By Fineline Cube 
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that its Class 1 chemical drug Foritinib Succinate Capsules (SAF‑189) has received approval from China’s National Medical Products Administration (NMPA) to proceed with clinical trials. The drug targets ALK‑positive and ROS1‑positive non‑small‑cell lung cancer (NSCLC) patients who have undergone radical tumor resection and are in the adjuvant setting (stage IB‑IIIA).
What Foritinib Brings to the ALK‑NSCLC Landscape
- Targeted Small‑Molecule – Designed to inhibit ALK and ROS1 tyrosine‑kinases, offering a precision‑medicine approach.
- Central Nervous System (CNS) Penetration – Preclinical data show significant activity against CNS metastases, a common hurdle in ALK‑NSCLC therapy.
- Favorable Safety Profile – Early clinical studies report manageable adverse events with low incidence of grade 3/4 toxicity.
Development Partnership & Commercialization Rights
| Entity | Role | Key Details |
|---|---|---|
| Fosun Pharma | Lead developer & marketer in China | Holds exclusive rights to develop, trial, and commercialize Foritinib within China. |
| Chongqing Fochon Pharmaceuticals | Co‑research partner | Joint preclinical work with Shanghai Institute of Materia Medica. |
| Shanghai Institute of Materia Medica (CAMS) | Academic collaborator | Provided pivotal preclinical data supporting CNS efficacy. |
Trial Design & Patient Population
- Phase I/II Adjuvant Trial – Enrolling patients with resected stage IB‑IIIA ALK‑/ROS1‑positive NSCLC.
- Primary Endpoint – Disease‑free survival (DFS) at 24 months.
- Secondary Endpoints – Overall survival (OS), CNS relapse rate, and safety/tolerability.
Strategic Implications for Fosun Pharma
- First‑In‑Class Adjuvant Therapy – Addresses an unmet need for patients who have completed surgery but remain at high risk of recurrence.
- Portfolio Expansion – Adds a targeted oncology asset to Fosun’s growing drug pipeline.
- Regulatory Momentum – NMPA approval positions Fosun for a timely Phase III application and potential FDA interest.-Fineline Info & Tech