By Fineline Cube 
China’s Beijing Aosaikang Pharmaceutical Co., Ltd. (SHE: 002755) announced today that the first patient has been dosed in a pivotal Phase III registrational study of its Class 1 innovative drug ASK202 in combination with leatinib for the treatment of locally advanced or metastatic non‑small cell lung cancer (NSCLC). The trial targets patients who have failed epidermal growth factor receptor tyrosine kinase inhibitor (EGFR‑TKI) therapy and have MET amplification/overexpression.
Trial Design
- Population – Adults with advanced NSCLC harboring EGFR mutations and MET amplification/overexpression after progression on EGFR‑TKI therapy.
- Intervention – Oral ASK202 (c‑MET inhibitor) + leatinib (MET‑TKI).
- Phase – III, registrational.
- Primary Endpoint – Progression‑free survival (PFS) versus standard of care.
- Enrollment Goal – 600 patients across 30 sites in China and the United States.
ASK202 – A Novel c‑MET Inhibitor
- Mechanism – Highly selective oral c‑MET inhibitor with independent IP protection.
- Preclinical Efficacy – Demonstrated potent activity in EGFR‑TKI–resistant, MET‑amplified NSCLC models.
- Safety Profile – Early Phase I data show manageable adverse events and a favorable pharmacokinetic (PK) profile.
Strategic Significance
- First‑In‑Class Combination – The ASK202–leatinib pair represents a new therapeutic strategy for a hard‑to‑treat subset of NSCLC patients.
- Accelerated Development Pathway – Successful trial outcomes could fast‑track regulatory approval in China and the U.S.
- Competitive Advantage – Aosaikang’s IP‑protected c‑MET platform positions it ahead of other MET‑targeted agents still in earlier development stages.-Fineline Info & Tech