Shanghai Fosun Pharmaceutical's subsidiary, Aohong Pharmaceuticals, has had its drug registration application for the innovative drug Citrate Favipiravir Capsules accepted by the Center for Drug Evaluation (CDE).
10/01/2025
GMT Eight
On January 9, Shanghai Fosun Pharmaceutical (600196.SH; 02196.HK) announced that its controlling subsidiary, Jinzhou Aohong Pharmaceutical Co., Ltd. ("Aohong Pharmaceutical"), has recently had the drug registration application for the innovative small molecule CDK4/6 inhibitor Palbociclib Citrate Capsules (project code: FCN-437c, hereinafter referred to as "the new drug") accepted by the National Medical Products Administration ("NMPA"). This application is intended for use in combination with aromatase inhibitors as the initial endocrine therapy for premenopausal, postmenopausal, and perimenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.
Palbociclib Citrate Capsules is an orally administered, potent, highly selective, and structurally novel innovative small molecule drug intended for the treatment of advanced metastatic solid tumors (including HR+ HER2-negative advanced breast cancer). This new drug was included in the national "Major New Drug Creation" scientific research project in 2018. The drug registration application for the combination of this new drug with Fulvestrant for the treatment of locally advanced or metastatic breast cancer that has progressed after previous endocrine therapy in HR-positive and HER2-negative patients was also accepted by the NMPA in November 2023.
According to the latest IQVIA MIDASTM data, the global sales of CDK4/6 inhibitors in 2023 are estimated to be around $12.62 billion.
Shanghai Fosun Pharmaceutical, as a China-rooted, innovation-driven global pharmaceutical and health industry group, has established an open and global drug innovation research and development system that integrates independent research and development, collaborative development, licensed introduction, and industrial investment. As a subsidiary of Shanghai Fosun Pharmaceutical, Aohong Pharmaceutical continues to enrich its innovative product pipeline, focusing on the development of differentiated products with high technical barriers, and constantly enhancing the value of the pipeline. Currently, in the areas of neurology, cardiovascular, perioperative, anticancer, and pediatric drugs, Aohong Pharmaceutical has a rich pipeline under research, including first-class and second-class innovative drugs and high-barrier generic drugs.