Core Viewpoint - The company has received a positive review from the CHMP for its biosimilar HLX11, which is a competitor to Perjeta®, and is awaiting final approval from the European Commission [1][2]. Group 1: Regulatory Approvals - HLX11 has received a positive opinion from the CHMP, which will be submitted to the European Commission for final review in the next 2-3 months [1]. - If approved by the EC, HLX11 will be granted centralized marketing authorization across all EU member states and EEA countries [1]. - The company has also received GMP certificates from the Belgian Federal Agency for Medicines and Health Products, confirming compliance with EU GMP standards [1]. Group 2: Product Development and Market Potential - HLX11 is a biosimilar of the drug Perjeta® and was developed by the company [2]. - The company has entered into an exclusive licensing agreement with Organon LLC for the commercialization of HLX11 outside of China and Hong Kong, Macau, and Taiwan [2]. - According to IQVIA data, the global sales of Perjeta® are projected to be approximately $3.304 billion in 2024 [2].
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(C...