Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) has announced that another market approval filing for its FCN-437c has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment option for patients with hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer.
Indication and Treatment Protocol
The Chinese firm’s bid for the small molecule drug candidate this time is indicated for the treatment of HR+ and HER2- locally advanced or metastatic breast cancer. FCN-437c should be used together with an aromatase inhibitor as the initial endocrine therapy for premenopausal, postmenopausal, and perimenopausal women with breast cancer.
Drug Profile and Development
FCN-437c is an oral, highly selective CDK4/6 inhibitor being developed to treat advanced/metastatic solid tumors, including HR+ and HER2- advanced breast cancer. The drug is also awaiting regulatory decisions in China for the treatment of HR+ and HER2- locally advanced or metastatic breast cancer in patients with disease progression after endocrine therapy combined with fulvestrant.
Significance of the Market Filing
The acceptance of FCN-437c for review by the NMPA is a crucial milestone for Fosun Pharmaceutical. It brings the company one step closer to bringing this innovative treatment to market, potentially improving the management of advanced breast cancer for patients in China and beyond.-Fineline Info & Tech
