PT Etana Biotechnologies Indonesia

Business Proposal
Jakarta, 23rd October 2021
 Why Indonesia?

• As per 20th of October 2021, the Government of the Republic

of Indonesia has reported 4.237.201 persons with confirmed
COVID-19
• Medication cover by Ministry of Health (MoH)
• Vaccination support from government

There have been

143.077 deaths
related to COVID-19
reported

4.077.748 patients have recovered

from the disease
Population Forecast of Indonesia

Source: https://www.who.int/indonesia/news/novel-coronavirus
 Why Now?
Indonesia Vaccine Dashboard as of October 23 rd, 2021 – 6
p.m.

https://vaksin.kemkes.go.id/#/vaccines
› Target vaccination: 208,265,720 people (> 12 years old)
› Total Vaccination 1st dose: 112,271,928 dose
› Total Vaccination 2nd dose: 67,165,732 dose
› Total Vaccination 3rd dose: 1,101,418 (healthcare professional)
 PT Etana Biotechnologies Indonesia
Progressing to be the ASEAN Leader in Biopharmaceutical Commercialization

• Expected to be the leading manufacturer of Biopharmaceutical product in Indonesia

• Has experienced and dedicated marketing team in the Biopharmaceutical segment
• Possess strong relationship with Indonesia government (MoH, BPOM) and Medical association
• Projected to be the Market Leader in the Biopharmaceutical segment by 2025

STRONG UNDERSTANDING STRONG RELATIONSHIP CONNECTED WITH THE REGIONAL PIONEER IN USING LATEST TECHNOLOGY
AND DEDICATED TEAM WITH AND FULL SUPPORT LARGEST SALES NETWORK BIOSIMILAR WITH VERY FEW TO ENSURE HIGH QUALITY,
FOR PROMOTING FROM THE INDONESIAN IN ASEAN, A MARKET OF COMPETITORS IN THE LOW-COST PRODUCTION,
BIOLOGICAL PRODUCTS GOVERNMENT OVER 600 MILLION PEOPLE REGION: AND PIC/S COMPLIANT.
RIGHT TIME TO INVEST. STRONG PIPELINE STRATEGY

Source: Etana Biotechnologies Indonesia -- Confidential --

 About the Product

Product Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Product presentation Pre-filled syringes, Can

Composition (per dosage) Ad5-nCoV /0.5 mL per dose: target 5 ×10 1 0 vp/dose
Route of Administration Intramuscular (IM) Injection and Inhalation (IH)
Target population Booster for Adults a n d I n i t i a t i o n f o r c h i l d r e n & a d o l e s c e n t s
Storage temperature (℃) 2-8 ℃

Objective

Source: Etana Biotechnologies Indonesia -- Confidential --

 Phase III Efficacy and Immunogenicity Results
Efficacy of 14 days post single-dose Efficacy of 28 days post single-dose

Antibody level from immunogenicity cohort

Strong humoral immunity response

 Phase III Version 2.0
 Efficacy Objective
The efficacy of Ad5-nCoV in preventing virologically confirmed COVID-19 disease occurring 28 days after
first dose vaccination and before the second dose vaccination, regardless of severity.
and the relative efficacy of Ad5-nCoV(2 dose vs. 1 dose) in preventing virologically confirmed (PCR
positive) COVID-19 disease occurring from 14 and 28 days to 24 weeks after the second
vaccination, regardless of severity.
 Safety Objective
To evaluate the incidence rate of SAEs and MAEs after the first dose until 24 weeks after the second
dose of Ad5-nCoV vaccination in all participants.
 Dosage: 0.5 ml (5×1010 vp) IM Injection
Current status of the Phase III Study - second dose

Total number of subjects

Mexico Chile Argentina Russia
Pakistan

20761 8870 455 1425 3090

6921 Preparing for the first analysis

 Inhalation Route Phase III Efficacy Trial in Mexico

Study to evaluate the inHaled recombinant novel coronavirus vaccine

(adenovirus type 5 vector) On the Protective -Efficacy in adults

Main cohort: 13000

subjects
• Endpoint-driven randomized, double-blind,
parallel-controlled, multicenter clinical trial
• Recruit volunteers who have previously received 1
Immunogenicity Asymptomatic infection
surveillance cohort: 3000 dose of Ad5-nCoV
cohort:
subjects
6I0m0msuunbizej actitosn • 1 dose of inhalation vaccine
Safety cohort: 3000
subjects • 4 cohorts
• IDMC and ERC

Will initiate in Mexico soon, 15 sites involved

 Inhalation Route Phase III Trial
in children and adolescents

Extended- Immuno-
Sample
Country Group Regimen immunogenicit persistency
size
y subgroup subgroup

Adolescents 500 150 50

Mexico
IM(0.3 ml)
Children 500 150 50
+IH(0.1 ml)

Adolescents 500 (56 days 150 50

Chile interval )
Children 500 150 50

Total 2000

Will initiate in Chile and Mexico soon, 6 sites involved

Source: Etana Biotechnologies Indonesia -- Confidential --

 Scope of the Cooperation
› Supplier of IM Bulk Product and IM and IH Finished Products
› Tech Transfer of IM product

› Marketing Authorization holder of finished product for IM and IH

› Manufacturing of IM product
› Commercialization of the IM and IH product

Commercial Terms

Regulatory Filling Etana will bear all the cost for the EUA transfer with support
of CanSino Bio
Led time of the Product Sixty (60) Calendar days
Term TBD

Source: Etana Biotechnologies Indonesia -- Confidential --

 Sales Forecasting
ETANA will only purchase the Finished Product processed from CanSino BIO’s Bulk Products,
in concordance with the following detail of total purchase volume:

Product 2022 2023 2024 2025

IM product
Adult (0.5ml) TBD TBD TBD TBD
Children (0.3ml) 20 mil dose 5 mil dose 1 mil dose 1 mil dose

IH product
Adult 2 mil dose 20 mil dose 20 mil dose 20 mil dose
Children 5 mil dose 20 mil dose 25 mil dose 25 mil dose

Purchase Milestones:
1. Sales forecasting 2026 onwards will discuss further
2. Both IM and IH price will determine in the definitive agreement
3. Term of payment will discuss by the parties and determine in the definitive agreement

Source: Etana Biotechnologies Indonesia -- Confidential --

 Clinical and EUA Approval
2021 2022
2023
Q1
Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Phase III efficacy and immunogenicity results
Clinical trials and results of Homologous booster dose
Clinical trials and results of Heterologus booster dose
Clinical trials and results in children and adolescents
EUA Approval in Indonesia (IM)

UPCOMING CLINICAL TRIAL

Clinical trials of Inhalation route in Mexico and Chile
Analysis for Interim report from Global
EUA Submission with global report to Indonesia
EUA Approval in Indonesia (IH)
Post Marketing Surveillance (PMS)

Note:
• EUA Approval in Indonesia (IM) transfer from PT Bio Farma to PT Etana
• Nov 2021 obtain Indonesia EUA Approval for IM route
• For Children and adolescents, awaiting the readiness data of Mexico and Chile Interim report
• Mar 2022 obtain Indonesia EUA Approval for IH route
Source: Etana Biotechnologies Indonesia -- Confidential --
 Manufacturing for IM Product

1. CanSino BIo shall manufacture and supply Etana the Bulk Product for the purposes of the
1 Bulk Product Manufacturing of the Finished Products for Commercialization in the Territory
2. Etana bears liability and performs the Manufacturing process of Finished Products.

CanSino BIO hereby grants Etana the non-sublicensable and non-transferrable license to use
2 Manufacturing the Manufacturing Know-How including process procedure etc in the Territory for
Know-How Manufacturing the Finished Products from the Bulk Product in the Territory.

CanSino BIO hereby grants Etana the non-sublicensable and non-transferrable license to use
3
Quality the Manufacturing Know-How of quality control process of Bulk Product and Finished Product
Know-How in the Territory for quality control release of Products in accordance to the regulation in
Territory and obtaining all necessary authorizations for the Products within the Territory.

1. CanSino BIo will endeavor to provide Etana expertise and reasonable assistance as may be
4 Training requested by Etana to achieve its manufacturing objectives
2. CanSino shall perform necessary training for the Etana personnel
Source: Etana Biotechnologies Indonesia -- Confidential --
 Marketing Strategic Summary
Key Customer What are the key customer issues /
opportunities that will encourage/
Issues/Opportunities
hinder the success of the brand?
Behavioral What behaviors / actions we
Objectives wish customers to do / change?
Strategic What must occur for the brand to
be successful in light of the issues /
Imperatives
opportunities indentified?
Marketing How will we achieve the
Programs strategic imperatives?
What percent of total resources
Resource $ (people or $) will be placed
Allocation against achieving this strategic
imperative?
Source: Etana Biotechnologies Indonesia
Indonesia government,
KOL from Paediatrician, and
Pulmonolgist, IM
All stakeholder (HCPs, payer,
patients, etc.) become clear
about benefit of Convideica
(IM and IH)
Make sure Convideica listed into
the Indonesia vaccination list
program and Pediatric guideline
Access to Vaccination program
by listed in Ministry of Health
40%
budget
1st year: 2022
-- Confidential --
Product quality & efficacy
conduct the Local clinical trial for
Inhaler in Indonesia as evidence-
based medicine product
Physicians using Convideica (IM
and IH) as a booster and
Pediatric by recommendation
from MoH
escalate information by media
partner about the clinical trial
and product usage for the HCP’s
& Patients
Conduct the Advisory board
Meeting and expert forum
especially Pediatricians
30%
budget
Collaborating with MoH, KOL as
Principal Investigator and clinical
trial to convince usage of the
product
All Indonesian people above 6
years old, as a booster or
initiation dose
Convidecia as a booster and
standard initiation for children
Execution excellent all the MKT
activities by identify the
market needs
30%
budget
 THANK YOU!

Jl. Rawa Gelam V Blok L, Kav.11 – 13

PT Etana Biotechnologies Indonesia Kawasan Industri Pulogadung, Jakarta Timur https://www.id.etanabiotech.com/
Indonesia 13930