPC
A140 (EGFR biosimiliar) RASwt CRC Regulatory 2H23 Complete primary analysis of pivotal ph3 trial and filed NDA with NMPA for 1L RASwt CRC
Regulatory 2H24 Launch in China market for 1L RASwt CRC
A223 (JAK1/2) RA Clinical development 2H23 Initiate a pivotal ph3 trial for moderate-to-severe rheumatoid arthritis (RA)
AA Clinical development 2H23 Complete pts enrollment of A223's ongoing ph2 trial for severe alopecia areata (AA)
Major catalysts
Competitive products
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Risks
As Kelun Biotech is still an early-stage biotech company without product sales, we view
most of the risks as associated with the ADC development and commercialization:
1fc9fa9cf8844a388c506688498547c5
company’s ADC assets may carry inherent development risks that could result in
delays, failure or cost overruns if NMPA may require additional clinical studies to
grant approval, thus pose downside risk to the revenue outlook.
n Increasing competition in ADC field – Global ADC market is becoming increasingly
heated in both R&D interest and business development (BD) activities since 2019.
We see competition coming from 1) ADCs targeting the same target, 2) ADCs with
different targets developed for same indication (e.g., TROP2 ADC vs. Enhertu in
HER2-low BC), and 3) treatment regimens based on other modalities (e.g.,
antibodies, chemotherapies, target therapies as in NSCLC).
n Limited commercial manufacturing and sales track record – Although Kelun
Biotech has extensive R&D experience in ADC, the operating history of seven years
as a standalone company is relatively short, with limited market approval and
commercialization track record. An insufficient commercialization layout could
negatively impact the market penetration of key assets such as SKB264, which
could indicate 1) higher follow-up investment in sales & marketing may be needed,
and 2) our estimated peak sales may not be reached, thereby putting pressure on
the revenue outlook.
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Exhibit 4: Broad pipeline with ADC as the core and other franchise products to supplement
Summary of Kelun Biotech’s products and key pipeline
Commercial IN
Candidates Targets Potential indications Ph 1a Ph 1b/2 Registrational NDA Filing Approved
rights D
HR+/HER2-BC (3L+)
EGFR-mutant NSCLC (TKI failure)
EGFR-wild type (1L) and EGFR-mutant (TKI failure) NSCLC
EGFR-mutant NSCLC (1L)
NSCLC (EGFR-wild type (1L))
GC (2L+)
OC (platinum-resistant)
Solid tumors (SCLC, UC, HNSCC and EC)
NPC (PD-(L)1 relapse or refractory)
ADC
CC (2/3L)
UC (1L)
OC (2L maintenance)
CRPC (2L+)
A166 HER2 HER2+ BC (3L+) Global 2H24
HER2+ BC (2L+)
HER2+ GC (2L+)
HER2+ CRC (3L+)
SKB315 CLDN18.2 Solid tumors (GC, PC etc.) Licensed-out
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SKB410 Nectin-4 Solid tumors Greater China
Up to seven PCC Solid tumors Greater China
A167 PD-L1 NPC (3L+) Greater China 2H23
NPC (1L)
A140 Erbitux biosimilar CRC Global
A400 RET RET+ NSCLC (1L) Greater China >>> (2H 2023)
RET+ NSCLC (2L+) and part of Asia
Non-ADC
RET+ MTC and other RET+ solid tumors
Oncology
RET+ inhibitor-resistant solid tumors
SKB337 PD-L1/CTLA4 Solid tumors Global
A289 LAG3 Solid tumors Global
A296 STING Solid tumors (intravenous infusion) Global
Solid tumors (intratumoral injection)
A223 JAK 1/2 Rheumatoid arthritis Global >>> (2H 2023)
Alopecia areata
Non-oncology A277 KOR CKD-aP Global
SKB378 TSLP Asthma Global
SKB336 FXI/FXIa Thromboembolic disorders Global
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franchise led by SKB264 as the primary driver of the pipeline value and expect ADCs to
contribute sales of Rmb7.1bn in 2033E or 68% of total revenue as part of our
risk-adjusted DCF framework.
12,000 Rmb, mn
SKB315 global launch
10,000
SKB264
8,000
ex-China launch
6,000
SKB264 / A166
4,000
ADC
68%
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2,000
-
2021A 2022A 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E
SKB264 as the primary value driver with global potential - Among the three
clinical-stage ADC assets (TROP2 / HER2 / CLDN18.2), we see SKB264 as the most
critical asset, and expect it to contribute over Rmb5.3bn in revenues by 2033E (or 75%
of ADC franchise revenue, c.63% of total equity value, see breakdown details below),
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given: 1) the broad spectrum of indications where TROP2 has over-expression (e.g.
BC/NSCLC/UC/GC), 2) the unique drug design of SKB264 could potentially deliver
clinical benefits over TROP2 ADC peers as illustrated in early encouraging data, and 3)
the strong leverage of MSD’s expertise and network in the global market to drive
clinical development and commercialization in both mono and combo settings (we
estimate ex-China risk-adjusted peak sales to contribute to 89% of total peak sales by
2033E).
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US$ mn
PoS
70%
US mn
PoS PoS
653
PoS 20% PoS 65%
36% 71%
2,539 US mn
PoS
PoS 81%
PoS 77%
73%
PoS
27%
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Exhibit 7: NSCLC indication as the major part of pre-PoS overseas Exhibit 8: Sales from BC and NSCLC contributes to major part of
sales of SKB264 overseas valuation of SKB264
Pre-adjusted sales breakdown of SKB264 (TROP2 ADC) by indications Global valuation breakdown of SKB264 (TROP2 ADC) by indications
(exclude China) (exclude China)
US$ mn US$ mn
BC NSCLC Others BC NSCLC PoS Others
50%
PoS
32% PoS
PoS 7%
22% PoS
US mn
581
7%
5,373 US mn
1fc9fa9cf8844a388c506688498547c5
PoS
1,375 US mn
58%
US mn
8,969
764 US mn
PoS
72%
US mn
2,913
Source: Goldman Sachs Global Investment Research Source: Goldman Sachs Global Investment Research
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given 1) it is among the leading CLDN18.2 ADCs with Kthiol-based design to expand
therapeutic window, and 2) potential advantage in ex-China market on the back of MSD’s
commercial execution. For A166, despite the competitive efficacy data, we are more
conservative on sales forecasts (PoS-adjusted of Rmb941m, or c. US$140m) with likely
strong competition from Enhertu and the possible examination requirement due to
ocular toxicity.
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ADC.
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Exhibit 9: ADC and non-ADC franchise synergistically cover major oncology areas with significant unmet needs
Mapping of major markets targeted by Kelun Biotech’s oncology franchise
128k
(global)
234k
(global)
176k
(global)
325k
(global)
83k
(global)
126k 99k
(global) (global) 43k 31k 21k
(global) (global) (global)
https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.4038
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15k
200k 229k
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6135466/
(global) (global)
63k 41k
(global) (global)
61k
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45k
128k
(global) 67k
42k 25k 36k
(global) (global) (global)
29k 11k 8k
Note: Size of shaded areas represent the number of addressable patients in FY2022 (global number for indications of SKB264 / SKB315, others are China)
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n US$3.6bn risk-adjusted global sales for SKB264 by 2033E – We forecast sales for
BC/NSCLC and potential expanded indications in GC/OC etc. by 2033E, and the
US/EU market to contribute 55%/34% of risk-adjusted global sales. Our estimates
are based on 1) the clinical benefit of TROP2 ADC compared to the standard of care
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(SOC) in BC and NSCLC, 2) the large number of addressable patients globally (close
to 400k addressable BC patients and over 1mn addressable NSCLC patients
according to Globocan 2020), and 3) encouraging preliminary data of SKB264 vs.
front-runners Trodelvy and Dato-DXd. China sales and royalties on non-China sales
for SKB264 could add up to Rmb5.3bn as revenue to Kelun Biotech in 2033E.
Exhibit 10: We forecast global sales of SKB264 to reach $3.6bn by Exhibit 11: …and US as the largest market contributing over half of
2033E with NSCLC as the biggest driver… global sales
Estimated combined sales of SKB264 globally during 2024E-2033E Sales breakdown by geographic regions during 2024E-2033E
(risk-adjusted)
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2,500 34%
200% 2,500
2,000
150% 2,000
1,500
100% 1,500
1,000
500 50% 1,000
55%
0 0% 500
0
2024
2033
2025
2026
2027
2028
2029
2030
2031
2032
TNBC HR+/HER2- BC
NSCLC - 1L NSCLC - 2L US EU5 China
Others yoy
Source: Goldman Sachs Global Investment Research Source: Goldman Sachs Global Investment Research
n We expect material global market share; await more data to assess further
potential – SKB264 has shown some early encouraging clinical data in comparison
with TROP2 ADC peers, e.g., higher ORR/PFS in 2L EGFRmut patients and generally
better safety profile across indications. Leveraging MSD’s expertise in clinical
development, we see the value of SKB264 could be better unveiled in the coming
years, and the asset could capture material market share globally. More positive data
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could further strengthen its market position. We elaborate more on the treatment
landscape and SKB264’s position in the following sections.
n Potential higher market share in China - In China, we see additional competitive
advantage of SKB264 given the early market access (BLA in 2H23) and the premium
pricing of Trodelvy, which will cost Rmb80k per month, materially higher than other
BC treatments in China, e.g. 1) ADCs: Enhertu (Rmb44k per month without PAP),
and 2) CDK4/6i (Rmb4-5k for palbociclib/abemaciclib). Given the CMC challenges,
we expect Trodelvy to be less flexible on price cut which could limit its ability to get
into NRDL for broader usage, and therefore we expect SKB264 to capture higher
market share in China (5% higher than in US/EU).
EU SKB264 share (%) 25% 25% 25% 30% 30% 30% 30% 30% 35% 35% 25% 25%
SKB264 treated pts (k) 2 2 2 6 6 2 1 4 14 8 2 2
DOT (month) 8 7 6 6 7 6 18 7 9 5 9/5 9
pre-POS sales (mn USD) 310 260 242 793 1,000 309 580 667 3,160 966 284 384
China TROP2 penetration (%) 20% 35% 55% 30% 45% 55% 10% 35% 25% 25% 20%/25% 25%
SKB264 share (%) 30% 30% 30% 35% 35% 35% 35% 35% 40% 40% 30% 30%
SKB264 treated pts (k) 2 2 1 2 5 2 7 17 28 15 19 2
DOT (month) 8 7 6 6 7 6 18 7 9 5 9/5 9
pre-POS sales (mn USD) 26 23 12 22 62 20 246 220 462 141 249 34
Monthly price (k USD) - China 2
Monthly price (k USD) - US 30
Monthly price (k USD) - EU5 19
pre-POS sales (mn USD) 335 283 254 815 1,062 328 826 886 3,622 1,107 533 418
POS (%) 58% 81% 81% 58% 58% 58% 7% 50% 22% 32% 8% 8%
risk-adj sales (mn USD) 193 229 206 469 612 189 60 447 782 349 43 34
Total risk-adj sales (mn USD) 3,636
Total sales also include add-on sales from other smaller indications.
1fc9fa9cf8844a388c506688498547c5
Differentiated drug design to improve therapeutic window
Leveraging the ADC platform and expertise, SKB264 is designed to improve upon the
first FDA-approved TROP2 ADC, Trodelvy, with a differentiated drug design:
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Source: Company data (for SKB264), Frontiers in Oncology (for Trodelvy), Clinical Cancer Research 22.20 (2016) (for Dato-DXd)
1fc9fa9cf8844a388c506688498547c5
payload half-life of 56.3h/15.5h for SKB264/Trodelvy, respectively), SKB264 is able to
carry significantly higher payload in tumor tissue vs in plasma compared to Trodelvy
(based on preclinical CDX model findings), suggesting potentially improved efficacy
and therapeutic window of SKB264.
n Potentially better homogeneity than Dato – Similar to Trodelvy, SKB264 adopts a
high DAR strategy (DAR=7.4) to complement the moderate potency of the payload.
In contrast, Dato-DXd has a DAR of 4 and could potentially have higher
heterogeneity in DAR distribution with less than 60% of products with DAR=4.
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Exhibit 14: SKB264 exhibited comparable level of plasma payload Exhibit 15: … but about 4.6 times higher payload exposure in tumor
with Trodelvy, … tissue
Plasma concentrate-time curve of KL610023 & SN38 Tumor concentration-time curve of KL610023 & SN38
TROP-2 is validated in 3L TNBC – For TNBC, which is c. 11% of total breast cancer
patients, the SOCs are limited especially for patients who lack actionable genetic
alterations (AGA) (e.g., PD-L1 negative, BRCA1/2 wild-type). TROP-2 ADC has proven to
be a better option in this population: with significant improvement in progression-free
survival (PFS) and overall survival (OS) over chemotherapy in 3L+ TNBC, FIC TROP-2
ADC Trodelvy obtained FDA approval in April 2020 and full approval in 2021.
1fc9fa9cf8844a388c506688498547c5
HER2+, 15%
TNBC, 11%
HR+/HER2-low (IHC 1+
or IHC 2+/ISH -), 49%
HR+/HER2-zero
(IHC 0), 25%
Targeted patients
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Exhibit 17: 3L TNBC as the baseline for TROP2 ADC with opportunity to push for earlier-lines adoption
SOCs for different lines of treatment for TNBC
SOC / Efficacy Safety
Setting Subtype/Biomarker Competitor ORR (%) PFS (mos) OS (mos) SAE G3+ AE Discontinuation Clinical trial
1L PD-L1 CPS>=10 Keytruda+chemo 53% 9.7 23 68% KEYNOTE-355
PD-L1 CPS<10 and BRCA1/2mut PARPi 60% 7 19.3 37% 5% OlympiAD
PD-L1 CPS<10 and BRCA1/2wt chemo 38% 6.1 21
2L BRCA1/2mut PARPi 60% 7 19.3 37% 5% OlympiAD
Any Trodelvy 35% 5.6 12.1 15% 64% 5% ASCENT
chemo 11% 3.3 10.8 20% 36% KEYNOTE-119
BRCA1/2wt and HER2-low Enhertu 50% 8.5 18.2 28% 53% 16% Destiny-Breast04
3L Biomarker positive (TMB-H etc.) targeted therapy 18% 8% 15% 9% KEYNOTE-158
Any chemo 5% 1.7 6.7 8% 47% 5% ASCENT
Emerging opportunity in earlier lines – some early data from TROP-2 ADCs in are
encouraging – e.g., SKB264 / A167 showed ORR 85.7% (n=7, phase 1/2) in 1L TNBC,
and Dato-DXd / durvalumab combo 73.6% (n=61) in the same setting. Both look higher
than SOC (Keytruda / chemotherapy, ORR of 52.7%, ph3 KEYNOTE-355), though need
to be validated in larger samples. We note that all three TROP2 ADCs have initiated
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clinical trials for 1L TNBC, and even adjuvant setting for Dato-DXd / Trodelvy.
Exhibit 18: TROP2 ADC showed encouraging response data in 1L TNBC over SOC
Clinical data of SKB264, Dato-DXd, and SOC (Keytruda+chemo) in 1L TNBC
Molecule SKB264 Dato-DXd Keytruda + chemotherapy
Developer Kelun Biotech Daiichi Sankyo/AstraZeneca MSD
Study SKB264-II-07 (China trial) BEGONIA1 KEYNOTE-355
Latest reported time 29-Dec-2022 8-Dec-2022 21-Jul-2022
Follow-up period, median N/A 7.2 months vs 16.6 months 44.1 months
NCT no. NCT05445908 (phase 2) NCT03742102 (phase 1b/2) NCT02819518 (phase 3)
Combo A167 (PD-L1) Durvalumab (PD-L1) PD-1 + chemotherapy
Treatment line 1L TNBC 1L TNBC 1L TNBC
Baseline N 8 61 (Arm 7: Dato-DXd + PD-L1) vs 23 220 vs 103 (PD-L1 CPS ≥10)
(Arm 1: PD-L1 + chemo)
Prior treatment previously untreated: 41% (25/61) in previously untreated locally recurrent
Arm 7 (Dato-DXd + PD-L1) inoperable or metastatic TNBC
1fc9fa9cf8844a388c506688498547c5
Median age (yrs) 53 (31-74) 52 vs 55
ECOG ECOG PS 1: 86% vs 41%
Efficacy ORR 85.7% (6/7) 73.6% (39/61) vs 56.5% (13/23) 52.7% (116/220) vs 40.8% (42/103)
DCR 100% (7/7) 65.0% vs 54.4%
DOR, m 12.8 vs 7.3
PFS, m 9.7 vs 5.6 (HR=0.66)
OS, m 23.0 vs 16.1 (HR=0.73)
AE G3+ AE 37.5% (3/8) 41% (25/61) 68.1% vs 66.9%
SAE 0 16.4% (10/61)
TR death 0 0 2 vs 0
AE of concern mainly Grade 1/2 events including predominantly Grade 1/2 events neutropenia (29.7% vs 29.9%);
neutropenia (62.5%), lymphopenia including stomatitis, rash, pruritus, neutrophil count decreased (17.4% vs
(62.5%), rash (62.5%), and and dry eye (≥10% of patients) 20.3%);
stomatitis (62.5%) anemia (16.5% vs 14.6%)
Discontinuation N/A 6.6% (4/61)
Note: 1. Ph1 data reported on 2022 SABCS (Arm 7, data cut-off: Jul 2022) and 2021 SABCS (Arm 1, data cut-off: Sep 2020)
Source: Company data for SKB264, SABCS 2022 for Dato-DXd, New England Journal of Medicine (2022) for Keytruda
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Exhibit 19: We estimate the penetration of TROP2 ADC in TNBC by comparing with SOC across the
treatment paradigm
Treatment paradigm for TNBC
38%
PD-L1 PARPi
CPS<10 refractory 60%
11% 62%
BRCA1/2 PD-L1 PARPi:
mutation 20%
CPS>=10 ORR=60%
2 L TNBC 89% 55% 40%
BRCA1/2 Enhertu: ORR=
wildtype HER2-low 44% for 20%
ORR=50%
SKB264 3L
45% TNBC
Trodelvy
1fc9fa9cf8844a388c506688498547c5
HER2-zero 60%
chemo:
3 L TNBC ORR=5% 60% 60%
Source: NCCN guidelines for treatment regimens, FDA labels for SOC data, Goldman Sachs Global Investment Research for penetration estimates
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Exhibit 20: Close to 60% of global sales in TNBC expected from US Exhibit 21: 2L adoption to be the major clinical usage in TNBC
SKB264 global sales in TNBC breakdown by geographic regions TNBC sales breakdown by lines of treatment
300 37%
300
200 200
57%
100 100
33%
0 0
2026
2024
2025
2027
2028
2029
2030
2031
2032
2033
2024
2029
2025
2026
2027
2028
2030
2031
2032
2033
US EU5 China 1L TNBC 2L TNBC 3L TNBC
For the exclusive use of KECHENG.JIN@BITMAIN.COM
Source: Goldman Sachs Global Investment Research Source: Goldman Sachs Global Investment Research
n Expect SKB264 to capture 27% TNBC pts by 2033E - We expect c.10k TNBC
patients globally (5/2/2 for China/US/EU) to be treated by SKB264 by 2033E. We
assume 25% of market share in 1L-3L TNBC for SKB264 in ex-China market, while
market share is 5% higher in China. Based on that:
1fc9fa9cf8844a388c506688498547c5
to be meaningful (7 vs. 61) in defining differentiation; we await more matured data in
earlier line of TNBC.
Exhibit 22: TROP2 ADCs are targeting TNBC in both front-line and late-line treatment
Clinical development landscape of TROP2 ADC in TNBC
Company TROP-2 Study Lines PD-L1 Regimen Trial status
ADC eL 1L 2L+ + - Mono Combo Ctrl Phase Masking N1 Endpoint Start Completion
SKB264-III-03 NS Chemo Ph3 Open label 254 PFS Jun-2022 Oct-2023
Kelun Biotech SKB264 KL264-01 NS - Ph2 Open label 59 MTD/ORR Feb-2020 Nov-2024
SKB264-II-07 NS +/- PD-L1 - Ph2 Open label 95 ORR Jul-2022 Apr-2024
TROPION-Breast02 NS ICC2 Ph3 Open label 600 PFS/OS May-2022 Dec-2025
AstraZeneca
TROPION-Breast03 adj. NS +/- PD-L1 ICT3 Ph3 Open label 1,075 iDFS Nov-2022 Sep-2027
/ Daiichi Dato-Dxd
BEGONIA +PD-L1 PD-L1+chemo Ph1b/2 Open label 61 ORR Dec-2018 Aug-2024
Sankyo
TROPION-PanTumor01 NS - Ph1 Open label 44 DLT Jan-2018 Jan-2025
IMMU-132-01 NS - Ph1/2 Open label 108 ORR Dec-2012 Mar-2019
ASCENT NS TPC4 Ph3 Open label 529 PFS Nov-2017 Mar-2020
ASCENT-03 TPC5 Ph3 Open label 540 PFS Jul-2022 May-2027
Gilead Trodelvy
ASCENT-04 +PD-1 PD-1+TPC5 Ph3 Open label 440 PFS Jul-2022 Feb-2027
ASCENT-05 adj. NS +PD-1 PD-1+/-chemo Ph3 Open label 1,514 iDFS Dec-2022 Jul-2027
ELEVATE TNBC +CD47 - Ph3 Open label 144 ORR Dec-2021 Aug-2024
Note: 1. Estimated number is used when no actucal enrollment reported; 2. Investigator's choice of chemotherapy; 3. Capecitabine and/or pembrolizumab; 4. Eribulin, capecitabine,
gemcitabine, or vinorelbine; 5. Treatment of physician's choice: Paclitaxel, or nab-paclitaxel, or gemcitabine + carboplatin.
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Source: Company data for SKB264, FDA drug label (2023) for Trodelvy, SABCS 2022 for Dato-DXd
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Exhibit 24: We estimate $0.6bn sales with 10k patients in TNBC for SKB264 globally (2033E)
Estimation process for the sales of SKB264 in TNBC patients globally
Peak sales (2033E) China US EU5 Source and assumption
Population base
1413mn/332mn/325mn for China/US/EU5 in 2021 (World
Population (mn) 1,396 364 337 Bank, stats.gov.cn)
BC incidence, 1/105 45 82 89 Globocan 2020
CAGR of BC incidence 3% 1% 1% cancer.org, PMC8330522
New BC pts (k) 628 299 301
Subtype breakdown within BC
TNBC 13% 13% 13% cancer.org, BMC Cancer (2011)
Advanced stage % 42% 37% 37% SEER, medRxiv (2021)
Addressable advanced TNBC pts
(k) 34 14 14
1L treatment
Treatment rate % 90% 95% 95% established chemotherapy in 1L
benchmarks: 18% for Trodelvy in 1L TNBC in US (GSe for POS=58%
GILD); 30% for Enhertu for 1L HER2+ BC (GSe for DS); phase 1b/2
TROP2 ADC penetration 20% 25% 25% assume lower penetration in China
DOT=7.6m
1L pts on TROP2 (k) 6.1 3.3 3.3 PFS for Keytruda /
3rd-in-market product with non-inferiority 21-33% (Nature chemo in
Reviews Drug Discovery (2023)); assume lower market KEYNOTE-355
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POS=81%
SKB264 market share % 30% 25% 25% registraional trial
2L pts on SKB264 (k) 1.9 0.8 0.8
3L treatment DOT=6.6m/5.6m for
Treatment rate % 75% 80% 80% lower rate due to drop-out 2L/3L
PFS for Trodelvy
in ASCENT
TROP2 ADC penetration 55% 60% 60% assume higher penetration given fewer options in later-lines
3L pts on TROP2 (k) 3.9 3.5 3.5
1fc9fa9cf8844a388c506688498547c5
SKB264 market share % 30% 25% 25%
3L pts on SKB264 (k) 1.2 0.9 0.9
Total pts on TROP2 (k) 16.4 9.9 9.9
Total TNBC pts on SKB264 (k) 5 2 2
Monthly price (k) USD 2 30 19 benchmark with Trodelvy price
SKB264 Sales, unadjusted,
mn USD 61 494 318
TROP2 market, mn USD 203 1,975 1,270 TROP2 global market in TNBC (mn USD) = 3,449
Source: stats.gov.cn, Globocan 2020, Nature Reviews Drug Discovery (2023), BMC Cancer (2011), National Cancer Institute SEER Incidence Data, Cancer Biol Med (2021), NCCN guidelines, Goldman
Sachs Global Investment Research
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endocrine therapies are well established for 1/2L treatment. Nevertheless, the
treatment options are limited if the patients become refractory/recurrent from these
combo therapies. With the phase 3 TROPiCS-02 study, Trodelvy demonstrated improved
survival (mPFS=5.5 vs. 4.0 months, mOS=14.4 vs. 11.2 months) over chemotherapy in
3L+ HR+/HER2- BC and obtained FDA approval in Feb 2023.
Exhibit 25: CDK4/6i-based combo therapies are established in early-line treatment for HR+/HER2- BC
SOCs for different lines of treatment for HR+/HER2- BC
SOC / Efficacy Safety
Setting Subtype/Biomarker Competitor ORR (%) PFS (mos) OS (mos) SAE G3+ AE Discontinue Clinical trial
1L Endocrine therapy (ET)+CDK4/6i 32% 20.5 53.7 29% rare MONALEESA-3
Aromatase inhibitor+CDK4/6 42% 24.8 53.9 20% 76% 10% PALOMA-2
57% 30.6 90% DAWNA-2
2L BRCA1/2wt ET+CDK4/6 if not used in 1L 35% 16.4 46.7 22% 61% 9% MONARCH-2
27% 15.7 6% 88% 3% DAWNA-1
systemic chemo 3.4 25.6 PMC7501162
BRCA1/2mut PARPi (Lynparza etc.) 52% 7 19.3 37% 5% OlympiAD
3L HER2-low Enhertu 53% 10.1 23.9 28% 53% 16% DESTINY-Breast04
HER2-zero Trodelvy 21% 5.5 14.4 14% 6% TROPiCS-02
n For HER2-low patients, Enhertu was FDA approved in August 2022, and is the
preferred treatment in NCCN guidelines, as it showed significant clinical benefit over
chemotherapy (mPFS=10.1 vs. 5.4 months, mOS=23.9 vs. 17.5 months,
DESTINY-Breast04 study).
n For HER2-zero, Trodelvy is guideline recommended. There are debates on the
potential threat from Enhertu and DESTINY-Breast06 readouts could provide more
visibility, although we see TROP-2 ADC has a higher chance of maintaining its
favorable position, as Enhertu’s phase 2 DAISY trial suggested deteriorating efficacy
1fc9fa9cf8844a388c506688498547c5
with lower HER2 expression - in late-line setting, mPFS is 4.2 months for HER2-zero
vs. 6.7 months for HER2-low / 11.1 months for HER2+.
n Penetration: Given that 1) the current SOC is primarily chemotherapy for patients
progressed after ET/CDK4/6i combo, and 2) Trodelvy/Enhertu are the preferred
recommendation for 3L HER2-zero/HER2-low subsectors respectively (v4.2023
NCCN guidelines), we expect 2L adoption of SKB264 to contribute 48% of revenue
in HR+/HER2- BC by 2033E. We estimate that TROP2 ADC will only be used in
HER2-low subsector when patients are not responsive to Enhertu (0/30% for 2L/3L)
given the strong position of Enhertu, while higher penetration (50%/60% for 2L/3L)
could be seen in HER2-zero subsector.
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Exhibit 26: We estimate the penetration of TROP2 ADC in HR+/HER2- BC by comparing to SOC across the
treatment paradigm
Treatment paradigm in HR+/HER2- BC
HR+ HER2-
Subtypes SOC data TROP2 data Penetration
BC
Endocrine
1L therapy +
CDK4/6i:
9%
BRCA1/2 PARPi:
mutation 20%
ORR=52%
2L 91% 66%
BRCA1/2 HER2- Enhertu:
wildtype 0%
low ORR=53%
34% ORR=
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HER2- Enhertu
60%
low refractory
3L 34%
HER2- Trodelvy:
60%
zero ORR=21%
Source: NCCN guidelines for treatment regimens, FDA labels for SOC data, Goldman Sachs Global Investment Research for penetration estimates
n Assume 5.5 months of DOT in HR+/HER2- BC: In 2L/3L settings, median PFS of
5.5 months from Trodelvy’s ph3 TROPiCS-02 study was used as the benchmark for
DOT of SKB264.
1fc9fa9cf8844a388c506688498547c5
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Exhibit 27: Close to 60% of global sales in HR+/HER2- BC expected Exhibit 28: 2L adoption as a primary revenue driver
from US HR+/HER2- BC sales breakdown by lines of treatment
SKB264 global sales in HR+/HER2- BC breakdown by geographic regions
600
600
400
400 48%
58% 200
200
0
2030
2024
2025
2026
2027
2028
2029
2031
2032
2033
0
2033
2024
2025
2026
2027
2028
2029
2030
2031
2032
2L HR+/HER2- BC 3L HR+/HER2- BC
For the exclusive use of KECHENG.JIN@BITMAIN.COM
US EU5 China
Source: Goldman Sachs Global Investment Research Source: Goldman Sachs Global Investment Research
n Expect 30-35% of market share for SKB264: within TROP2 ADC class across
regions, considering its potential competitive advantage with higher ORR and good
safety profile illustrated in HR+/HER2- BC.
n Time to market: with an ongoing ph2 study and Kelun to commence registrational
ph3 trial in 2H23, we expect SKB264 to have data readout and to file NDA in 2025,
followed by potential China approval in 2026 and in US/EU as early as 2027.
Exhibit 29: The focus of TROP2 ADC is largely settled in 2L+ HR+/HER2- BC
Clinical development landscape of TROP2 ADC in HR+/HER2- or HR+/HER2-low BC
1fc9fa9cf8844a388c506688498547c5
Company ADC Study Lines Regimen Trial status
Phase Masking
1L 2L+ Mono Combo Ctrl N1 Endpoint Start Completion
Kelun Biotech SKB264 KL264-01 Ph2 - Open label 59 MTD/ORR Feb-2020 Nov-2024
TROPION-Breast01 ICC2 Ph3 Open label 733 PFS/OS Oct-2021 Aug-2025
AstraZeneca Dato-Dxd
TROPION-PanTumor01 - Ph1 Open label 41 DLT/safety Jan-2018 Jan-2025
/ Daiichi
DESTINY-Breast04 TPC3 Ph3 Open label 494 PFS Dec-2018 Jan-2022
Sankyo Enhertu
DESTINY-Breast06 TPC4 Ph3 Open label 850 PFS Jul-2020 Jul-2023
IMMU-132-01 - Ph1/2 Open label 54 ORR Dec-2012 Mar-2019
Gilead Trodelvy TROPiCS-02 TPC5 Ph3 Open label 543 PFS/OS May-2019 Oct-2024
ASCENT-07 TPC4 Ph3 Open label 654 PFS May-2023 Sep-2025
Note: DESTINY-Breast04 and DESTINY-Breast06 enrolled patients with HER2-low BC; 1. Estimated number is used when no actucal enrollment reported; 2.
Investigator's choice of chemotherapy: eribulin, vinorelbine, capecitabine, and gemcitabine; 3. Treatment of physician's choice: capecitabine, eribulin,
gemcitabine, paclitaxel, and nab-paclitaxel; 4. Treatment of physician's choice: capecitabine, paclitaxel, nab-paclitaxel; 5. Treatment of physician's choice:
eribulin, capecitabine, gemcitabine and vinorelbine.
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the ORR data of SKB264 could put it in a more competitive position in IHC1+
subgroup despite the presence of Enhertu, particularly if the efficacy can be
maintained in larger clinical trials.
1fc9fa9cf8844a388c506688498547c5
Discontinuation None 6% vs 4% 12% 16.2% vs 8.1%
Note: 1. Data from patients across all indications (n=211) in the Ph1b/2 dose expansion cohort; 2. Safety results are based on all cohort data (n=543).
Source: Company data for SKB264, ESMO 2022 for Trodelvy, AACR 2023 for Dato-DXd, New England Journal of Medicine (2022) for Enhertu
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Exhibit 31: We estimate $1.3bn sales with 24k HR+/HER2- BC patients for SKB264 globally (2033E)
Estimation process for the sales of SKB264 in HR+/HER2- patients
Peak sales (2033E) China US EU5 Source and assumption
Population base
1413mn/332mn/325mn for China/US/EU5 in 2021
Population (mn) 1,396 364 337 (World Bank, stats.gov.cn)
BC incidence, 1/105 45 82 89 Globocan 2020
CAGR of BC incidence cancer.org, PMC8330522
New BC pts (k) 628 299 301
Subtype breakdown within BC
Luminal A (HR+/HER2-) 49% 68% 68% cancer.org, BMC Cancer (2011)
Advanced stage % 28% 37% 37% SEER, PMC7898196
Addressable advanced Luminal
A BC pts (k) 84 75 75
1L treatment
Treatment rate % 90% 95% 95% established chemo or endocrine therapy in 1L
2L treatment
Treatment rate % 80% 85% 85% lower rate due to drop-out
2L Luminal A BC pts (k) 61 60 61
1fc9fa9cf8844a388c506688498547c5
HER2-low pts on SKB264 (k) 2 3 3
HER2-zero 10 6 6
TROP2 ADC penetration 55% 60% 60% TROP2 recommended for HER2-zero pts
HER2-zero pts on TROP2 (k) 6 4 4
SKB264 market share % 35% 30% 30%
HER2-zero pts on SKB264 (k) 2 1 1
3L pts on TROP2 (k) 12 13 13
3L pts on SKB264 (k) 4.2 4.0 4.0
Monthly price (k USD) 2 30 19 benchmark with Trodelvy price
SKB264 Sales, unadjusted
(mn USD) 104 1,279 822
TROP2 market, mn USD 319 4,670 3,003 TROP2 global market (mn USD) = 7,991
Source: stats.gov.cn, Globocan 2020, Cancer Biology & Medicine (2021), BMC Cancer (2011), National Cancer Institute SEER Incidence Data, Nature Reviews Drug Discovery (2013), Breast Cancer
Research (2022), Goldman Sachs Global Investment Research
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TROP2 ADCs showed early encouraging data in late line NSCLC patients that
failed SOCs – In 1L NSCLC, Dato-Dxd / pembro combo showed a comparable PFS of
8.3 months vs. other PD-1/PD-L1 combos at c. 8 months; while in later line, SKB264,
based on the first set of data to be presented at ASCO 2023, showed encouraging
response in both EGFRwt patients and EGFRmut (TKI failed) patients.
Exhibit 33: SKB264 showed encouraging efficacy in 2L+ EGFR TKI-failed NSCLC
ORR and PFS of monotherapies in pretreated NSCLC
1fc9fa9cf8844a388c506688498547c5
50% 7.2 8.2
8
40% 6.4
44% 6
30% 35% 40%
4
20%
10% 2
0% 0
SKB264 Dato-DXd HER3-DXd Tyvyt Atezo PD-1/VEGF EGFR/HER3
(ph1/2, n=20) (ph1, n=34) (ph1, n=102) +chemo +chemo BsAb (AK112) ADC
+beva +beva +chemo (BL-B01D1)
(ph3, n=158) (ph2, n=149) (ph2, n=19) (ph1, n=34)
Source: ASCO 2023 for KL264-01, Journal of Thoracic Oncology (2021) for TROPION-PanTumor01, ASCO 2023 for HER3-DXd, Journal of Clinical Oncology
(2017) for IMMU-132-01, European Journal of Cancer for GFPC 06-2018, Journal of Thoracic Oncology 14.5 (2019) for CheckMate078, ASCO2022 for
AK112-201, ASCO 2023 for BL-B01D1-101
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Exhibit 34: TROP2 ADC showed early comparable efficacy data in Exhibit 35: … while we await more data vs. VEGF/chemo combos in
combo with PD-1 +/- chemo in 1L EGFRwt NSCLC, … 2L+ EGFRwt NSCLC
ORR and PFS of various treatment regimens in combo with PD-1 in 1L ORR and PFS of TROP2 ADC vs. PD-1 monotherapy in 2L+ EGFRwt
NSCLC NSCLC
ORR PFS
40% 8
mos ORR PFS mos
80% 15
35% 6.9 7
70%
30% 6
60% 64% 64% 5.3
5.4
10 25% 28% 5.2 5
57%
50% 8.8 26%
50% 8.3 23% 4.0
7.8 48% 20% 4
40% 6.8
8.3 19%
15% 17% 3
30%
5
38%
10% 2
20%
10%
5% 1
0% 0 0% 0
Dato-DXd Dato-DXd Pembro Atezo Nivo PD-1/VEGF SKB264 Dato-DXd Trodelvy HER3-DXd Pembro
+pembro +pembro + +chemo +VEGF +CTLA-4 BsAb (AK112) (ph1/2, n=19) (ph1, n=50) (ph1/2, n=54) (ph1, n=30) (ph2/3,
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Dato-Dxd updated TROPION-Lung02 data (on Jun 5 2023, with longer follow-up) showed On July 3, 2023, AZ/DS announced topline data of TROPION-Lung01 ph3 trial in 2L+ NSCLC
deteriorating efficacy in both 1L/2L+ EGFRwt NSCLC v.s. previous results reported on ASCO 2023 (Dato-DXd vs. docetaxel) with presence of ILD-related death.
(e.g., in doublet cohort, PFS decreased from 10.5m to 8.3m, ORR decreased from 60% to 50%)
Source: ASCO 2023 for KL264-01, WCLC 2021 for TROPION- PanTumor01, Journal of Clinical
Source: Company data for TROPION-Lung02, New England Journal of Medicine (2018) for Oncology (2017) for IMMU-132-01, ASCO 2023 for U31402-A-U102, Lancet (2016) for
KEYNOTE-189, New England Journal of Medicine (2018) for Impower150, Lancet Oncology (2021) KEYNOTE-010, company data for TROPION-Lung01
for CheckMate 9LA, ASCO 2023 data for AK112-201
1fc9fa9cf8844a388c506688498547c5
Exhibit 36: 52% of global sales in NSCLC expected from US Exhibit 37: EGFRwt and EGFR-TKI failed patients to be the major
SKB264 global sales in NSCLC breakdown by geographic regions contributors in NSCLC
NSCLC sales breakdown by lines of treatment
800 800
600 600
400 400
52% 27%
200 200
0 0 4%
2026
2027
2028
2029
2030
2031
2032
2033
2030
2026
2027
2028
2029
2031
2032
2033
Source: Goldman Sachs Global Investment Research Source: Goldman Sachs Global Investment Research
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We factor in four potential patient segments (1L and 2L for NSCLC without AGA; and 1L
EGFRmut NSCLC and patients who failed EGFR TKI) for SKB264, while assigning
different PoS (higher for two 2L setting given the ASCO data, lower for 1L EGFRwt for
potential TROP-2 / PD-1 combo, and lowest for EGFRmut 1L for potential TROP-2 /
Tagrisso combo). Again, we are fully aware of the caveats of cross-trial comparison,
given the patient baseline could vary meaningfully in those early-stage studies;
nevertheless, we believe those shoulder-to-shoulder comparisons could set the
framework for us to evaluate the potential relative performance of each TROP-2 ADC
asset, subject to easy modification with more clinical readouts.
Exhibit 38: Dato-DXd leads the clinical development of TROP2 ADC in lung cancer
Clinical development landscape of ADC drugs in NSCLC
Company ADC Study Lines AGA PD-L1 Regimen Trial status
1L 2L+ + - + - Mono Combo Ctrl Phase Masking N* Endpoint Start Completion
SKB264-II-08 NS - Ph2 Open label 237 ORR Nov-2022 Oct-2024
Kelun
SKB264 KL264-01 NS - Ph2 Open label - MTD/ORR Feb-2020 Nov-2024
Biotech
SKB264-II-05 +PD-L1 / (Pt) - Ph2 Open label 110 ORR Apr-2022 Aug-2023
TROPION-PanTumor01 NS - Ph1 Open label 180 DLT Jan-2018 Jan-2025
TROPION-LUNG01 NS DTX Ph3 Open label 590 PFS/OS Dec-2020 Sep-2023
TROPION-LUNG02 NS +PD-1 / (Pt^) - Ph1b - 140 Tox Sep-2020 Dec-2023
TROPION-LUNG04 NS +ICI/ (Pt) - Ph1b - 232 Tox Feb-2021 Feb-2025
Dato-Dxd
AstraZeneca TROPION-LUNG05 NS Ph2 - 137 ORR Mar-2021 Sep-2023
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/ Daiichi TROPION-LUNG07 TPS<50% +PD-1 / (Pt) PD-1+Pt Ph3 Open label 975 PFS/OS Jan-2023 Aug-2027
Sankyo TROPION-LUNG08 TPS≥50% +PD-1 PD-1 Ph3 Open label 740 PFS/OS Mar-2022 Jun-2026
AVANZAR NS +PD-L1 / (Pt) PD-1+Pt Ph3 Open label 1,000 PFS/OS Dec-2022 May-2027
U31402-A-U103 NS +Osimertinib Ph1 Open label 280 DLT/ORR Jun-2021 Jun-2025
HER3-DXd HERTHENA-Lung01 3L+ NS Ph2 Open label 420 ORR Feb-2021 Nov-2023
HERTHENA-Lung02 NS PBC# Ph3 Open label 560 PFS May-2022 Aug-2024
IMMU-132-01 NS - Ph1/2 Open label 108 ORR Dec-2012 Mar-2019
EVOKE-01 NS DTX Ph3 Open label 580 OS Nov-2021 May-2024
Gilead Trodelvy
EVOKE-02 NS +PD-1 / (Pt) - Ph2 Open label 224 ORR/DLT Mar-2022 May-2023
EVOKE-03 TPS≥50% +PD-1 PD-1 Ph3 Open label 614 PFS/OS Feb-2023 Jan-2027
BL-B01D1-101 NS Ph1 Open label 96 Tox Nov-2021 Dec-2023
BL-B01D1
Baili Pharma BL-B01D1-203 NS +Osimertinib Ph2 Open label 42 ORR Jul-2023 Jul-2025
(EGFR/HER3)
BL-B01D1-SI-B003-201-01 NS +PD-1/CTLA-4 BsAb Ph2 Open label 90 ORR Aug-2023 Aug-2025
*: Estimated number is used when no actucal enrollment reported; ^: Platinum based drugs; #: Platinum-based chemotherapy
Exhibit 39: We estimate the penetration of TROP2 ADC in NSCLC by comparing to SOC across the treatment
paradigm
Treatment paradigm of NSCLC
1fc9fa9cf8844a388c506688498547c5
24%
EGFR Tagrisso: ORR=80%,
10%
mutation PFS=19m, OS=39m
1L
76%
EGFR Keytruda + chemo:
Dato-DXd + 30%
wildtype ORR=32%-49%, PFS=6-
PD-1:
10m, OS=17-30m;
ORR=50%,
PD-1+ VEGF + chemo:
PFS=8m
ORR=64%, PFS=8m
24%
EGFR PD-1+chemo: ORR=31%,
SKB264: 40%
mutation PFS=6m; PD-1+ VEGF+
ORR=60%,
chemo: ORR=44-68%,
2L PFS=11m
PFS=7-8m, OS=17-21m
76%
EGFR Cyramza + chemo: SKB264:
30%
wildtype ORR=29%, PFS=4m, ORR=26%,
OS=12m PFS=5m
Source: NCCN guidelines for treatment regimens, FDA labels for SOC data, Goldman Sachs Global Investment Research for penetration estimates
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duplets deteriorated with lower follow-up and expanded sample size - ORR
down from 60%/22.2% to 50%/20% in 1L and 2L/2L+, respectively, and
blended mPFS down from 10.5 to 8.3 months, which make it less
differentiated vs. available treatment options; 2) for TROPION-Lung01 ph3
study in late-line NSCLC, though Daiichi/AZ reported positive topline with PFS
meeting the endpoint, OS has not showed statistical significance yet (still
relatively short follow-up), and fatal AEs observed, which lower the chance for
frontline. Given the lack of visibility on EGFRwt NSCLC indications, we assign
30% penetration in 1L and 2L/2L+ EGFRwt NSCLC and PoS at 32% for
late-line / 22% for frontline.
1fc9fa9cf8844a388c506688498547c5
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IND approval in
EGFR-wt/mut (1L), EGFR- Phase 2 basket study (initiate in 1H23)
Jan 2023
mut (TKI failure) NSCLC
1fc9fa9cf8844a388c506688498547c5
1/2L a/m NSCLC Phase 1 (data readout in 2024 or after)
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initiated phase 2 trials for both first-line and late-line settings, and most
recently initiated its first phase 3 China trial in EGFR-TKI failed patients (based
on clinicaltrials.gov). Given the progress, we see SKB264 as the potential 2nd
or 3rd to market TROP-2 ADC in different NSCLC indications.
o EGFR TKI failed NSCLC – potentially a better option: SKB264 data appears
stronger in EGFRmut patients that failed prior EGFR TKI treatment, with ORR
of 60%, notably higher vs. 35% for Dato-Dxd, and DCR is 100%; more
encouragingly, mPFS is 11.1 months with 9-month OS at 66.7%, which looks
more favorable vs. Dato-Dxd’s DoR of 9.5 months. We see chance for SKB264
to be a better option for this group of patients among TROP-2 ADCs, and thus
assign a market share of 30%.
o 2L+ EGFRwt NSCLC – comparable efficacy so far to Dato: Based on
SKB264’s ASCO2023 data, SKB264 showed ORR of 26% vs. 28% for
Dato-Dxd (6mg/kg, the dose chosen for phase 3) and 17% for Trodelvy.
Reminder that in Dato-Dxd’s PanTumor01 study, the lung cohort included 16%
EGFRmut patients (better ORR vs. EGFGwt), the effective ORR for EGFRwt in
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2L is likely lower than 28%. PFS/OS data was more mixed: SKB264 showed
mPFS of 5.3 months, similar to Trodelvy’s 5.2 months, while 9-month OS of
80.4% looks more favorable vs. Trodelvy’s mOS at 9.5 months. Given the
mixed message from those early data, we assume SKB264 to show
comparable clinical benefits in this setting vs. Dato-Dxd, while potentially
more competitive vs. Trodelvy, and hence we assign a market share of 35%.
o 1L EGFRwt/mut NSCLC – lower visibility so far: While frontline poses more
significant opportunities, the SoC set a higher bar to beat. SKB264 has not
presented any data in this setting, though a phase II for PD-1/SKB264 combo
is ongoing, and we could potentially see data in 2024. We believe TROP-2
ADC / PD-1 combo works in this setting, per Dato-Dxd’s TROPION-Lung02
study, and assign a similar market share of 35% for SKB264 to 2L EGFRwt
1fc9fa9cf8844a388c506688498547c5
setting.
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Exhibit 41: SKB264 showed comparable efficacy in 2L+ NSCLC without EGFR mutations...
Clinical data comparison of ADC drugs in EGFRwt NSCLC
Molecule SKB264 Trodelvy Dato-DXd HER3-DXd BL-B01D1
Developer Kelun Biotech Gilead Daiichi Sankyo/AstraZeneca Baili Pharma
Study KL264-01 IMMU-132-01 TROPION-PanTumor011 TROPION-Lung01 TROPION-Lung022 U31402-A-U102 BL-B01D1-101
Data cutoff date 9-Feb-2023 16-Oct-2016 6-Apr-2021 3-Jul-2023 7-Apr-2023 26-Mar-2021 31-Dec-2022
Follow-up period, 11.5 months 6.0 months 13.4 months Ongoing 14.8 (doublet) / 9.5 months /
median / 12.9 (triplet)
NCT no. NCT04152499 NCT01631552 NCT03401385 NCT04656652 NCT04526691 (phase 1b) NCT03260491 NCT05194982
(phase 1b/2) (phase 1/2) (phase 1) (phase 3) (phase 1) (phase 1)
Combo Mono Mono Mono Mono + pembrolizumab (doublet) +/- Mono Mono
platinum chemotherapy (triplet)
Treatment line 2L+ 2L+ 2L+ 2L+ 2L+ 1L 2L+ 2L+
Baseline N 19 54 50 (4mg/kg) / ~590 27 (doublet) / 34 (doublet) / 30 (w/o AGA) 42
50 (6mg/kg) / 19 (triplet) 53 (triplet)
80 (8mg/kg)
Prior median 2 (incl. anti- ≥1: 91% (49/54) median 3 (1-9) w/o AGA: PLT+ 2L+ None median 3 (0-8) median 2 (1-8)4
treatment PD-1/L1) PD-1
w/ AGA: PLT+TKI
Median age 59 64 61 / 63 / 64 62
(yrs)
ECOG 88% ECOG PS 1 91% ECOG PS 1
Efficacy ORR 26% (5/19) 17% (9/54) 24% / 28% / 24% 22% (doublet) / 50% (doublet) / 23% 41%
26% (triplet) 57% (triplet)
DCR 89% (17/19) 74% (doublet) / 91% (doublet, 95%
For the exclusive use of KECHENG.JIN@BITMAIN.COM
Source: ASCO 2023 for SKB264, Journal of Clinical Oncology (2017) for Trodelvy, ESMO 2021/ WCLC 2021/ ASCO 2023 for Dato-DXd, ASCO 2022 for HER3-DXd, ASCO 2023 for BL-B01D1
1fc9fa9cf8844a388c506688498547c5
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Exhibit 42: ...and demonstrated competitive efficacy in late-line NSCLC with EGFR mutations
Clinical data comparison of ADC drugs in EGFRmut NSCLC
Molecule SKB264 Dato-DXd HER3-DXd BL-B01D1
Developer Kelun Biotech Daiichi Sankyo/AstraZeneca Baili Pharma
Study KL264-01 TROPION-PanTumor011 U3-1402 BL-B01D1-1012
Data cutoff date 9-Feb-2023 6-Apr-2021 16-Mar-2023 31-Dec-2022
Follow-up period, median 11.5 months 13.4 months 23 months /
Discontinue 0%
Note: 1. Data reported on 2021 ESMO, 2. Data reported on 2023 ASCO, 3. All had prior EGFR TKI, 88% (30/34) had prior 3rdgen EGFR TKI and 68% (23/34) had prior
platinum-based chemotherapy (PBC).
Source: ASCO 2023 for SKB264, ESMO 2021 for Dato-DXd, Company data for HER3-DXd, ASCO 2023 for BL-B01D1
1fc9fa9cf8844a388c506688498547c5
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Exhibit 43: We estimate $1.6bn of sales with 95k NSCLC patients to be treated by SKB264 (2033E) globally
Estimation process for the sales of SKB264 in NSCLC
Peak sales (2033E) China US EU5 Source and assumption
Population base
1413mn/332mn/325mn for China/US/EU5 in 2021 (World
Population (mn) 1,396 364 337 Bank, stats.gov.cn)
LC incidence, 1/105 85 69 73 Globocan 2020
CAGR of LC incidence 3% 0% 0% PMC7797233
NSCLC % 85% 85% 85% PMC3256477
New NSCLC pts (k) 1,006 214 209
Stage 3b/4 % 61% 56% 56% Journal of thoracic oncology (2010)
New advanced NSCLC pts (k) 615 119 116
1L treatment
Treatment rate % 90% 92% 92% established chemo/PD-1 as 1L
Pts on 1L treatment (k) 554 110 107
EGFR mutation rate % 38% 24% 14% PMC5346692
EGFRwt/AGA(-) rate % 50% 59% 66% PMC7043073
1L EGFRwt/AGA(-) NSCLC
POS=22%
1L EGFRwt/AGA(-) NSCLC pts (k) 279 65 70 phase 1b/2
assume lower than in TNBC given more treatment
TROP2 ADC penetration % 25% 30% 30% options in front-line NSCLC DOT=9m
EGFRwt NSCLC pts on TROP2 (k) 70 19 21 PFS for Keytruda /
3rd-in-market product with non-inferiority 19-31% (Nature chemo in
KEYNOTE-189
SKB264 market share % 40% 35% 35% Reviews Drug Discovery (2023))
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1fc9fa9cf8844a388c506688498547c5
TROP2 ADC penetration % 35% 40% 40%
EGFR-TKI failed pts on TROP2 (k) 49 8 4
SKB264 market share % 35% 30% 30% assume higher share given competitive ORR data
EGFR-TKI failed pts on SKB264 (k) 17 2 1
Total NSCLC pts on SKB264 (k) 68 14 13
Monthly price (k USD) 2 30 19 benchmark with Trodelvy price
SKB264 sales, unadjusted
1,069 3,348 2,025
(mn USD)
SKB264 sales, risk-adjusted,
273 858 506 SKB264 global risk-adjusted sales (mn USD) = 1,637
(mn USD)
Source: stats.gov.cn, Globocan 2020, Chinese Journal of Cancer Research (2020), Journal of Thoracic Disease (2010), Oncotarget (2016), Journal of Thoracic Oncology (2010), Nature Reviews Drug
Discovery (2013), Goldman Sachs Global Investment Research
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Source: Company data for SKB264, FDA label for Trodelvy, ASCO 2023 for Dato-DXd
1fc9fa9cf8844a388c506688498547c5
as an adverse drug reaction characterized by lung inflammation and could be
life-threatening. ILD was brought into attention in Enhertu’s studies and has been
observed with multiple ADCs with TOPO1 inhibitors (e.g., Dato-DXd and HER3-DXd).
Per Enhertu FDA label, strict management of ILD is applied with 1) corticosteroid
treatment as soon as ILD is suspected, 2) dose interruption with grade 1 ILD, and 3)
permanent discontinuation with G2+ ILD. This AE was not observed in 188 patients
treated with SKB264 across solid tumors (vs. 17%/0.4% in Dato-DXd/Trodelvy).
n Mixed blood safety – For the blood-related AEs, we note that SKB264
demonstrated mixed safety profile: 1) better control in neutropenia on which FDA
issued a black box warning for Trodelvy (26% vs. 52% on G3+ events for SKB264
and Trodelvy) requiring dosage withhold for neutropenic fever, and 2) higher
occurrences in anemia (23% of G3+ AE for SKB264, vs. 9%/2% for
Trodelvy/Dato-DXd), lymphopenia and thrombocytopenia which would require
corresponding clinical management.
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Exhibit 45: SKB264 basket trial plan to drive long-term growth across various solid tumors
Comparison between global TROP2 ADC basket trials
Company TROP-2 Basket Study Indications Regimen
ADC OC CC GC UC SCLC HNSCC EC BLC CRC CRPC GBM HCC PC RCC Mono Combo
Kelun Biotech SKB264 KL264-01
SKB264-II-05 +PD-1
+PD-1
AstraZeneca
Dato-Dxd TROPION-PanTumor03 +/- PARP
/ Daiichi Sankyo
+/- chemo
Gilead Trodelvy IMMU-132-01
OC: ovarian cancer, CC: cervical cancer, GC: gastric cancer, UC: urothelial cancer, SCLC: small cell lung cancer, HNSCC: head and neck squamous cell carcinoma,
EC: endometrial carcinoma, BLC: bladder cancer, CRC: colorectal cancer, CRPC: castration-resistant prostate cancer, GBM: glioblastoma multiforme, HCC:
hepatocellular carcinoma, PC: pancreatic cancer, RCC: rental cell cancer.
For the exclusive use of KECHENG.JIN@BITMAIN.COM
Exhibit 46: CLDN18.2 as a pan-cancer target is highly expressed in Exhibit 47: Lacking effective therapies for patients progressing
gastric cancer and pancreatic cancer from prior lines
Global incidence of major cancers and percentage of CLDN18.2 Current SOC in cancers with CLDN18.2 expressions
overexpression
1fc9fa9cf8844a388c506688498547c5
555 Unit: K
vs. HER2+
~16%
370
252
42%
30% 60%
GC EC PC
CLDN18.2 medium to high expression
* GC - gastric cancer; EC - esophageal cancer;
PC - pancreatic cancer
Source: Frost & Sullivan , Globocan 2020, Journal of Hematology & Oncology (2019) Source: Lancet (2021), The lancet oncology (2014, 2018) for GC; New England Journal of
Medicine (2011), New England Journal of Medicine (2013) for PC; New England Journal of
Medicine (2022), Journal of Clinical Oncology (2022) for EC
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Exhibit 48: We forecast global sales of SKB315 to reach $558mn by Exhibit 49: …and China to account for 58% of patients and 15% of
2033E in GC and PC… global sales by 2033E
Estimated combined sales of SKB315 globally during 2027E-2033E Sales breakdown by geographic regions during 2027E-2033E
(risk-adjusted)
0 0% 0
2027 2028 2029 2030 2031 2032 2033 2027 2028 2029 2030 2031 2032 2033
GC PC yoy US EU5 China
For the exclusive use of KECHENG.JIN@BITMAIN.COM
Source: Goldman Sachs Global Investment Research Source: Goldman Sachs Global Investment Research
1fc9fa9cf8844a388c506688498547c5
as revenues by 2033E (primarily China sales and royalties from ex-China sales),
which feeds into our DCF valuation framework.
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Exhibit 50: We expect SKB315 to have $558mn risk-adjusted global sales by 2033E
Key estimates and assumptions for SKB315
1fc9fa9cf8844a388c506688498547c5
Source: Goldman Sachs Global Investment Research
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Exhibit 51: CLDN18.2 received tremendous R&D interest in a variety of drug modalities
CLDN18.2 competitive landscape (as of August 2023)
Stage mAb ADC BsAb CART
NDA IMAB362 / Zolbetuximab
Ph3 TST001
Ph2 CT041; CT048
Ph1/2 ASKB589 LM-302 PM1032
ZL-1211 SHR-A1904
BNT141 RC118; YH005
LM-102 SOT102
Ph1 AB011 BA1301 ASP2138 IBI345
MIL93 IBI343 Q-1802 LB1908
M108 JS107 BC007 LY011
BA1105 CMG901 IBI389 IM92
KD-496; KD-182;
BC008 SYSA1801 TJ-CD4B
KD-275; KD-U182
NBL-015 SKB315 QLS31905 CTB001
DR30303 ATG-022 PT886
IBI360
JS012
QL1779
For the exclusive use of KECHENG.JIN@BITMAIN.COM
Source: Pharmcube
n Promising early data for CLDN18.2 ADC vs other modalities – Among the
CLDN18.2-targeting modalities, different indication strategies are being adopted:
o Antibodies target the first-line treatment with zolbetuximab demonstrated
improved survival data (OS=14.4 months with HR=0.77) though had minimal
improvement on ORR (54% vs. 49%) and worse GI safety profile;
1fc9fa9cf8844a388c506688498547c5
o CLDN18.2-ADCs are targeting 2L+ patients with encouraging preliminary
efficacy shown by CMG901 with an ORR of 75% among 8 patients (vs.
54%/73% of zolbetuximab/TST001 in 1L GC) as well as good control of safety
events (3 out of 27 with grade 3+ AE);
o BsAbs and CAR-T products started clinical trials with later-line
treatment, e.g., CT041 targeted patients with 2+ prior treatments, and
Q-1802 (PD-L1/CLDN18.2 BsAb) targeted 4L+ patients.
n Current SOCs for GC/PC are mainly chemoimmunotherapies, which deliver only
modest efficacy (e.g., ORR less than 50% in 1L GC of chemotherapy as in GLOW
study), with limited options for later-line treatment. Though we are still waiting for
more clinical data of CLDN18.2-targeting therapies across ADC/BsAbs/CAR-T, we
see the current results from the ADC class encouraging with potential to improve
efficacy without much deteriorated safety profile compared to antibodies, which
could provide potential upside with higher penetration in front-line adoption.
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Baseline N 254 vs 253 283 vs 282 51 64 (15 / 49 at dose 24 (13 in 20mg/kg, 11 in 21(Part B: ASKB589 + 13 33 9 (dose expansion) 14
escalation / expansion) 30mg/kg) chemo)
Prior treatment Part B: pts had no prior median 2 (1-5) SULRUOLQHV PRVWUHFHLYHGSULRU 85.7% had received 2
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Efficacy ORR 53.8% vs 48.8% similar between treatment 73.3% (11/15) 67.5% (27/40), confirmed 52.2% (12/23) 75% (9/12) 75.0% (6/8) 47.1% (8/17) for GC, 0 22.2% (2/9) 57.1% (8/14)
arms 52.5% (21/40) for PC
DCR 100% (15/15) 100% (12/12) 100% (8/8) 64.7% (11/17) for GC, 66.6% (6/9) 78.6% (11/14)
25% (1/4) for PC
PFS, m 8.21 vs 6.80 (HR=0.69) 10.61 vs 8.67 not reached 5.6
(HR=0.75)
OS, m 14.39 vs 12.16 18.23 vs 15.54 (HR=0.75) not reached 10.8
(HR=0.77)
AE G3+ AE 72.8% vs 69.9% 62.5% (15/24) 38% (8/21) 11.1% (3/27) 24% 24.1% (7/29)1 100%
SAE 47.2% vs 49.8% 44.8% vs 43.5% 37.5% (9/24) 14.3% (2/14)
TR death 2.4% vs 2.8% 0 0 0
AE of concern All grades: nausea All grades: nausea Mostly grade 1-2, All grades: nausea (65%, G3+: Nausea (12.5%), All grades: All grades: nausea All grades: mainly GI AEs G3+: Lymphopenia
(68.5% vs 50.2%), (82.4% vs 60.8% in including nausea, 2% for G3), vomiting (46%, Hypoalbuminemia Part B: nausea (76%), (42.4%), vomiting (89.7%, 26/29), including (100%), Leukopenia
vomiting (66.1% vs zolbetuximab vs placebo hypoalbuminemia, 2% for G3), (8.3%), Anemia (8.3%), vomiting (66%), (36.4%), dry eye nausea 18/29 (62.1%), (78.6%), Neutropenia
30.9%), and decreased arms), vomiting (67.4% vs anemia, vomiting, hypoalbuminemia (65%, 2% and vomiting (4.2%) hypoalbuminemia syndrome (21.2%) and vomiting 18/29 (62.1%), (50%), Anemia (14.3%),
appetite (41.3% vs 35.6%), and decreased platelet count decreased for G3) (52%), granulocytopenia anemia (21.2%); abdominal pain 8/29 (27.6%), Lipase elevation (14.3%)
33.7%) appetite (47.0% vs 33.5%) (38%) and 2 DLTs at 3mg/kg dose gastroesophageal reflux
hypoleukemia (33%) disease 7/29 (24.1%)
Source: 2023 ASCO Plenary Series for zolbetuximab, 2023 ASCO for Osemitamab/SYSA1801, 2023 ASCO GI for AB011/ASKB589/CMG901/Q-1802, 2022 ASCO for CT041
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n Strong global leverage as competitive edge – In June 2022, SKB315 was out
licensed with a plan for MSD to exclusively develop and commercialize SKB315
1fc9fa9cf8844a388c506688498547c5
globally. In addition to a US$35mn upfront payment and aggregate milestone fees
over US$900mn (416mn in R&D and 485mn in future sales), Kelun biotech will
receive tiered royalties ranging from mid-single to low-double digit precent of the net
sales. We note that, although the competition of CLDN18.2 ADC in China is
growing, there are only very few assets that have secured global partners, among
which MSD is the most notable partner with deep expertise in R&D and extensive
global networks. With the support of MSD, we expect SKB315 will have competitive
advantages in overseas markets compared to other domestic players.
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Exhibit 54: SKB315 is among the very few CLDN18.2 ADCs that have global partners
Global partners of CLDN18.2 ADC and deal details
Molecules Company Stage Global Partner Deal Details Out-licensed Rights
Turning Point Upfront $25mn; Milestone $195mn; exclude China &
LM-302 LaNova Ph1/2
(BMS) Mid-single digit to mid-teens royalties South Korea
SHR-A1904 Hengrui Ph1/2
RC118 RemeGen Ph1/2
SOT102 Sotio Ph1/2
Upfront $63mn; Milestone $1.1bn;
CMG901 Keymed/Lepu Ph1 AstraZeneca Global
Up to low double-digit royalties
Upfront $27mn; Milestone $1.2bn;
SYSA1801 CSPC Ph1 Elevation Oncology ex-Greater China
Up to double-digit percent royalties
Source: Pharmcube
For the exclusive use of KECHENG.JIN@BITMAIN.COM
1fc9fa9cf8844a388c506688498547c5
Setting
Biomarker Competitor ORR (%) PFS (mos) OS (mos) SAE G3+ AE Discontinuation Clinical trial
1L HER2+ Herceptin+chemo 47% 6.7 13.8 32% 68% ToGA
HER2- Opdivo+chemo 60% 7.7 13.8 22% 60% 36% CheckMate-649
CLDN18.2+ zolbetuximab+chemo 54% 8.2 14.4 47% 73% GLOW
2L HER2+ Enhertu 51% 5.6 12.5 15% DESTINY-Gastric01
Any Cyramza+docetaxel 28% 4.4 9.6 47% 81% 12% RAINBOW
3L+ Trifluridine/Tipiracil 2 5.7 43% 80% TAGS
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Exhibit 56: CLDN18.2-ADC currently targeting usage in 2L+ GC with potential front-line adoption
Clinical development landscape of CLDN18.2 ADC in GC
Company CLDN18.2 Study Lines Regimen Trial status
ADC 1L 2L+ Mono Combo Phase Masking N1 Endpoint Start Completion
GC/GEJ
Turning Point Therapeutics CA128-1033 Ph1/2 Open label 42 DLT Feb-2022 Aug-2024
LM-302
LaNova LM302-01-201 +PD-12 Ph1/2 Open label 50 DLT/RP2D/OBD/MTD May-2022 Oct-2023
Sotio SOT102 CLAUDIO-01 +chemo Ph1/2 Open label 269 MTD/RP2D/ORR Mar-2022 Dec-2023
Keymed/Lepu Biopharma CMG901 KYM901 Ph1 Open label 162 DLT/ORR/RP2D Dec-2020 May-2024
Kelun Biotech SKB315 SKB315-I-01 Ph1 Open label 206 DLT/ORR Mar-2022 May-2024
Junshi JS107 JS107-001-I +PD-12 Ph1 Open label 118 MTD/RP2D/ORR Jul-2022 Jul-2024
CSPC SYSA1801 SYSA1801-CSP-001 Ph1 Open label 272 DLT/RP2D Sep-2021 Dec-2023
TORL Biotherapeutics TORL-2-307 TORL2307ADC-001 Ph1 Open label 70 MTD/RP2D Feb-2022 Jan-2025
Note: GC/GEJ: Gastric cancer/gastroesophageal junction adenocarcinoma; 1. Estimated number is used when no actucal enrollment reported; 2. Toripalimab.
framework.
n More than 77% of GC pts come from China - We expect c. 28k pts with GC
globally (22k/2k/4k in China/US/EU) to be captured by SKB315 by 2033E. We
estimate SKB315 to capture 25% of market share in China amid growing
competition in the domestic market (vs. 45% in US and EU).
1fc9fa9cf8844a388c506688498547c5
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Exhibit 57: We estimate around $300mn of sales with 28k GC patients treated by SKB315 (2033E) globally
Estimation process for the sales of SKB315 in GC
Peak sales (2033E) China US EU5 Source and assumption
Population base
1413mn/332mn/325mn for China/US/EU5 in 2021 (World
Population (mn) 1,396 367 337
Bank, stats.gov.cn)
5
GC incidence, 1/10 31 7 13 Globocan 2020
CAGR of GC incidence -1% -1% -1% PMC8124120, SEER
New GC pts (k) 432 24 44
Subtype breakdown
Advanced stage % 65% 36% 39% China Oncology (2016), cancer.net
Newly diagnosed advanced GC pts (k) 281 9 17
accumulated advanced pts (k) 181 10 18
Total advanced pts (k) 461 19 36
HER2 % 16% 24% 24% Journal of Hematology & Oncology (2019)
HER2- advanced GC pts (k) 386 14 27
CLDN18.2>=40%, % 49% 49% 49% Ann Oncol (2021)
CLDN18.2+/HER2- advanced GC pts (k) 189 7 13
1L treatment
Treatment rate % 95% 95% 95% consistent with Transcenta model (same for 2/3L) POS=18%
1L GC pts (k) 180 7 13 phase 1a
CLDN18.2 penetration % 60% 75% 75% benchmark to HER2/EGFR class penetration based on PDB
DOT=9m
ADC market share % 20% 25% 25% benchmark to TROP2 ADC in TNBC (same for 2/3L) PFS=8.2/10.6 for
Zolbetuximab in
SKB315 is among the leading players in CLDN18.2 ADC, ph3 GLOW and
SKB315 market share % 25% 45% 45%
For the exclusive use of KECHENG.JIN@BITMAIN.COM
1fc9fa9cf8844a388c506688498547c5
DOT - 1L GC, mos 9.0 9.0 9.0
DOT - 2/3L GC, mos 4.5 4.5 4.5
SKB315 Sales, unadjusted, mn USD 244 364 457
SKB315 sales, risk-adjusted, mn USD 69 102 128 SKB315 global risk-adjusted sales (mn USD) = 299
CLDN18.2 ADC market in GC, mn USD 976 808 1,014 CLDN18.2 ADC global market in GC (mn USD) = 2,799
Source: stats.gov.cn, Globocan 2020, Cancer Medicine (2021), National Cancer Institute SEER Incidence Data, China Oncology (2016), Journal of Hematology & Oncology (2019), Annals of Oncology
(2021), NCCN guidelines, Goldman Sachs Global Investment Research
PC: significant unmet clinical needs with more than 90% sales from
overseas markets
Limited treatment options for PC – Current SOC for PC is more limited compared to
GC: 1) for front-line treatment, chemotherapies are the primary recommendations with
low ORR (23-32%) and short survival data (PFS=5.5-6.4 months, OS=8.5-11.1 months),
2) more targeted therapies are recommended for patients with positive NTRK fusion
(entrectinib) or TMB-H (Keytruda), however, only 1% or less of PC patients are eligible
given the low prevalence of the biomarkers in PC, and 3) no preferred recommendations
for patients progressed after two lines of treatment.
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Exhibit 59: CLDN18.2-ADCs are mostly developed in the early stage and target usage in 2L+ PC
Clinical development landscape of CLDN18.2 ADC in PC
Company CLDN18.2 Study Lines Regimen Trial status
ADC 1L 2L+ Mono Combo Phase Masking N1 Endpoint Start Completion
PC
Turning Point Therapeutics CA128-1033 Ph1/2 Open label 42 DLT Feb-2022 Aug-2024
For the exclusive use of KECHENG.JIN@BITMAIN.COM
LM-302
LaNova LM302-01-201 +PD-12 Ph1/2 Open label 50 DLT/RP2D/OBD/MTD May-2022 Oct-2023
Sotio SOT102 CLAUDIO-01 +chemo Ph1/2 Open label 269 MTD/RP2D/ORR Mar-2022 Dec-2023
Keymed/Lepu Biopharma CMG901 KYM901 Ph1 Open label 162 DLT/ORR/RP2D Dec-2020 May-2024
Kelun Biotech SKB315 SKB315-I-01 Ph1 Open label 206 DLT/ORR Mar-2022 May-2024
JS107-001-I +PD-12 Ph1 Open label 118 MTD/RP2D/ORR Jul-2022 Jul-2024
Junshi JS107
JS107-002-I +PD-12 Ph1 Open label 106 MTD/RP2D Dec-2022 Sep-2024
CSPC SYSA1801 SYSA1801-CSP-001 Ph1 Open label 272 DLT/RP2D Sep-2021 Dec-2023
TORL Biotherapeutics TORL-2-307 TORL2307ADC-001 Ph1 Open label 70 MTD/RP2D Feb-2022 Jan-2025
Note: 1. Estimated number is used when no actucal enrollment reported; 2. Toripalimab.
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CLDN18.2 penetration % 60% 75% 75% benchmark to HER2/EGFR class penetration based on PDB DOT=6m
PFS=6 for
ADC market share % 20% 25% 25% benchmark to TROP2 ADC in TNBC (same for 2L) FOLFIRINOX in
1L PC
SKB315 is among the leading players in CLDN18.2 ADC,
SKB315 market share % 25% 45% 45%
expect higher share in ex-China with MSD leverage
For the exclusive use of KECHENG.JIN@BITMAIN.COM
1fc9fa9cf8844a388c506688498547c5
Source: stats.gov.cn, Globocan 2020, NCCN guidelines for treatment line of CLDN18.2 ADC in PC, Goldman Sachs Global Investment Research
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Exhibit 61: HER2 is highly expressed in BC/GC Exhibit 62: HER2-targeting therapies are established in guidelines
Major cancers’ incidence in China with HER2 overexpression Current SOC in cancers with HER2 overexpression
VEGFi HER2 mAb HER2 ADC Chemo
479 Unit: K 1L 2L 3L
416 ORR: ~47%; ORR: ~51%; mPFS: 2m;
GC
mPFS: ~6.7m; mPFS: ~5.6m; mOS:5.7m
mOS: ~13.8m mOS: ~12.5m
306
HER2+ tumor
ORR: ~80%; ORR: ~79%; ORR: ~41%;
BC
mPFS: ~18.5m; mPFS: ~28.8m; mPFS: ~7.8m;
mOS: ~56.5m mOS: 21.9m
ORR: ~57%; ORR: ~38%; ORR: ~45%;
RASwt
mPFS: ~11.7m; mPFS: ~8.2m; mPFS: ~6.9m;
CRC
30%
16% 7% mOS: ~29.8m mOS: ~24.1m mOS: ~15.5m
GC BC CRC
HER2+
GC - gastric cancer; BC - breast cancer; CRC - colorectal cancer Source: NCCN guidelines
Source: Journal of Hematology & Oncology (2019) for HER2+ in GC, BMC Cancer (2011) for
HER2+ in BC, Frontiers in Oncology (2022), Globocan 2020 for cancer incidence
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Source: Company data
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Exhibit 64: A166 is the first domestic HER2 ADC to file for late-stage BC
Competitive landscape of HER2 ADC in China
Indications
Drug Company
BC GC CRC UC
Enhertu AstraZeneca/Daiichi Sankyo Approved Ph3 / /
Kadcyla Roche Approved Ph2/3 / /
Aidixi/RC48 RemeGen Ph3 Approved Ph2 Approved
A166 Kelun Biotech NDA filed* Ph1 Ph1 /
LCB14-0110 LegoChem/Fosun Pharma Ph3 Ph2 Ph2 /
ARX788 NovoCodex/Ambrx Ph2/3 completed Ph2/3 / /
MRG002 MiracoGen Ph2 Ph2 / Ph3
SHR-A1811 Hengrui Ph3 Ph1/2 Ph1 /
SYSA1501 CSPC Ph3 Ph2 / /
DX126-262 DAC Biotech Ph2 Ph1/2 / Ph1/2
BB-1701 Morphotek/BlissBio IND IND / Ph1/2
* NMPA NDA acceptance on May 11, 2023
Source: Pharmcube
n Expect A166 to capture 21k pts in China by 2033E – We expect c.21k patients
with HER2+ GC, BC, and CRC in China to be treated by A166 by 2033E. We
estimate that A166 will gain 22% domestic market share in HER2+ BC (18% in GC
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and CRC), given its overall competitive drug profile compared to top players in HER2
ADC (see details below).
n Rmb941mn of risk-adjusted peak sales in China for A166 – With
probability-of-success rate assigned for GC/BC/CRC (68%/90%/65%) based on
current clinical progress, we estimate the risk-adjusted China sales for A166 to reach
c.Rmb941mn by 2032E, in which c.62% of the sales will be contributed by gastric
cancer. Given the large size of the HER2+ BC/GC markets we see room for multiple
players including Enhertu, Aidixi, A166, and SHR-A1811.
Exhibit 65: We estimate over Rmb900mn of risk-adjusted China Exhibit 66: We expect A166 to have over Rmb900mn of risk-adjusted
sales for A166 by 2033E sales in China by 2032E
Estimated A166 sales by indication during 2024E-2033E Key estimates and assumptions for A166
1fc9fa9cf8844a388c506688498547c5
1,000 Revenue 60% HER2+ HER2+ HER2+
(RMB, mn)
900 2L+ 3L+ 3L+
50%
800 China Addressable patients (k) 103 8 6
700 40% A166 share (%) 18% 22% 18%
600 A166 treated pts (k) 18 2 1
30%
500 DOT (month) 5 12 5
20%
400 pre-POS sales (mn RMB) 854 263 54
300 10% Monthly price (k RMB) - China 10
200 POS (%) 68% 90% 65%
0%
100 risk-adj sales (mn RMB) 584 236 35
GC BC Other yoy
Source: Goldman Sachs Global Investment Research Total sales also include add-on sales of Rmb86mn from other indications.
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Exhibit 67: A166 shows encouraging safety profile in late-line HER2-positive GC compared to Enhertu
Clinical data comparison of HER2 ADC in HER2-positive GC/GEJ
Molecule A166 Kadcyla Enhertu Aidixi/RC48
Developer Kelun Roche Daiichi Sankyo / RemeGen
AstraZeneca
Study KL166-I-05 (China trial) GATSBY DESTINY-Gastric01 RC48-C008 (China trial)
Latest reported time 9-Feb-2023 23-Mar-2017 18-Jun-2020 20-May-2021
Follow-up period, median 6.7 months 17.5 (T-DM1) vs 15.4 4.6 (DS-8201a) vs 2.8 7.6 months
(taxane) months (chemo) months
For the exclusive use of KECHENG.JIN@BITMAIN.COM
NCT no. CTR20213396 (phase 1b) NCT01641939 (phase 2/3) NCT03329690 (phase 2) NCT03556345 (phase 2)
Treatment line 2L+ HER2+ GC/GEJ 2L+ HER2+ GC/GEJ 3L/3L+ HER2+ GC/GEJ 3L/3L+ HER2+ GC/GEJ
Baseline N 16 228 (T-DM1) vs 125 (DS-8201a) vs 125
117 (taxane) 62 (chemo)
Prior treatment trastuzumab previous anti-HER2 therapy: median 2 2 prior line (52.8%); ≥ 3
79% vs 76% prior lines (47.2%)
Median age (y) 62 vs 62 65 vs 66 58
ECOG ECOG PS 1: 62% vs 56% ECOG PS 1: 50% vs 52% ECOG PS 1: 76.8%
Genotype IHC 3+ or 2+/FISH+ IHC 2+ or 3+ IHC 3+ or IHC 2+/ISH+ IHC 2+ or 3+
ORR 31.3% (5/16) 20.6% vs 19.6% 42.9% vs 12.5% 24.8%
DCR 68.8% (11/16) 86% vs 62% 42.4%
Efficacy
1fc9fa9cf8844a388c506688498547c5
G3+ AE 37.5% 60% vs 70% 85.6% vs 56.5% 56.8% (71/125)
SAE 29% vs 28% 16% (20/125)
TR death 4% vs 4% 0.8% (1/125) vs 0 0
AE of concern All grades: blurred vision All grades: anaemia (26%); G3+: Neutrophil count G3+: Decreased WBC
(68.8%), corneal thrombocytopenia (11%) decreased (51% vs 24%); count (14.4%);
epitheliopathy (68.8%), dry haemorrhage (10%) Anemia (38% vs 23%); Decreased neutrophil count
AE
Source: Company data for A166, The Lancet Oncology (2017) for Kadcyla, New England Journal of Medicine (2020) for Enhertu, Cancer Communications (2021) for Aidixi/RC48
n Mixed safety profile: In both BC and GC, A166 demonstrated mixed safety profile
compared to other HER2 ADCs: 1) cardiac, hematological, GI and lung toxicities
were uncommon (< 10%) and mostly mild (vs. 20+% of grade3+ neutropenia in
Enhertu in BC), 2) relatively good control of grade 3+ AEs particularly in GC (37.5%
vs. 85.6% in Enhertu), but 3) significantly higher ocular TRAEs (e.g., 31% of G3+
corneal epitheliopathy, 18.5% of blurred vision, vs. N.A. for T-DM1/Enhertu/RC-48)
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which could potentially require ophthalmic examination prior to doses (as is the case
for Tivdak with the FDA black box warning).
n Accessibility could be additional lever: With BC as the leading indication, and
GC/CRC as fast follow-ups, Kelun biotech adopted a multi-indication clinical
development plan to rapidly advance A166 in China, targeting for product launch in
the second half of 2024 or the first half of 2025. Leveraging the extensive network
of Kelun Pharmaceutical in China, the accessibility of A166 could be an additional
lever in the competitive HER2 ADC market in China.
3,000 140%
120%
2,500
100%
2,000
80%
1,500
60%
1fc9fa9cf8844a388c506688498547c5
1,000
40%
500 20%
- 0%
2024 2025 2026 2027 2028 2029 2030 2031 2032 2033
n A167 (PD-L1): the I/O backbone for combination – Though the PD-(L)1 market in
China is competitive with fifteen approved products as of April 2023, A167 was
strategically developed more as the I/O backbone for combination with ADCs as
compared to monotherapy. Designed with a silenced Fc region to remove
antibody-dependent cellular cytotoxicity (ADCC) / complement-dependent
cytotoxicity (CDC), A167 demonstrated good safety profile with well-managed
immune-related adverse events (irAE), which enables the combination with SKB264
to target 1L treatment for TNBC and EGFRwt NSCLC.
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Exhibit 69: A400 shows potentially better safety profile with promising efficacy in 2L+ RET+ NSCLC
Non-head-to-head comparisons of RET inhibitors for the treatment of RET+ NSCLC
pralsetinib selpercatinib
RET+ NSCLC A400
(Gavreto) (Retevmo)
RP2D 90mg, QD 400mg, QD 160mg, BID
Stage Ph1/2 Ph1/2 Ph1/2
NCT05265091 NCT03037385 NCT03157128
Trial No.
(KL400-Ⅰ/Ⅱ-01) (ARROW) (LIBRETTO-001)
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1fc9fa9cf8844a388c506688498547c5
Phosphate reduction N.A. 0% N.A. N.A. N.A. N.A.
Neutropenia N.A. 0% 46% 20% 25% 3%
Cardiovascular AEs
Hypertension N.A. 0% 25% 12% 28% 13%
Prolonged QT interval <5% 0% 5% 0% 16% 3%
Infections
Pneumonia N.A. 2% 12% 2% N.A. N.A.
Discontinuation 7% 7% 8%
Note: RP2D: recommended phase 2 dose; QD: once daily; BID: twice daily; SRI: selected RET inhibitor; TRAEs:
treatment-related adverse events; *: TRAEs data at all grades for A400 is based on full safety population (n=87)
treated with multiple doses (10-120mg, QD).
Source: ASCO 2023 for A400, Annals of Oncology (2022) for pralsetinib, Journal of Clinical Oncology (2023) for selpercatinib
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Goldman Sachs Kelun Biotech (6990.HK)
Exhibit 70: A223 demonstrates encouraging safety profile at potentially lower effective dose compared to
other approved JAK1/2 inhibitors in China
Non-head-to-head comparisons of JAK1/2 inhibitors for the treatment of moderate-to-severe rheumatoid arthritis
(RA)
tofacitinib baricitinib upadacitinib
Moderate-to-severe RA A223
(Xeljanz) (Olumiant) (Rinvoq)
Dosage1 2mg, QD 5mg, BID 4mg, QD 15mg, QD
Stage Ph2 Ph3 Ph3 Ph3
CTR20202664 NCT00847613 NCT02265705 NCT02955212
Trial No.
(KL223-Ⅱ-03) (RA-III) (RA-BALANCE) (M15-557)
No. of patients 39 321 116 169
Efficacy (at week 12)
Treatment ACR20 64% 55% 53% 72%
Placebo ACR20 29% 27% 23% 31%
Difference in ACR20 35% 28% 31% 40%
Treatment ACR50 39% 29% 25% 41%
Placebo ACR50 6% 8% 4% 8%
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Source: Company data for A223, Arthritis & Rheumatology (2019) for tofacitinib, Rheumatology and Therapy (2020) for baricitinib, and company data
(AbbVie) for upadacitinib
1fc9fa9cf8844a388c506688498547c5
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Goldman Sachs Kelun Biotech (6990.HK)
Key strengths
Deep ADC franchise - Kelun Biotech has developed a deep pipeline of ADC franchise
with three clinical assets and over ten preclinical assets, led by SKB264 (TROP2), which
1) has a differentiated drug design for improved drug profile upon Trodelvy, 2) is
positioned to be the first domestically developed TROP2 ADC, and 3) has a broad
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spectrum of cancer indications with MSD as the global partner. The other two clinical
ADC assets, A166 and SKB315, also demonstrate potential to be competitive options
among the HER2/CLDN18.2-targeting ADC classes with differentiated drug profiles. In
addition, Kelun Biotech has over ten preclinical ADC assets covering a range of high
potential targets expressed across a broad spectrum of solid tumors, among which up
to seven preclinical assets are under the license agreement with MSD.
1fc9fa9cf8844a388c506688498547c5
combination, setting a higher barrier for companies to participate. With over 40 patents
and patent applications, Kelun Biotech has established OptiDC as a fully integrated ADC
development platform to support the systematic development of ADCs with key
capabilities in three major capability pillars:
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Goldman Sachs Kelun Biotech (6990.HK)
Exhibit 71: Strategic collaborations between Kelun Biotech and MSD totaled close to $12bn
Deal structures of ADC collaboration between Kelun Biotech and MSD
Asset SKB264 (TROP2)* SKB315 (CLDN18.2)* Up to 7 preclinical ADC assets
Deal date May 2022 June 2022 December 2022
Stage at licensing Ph3 Ph1a Pre-clinical
Partner MSD MSD MSD
1fc9fa9cf8844a388c506688498547c5
Upfront (US$, mn) 102 35 175
Milestone (US$, mn) 380 (R&D) + 780 (Sales) 416 (R&D) + 485 (Sales) 9,300
Royalties mid-single to low-double digit mid-single to low-double digit tiered royalties
Global commerical • MSD: ex-Greater China • MSD: develop and • MSD: ex-Greater China
rights • Kelun: Greater China commercialize SKB315 globally • Kelun: Greater China
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Goldman Sachs Kelun Biotech (6990.HK)
Exhibit 72: MSD has been an active buyer in ADC market Exhibit 73: All three Kelun & MSD deals are among the largest ADC
Global top ADC buyers, led by Pfizer, Gilead, and MSD (deal value in deals
USD bn) Number of global ADC deals grouped by dollar value (including
upfront/milestones, USD mn)
- 5 10 15 20 25 30 35 40 45 USD mn
Seagen
Gliead 21.0 acquisition Kelun & MSD deal on 7 PCC (up to
(2023) 800-1,000 10 $9.5bn), and SKB264 (up to $1.3bn)
MSD 2.8 16.3 19.0
Immunomedics
acquisition (2020)
AstraZeneca 14.7 Kelun & MSD deal
License deal with Kelun 600-800 2 on SKB315 (up to $936mn)
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1fc9fa9cf8844a388c506688498547c5
With Kelun Pharmaceutical and MSD as the top 2 shareholders (75%/7% as of Feb
2023), Kelun Biotech is well placed to leverage resources from the two large
pharmaceutical companies in areas such as clinical trial design, indication expansion
strategy, KOL engagement, and commercialization setup.
n China market – Kelun Pharmaceutical could provide help in: 1) market access
expertise as one of China’s largest and most established pharmaceutical
companies, 2) regulator communication experience which could smooth the
regulatory process, and 3) manufacturing management to support the sales
ramp-up.
n Global market – MSD could provide strategic edge in: 1) global clinical R&D
capability which includes its top-tier expertise in trial design/indication
expansion/clinical execution, 2) biomarker CDx development that is particularly
critical for TROP2 and CLDN18.2 to increase clinical adoption, and 3)
commercialization capacity with its extensive global network and the synergies in
combination use with Keytruda to exploit the global market potential of the
out-licensed ADC assets led by SKB264.
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Goldman Sachs Kelun Biotech (6990.HK)
Experienced leadership
Kelun Biotech’s senior management team has extensive experience in drug
development, consisting of industry veterans, regulatory experts, scientists, physicians,
and financial specialists.
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Goldman Sachs Kelun Biotech (6990.HK)
Exhibit 74: Kelun Biotech’s management team has extensive experience in biopharma industry
Name Prior experience Education
Title
Appointment time
Mr. LIU Gexin Founder of Kelun Pharmaceutical and chairman of Kelun M.S., Cardiovascular Pharmacology
Non-executive director, Pharmaceutical since establishment; Chongqing Medical University, China
Chairman Currently hold positions in four subsidiaries of Kelun Group M.A., Political Economics
Joined in Nov 2016 Southwest University, China
Dr. GE Junyou Kelun Pharmaceutical (Jul 2009 - Feb 2021) : Deputy general manager B.S., Pharmacy
Executive director and (quality management), joined Kelun in Jun 2007; Shanghai Medical College Fudan University,
general manager Ratiopharm GmbH (Jan 2006 - May 2007) : Quality manager; China
Joined in Feb 2021 Zhejiang Hisun Pharmaceutical (Jan 2004 - Jan 2006) : Assistant to M.S., Pharmaceutical Engineering
general manager; East China University of Science and
Boehringer Ingelheim Pharmaceutical (Shanghai) (Apr 2000 - Jan 2004) Technology, China
: GMP compliance manager; Ph.D., Biology and Medicine
Shanghai Hengshoutang Pharmaceutical (1998 - 2000): Deputy manager Fudan University, China
of technical department;
Shanghai Yan’an Pharmaceutical Factory (1994-1997): Production and
R&D officer
Mr. FENG Yi Kelun Research Institue (Nov 2018 - Nov 2020): Senior vice dean and B.S., Aviation Medicine
Deputy general manager, chief strategy officer; The Fourth Military Medical University of the
Chief Strategy Officer, and Clinchoice Inc. (Jan 2016 - Aug 2018): President of Greater China; Chinese People’s Liberation Army, China
senior vice president Covington & Burling Law Firm (China office) (Feb 2014 - Dec 2015): M.S., Radio Medicine
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Joined in Dec 2020 Senior consultant for drug regulations Chinese People’s Liberation Army Academy of
Center of Drug Evaluation, NMPA: Assistant of the director Military Medical Sciences, China
Dr. ZHANG Yiwei Eli Lilly (Nov 2008 - Dec 2017): Senior scientist in quality control and B.S., Medicine
Deputy general manager technology development of biomacromolecule drugs; Chongqing Medical University, China
Joined in Jan 2018 ImClone System, Inc (Jun 2007 - Oct 2008): Quality control scientist; Ph.D., Theoretical and Applied Biology
Albert Einstein College of Medicine (Aug 1995 - May 2007): Postdoc University of Leeds, UK
fellow and associate researcher in Dept. of Pathology
Dr. TAN Xiangyang Duality Biologics (Mar 2021 - Jul 2021): Senior vice president (formulation B.S., Clinical Medicine
Deputy general manager, and implementation of the technology platform for preclinical innovative Harbin Medical University
and Chief Science Officer of drug); M.S., Microbiology and Immunology
Biologics R&D 4B Technologies (Aug 2019 - Feb 2021): Vice president in R&D; Wuhan Institute of Biological Products
Joined in Jul 2021 Harbour BioMed (Jul 2017 - May 2019): Vice president; Ph.D., Cell and Molecular Biology
Apbro Corporation (Jan 2016 - Jul 2017): Department head; Manchester Metropolitan University, UK
Biogen Inc. (Feb 2009 - Nov 2015): Principal scientist;
Pfizer Inc. (Jan 2008 - Jan 2009): Principal scientist;
Wyeth, LLC (Jan 1998 - Jan 2008): Principal scientist
Dr. JIN Xiaoping Akeso (May 2017 - Aug 2021): Vice president and head of clinical B.S., Chemistry
Deputy general manager development; Nanjing University, China
1fc9fa9cf8844a388c506688498547c5
and Chief Medical Officer AstraZeneca (Jun 2014 - Apr 2017): Scientific director; M.S., Statistics
Joined in Sep 2021 Daiichi Sankyo Inc. (Jul 2005 - Jun 2014): Staff biostatistician Washington State University, US
Ph.D., Biostatistics
University of Minnesota, US
Mr. ZHOU Zejian IDG Capital (Nov 2017 - Jul 2022): Managing director; B.A., Financial Managment
CFO and board secretary Goldman Sachs Gao Hua Securities (Apr 2014 - Nov 2017): Executive Renmin University, China
Joined in Feb 2022 director; M.A., Finance
Various investment banking experience in CICC and J.P. Morgan First Renmin University, China
Capital Securities
Mr. GUO Yong Everest Medicines (Mar 2021 - Jul 2021): Chief commercial officer; B.S., Clinical Medicine
Deputy general manager Eisai Inc (US) (Jan 2018 - Jan 2021): Vice president and deputy global Fourth Military University, China
and Chief Commercial brand lead; M.B.A.
Officer Eisai China Inc (Nov 2014 - Dec 2017): Vice president; China Europe International Business School
Joined in May 2023 Shanghai Roche Pharmaceutical Ltd (Dec 2010 - Oct 2014): Vice
president;
GlaxoSmithKline (China) Investment Company Ltd (Nov 2009 - Dec
2010): north China sales director of vaccine;
Wyeth Pharmaceutical Co., Ltd (May 2003 - Nov 2009): senior product
manager, market manager and associate market director;
Eli Lilly Asia Inc (May 1998 - April 2001): sales representative and product
executive
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Goldman Sachs Kelun Biotech (6990.HK)
Key risks
As described earlier, R&D competition in the ADC field is becoming crowded on a few
top targets (e.g., HER2, TROP2, CLDN18.2) which are also the targets of lead ADC
assets of Kelun Biotech. For ADC assets, the competition comes from 1) ADCs
targeting the same target, 2) ADCs targeting different targets (e.g., TROP2 ADC vs.
Enhertu in HER2-low BC), and 3) treatment of other modalities (e.g., antibodies,
chemotherapies, target therapies as in NSCLC). Amid the competition, if the company’s
three leading ADC assets do not capture as much market share as we estimate, it could
put downward pressure on the company’s revenue outlook.
1fc9fa9cf8844a388c506688498547c5
major domestic companies and MNCs with well-established sales channels (e.g.,
AstraZeneca has extensive sales network in China to facilitate market penetration of
Dato-DXd). An insufficient commercialization layout may negatively impact the market
penetration of key assets such as SKB264, which could indicate 1) higher follow-up
investment in sales & marketing may be needed, and 2) our estimated peak sales may
not be reached which could put pressure on the revenue outlook.
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Goldman Sachs Kelun Biotech (6990.HK)
Financials
license income from upfront and milestone payments. With the company expecting
A167 (PD-L1) to be approved by NMPA in 2H23, and two leading ADC assets, SKB264
(TROP2 ADC) and A166 (HER2 ADC), to be launched in 2H24, we estimate that the
company’s revenue will start to see significant growth driven by product sales starting
from 2025E (we forecast sales of Rmb0.72/0.53/1.23bn in 23E/24E/25E if excluding the
R&D reimbursement from partner, sales of Rmb1.07/0.93/1.68bn in 23E/24E/25E if
included). Driven by the expanding product sales, we expect the net losses to start
narrowing in 2025E (net losses of Rmb-0.73/Rmb-1.13/Rmb-0.64bn in 23E/24E/25E).
Exhibit 75: We expect Kelun Biotech’s revenue (ex. R&D Exhibit 76: We expect Kelun Biotech to remain loss-making during
reimbursement) to exceed Rmb1bn by 2025E 2021A-2025E
Sales and gross margin in 2021A-2025E Operating pro fit / net profit (ex. other net income), 2021A-2025E
1fc9fa9cf8844a388c506688498547c5
1,400 Rmb, mn 80% 0 Rmb, mn
1,200 70%
116 -200
60%
1,000 134
50% -400
800 282
40%
-600
600
30%
350
400 -800
723 240 20%
504
200 10%
321 -1000
220
32
- 0%
2021A 2022A 2023E 2024E 2025E Rmb, mn
License income Other drugs -1200
2021A 2022A 2023E 2024E 2025E
A166 (HER2) SKB264 (TROP2)
A400 (RET) A223 (JAK)
Operating profit Net profit
Gross margin
Source: Company data, Goldman Sachs Global Investment Research Source: Company data, Goldman Sachs Global Investment Research
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Goldman Sachs Kelun Biotech (6990.HK)
Exhibit 77: Out-of-pocket R&D expenses to rise steadily from 2021A Exhibit 78: SG&A expenses to rise with the product launch in
to 2025E 2021A-2025E
R&D spending in 2021A-2025E SG&A expenses in 2021A-2025E
900
700
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800
600
700
500
600
500 400
924 734
846 863 880
400
728 300 607
300
436
200
200
100
100
96 95
0 0
2021A 2022A 2023E 2024E 2025E 2021A 2022A 2023E 2024E 2025E
1fc9fa9cf8844a388c506688498547c5
Source: Company data, Goldman Sachs Global Investment Research Source: Company data, Goldman Sachs Global Investment Research
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Goldman Sachs Kelun Biotech (6990.HK)
1fc9fa9cf8844a388c506688498547c5
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Goldman Sachs Kelun Biotech (6990.HK)
1fc9fa9cf8844a388c506688498547c5
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Goldman Sachs Kelun Biotech (6990.HK)
1fc9fa9cf8844a388c506688498547c5
Kelun’s growing franchise prior to break-even in 2026E.
Valuation
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Goldman Sachs Kelun Biotech (6990.HK)
RMB, Mn 2021A 2022A 2023E 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E
SKB264 (TROP2 ADC) 37 109 298 878 1,702 2,341 2,692 2,804 2,840 2,840
ex-China royalties 25 45 204 703 1,379 1,695 2,303 2,409 2,487
A166 (HER2 ADC) 28 282 437 662 801 891 931 936 941 924
SKB315 (CLDN18.2 ADC)
royalties only 1 12 51 133 233 308 371
A400 (RET) 116 329 625 699 903 995 1,010 1,027 1,045
A223 (JAK 1/2) 29 154 341 497 573 619 666 682 696
Other products
(A140/A167/A277 etc.) 240 350 713 931 1,114 1,218 1,314 1,395 1,474 1,554
Licensing revenue
(ex. royalties) 4 786 1,054 603 743 825 866 909 955 1,003 1,053 1,105 1,161
Provision of R&D services 28 18 19 20 21 22 23 24 25 27 28 29 31
Revenue 32 804 1,073 928 1,675 2,823 4,530 6,461 8,336 9,409 10,428 10,815 11,109
yoy% 2387% 33% -13% 80% 69% 60% 43% 29% 13% 11% 4% 3%
Gross Profit 12 527 723 495 1,161 2,202 3,764 5,559 7,319 8,314 9,284 9,629 9,884
GP, % 36% 66% 67% 53% 69% 78% 83% 86% 88% 88% 89% 89% 89%
SG&A expenditure (96) (95) (436) (607) (734) (1,073) (1,563) (2,003) (2,292) (2,493) (2,659) (2,650) (2,722)
yoy% -1% 357% 39% 21% 46% 46% 28% 14% 9% 7% 0% 3%
R&D expenditure (728) (846) (863) (880) (924) (970) (1,019) (1,070) (1,123) (1,180) (1,238) (1,300) (1,365)
yoy% 16% 2% 2% 5% 5% 5% 5% 5% 5% 5% 5% 5%
EBIT (812) (414) (576) (992) (498) 159 1,182 2,486 3,903 4,641 5,387 5,679 5,796
yoy% -49% 39% 72% -50% -132% 645% 110% 57% 19% 16% 5% 2%
Operating Margin 6% 26% 38% 47% 49% 52% 53% 52%
Add: share-based comp 6 20 46 84 125 156 175 175 175 175 175 175 175
Less: Taxes (49) (2.0) (155.3) (351.6) (565.5) (678.5) (793.2) (840.2) (861.3)
For the exclusive use of KECHENG.JIN@BITMAIN.COM
Tax rate 0% 0% 0% 0% 0% 15% 15% 15% 15% 15% 15% 15% 15%
NOPAT (806) (443) (530) (908) (373) 313.0 1,201.3 2,309.3 3,512.4 4,137.6 4,768.1 5,013.2 5,109.9
Net Margin 11.1% 26.5% 35.7% 42.1% 44.0% 45.7% 46.4% 46.0%
Net Margin (ex. royalties) 9.6% 23.0% 27.8% 30.2% 30.5% 28.3% 28.4% 27.3%
Depreciation & amortization 23 67 65 83 100 117 136 158 181 205 230 254 276
y/y 194% -3% 27% 21% 16% 17% 16% 15% 14% 12% 10% 9%
Capital expenditures (95) (33) (314) (325) (335) (339) (408) (452) (500) (546) (584) (584) (578)
y/y -66% 861% 3% 3% 1% 20% 11% 11% 9% 7% 0% -1%
Changes in working capital 279 35 43 (67) (57) (114) 69 (57) (45) 128 2 7 10
y/y -88% 24% -257% -15% 99% -161% -183% -22% -387% -98% 180% 37%
Unlevered free cash flow (598) (374) (736) (1,217) (664) (23) 999 1,957 3,148 3,925 4,417 4,690 4,817
USD/CNY 7.0
USD/HKD 7.8
HKD/CNY 1.1
1fc9fa9cf8844a388c506688498547c5
Source: Company data, Goldman Sachs Global Investment Research
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Goldman Sachs Kelun Biotech (6990.HK)
1fc9fa9cf8844a388c506688498547c5
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Goldman Sachs Kelun Biotech (6990.HK)
Proof-of-
Probability of Success First-in-human Pivotal NDA
concept
PoS (Ph I) (Ph II) (Ph II / III)
SKB264 (TROP2)
3L+ TNBC 81% 100% 100% 90% 90%
1L TNBC 58% 100% 80% 80% 90%
3L+ HR+/HER2- BC 58% 100% 80% 80% 90%
EGFR-TKI failed NSCLC 50% 100% 80% 70% 90%
1L EGFRwt NSCLC 22% 100% 60% 40% 90%
1L EGFRmut NSCLC 7% 100% 40% 20% 90%
2L EGFRwt NSCLC 32% 100% 70% 50% 90%
GC 8% 100% 30% 30% 90%
OC 8% 100% 30% 30% 90%
UC 0% 100% 70% 0% 90%
A166 (HER2)
3L+ HER2+ BC 90% 100% 100% 100% 90%
2L+ HER2+ GC 68% 100% 95% 80% 90%
3L+ HER2+ CRC 65% 100% 90% 80% 90%
SKB315 (CLDN18.2)
GC 35% 80% 70% 70% 90%
PC 20% 80% 40% 70% 90%
A167 (PD-L1)
3L NPC 90% 100% 100% 100% 90%
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1fc9fa9cf8844a388c506688498547c5
Exhibit 84: Sensitivity analysis on WACC and terminal growth rate
WACC
115 12.5% 13.0% 13.5% 14.0% 14.5%
0.0% 110 103 97 92 87
1.0% 116 109 102 96 91
TGR
2.0% 124 115 108 101 95
3.0% 133 123 115 107 101
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Goldman Sachs Kelun Biotech (6990.HK)
Glossary
Exhibit 86: Glossary for key items
ADC antibody drug conjugate HR hormone receptor
ADCC antibody-dependent cell-mediated cytotoxicity IHC immunohistochemistry
ADCP antibody dependent phagocytosis ILD interstitial lung disease
AE adverse event IND investigational new drug
sALCL systemic anaplastic large cell lymphoma IgG immunoglobulin G
ALK anaplastic lymphoma kinase I/O Immuno-Oncology
ALL acute lymphocytic leukemia JAK1/2 Janus kinase 1 or Janus kinase 2
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1fc9fa9cf8844a388c506688498547c5
EGFRwt epidermal growth factor receptor (wild type) RA rheumatoid arthritis
EGFRmut epidermal growth factor receptor (mutant) RET rearranged during transfection
ESOP employee stock ownership plan SAE serious adverse event
FcγR fragment crystallizable gamma receptors STING stimulator of interferon genes
FISH fluorescence in situ hybridization TR death treatment-related death
FXI/FXIa factor XI/factor Xia TKI tyrosine kinase inhibitor
GC gastric cancer TNBC triple-negative breast cancer
GEJ gastroesophageal junction adenocarcinoma TROP2 human trophoblast cell-surface antigen 2
GI gastrointestinal TSLP thymic stromal lymphopoietin
HCC hepatocellular carcinoma UC urothelial cancer
HER2 human epidermal growth factor receptor 2 VEGF vascular endothelial growth factor
HNSCC head and neck squamous cell carcinoma
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Appendix
Exhibit 87: Corporate and shareholding structure of Kelun Biotech (as of August 3, 2023)
Chengdu Wenjiang
Kelun Dr. WANG Wealthy Kexin LAV Anling Zhuhai Public
FIIF II Gygus Real Emerging Industry
Pharmaceutical Jingyi Linkage Lunda Kecheng Weijian Liangheng shareholders
Venture
54.29% 2.60% 3.32% 3.26% 1.06% 0.35% 0.44% 0.31% 0.18% 0.11% 10.21%
13.69% 6.13% 0.92% 1.92% 0.18% 0.18% 0.34% 0.28% 0.18% 0.09%
Sichuan Kelun-Biotech
Biopharmaceutical Co., Ltd. (PRC)
expansion; and 3) extensive collaborations with MSD for global market access (2 clinical
stage and 7 pre-clinical assets, and MSD as a top shareholder) and Kelun Pharma (the
parent company) for China commercialization. We expect SKB264 (TROP2 ADC) to be
the key driver of Kelun Biotech’s future growth given: 1) the broad spectrum of
indications where TROP2 has over-expression (e.g. BC/NSCLC/UC/GC), 2) the unique
drug design of SKB264 could potentially deliver clinical benefits over TROP2 ADC peers
as illustrated in early encouraging data, and 3) the strong leverage of MSD’s expertise
and network in the global market to drive clinical development and commercialization.
We are Buy-rated. Key risks: 1) R&D risks in developing new indications and future
ADCs; 2) increasingly heated competition in ADC field; 3) limited commercial
manufacturing and sales track record; 4) challenges in talent competition; and 5) alliance
risks in partnership.
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Our 12-m TP of HK$115 is based on a risk-adjusted DCF methodology assuming: 1)
13.5% discount rate; 2) 3% terminal growth rate; and 3) probability of success (PoS)
based on industry average success rates in different stages and adjustments based on
available clinical data. Key risks: 1) R&D risks in developing new indications and future
ADCs; 2) increasingly heated competition in ADC field; 3) limited commercial
manufacturing and sales track record; 4) challenges in talent competition; and 5) alliance
risks in partnership.
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Disclosure Appendix
Reg AC
We, Ziyi Chen, Linhai Zhao, Ph.D. and Diwen Tang, hereby certify that all of the views expressed in this report accurately reflect our personal views
about the subject company or companies and its or their securities. We also certify that no part of our compensation was, is or will be, directly or
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Unless otherwise stated, the individuals listed on the cover page of this report are analysts in Goldman Sachs’ Global Investment Research division.
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Quantum
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Disclosures
The rating(s) for Kelun Biotech is/are relative to the other companies in its/their coverage universe: 3SBio Inc., Angelalign Technology, Autobio,
BeiGene Ltd. (A), BeiGene Ltd. (ADR), Betta Pharma, BioKangtai, CSPC Pharma, China Medical System Holdings, Dian Diagnostics, Eyebright, Fosun
Pharma (A), Fosun Pharma (H), Hansoh Pharma, Hengrui Medicine, Huadong Medicine Co., Hualan Biological Engineering, InnoCare Pharma (A),
InnoCare Pharma (H), Innovent Biologics, Jiangsu Nhwa Pharmaceutical Co., Kelun Biotech, Kingmed, Lepu, Livzon Pharmaceutical Group (A), Livzon
Pharmaceutical Group (H), Mindray, Pien Tze Huang, Shandong Weigao Group, Sichuan Kelun Pharmaceutical Co., Sino Biopharmaceutical, Tong Ren
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Tang Ltd., Tonghua Dongbao, United Imaging, Walvax, Zai Lab (ADR), Zai Lab (H), Zhejiang Huahai Pharmaceutical, Zhifei
As of July 1, 2023, Goldman Sachs Global Investment Research had investment ratings on 3,008 equity securities. Goldman Sachs assigns stocks as
Buys and Sells on various regional Investment Lists; stocks not so assigned are deemed Neutral. Such assignments equate to Buy, Hold and Sell for
the purposes of the above disclosure required by the FINRA Rules. See ‘Ratings, Coverage universe and related definitions’ below. The Investment
Banking Relationships chart reflects the percentage of subject companies within each rating category for whom Goldman Sachs has provided
investment banking services within the previous twelve months.
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