Yongchao Li

Medical Director

About

Medical Director specializing in oncology drug development with deep expertise in ADCs, PDCs, mAbs, and targeted therapies. I lead early- to late-phase clinical development, regulatory strategy, medical oversight, and cross-functional coordination. Successfully contributed to China’s first approved ADC (Disitamab Vedotin/RC48) and secured multiple IND and FDA ODD approvals. Passionate about advancing novel oncology therapeutics through strategic clinical development and strong investigator collaboration.

Country

China

City

Pudong

Industry

Pharmaceuticals

Skill

China CFDA and U.S. FDA communications, Phase I/II/III clinical trials design in Oncology, Excellent cross-functional collaboration and communication skills, medical strategy, Pharmaceutics, Investigational New Drug Application (IND), Clincal devlopment plan design, Medical Affairs, BD communication, Clincal trial design

Experience

Medical Director

Tianjin Conjustar Co, Ltd.

2023-4 - 2025-8 · 2 yrs 5 mos

Pudong, Shanghai, China

Led Phase I study design and IND submissions (four filings) for SC-101 (Nectin-4 PDC) and SC-102 (EphA2 PDC) in China and the U.S.; all approved. Obtained FDA Orphan Drug Designation for SC-101 in esophageal cancer. Led Phase IIa study design for SC-101 in NECTIN4 gene-amplified solid tumors. Managed KOL selection and engagement for ongoing Phase I and IIa studies. Developed medical strategy, assessed study feasibility, and provided safety oversight for ongoing trials. Coordinated medical, PV, biostatistics, and clinical pharmacology teams across CRO partners. Provided medical insights to support BD discussions. Prepared and submitted SC-101 Phase I results to ESMO 2025, accepted for poster presentation.

Senior Medical Manager

Minghui (shanghai) Biopharma

2022-7 - 2022-12 · 6 mos

Pudong, Shanghai, China

Led IND submissions for MHB036C (TROP-2 ADC) and MHB018A (IGF-1R mAb for TED); both approved. Developed medical strategy for MHB036C and identified lead principal investigators.

Senior medical manager

Keymed Biosciences

2021-10 - 2022-7 · 10 mos

Dongcheng District, Beijing, China

Provided medical strategy and safety monitoring for Phase I studies of CM313 (CD38 mAb) and CM336 (BCMA×CD3 bispecific antibody) in RRMM. Managed principal investigator relationships. Led IND submission for a Phase Ib/II combination study of CM313; approved.

Medical Manager

RemeGen荣昌生物

2019-5 - 2021-10 · 2 yrs 6 mos

Chaoyang District, Beijing, China

Led IND submission for RC108 (c-Met ADC); approved. Oversaw safety monitoring and medical strategy for Phase I studies of RC88 (MSLN ADC) and RC108. Key contributor to the BLA submission for Disitamab Vedotin (RC48), including CSR authoring, labeling documentation, protocol writing for the confirmatory Phase III trial, and participation in CDE panel meetings. Designed and developed the Phase II study of RC48 in melanoma.

Associated Medical Director

Yuce Biotech.

2018-5 - 2019-5 · 1 yr 1 mo

Shenzhen, Guangdong, China

Led study design and medical strategy for clinical research programs. Managed medical affairs and supervised the medical team. Provided medical insights to support commercial activities. Led scientific data generation and presentations at AACR and CSCO.