又一款国产司美格鲁肽报上市！

药事纵横2025-08-07

8月5日，中国国家药监局药品审评中心（CDE）官网公示显示，石药集团以化药注册分类2.2类申报的司美格鲁肽注射液上市申请已正式获得受理。该产品原料完全通过化学合成法制备，成为全球范围内首个采用全化学合成路径开发的司美格鲁肽注射液。作为目前减重领域最大单品，此次申报标志着我国在GLP-1类药物研发领域取得重大突破。据公开资料，本次申报的司美格鲁肽注射液核心原料完全通过化学合成法制备，采用先进的合成、...

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market!","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"01093":0.9},"content_text":"8月5日，中国国家药监局药品审评中心（CDE）官网公示显示，石药集团以化药注册分类2.2类申报的司美格鲁肽注射液上市申请已正式获得受理。该产品原料完全通过化学合成法制备，成为全球范围内首个采用全化学合成路径开发的司美格鲁肽注射液。作为目前减重领域最大单品，此次申报标志着我国在GLP-1类药物研发领域取得重大突破。据公开资料，本次申报的司美格鲁肽注射液核心原料完全通过化学合成法制备，采用先进的合成、纯化和表征技术。该技术路径与传统DNA重组技术相比具有显著优势：制备出的原料纯度更高，避免了生物发酵过程引入的宿主蛋白等免疫原性物质。杂质谱对比研究结果证实，该产品杂质水平明显低于DNA重组技术制备的司美格鲁肽注射液，且在2-8℃长期储存条件下无新杂质产生。这一特性对于保证药物长期使用的安全性具有重要意义。石药集团开发的该产品属于中国化药注册分类2.2类。目前，全球范围内尚无化学合成的司美格鲁肽产品上市，这使得该产品极具临床开发价值与市场潜力。临床进展：糖尿病与减重双赛道并进2024年8月和9月，该产品先后在中国完成治疗2型糖尿病和体重管理的3期临床试验全部受试者入组。临床前研究结果显示，该化学合成产品与DNA重组技术制备的司美格鲁肽注射液具有相似的生物活性和减重效果，体内降糖效果相当。在食蟹猴模型中，该产品展示出一致的代谢特征和安全性，无全身主动过敏反应且局部耐受性良好。2024年3月25日，石药集团公告其司美格鲁肽注射液获国家药监局批准，在中国开展成人超重或肥胖患者的体重管理适应症临床试验，这是该产品继成人2型糖尿病患者的血糖控制后，获批临床试验的第二个适应症。截至目前，国内司美格鲁肽注射液体重管理适应症暂无进口及国内产品上市。国内已有联邦制药、九源基因、健康元等企业获批开展司美格鲁肽注射液减重适应症临床试验。除本次申报上市的司美格鲁肽注射液外，石药集团正在开发GLP-1受体激动剂司美格鲁肽长效注射液（SYH9017），为每月一次给药的司美格鲁肽制剂。该长效产品经皮下注射后形成凝胶贮库，实现药物长效递送。SYH9017已于2024年12月在中国获批临床，适应症为用于减少热量饮食和增加体力活动的基础上对成人超重或肥胖患者的体重管理。根据新诺威披露的投资者关系活动记录，石药百克GLP-1管线产品布局丰富。目前处于临床III期阶段的包括TG103注射液和司美格鲁肽注射液两款产品。司美格鲁肽注射液的减重/糖尿病适应症和TG103注射液减重适应症计划2025年递交上市申请，预计从2026年后陆续获批上市。此外，还有多个产品在早期开发阶段，包括司美格鲁肽长效注射液进入临床I期入组阶段，GLP-1口服小分子片剂已经递交IND申请。百亿蓝海竞争格局初显司美格鲁肽作为目前减重领域的最大单品，市场仍在快速增长。石药集团通过化学合成技术路径切入这一市场，有望打破传统生物制备技术的垄断地位。其产品在纯度、稳定性和生产成本上的潜在优势，可能重塑市场竞争格局。新诺威在2025年3月披露的信息显示，石药百克将持续加强GLP-1系列产品的开发，构建从注射剂到口服剂型、从短效到长效的全剂型产品矩阵。全球尚无化学合成的司美格鲁肽产品上市，石药的突破将改变GLP-1类药物市场格局。随着此次上市申请获得受理，国内糖尿病和肥胖症患者有望在2026年用上这款国产创新药。药事纵横投稿须知：稿费已上调，欢迎投稿","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"1","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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