全国招募患者，

通过乐城先行区加速产品上市
启动收费治疗，
获得收入

乐城落地

① 乐城特许落地
使用申请

全国专家赴乐城
② RWD 路 开展治疗： a. 单独提交 NMPA
径申请 KOL 工作和培 NMPA 审核后批准
训提前
乐城注册

患者治疗与随访 真实世界 更大范围学术推广，更

RWD 收集 证据整理 快进入全国医院，销售
获得收入 更大范围学术推广，更
快进入全国医院，销售
启动临床试验 提交 NMPA 获得收入

NMPA 注册

临床试验开展、随 b. 作为注册研究 NMPA 优先审批，

产品检测 访、收集数据、分 的补充资料提 审核后批准
析结果 交 NMPA

1 年， 2 年， 3 年…

临床试验开展、
随访、收集数据、 NMPA 排队，审 开始进院，销售，
启动临床试验 分析结果 核后批准 获得收入

常规路径

产品检测 提交 NMPA 开始学术推广和

KOL 培训
 How can Lecheng Pilot Zone accelerate the launch of your products in China
Paid treatment to patients
recruited nationwide, and
earn income immediately
Franchise use
in Lecheng
① Application of
Franchise use in
Lecheng Pilot Zone
Training the a. Submit RWD Nationwide academic
trainer(KOLs from to NMPA as promotion, faster access
② Application of nationwide) in only clinical to hospitals, and faster
RWD path Lecheng data sales revenue
RWD path in
Lecheng
Patients recruitment, Real world Launch approval
treatment and follow up, data from NMPA
real world data collection analysis
Submit Registration Accelerate
Clinical trial application to NMPA approval from
Kick off NMPA
NMPA path
Type inspection Patients recruitment, b. Submit RWD to Nationwide academic
, etc treatment and follow up, NMPA as promotion, faster access
trial data collection & support data to hospitals, and faster
analysis sales revenue

Patients recruitment,
1yr, 2yrs, 3yrs…
treatment and follow up, Receive approval Access to hospitals,
Clinical trial trial data collection & after queue up in and earn sales
Kick off analysis NMPA revenue
NMPA path

Type inspection, Submit Registration Training the trainer,

etc application to NMPA academic promotion