Shanghai Fosun Pharmaceutical(02196): The drug registration application for the new indication of Citric Acid Oseltamivir Capsules has been approved by the National Medical Products Administration.

Shanghai Fosun Pharmaceutical (02196) announced that its controlling subsidiary, Jinzhou Aohong Pharmaceutical Co., Ltd., recently received approval from the National Medical Products Administration for a new indication for its drug, Focitidine Fosinib Capsules (trade name: Fotuning, project code: FCN-437c). The approved indication is for use in adult patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, in combination with aromatase inhibitors as initial endocrine therapy. This drug is an innovative small molecule CDK4/6 inhibitor with independent intellectual property rights owned by the group (including the company and its subsidiaries/units). It is an orally administered, potent, highly selective, and structurally novel innovative small molecule drug that was included in the National "Major New Drug Innovation" major scientific project in 2018. In addition to the newly approved indication, another indication of this drug (combination with fulvestrant for hormone receptor-positive, HER2-negative adult patients with recurrent or metastatic breast cancer who have previously received endocrine therapy) was approved for sale in China (excluding Hong Kong, Macao, and Taiwan) in May 2025. As of August 2025, the group's cumulative research and development investment in this drug is approximately 617 million yuan (unaudited). According to the latest IQVIAMIDAS data, in 2024, the global sales of CDK4/6 inhibitors were approximately 14.912 billion US dollars. The approval of the new indication will further enhance the market competitiveness of this drug and bring more treatment options to breast cancer patients in China.