恒瑞医药：阿得贝利单抗注射液新适应症的药品上市许可申请获国家药监局受理

Core Viewpoint - Heng Rui Medicine's subsidiary, Shanghai Shengdi Pharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the marketing authorization application of the new indication for Adebeli monoclonal antibody injection [1] Group 1: Product Information - Adebeli monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody developed by the company, which can specifically bind to the PD-L1 molecule to block the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1] - Similar products abroad include Atezolizumab (brand name: Tecentriq), Avelumab (brand name: Bavencio), and Durvalumab (brand name: Imfinzi), which have been approved for sale in the United States, with Atezolizumab and Durvalumab also approved in China [1] Group 2: Market Context - The global sales of Atezolizumab, Avelumab, and Durvalumab are projected to total approximately $9.648 billion in 2024 [1] - Domestic competitors include similar products such as Envolimab from CanSino Biologics, Sugilumab from CStone Pharmaceuticals, and Bemarituzumab from Zhenhua Tianqing Pharmaceutical, all of which have been approved for sale [1] Group 3: R&D Investment - The cumulative R&D investment related to Adebeli monoclonal antibody injection has reached approximately 939 million yuan [1]