Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has received acceptance from the FDA for its Biologics License Application (BLA) for Hanbeitai® (Bevacizumab Injection), indicating a significant step forward in its drug development pipeline [1] Group 1: FDA Acceptance - The FDA has accepted the BLA for Hanbeitai®, which is a major milestone for the company [1] - The application includes multiple indications, showcasing the drug's potential versatility in treating various cancers [1] Group 2: Indications Included - The BLA covers the following indications: 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]
复宏汉霖(02696)：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