创新型小分子CDK4/6抑制剂
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上海复星医药(02196.HK):枸橼酸伏维西利胶囊新增适应症获注册批准
Ge Long Hui· 2025-09-15 09:57
Core Insights - Shanghai Fosun Pharmaceutical announced that its subsidiary, Jinzhou Aohong Pharmaceutical, received approval from the National Medical Products Administration for a new indication of the drug FCN-437c (brand name: Fuzhuoning) for use in HR-positive, HER2-negative locally advanced or metastatic breast cancer in adults [1] - The drug is an innovative small molecule CDK4/6 inhibitor with independent intellectual property rights, classified as a new structure oral medication, and was included in the national "Major New Drug Creation" technology major project in 2018 [1] - The cumulative R&D investment for this drug is approximately RMB 617 million (unaudited) as of August 2025 [1] Industry Insights - According to IQVIA MIDAS data, global sales of CDK4/6 inhibitors are projected to reach approximately $14.912 billion in 2024 [2]
复星医药:枸橼酸伏维西利胶囊新增适应症药品注册申请获批
Zhi Tong Cai Jing· 2025-09-15 08:51
Core Viewpoint - Fosun Pharma (600196.SH) announced that its subsidiary, Jinzhou Aohong Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for a new indication for the drug FCN-437c (commercial name: Fuzhuoning), which is a CDK4/6 inhibitor for treating HR-positive, HER2-negative locally advanced or metastatic breast cancer in adults [1] Group 1 - The newly approved indication is for use in combination with aromatase inhibitors as initial endocrine therapy [1] - The drug is an innovative small molecule with independent intellectual property rights owned by the group [1] - FCN-437c was included in the national "Major New Drug Creation" science and technology major project in 2018 [1]