Fosun Pharma has received approval in its China homeland for CDK4/6 inhibitor FCN-437c in combination with aromatase inhibitors as first-line endocrine therapy for HR-positive HER2-negative advanced breast cancer. The orally available small molecule initially gained approval in May 2025 for second-line treatment with fulvestrant after endocrine therapy progression. FCN-437c was developed through China's National Major New Drug Innovation program with novel chemical structure differentiating it from established CDK4/6 inhibitors.

The expanded indication covers premenopausal, perimenopausal and postmenopausal women, providing broader patient access to CDK4/6 inhibition in first-line setting. Breast cancer remains China's most common female malignancy with HR-positive subtypes representing approximately 70% of cases. Fosun's subsidiary Ahon Pharma will commercialise FCN-437c, strengthening the company's oncology portfolio.

According to PharmCube's NextBiopharm® database, FCN-437c is also being developed for a solid tumours indication. Click here to request a free trial for NextBiopharm®.