复宏汉霖(02696):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

智通财经
28 Jul

智通财经APP讯,复宏汉霖(02696)发布公告,近日,HLX14获EMA人用医药产品委员会(Committee for Medicinal Products for Human Use,“CHMP”)积极审评意见,推荐批准HLX14的上市许可申请。CHMP的审评意见将会被递交至欧盟委员会(European Commission,“EC”),EC将参考该意见并在未来2-3个月做出最终审查决定。一旦获得EC批准,HLX14的集中上市许可将在所有欧盟成员国及欧洲经济区(EEA)国家冰岛、列支敦士登和挪威生效。

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