产业新闻 | 诺和诺德向FDA递交CagriSema上市申请；武田下一代小分子疗法达两项3期试验双主要终点……

药明康德2025-12-19

诺和诺德向FDA递交CagriSema上市申请诺和诺德今日宣布，已向美国FDA递交CagriSema的新药申请（NDA）。该疗法拟与减少热量饮食及增加体力活动联合，用于伴有至少一种与体重相关共病的肥胖或超重成人患者，以降低体重并长期维持减重效果。CagriSema是一款由长效胰淀素类似物cagrilintide（2.4 mg）和semaglutide（2.4 mg）组成的固定剂量联合疗法，设计为...

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Takeda's next-generation small molecule therapy reaches two phase 3 trials with dual primary endpoints...","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NVO":1.96,"TAK":1.91},"content_text":"诺和诺德向FDA递交CagriSema上市申请诺和诺德今日宣布，已向美国FDA递交CagriSema的新药申请（NDA）。该疗法拟与减少热量饮食及增加体力活动联合，用于伴有至少一种与体重相关共病的肥胖或超重成人患者，以降低体重并长期维持减重效果。CagriSema是一款由长效胰淀素类似物cagrilintide（2.4 mg）和semaglutide（2.4 mg）组成的固定剂量联合疗法，设计为每周一次皮下注射。根据新闻稿，若获批，CagriSema将成为首个可注射GLP-1受体激动剂+胰淀素类似物的联合治疗方案。本次NDA主要基于两项3期研究结果：REDEFINE 1与REDEFINE 2。其中REDEFINE 1试验结果显示，在不论患者是否持续用药的前提下，CagriSema组在第68周实现了20.4%的体重下降（平均基线体重236磅），而安慰剂组为3.0%（平均基线体重235磅），差异具有统计学显著性。而在假设所有患者均持续用药的前提下，CagriSema组在第68周的体重下降幅度为22.7%，安慰剂组为2.3%。此外，CagriSema组有91.9%的受试者体重下降幅度达到或超过5%，而安慰剂组为31.5%。武田下一代小分子疗法达两项3期试验双主要终点武田（Takeda）今日宣布，其在研下一代、高度选择性的口服酪氨酸激酶2（TYK2）抑制剂zasocitinib（TAK-279），在中重度斑块状银屑病（PsO）成人患者中开展的两项关键性3期研究取得积极顶线结果。两项试验均为随机、多中心、双盲设计，并设置安慰剂及活性药物对照。结果显示，在第16周，zasocitinib在共同主要终点静态医师整体评估（sPGA）0/1和银屑病面积与严重程度指数（PASI）改善至少75%（PASI 75）方面均优于安慰剂。除主要终点外，研究还显示，zasocitinib在PASI 75应答率上的优势最早在第4周即已显现，并在随后随访中持续增加直至第24周。两项研究同时达成全部44项分层次要终点，包括相较安慰剂以及与活性对照药物比较时的PASI 90、PASI 100与sPGA 0等指标，显示该疗法有望帮助部分患者实现更接近“完全皮损清除”的治疗目标。安全性方面，zasocitinib整体耐受性良好，其安全性特征与既往临床研究一致。FDA批准强生抗癌双抗皮下制剂强生（Johnson & Johnson）日前宣布，美国FDA已批准人源化EGFR/MET靶向双特异性抗体Rybrevant Faspro（amivantamab和hyaluronidase）皮下制剂，用于Rybrevant（amivantamab）已获批的全部适应症。根据新闻稿，Rybrevant Faspro为首个用于表皮生长因子受体（EGFR）突变型非小细胞肺癌（NSCLC）患者的皮下（SC）给药疗法。新闻稿同时指出，Rybrevant Faspro可将给药时间从小时级缩短至分钟级，并显著降低与给药相关的不良反应。这次批准主要基于3期PALOMA-3研究的结果。分析显示，Rybrevant Faspro在疗效与用药一致性方面与Rybrevant表现一致，并达成了两项共同主要药代动力学（PK）终点。该终点以血液中药物活性成分amivantamab的药物浓度为衡量指标，包括：第2周期第1天或第4周期第1天的谷浓度（Ctrough），以及第2周期给药后第1天至第15天的曲线下面积（AUC D1–D15）。参考资料：[1] Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP‑1 and amylin analogues for weight management. Retrieved December 18, 2025 from https://www.prnewswire.com/news-releases/novo-nordisk-files-for-fda-approval-of-cagrisema-the-first-once-weekly-combination-of-glp1-and-amylin-analogues-for-weight-management-302645868.html[2] Takeda’s Zasocitinib Landmark Phase 3 Plaque Psoriasis Data Show Promise to Deliver Clear Skin in a Once-Daily Pill, Catalyzing a New Era of Treatment. Retrieved December 18, 2025 from https://www.businesswire.com/news/home/20251218728397/en/Takedas-Zasocitinib-Landmark-Phase-3-Plaque-Psoriasis-Data-Show-Promise-to-Deliver-Clear-Skin-in-a-Once-Daily-Pill-Catalyzing-a-New-Era-of-Treatment[3] U.S. FDA Approval of RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when Combined with LAZCLUZE (lazertinib). Retrieved December 18, 2025 from https://www.prnewswire.com/news-releases/us-fda-approval-of-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-enables-the-simplest-shortest-administration-time-for-a-first-line-combination-regimen-when-combined-with-lazcluze-lazertinib-302645263.html免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在“药明康德”微信公众号回复“转载”，获取转载须知。","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":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"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/2592180118","isCrawlerRequest":true}