智通财经APP获悉,荃信生物-B(02509)尾盘涨超30%,截至发稿,涨30.03%,报11.3港元,成交额388.83万港元。
消息面上,荃信生物公告,乌司奴单抗注射液(QX001S 商品名:赛乐信)新增儿童斑块状银屑病适应症的补充申请获得国家药品监督管理局批准。据悉,去年11月初,QX001S上市许可申请获得国家药监局(NMPA)批准,用于治疗成年中重度斑块状银屑病。赛乐信是中国首个获批的乌司奴单抗注射液生物类似药,同时也是荃信生物首个商业化的产品。
值得注意的是,荃信生物今年2月公告,乌司奴单抗注射液(静脉输注)和乌司奴单抗注射液(研发代码:QX001S/HDM3001-2)用于克罗恩病的上市许可申请和补充申请获得受理。QX001S是原研产品Stelara的生物类似药,由中美华东与公司共同推进III期临床试验研发。
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