复宏汉霖(02696.HK)旗下药品HLX02营销授权申请获欧盟委员会批准
复宏汉霖-B(02696.HK)公布,其商务合作夥伴Accord Healthcare S.L.U.递交的HLX02营销授权申请获欧盟委员会批准。获批後,HLX02在所有欧盟成员国及冰岛、列支敦士登和挪威获得集中上市许可。
HLX02是公司按照中国及欧盟生物类似药指导原则自主开发的单抗生物类似药,是用於HER2阳性的早期乳腺癌、HER2阳性的转移性乳腺癌,以及未经治疗的HER2阳性的转移性胃癌或胃/食管交界处腺癌治疗。
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