智通财经APP获悉,海普瑞(09989)早盘涨超8%,截至发稿,涨8.31%,报4.31港元,成交额1822.56万港元。
消息面上,海普瑞公布,公司于近日收到国家药品监督管理局核准签发的《药物临床试验批准通知书》,批准注射用H1710开展临床试验。据悉,H1710是公司自主研发的候选药物,公司具有H1710的全球开发及商业化权益。截至本公告日,于全球范围内尚无同一分子机制的同类产品上市。
此外,海普瑞已于近日收到波兰卫生监督机构根据欧洲药品管理局相关规定发出的“药品GMP证书”,认证产品为PFS1-PFS3灌装生产线、PFSP1-PFSP4包装线,认证产品是依诺肝素钠预灌注射液。公司指,海普瑞坪山园区的新建预灌封制剂生产线项目去年已完成并首次通过欧盟GMP认证。根据欧盟成员国之间的GMP互认制度,本次通过GMP认证表明本次接受认证的生产线已符合欧盟GMP标准。
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