项目代号:HLX11)注射液
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复星医药控股子公司药品获美国FDA注册批准
Zhi Tong Cai Jing· 2025-11-14 09:13
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received FDA approval for its biologics license application (BLA) for the injection of POHERDY1, a drug indicated for HER2-positive metastatic breast cancer and early-stage breast cancer treatment [1] Group 1: FDA Approval Details - The FDA approved POHERDY1 for use in combination with trastuzumab and docetaxel for adult patients with HER2-positive metastatic breast cancer who have not previously received anti-HER2 treatment or chemotherapy [1] - The drug is also approved as part of a treatment regimen for early breast cancer, specifically for HER2-positive locally advanced, inflammatory, or early breast cancer patients with tumors larger than 2 cm or positive lymph nodes [1] - Additionally, it is indicated for adjuvant treatment in adult patients with HER2-positive early breast cancer at high risk of recurrence [1]