复宏汉霖(02696.HK):汉贝泰®(贝伐珠单抗注射液)的生物制品许可申请(BLA)获美国FDA受理

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), announced that its self-developed drug Hanbeitai® (Bevacizumab Injection) has received acceptance for its Biologics License Application (BLA) by the U.S. Food and Drug Administration (FDA) [1] Summary by Categories Product Development - The BLA application includes indications for multiple cancers: 1. Metastatic colorectal cancer 2. First-line treatment of unresectable locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel 3. Recurrent adult glioblastoma 4. Metastatic renal cell carcinoma in combination with interferon α 5. Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer 6. Persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel and cisplatin, or paclitaxel and topotecan [1]

Shanghai Henlius-复宏汉霖(02696.HK):汉贝泰®(贝伐珠单抗注射液)的生物制品许可申请(BLA)获美国FDA受理 - Reportify