By Fineline Cube 
China‑based Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced today that it has filed a New Drug Application (NDA) for HS‑10365 with the National Medical Products Administration (NMPA) of China. The application seeks approval for the treatment of adult patients with locally advanced or metastatic non‑small cell lung cancer (NSCLC) who harbor RET gene fusions.
Product Profile
| Attribute | Details |
|---|---|
| Drug Class | Class 1 innovative small‑molecule RET receptor tyrosine kinase inhibitor |
| Mechanism of Action | Competitive ATP binding to intracellular tyrosine kinase domain → inhibition of RET phosphorylation → suppression of tumor cell proliferation |
| Development Status | Independently developed by Hansoh; NDA filed for first‑in‑class RET‑targeted therapy in China |
Regulatory Milestone
- NDA Submission – 23 Oct 2025 to NMPA
- Target Indication – Adult patients with RET‑fusion‑positive NSCLC
- Next Steps – NMPA review, potential clinical trial prerequisites, and eventual market launch pending approval
Strategic Significance
- Pipeline Diversification – Adds a precision‑oncology asset to Hansoh’s growing oncology portfolio.
- Market Opportunity – RET fusions occur in ~1–2 % of NSCLC cases; a highly selective inhibitor could capture a niche yet unmet need.
- Innovation Leadership – Positions Hansoh as a domestic pioneer in targeted small‑molecule therapies for lung cancer.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech