又有国内药企公布积极研究数据，减肥药如何“卷”出差异化？

澎湃新闻05-07 16:15

在两大减肥药巨头公布一季报之际，多家手握减肥药管线的国内外药企也相继公布研究进展。　　5月5日，博瑞生物医药（苏州）股份有限公司（博瑞医药，688166）宣布，其自主研发BGM0504注射液在一项旨在评估其在超重或肥胖受试者中有效性和安全性的三期临床研究中取得积极顶线结果。　　公司称，BGM0504原料药已收到国家药品监督管理局的受理通知书，公司会按既定计划全力推进BGM0504注射液在中国递交...

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How can weight loss drugs \"roll out\" differentiation?","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"600276":1,"603087":1},"content_text":"在两大减肥药巨头公布一季报之际，多家手握减肥药管线的国内外药企也相继公布研究进展。　　5月5日，博瑞生物医药（苏州）股份有限公司（博瑞医药，688166）宣布，其自主研发BGM0504注射液在一项旨在评估其在超重或肥胖受试者中有效性和安全性的三期临床研究中取得积极顶线结果。　　公司称，BGM0504原料药已收到国家药品监督管理局的受理通知书，公司会按既定计划全力推进BGM0504注射液在中国递交用于长期体重管理的新药上市申请。此外，其二型糖尿病适应证在国内也处于三期临床试验阶段。　　BGM0504属于GLP-1（胰高血糖素样肽-1）/GIP（葡萄糖依赖性促胰岛素多肽）受体双重激动剂，与礼来的替尔泊肽属于同一靶点。2025年，替尔泊肽以365亿美元的收入成为全球“药王”，今年一月份更是为礼来贡献了128亿美元的收入，其中减重版替尔泊肽第一季度收入达到41.6亿美元。　　当前，国内已经有多款GLP-1减肥药获批并应用，包括礼来的替尔泊肽、诺和诺德的司美格鲁肽、信达生物（1801.HK）的玛仕度肽、先为达生物/辉瑞的埃诺格鲁肽等。未来，随着博瑞医药这样的玩家进入市场，可以预见的是，减肥药赛道的竞争将更加激烈。　　恒瑞医药（600276.SH；1276.HK）也有一款GLP-1/GIP在研产品瑞普泊肽，且获批上市可期。公司在2026年一季报发布时曾提到，该药物在中国拟开发用于超重/肥胖及相关合并症、2型糖尿病等适应证，其中注射剂型用于成人长期体重管理的上市申请已获受理。　　甘李药业（603087.SH）在四月底也宣布，其自主研发的GLP-1双周制剂博凡格鲁肽注射液，针对不使用气道正压通气治疗（PAP）的肥胖合并中重度阻塞性睡眠呼吸暂停（OSA）受试者所开展的三期临床研究，已完成首例受试者给药，这是博凡格鲁肽开展的第六项三期研究。　　跨国药企方面，勃林格殷格翰四月底公布了三期SYNCHRONIZE-1临床试验取得的积极顶线结果。在该试验中，GCG/GLP-1双重激动剂索弗度肽（survodutide）达到了主要终点。采用疗效估计目标评估时，在患有肥胖或超重但无2型糖尿病的成年人为期76周的治疗中，索弗度肽组实现了平均高达16.6%的持续体重下降。　　GLP-1药物原本用于二型糖尿病治疗，此后因为减肥效果而出圈。当前，替尔泊肽和司美格鲁肽占据主导地位，随着同类在研产品越来越多，各家也在积极寻找其差异性。　　博瑞医药强调BGM0504的综合获益，称在研产品在实现平均19.3%的显著体重下降以及16.5cm腰围的减少，其中48.9%患者体重平均降幅≥20%，还可带来血压、血脂、血糖等身体指标的获益。博瑞医药董事长袁建栋表示，理想的减重药物不仅仅只关心体重的下降，更应关心人体内的心血管代谢的全方位调节。　　当下的GLP-1减肥药多为周制剂，即每七天打一针，而甘李药业的博凡格鲁肽打出了“双周制剂”的差异点。公司称，其安全性和耐受性特征与其他GLP-1类药物一致，有望成为全球首款上市的GLP-1双周制剂。　　恒瑞医药除了布局注射针剂，还早早加码了口服减肥药。最新进展是，口服瑞普泊肽已公布中国二期减重研究结果，计划在中国推进肥胖症三期临床。　　全球范围来看，GLP-1减肥药已进入口服时代。2025年底，诺和诺德的口服减重版司美格鲁肽在美国获批，成为首款口服GLP-1肥胖治疗药物。到了今年4月1日，礼来宣布FDA正式批准小分子口服GLP-1受体激动剂Orforglipron用于成人超重及肥胖症治疗成为目前唯一获批的小分子且不受进食限制的口服GLP-1减肥药。　　未来，减肥市场将处于口服和针剂长期并存的状态。有行业人士指出，有效性、安全性方面的数据表现始终是药物的第一竞争要素，但减肥药兼具消费属性，最终市场表现还要看各家企业的商业化能力和打法。（文章来源：澎湃新闻）","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 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":"4.42.1","shortVersion":"4.42.1","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/2633115292","isCrawlerRequest":true}