By Fineline Cube 
Guangzhou Baiyunshan Pharmaceutical Co., Ltd. (SHA: 600332) announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has provided feedback allowing the company to commence an open‑label, multicenter Phase I/II clinical trial of its selective RET small‑molecule inhibitor, BYS10 tablets. The trial will assess the safety, tolerability, pharmacokinetics, and efficacy of BYS10 in patients with advanced solid tumors harboring RET gene fusions or mutations.
Drug Profile
| Feature | Detail |
|---|---|
| Mechanism | Highly selective RET kinase inhibitor |
| Dosage Forms | 25 mg & 100 mg tablets |
| Indications | Advanced solid tumors – non‑small cell lung cancer (NSCLC), medullary thyroid carcinoma (MTC), and other RET‑mutated malignancies |
| Phase I Results | Demonstrated potent, durable anti‑tumor activity with favorable tolerability in RET‑mutant NSCLC, TC, and MTC patients |
Trial Design & Regulatory Path
- Open‑label, multicenter Phase I/II study to evaluate safety, PK, and efficacy.
- CDE Approval: Feedback received on September 15, 2025; trial can now begin.
- Future Pathway: Successful Phase II single‑arm trial could support marketing approval under NMPA’s accelerated review process.
Market Implications
- Targeted Oncology Gap – RET‑driven cancers represent ~1–2 % of NSCLC and ~5 % of thyroid cancers; current therapeutic options are limited.
- Competitive Landscape – BYS10 may compete with existing RET inhibitors (e.g., pralsetinib, selpercatinib) but offers a potentially more convenient oral tablet formulation.
- Strategic Positioning – Successful outcomes could position Baiyunshan as a key player in the rapidly expanding precision‑oncology market in China.
Company Outlook
Guangzhou Baiyunshan Pharmaceutical’s progression to Phase I/II underscores its commitment to developing next‑generation targeted therapies. The company’s ability to navigate the NMPA’s rigorous evaluation process and secure timely trial initiation strengthens its pipeline depth and investor appeal.-Fineline Info & Tech