Fosun Pharma drug gets new breast cancer indication approval

Shanghai Fosun Pharmaceutical Group announced that its controlled subsidiary, Jinzhou Aohong Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for a new indication for its drug, FCN-437c (P-FCN-437c). The drug, known as Volasertib Citrate Capsules, is now approved for initial endocrine therapy in adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor.

This new approval follows the drug's previous approval in May 2025 for another indication in mainland China, concerning patients with recurrent or metastatic adult breast cancer after prior endocrine therapy. Fosun Pharma's total research and development investment for FCN-437c reached approximately CNY 617 million as of August 2025.

FCN-437c is an innovative small-molecule CDK4/6 inhibitor, fully owned by Fosun Pharma, and was part of the national "Major New Drug Innovation" science and technology project in 2018. The global sales of CDK4/6 inhibitors were approximately $14.912 billion in 2024, according to IQVIA MIDAS™ data.