By Fineline Cube 
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that its subsidiary Avanc Pharmaceutical Co., Ltd. has secured National Medical Products Administration (NMPA) approval for a new indication of fovinaciclib, a next‑generation CDK4/6 inhibitor. The drug is now authorized for use in combination with an aromatase inhibitor as first‑line endocrine therapy in adults with hormone‑receptor (HR)‑positive, HER2‑negative locally advanced or metastatic breast cancer.
Key Highlights
| Feature | Detail |
|---|---|
| Drug | Fovinaciclib – oral, potent, highly selective CDK4/6 inhibitor with a novel molecular scaffold |
| New Indication | Combination with aromatase inhibitor for initial endocrine therapy in HR‑positive, HER2‑negative breast cancer |
| Prior Approval | May 2025 – fovinaciclib + fulvestrant for recurrent/metastatic HR‑positive, HER2‑negative breast cancer after endocrine therapy |
| Intellectual Property | Independent IP owned by Fosun Pharmaceutical Group |
| Regulatory Status | Included in China’s 2018 “Major New Drug Innovation” science‑and‑technology project |
Clinical Significance
- Expanded Treatment Options – The new indication widens the therapeutic arsenal for HR‑positive, HER2‑negative breast cancer, a subtype that accounts for ~70 % of all breast cancers.
- First‑Line Efficacy – Early‑phase data suggest superior progression‑free survival compared with aromatase inhibitor alone, positioning fovinaciclib as a potential new standard of care.
- Safety Profile – Consistent with other CDK4/6 inhibitors, the most common adverse events are manageable neutropenia, fatigue, and nausea.
Market Impact
The breast‑cancer CDK4/6 inhibitor market is projected to exceed $10 billion by 2028. Fovinaciclib’s dual approvals strengthen Fosun Pharmaceutical’s pipeline and may accelerate its pursuit of global licensing and commercialization deals, especially with major oncology players in the U.S. and EU.
Company Outlook
Shanghai Fosun Pharmaceutical is leveraging its robust R&D platform and strategic partnerships to pursue further approvals, including potential indications in other HR‑positive cancers. The NMPA clearance for fovinaciclib underscores the company’s commitment to delivering innovative, patient‑centric therapies in the oncology space.-Fineline Info & Tech