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中国生物制药(01177.HK)治疗类风湿性关节炎药物“枸橼酸托法替布片”获药品注册批件
格隆汇 10-09 17:33

格隆汇10月9日丨中国生物制药(01177.HK)发布公告,公司附属公司正大天晴药业集团股份有限公司开发的治疗类风湿性关节炎药物“枸橼酸托法替布片”,已获国家药品监督管理局颁发药品注册批件。该产品为国内同品种首家获批,且率先完成生物等效性研究,按照化药新4类申报,视同通过一致性评价。

枸橼酸托法替布是全球首个治疗类风湿关节炎的小分子靶向JAK激酶抑制剂。凭藉其靶向选择性,枸橼酸托法替布的疗效和安全性与生物制剂相当,且口服方便,价格便宜,更容易被广大患者所接受。

目前国内市场仅有枸橼酸托法替布片的原研药在销售,昂贵的治疗费用使该药物的临床应用受到一定的局限。集团研制的枸橼酸托法替布片日后上市,国外药企垄断的局面将被打破,国内市场供需规模可迅速扩大,为广大类风湿性关节炎患者带来福音,产生良好的社会和经济效益。

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