复宏汉霖:汉贝泰 (贝伐珠单抗注射液)的生物制品许可申请(BLA) 获美国食品药品管理局(FDA)受理

Core Viewpoint - The company, Fuhong Hanlin (02696), has announced that its self-developed Hanbeitai (Bevacizumab Injection) has had its Biologics License Application (BLA) accepted by the U.S. Food and Drug Administration (FDA) [1] Group 1: Product Approval - The BLA acceptance involves multiple indications, including metastatic colorectal cancer [1] - It also includes first-line treatment for unresectable locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel [1] - Other indications include recurrent adult glioblastoma, metastatic renal cell carcinoma in combination with interferon α, epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, and persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan [1]