创新药研发充满荆棘，近期多家药企接连宣布“折戟”

制药网2025-12-18

创新药被喻为医药行业的“皇冠明珠”，成功上市往往意味着巨额回报与生命希望。但近期多家药企密集宣布研发失败或暂停的消息，再次揭开了这顶“皇冠”下的残酷真相——创新药研发从来都是一条周期漫长、成本高企、失败率惊人的“荆棘之路”。如赛诺菲近日公告称，公司研发的治疗晚期多发性硬化症的药物tolebrutinib在一项针对原发性进展型多发性硬化症的后期试验中，未能延迟患者残疾的进展。其PERSEUS 3期...

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Recently, many pharmaceutical companies have successively announced \"collapse\"","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"560600":1.86,"SNY":1.91},"content_text":"创新药被喻为医药行业的“皇冠明珠”，成功上市往往意味着巨额回报与生命希望。但近期多家药企密集宣布研发失败或暂停的消息，再次揭开了这顶“皇冠”下的残酷真相——创新药研发从来都是一条周期漫长、成本高企、失败率惊人的“荆棘之路”。如赛诺菲近日公告称，公司研发的治疗晚期多发性硬化症的药物tolebrutinib在一项针对原发性进展型多发性硬化症的后期试验中，未能延迟患者残疾的进展。其PERSEUS 3期研究(临床研究标识符：NCT04458051)结果显示，tolebrutinib在延缓原发性进展型多发性硬化症患者出现6个月复合确认残疾进展的时间方面，未达到其主要终点。多发性硬化症是一种影响大脑和脊髓的复杂疾病，会导致肌肉痉挛、麻木和疲劳等症状。该病有几种类型，常见的是病情突然恶化期与恢复期交替出现。而在原发性进展型多发性硬化症中，症状会持续恶化，没有任何恢复期。赛诺菲表示将不再就该适应症寻求监管批准，该适应症患者约占患者总数的10%。生物技术公司Arcus Biosciences与合作伙伴吉利德近日也联合宣布，正式终止PD-1+TIGIT+化疗联合一线治疗胃癌的III期临床试验STAR-221，理由是该研究在中期分析中显示无效。根据研究结果显示，与对照组纳武利尤单抗联合化疗相比，domvanalimab联合方案未能显著延长患者总生存期，试验未达到其主要终点。尽管两组的安全性相似，未发现新的安全性信号，但疗效不足的事实已足以让两家公司果断止损。此外，第一三共(Daiichi Sankyo)与默沙东(Merck & Co.)合作的B7-H3 ADC药物Ifinatamab Deruxtecan (I-DXd)，其针对小细胞肺癌的关键性III期研究 IDeate-Lung02 也确实已在全球范围暂停。科伦博泰自主研发的HER2靶向ADC药物博度曲妥珠单抗治疗三线HER2阳性乳腺癌上市审批已被国家药监局终止……业内表示，这些失败案例并非个例，而是行业常态。创新药从早期研发到上市，周期长，成功率低，研发成本高。漫长的研发周期中，任何环节的疏漏都可能导致满盘皆输，从靶点选择、分子设计到临床试验，每一步都暗藏风险。但研发失败并非终点，聪明的企业总能在挫折中调整航向。如上述Arcus在STAR-221失败后迅速战略重组，公司宣布立即停止所有与domvanalimab在上消化道肿瘤领域的开发工作，包括同步终止正在进行的II期EDGE-Gastric研究。取而代之的是，Arcus将资源集中投向潜在同类佳的HIF-2α抑制剂casdatifan(AB521)以及针对炎症和自身免疫疾病的五个小分子项目。这种灵活的资源调配能力，正是药企抵御风险的核心素养。业内表示，药企建立完善的研发期间风险管理计划，动态监测安全性与有效性数据，能有效降低研发风险。创新药研发的本质，就是在未知中探索确定性。每一次失败都在为后续研究积累经验。如赛诺菲相关人士表示，“我们对今天的结果感到失望；然而，我们确实相信这些结果将增进我们对多发性硬化症潜在疾病生物学的理解。”医药创新关乎生命健康，高风险背后是未被满足的临床需求。面对研发路上的“荆棘”，药企需要以更严谨的研发态度、更灵活的战略布局、更完善的风险管控，在失败中汲取力量。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":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 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2592156513","isCrawlerRequest":true}