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复妥宁®(枸橼酸伏维西利胶囊)
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复星医药1类创新药复妥宁新适应症获批 太美医疗科技提供IRC服务
Zhong Jin Zai Xian· 2025-09-26 05:16
Core Viewpoint - Fosun Pharma's subsidiary, Jinzhou Aohong Pharmaceutical, has received approval from the National Medical Products Administration for its innovative small molecule CDK4/6 inhibitor, Fovisei (Citrus Acid Vovisil Capsules), for a new indication in the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer in premenopausal, postmenopausal, and perimenopausal women [1][3]. Group 1 - The approval allows Fovisei to be used in combination with aromatase inhibitors as initial endocrine therapy for specific breast cancer patients [1][3]. - Breast cancer is a significant health threat to women, with approximately 357,200 new cases reported in China in 2022, making it the second most common malignant tumor among women [3]. - CDK4/6 inhibitors are crucial treatment options for HR+/HER2- populations with endocrine resistance [3]. Group 2 - Fovisei is classified as a first-class new drug, characterized as an oral, potent, highly selective, and structurally novel small molecule medication [3]. - The drug can penetrate the blood-brain barrier, providing new treatment opportunities for patients with brain metastases [3]. - Taimei Medical Technology, as a partner, played a key role in the independent imaging assessment for the drug's approval, leveraging its extensive experience and quality management systems [3].