POHERDY®1注射液(帕妥珠单抗)
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复星医药(600196.SH):控股子公司药品获美国FDA注册批准
Ge Long Hui· 2025-11-14 20:09
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its self-developed injectable drug POHERDY®1, which is indicated for treating HER2-positive metastatic breast cancer and early-stage breast cancer [1] Group 1 - The FDA approved the Biologics License Application (BLA) for POHERDY®1, a 420mg/14mL injectable solution [1] - The approved indications include treatment for adult patients with HER2-positive metastatic breast cancer who have not previously received anti-HER2 treatment or chemotherapy [1] - The drug is also indicated for use in combination with trastuzumab and chemotherapy for early-stage breast cancer patients, specifically for those with locally advanced, inflammatory, or early-stage breast cancer [1]