复宏汉霖：帕妥珠单抗生物类似药HLX11(重组抗HER2结构域II人源化单克隆抗体注射液)获欧洲药品管理局(EMA)人用医药产品委员会(CHMP)积极审评意见

Core Viewpoint - The company has received a positive review from the EMA's CHMP for its biosimilar HLX11, which is recommended for marketing authorization in the EU, pending final decision by the European Commission in the next 2-3 months [1] Group 1: Regulatory Approvals - HLX11's marketing authorization application (MAA) has been accepted by the EMA, and the final decision will be based on the CHMP's positive opinion [1] - The company has also received GMP certificates from the Belgian Federal Agency for Medicines and Health Products, confirming that HLX11's production lines meet EU GMP standards [1] Group 2: Product Development and Partnerships - HLX11 is a biosimilar to Perjeta (pertuzumab), and the positive review is based on data demonstrating high similarity in quality, safety, and efficacy [1] - The company has an exclusive licensing agreement with Organon LLC for the commercialization of HLX11 outside of China and Hong Kong, Macau, and Taiwan [2] - The product has received various regulatory acceptances, including NDA acceptance by the NMPA in December 2024 and BLA approval by the FDA in November 2025 [2] Group 3: Market Potential - The global sales of pertuzumab products are projected to be approximately $3.304 billion in 2024, indicating significant market potential for HLX11 as a biosimilar [2]