医药行业周报：礼来首个小分子口服GLP-1药物3期临床研究成功有望改变减重药物格局

平安证券股份有...2025-04-20

行业观点礼来首个小分子口服GLP-1药物3期临床研究成功，有望改变减重药物格局4月17日，全球制药巨头礼来公司公布了3期临床研究ACHIEVE-1的积极顶线结果，该研究评估了Orforglipron与安慰剂相比，在患有2型糖尿病和仅通过饮食和运动控制不足的成人中的安全性和有效性。据礼来介绍，Orforglipron是首款无需饮食、饮水控制的口服小分子GLP-1受体激动剂。若获得上市批准，公司有信心...

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drugs","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LLY":1,"GLP":1},"content_text":"行业观点礼来首个小分子口服GLP-1药物3期临床研究成功，有望改变减重药物格局4月17日，全球制药巨头礼来公司公布了3期临床研究ACHIEVE-1的积极顶线结果，该研究评估了Orforglipron与安慰剂相比，在患有2型糖尿病和仅通过饮食和运动控制不足的成人中的安全性和有效性。据礼来介绍，Orforglipron是首款无需饮食、饮水控制的口服小分子GLP-1受体激动剂。若获得上市批准，公司有信心“在全球范围内无限制地供应”这款药物。研究显示，在ACHIEVE项目的第一项3期临床试验中，Orforglipron达到了主要终点，即在40周时，经Orforglipron治疗后糖化血红蛋白（A1C）的降幅显著优于安慰剂组，A1C自8.0%的基线平均降低1.3%至1.6%（使用有效性估计目标）。在关键次要终点，超过65%的患者接受最高剂量的Orforglipron后A1C值降至≤6.5%，低于美国糖尿病协会定义的糖尿病阈值。在另一个关键次要终点，接受Orforglipron的患者在最高剂量下平均减重7.3kg。鉴于患者在研究结束时尚未达到体重平台期，可能表明尚未实现完全减重。公司目前也在研究Orforglipron对非糖尿病患者的减重效果。2023年发布的二期临床试验结果显示，每日服用这款药物36周后，根据剂量不同平均减重效果能达到9.4%至14.7%。礼来方面预计，将在今年年底前向全球监管机构提交Orforglipron用于体重管理的上市申请，预计于2026年提交其用于治疗2型糖尿病的上市申请。若获批，Orforglipron将成为第二款在美国上市的GLP-1口服药。目前诺和诺德的Rybelsus（司美格鲁肽口服片）获批治疗2型糖尿病。不过礼来的药物为非肽类制剂，更容易被人体吸收，也不像Rybelsus那样需要饮食控制。由于肽会被胃部消化，所以日本中外制药的研究人员找到了一种小分子，它能嵌入GLP-1靶向蛋白质的一个微小口袋中。当小分子进入口袋时，蛋白质会像整个蛋白质与GLP-1结合时那样发生形状变化。这一特点也使得Orforglipron能够在一天中任何时间服用，这在肽类药物领域几乎闻所未闻。以最常见的肽类药物胰岛素为例，虽然问世已经超过50年，但至今仍只能注射使用。2018年中外制药把药物授权给了礼来公司。投资策略建议关注“创新”、“出海”、“设备更新”与“消费复苏”。“创新”主线：围绕创新，布局具备全球竞争力的创新药品种，以及“空间大”“格局好”的品类，建议关注百济神州、东诚药业、云顶新耀、诺诚健华、中国生物制药、和黄医药、亚盛医药、千红制药、泰格医药、凯莱英、博腾股份、奥浦迈、药康生物、百奥赛图等。“出海”主线：掘金海外市场仍然有可能孕育中长期机会，建议关注新产业、迈瑞医疗、联影医疗、三诺生物、科兴制药、同和药业、健友股份、苑东生物等。“设备更新”主线：中央财政和地方专项债有望加强对医疗设备更新换代的支持，建议关注迈瑞医疗、联影医疗、澳华内镜、开立医疗等。“消费复苏”主线：消费提振政策的影响下，眼科、口腔、医美等优质赛道及相关周边产业有望回暖，建议关注普瑞眼科、通策医疗、昊海生科等。","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":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"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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医药行业周报：礼来首个小分子口服GLP-1药物3期临床研究成功 有望改变减重药物格局

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医药行业周报：礼来首个小分子口服GLP-1药物3期临床研究成功有望改变减重药物格局