Group 1 - The core point of the news is that HLX14, a biosimilar to Prolia, has received a positive opinion from the EMA's CHMP, recommending approval for its marketing authorization application [1] - The CHMP's positive opinion is based on data comparing HLX14 with the reference drug Prolia, including similarity studies and clinical comparisons [1][2] - If approved by the European Commission, HLX14 will be granted marketing authorization across all EU member states and EEA countries [1] Group 2 - HLX14 is developed by the company as a biosimilar for treating osteoporosis in postmenopausal women at high risk of fractures, among other indications [2] - The company has entered into an exclusive licensing agreement with Organon LLC for the commercialization of HLX14 outside of China and the Hong Kong-Macau-Taiwan region [2] - The marketing authorization applications for HLX14 have been accepted by EMA, Health Canada, and the FDA in 2024 [2]
复宏汉霖(02696.HK)：地舒单抗生物类似药HLX14(重组抗RANKL全人单克隆抗体注射液)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