汉贝泰®(贝伐珠单抗注射液)
Search documents
复宏汉霖:贝伐珠单抗注射液的生物制品许可申请获美国食品药品管理局受理
Jin Rong Jie· 2026-01-13 09:21
Core Viewpoint - The company, Fuhong Hanlin (02696.HK), has announced that its self-developed Hanbeitai® (Bevacizumab Injection) has had its biological product license application accepted by the U.S. Food and Drug Administration (FDA) [1] Group 1: Product and Indications - The application involves several indications, including: 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. Treatment of metastatic renal cell carcinoma in combination with interferon α 5. Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer 6. Treatment of persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel and cisplatin, or paclitaxel and topotecan [1]
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
Ge Long Hui· 2026-01-13 08:56
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]
复宏汉霖(02696) - 自愿公告 - 重组抗VEGF人源化单克隆抗体注射液HLX04-O用於湿性...
2025-04-02 13:09
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 本公告由上海復宏漢霖生物技術股份有限公司(「本公司」)自願作出,以告知 本公司股東及潛在投資者本公司最新業務更新。 茲提述本公司於2020年10月15日及2023年2月22日刊發的公告,內容有關本 公司將漢貝泰® (貝伐珠單抗注射液)於全球範圍眼科治療用途和/或療法的獨 家權利許可給Essex Bio-Investment Limited及珠海億勝生物製藥有限公司(合 稱「Essex」),並約定與Essex共同開發相關產品。本公司和Essex將分別承擔 20%及80%與相關產品開發活動有關的成本及開支。 本公司董事會(「董事會」)欣然宣佈,近日,重組抗VEGF人源化單克隆抗 體注射液HLX04-O(「HLX04-O」)在一項於濕性年齡相關性黃斑變性(wet age-related macular degener ...