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石药集团(01093.HK)附属胃癌获美国孤儿药资格认定
阿思达克 11-24 17:00
石药集团(01093.HK)公布,附属石药集团中奇制药技术(石家庄),自主研发的抗体药物偶联物(ADC)SYSA1801获得美国食品药品监督管理局(FDA)颁发针对治疗胃癌(包括胃食管交界处癌)的孤儿药资格认定。

该孤儿药资格认定将使集团可与美国药监局密切沟通,并加快SYSA1801的临床开发、注册及上市速度。集团计划於2021年提交该在研药物於中国及美国的临床试验申请。

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