Shanghai Fosun Pharmaceutical (Group) Co.,Ltd. (600196.SH) announced that its controlling subsidiary Jinzhou Aohong Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for a new indication application for Fuweisili citrate capsules (trade name: Futoning, project code: FCN-437c).

The newly approved indication is for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, to be used in combination with aromatase inhibitors as initial endocrine therapy.

The drug is an innovative small molecule CDK4/6 inhibitor with proprietary intellectual property rights owned by the Group. It is an oral, potent, highly selective, novel-structure innovative small molecule drug that was included in the national "Major New Drug Development" major science and technology project in 2018.