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长春高新:GenSci128片获得美国FDA孤儿药资格认定
人民财讯3月24日电,长春高新(000661)3月24日公告,子公司金赛药业收到美国食品药品监督管理局(简称“FDA”)通知,授予GenSci128片孤儿药资格认定,用于胃癌的治疗。此外,金赛药业收到国家药监局核准签发的《受理通知书》,金赛药业GenSci161注射液的境内生产药品注册临床试验申请获得受理。该药品适应症为非感染性葡萄膜炎。