港股异动 | 康希诺生物(06185)涨超5% 生产基地获得马来西亚PIC/S GMP认证

智通财经
Mar 06

智通财经APP获悉,康希诺生物(06185)涨超5%,截至发稿,涨5.53%,报33.98港元,成交额2325.1万港元。

消息面上,康希诺生物昨晚公布,公司自主研发的ACYW135群脑膜炎球菌多糖结合疫苗(CRM197载体)曼海欣®(MCV4)和13价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)优佩欣®(PCV13i)生产基地通过了马来西亚药监局(以下简称“NPRA”)PIC/S GMP符合性检查,并于近日获得NPRA颁发的GMP证书。

公司指,此次通过PIC/S GMP认证,标志着康希诺生物的生产和质量管理体系已达到国际药品检查合作组织(PIC/S)GMP标准要求。这一成果不仅将有助于推进曼海欣®(MCV4)和优佩欣®(PCV13i)在马来西亚的注册上市,也为两款疫苗在其他PIC/S成员国家和地区的准入奠定了重要基础,为公司创新疫苗的国际化布局提供关键支撑。

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