2025年上半年，NMPA批准创新药盘点

药智网2025-07-14

2025年上半年，CDE共受理6213个品种，同比增长15.83%，化药仍为主体，达4087个品种；中药818个品种；生物制品1305个品种。完成审评5848个品种，同比增长9.49%；共计批准创新药上市54个品种（根据药智数据企业版——药品注册与受理数据库统计，品种根据药品+企业维度统计）。审评情况2025年上半年，CDE已完成审批品种共计5848个（受理号8210个），同比增长9.49%，申请...

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href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250714094241a448a6a3&s=b><strong>药智网</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>2025年上半年，CDE共受理6213个品种，同比增长15.83%，化药仍为主体，达4087个品种；中药818个品种；生物制品1305个品种。完成审评5848个品种，同比增长9.49%；共计批准创新药上市54个品种（根据药智数据企业版——药品注册与受理数据库统计，品种根据药品+企业维度统计）。审评情况2025年上半年，CDE已完成审批品种共计5848个（受理号8210个），同比增长9.49%，申请...</p>\n\n<a 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Biopharma的盐酸来罗西利片。其余如四川科伦博泰的塔戈利单抗注射液（鼻咽癌）、江苏恒瑞的苹果酸法米替尼胶囊（宫颈癌）、百济神州的注射用泽尼达妥单抗（胆道癌）等实体瘤也迎来多款创新药物。除肿瘤领域，铂生卓越的艾米迈托赛注射液获NMPA附条件批准上市，用于治疗14岁以上消化道受累为主的激素治疗失败的急性移植物抗宿主病，成为国内首个获批上市的干细胞疗法。信达生物研发的首个GCG/GLP-1双受体激动减重药物——玛仕度肽注射液，其临床研究表明，使用玛仕度肽体重降幅达21%，降低肝脏脂肪含量超80%，腰围减少达11cm，颈围减少达3cm，兼顾改善血糖、血压、血脂、血尿酸和转氨酶水平等心血管及代谢指标，实现体重与代谢指标双改善。海思科的安瑞克芬注射液作为国内首批获得镇痛适应证的高选择性外周k受体激动剂，开启术后镇痛新时代。表1 2025年1~6月创新药上市申请审评结论情况注：数据统计至2025年7月9日数据来源：药智数据企业版——药品注册与受理数据库声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 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