复宏汉霖(02696)：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 opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its biosimilar HLX11, which is a monoclonal antibody similar to Perjeta, and is awaiting final approval from the European Commission [1][2]. Group 1 - HLX11's positive review is based on data demonstrating its high similarity in quality, safety, and efficacy compared to the reference drug Perjeta, including similarity studies and pharmacokinetic studies [2]. - The company received two GMP certificates from the Belgian Federal Agency for Medicines and Health Products in June 2025, confirming that HLX11's production line meets EU GMP standards [2]. - HLX11 is a biosimilar developed by the company, with a global commercialization agreement signed with Organon LLC in June 2022, excluding China and Hong Kong, Macau, and Taiwan [3]. Group 2 - The New Drug Application (NDA) for HLX11 was accepted by the National Medical Products Administration (NMPA) in December 2024, and the Marketing Authorization Application (MAA) was accepted by the EMA in March 2025 [3]. - The New Drug Submission (NDS) for HLX11 was accepted by Health Canada in May 2025, and the Biologics License Application (BLA) was approved by the FDA in November 2025 [3]. - According to the latest data from IQVIA, the global sales of the reference drug Perjeta are projected to be approximately $3.304 billion in 2024 [3].