Vincentage Pharma Co., Ltd

6月20日至23日，全球规模最大的糖尿病会议——第85届美国糖尿病协会（ADA）科学年会在美国芝加哥隆重举行，十余家中国生物制药企业携代谢领域的最新研究成果登上这一国际顶级舞台。据统计，本届ADA大会上共有信达生物、恒瑞医药、先为达生物、华东医药、博瑞医药、甘李药业、众生药业、华领医药、箕星药业（与闻泰医药合作）、来凯医药等十余家中国药企展示其创新成果，研究类型覆盖从临床前机制探索到III期注册性研究的全链条创新。中国药企展示的GLP-1类受体激动剂相关研究占整体展示项目的比重创历史新高，这些研究不仅在试验设计严谨性和数据质量上与国际标准全面接轨，更在减重幅度、代谢获益和给药方式等多个维度展现出令人瞩目的竞争优势。一、信达生物：玛仕度肽双受体激动剂信达生物与礼来共同推进的GCGR/GLP-1R双受体激动剂玛仕度肽（Mazdutide，IBI362）在本届ADA大会上获得高度关注，共有5项研究成果获得展示，其中包括一项口头报告。最令人瞩目的数据来自其首个糖尿病III期注册临床研究DREAMS-1的口头报告（摘要编号：306-OR）。DREAMS-1研究是一项为期24周的随机、双盲、安慰剂对照III期临床试验，纳入320例仅靠饮食和运动控制不佳的2型糖尿病患者。基线数据显示，入组患者平均HbA1c水平为8.24%，平均体重77.7kg。研究结果显示：降糖效果：在第24周，玛仕度肽4mg组和6mg组HbA1c水平较基线变化的最小二乘均值治疗差异分别为−1.43%和−2.02%（两组p值均<0.0001），显著优于安慰剂；减重效果：玛仕度肽组体重降幅≥5%的患者比例显著高于安慰剂组，同时达到HbA1c<7.0%且体重降幅≥5%的复合终点比例也显著优于安慰剂；安全性特征：最常见不良事件为胃肠道反应，且多为轻度至中度，未报告严重低血糖事件。除糖尿病适应症外，玛仕度肽在肥胖治疗领域的GLORY系列研究也取得突破性进展。在GLORY-1（中国超重或肥胖受试者III期研究）和GLORY-2（中国中重度肥胖受试者III期研究）中，玛仕度肽展现出卓越的减重效果。据壁报展示数据（摘要编号：777-P、1616-P、775-P），玛仕度肽通过激动GLP-1R和GCGR双靶点，不仅显著降低体重，还在改善肝脏脂肪代谢、降低血尿酸、改善肝纤维化等方面展现出差异化优势。这些发现为玛仕度肽治疗代谢相关脂肪性肝炎（MASH）和肥胖合并高尿酸血症等适应症提供了坚实的科学依据。二、恒瑞医药：双靶点与口服小分子并进恒瑞医药在本届ADA大会上展示了两款GLP-1类创新药的临床数据，覆盖注射剂与口服剂型，体现了公司在代谢疾病领域的全面布局。HRS9531（GIPR/GLP-1R双靶点激动剂）：一项随机、双盲、安慰剂对照II期临床试验（n=61）结果显示，在基线平均体重84.6kg、平均BMI31.3kg/m²的中国超重或肥胖成人中，治疗36周后：体重降幅：HRS9531组体重相对于基线的百分比变化的最小二乘均值差为-21.1%（95%CI：-25.6%~-16.6%；P<0.0001）；减重达标率：HRS9531组体重降幅≥5%、≥10%、≥15%、≥20%和≥25%的受试者比例分别为93.9%、91.8%、87.8%、59.2%和30.6%，而安慰剂组相应比例仅为16.7%、8.3%、0%、0%和0%；代谢获益：HRS9531组显著改善腰围、BMI、收缩压、空腹血糖、HbA1c和甘油三酯水平；安全性：大多数治疗期间不良事件为轻度胃肠道反应，无受试者因不良事件永久停药。HRS-7535（口服小分子GLP-1R激动剂）：一项为期36周的多中心、随机、双盲、安慰剂对照临床试验（n=235）结果显示，在基线平均体重91.6kg、平均BMI32.5kg/m²的肥胖或超重受试者中：26周减重效果：30mg、60mg、120mg、180mg剂量组经安慰剂校正后的体重降幅分别为-0.49%（p=0.7091）、-4.67%（p=0.0005）、-3.67%（p=0.0061）和-6.87%（p<0.0001）；36周持续获益：180mg组体重降幅达-9.50%（安慰剂组-1.40%），35.4%受试者体重降低≥10%（安慰剂组6.5%）；安全性与耐受性：最常见不良事件为胃肠道反应（恶心16.7%-54.2%；腹泻16.7%-21.7%；呕吐15.7%-37.5%），多为轻中度，未观察到肝酶升高趋势。三、箕星药业与闻泰医药：口服小分子GLP-1受体激动剂CX11/VCT220箕星药业与合作伙伴成都闻泰医药共同宣布，其每日一次口服小分子GLP-1受体激动剂CX11/VCT220的中国2期临床试验积极结果以壁报形式展示。这项随机、双盲、安慰剂对照2期临床试验纳入250名BMI≥28kg/m²或24-28kg/m²且伴有一种以上肥胖相关合并症的中国成人受试者。核心研究数据：减重效果：治疗16周后，CX11/VCT220各剂量组的体重较基线平均百分比变化范围为-5.8%至-9.7%，安慰剂组为-1.6%。在160mg快速滴定组和慢速滴定组中，体重较基线分别下降9.7%与9.4%（p≤0.001）减重达标率：55%-90%的受试者在第16周实现至少5%的减重目标（安慰剂组仅13%）代谢指标改善：所有测量的体重相关指标及心脏代谢指标均呈现改善，包括肝酶（ALT、AST）与血压等安全性优势：主要不良事件为胃肠道相关反应（95.8%为轻度至中度），未观察到药物引起的肝损伤，无任何药物相关严重不良事件四、博瑞医药：双靶点激动剂BGM0504博瑞医药的GLP-1R/GIPR双靶点激动剂BGM0504在ADA大会上展示了令人瞩目的减重数据。一项随机、双盲、安慰剂对照临床试验（n=120）评估了BGM0504在不伴糖尿病的中国肥胖人群中的安全性和有效性。突破性研究结果：减重幅度：从基线到第24周，5mg、10mg、15mg剂量组体重较基线平均降幅（扣除安慰剂效应）分别为-10.77%（-10.2kg）、-16.21%（-15.5kg）和-19.78%（-20.1kg）；腰围减少：各剂量组腰围较基线减少8.00-12.98cm（扣除安慰剂，p<0.001）；减重达标率：所有剂量组体重降低≥5%、≥10%和≥15%的受试者比例均显著高于安慰剂组（p<0.001），10mg和15mg剂量组体重降低≥20%的比例亦显著更高（p<0.05）；心血管代谢获益：收缩压较基线平均降幅（扣除安慰剂）为-11.60~-13.03mmHg，舒张压降幅为-5.98~-7.50mmHg（p<0.05）。五、先为达生物：GLP-1R激动剂伊诺格鲁肽GLP-1R激动剂伊诺格鲁肽（XW003）在一项随机、双盲、安慰剂对照临床试验（n=664）中显示出持久的减重效果。基线平均体重91.3kg、平均BMI32.5kg/m²的超重或肥胖中国受试者中：治疗48周后，1.2mg、1.8mg、2.4mg剂量组体重较基线平均降幅达-9.90%~-15.4%（安慰剂组-0.3%，p<0.0001）；体重降低≥5%、≥10%和≥15%的受试者比例分别为77.7%~92.8%、51.2%~79.6%和63.5%；同时观察到血脂水平和肝脏脂肪含量的显著改善。六、甘李药业：GLP-1RA双周制剂博凡格鲁肽甘李药业展示了其GLP-1RA双周制剂博凡格鲁肽（GZR18）和基础胰岛素周制剂GZR4注射液的II期临床研究成果。根据公布的摘要信息：博凡格鲁肽在中国成年2型糖尿病患者中显示出良好的降糖效果和心血管代谢风险因子改善作用；GZR4注射液在两项II期研究中表现优异：在胰岛素初治患者中与德谷胰岛素疗效相当；在已接受胰岛素治疗的患者中降糖效果优于德谷胰岛素七、众生药业：RAY1225注射液在ADA大会期间公布了RAY1225注射液的最新数据，该药物为GLP-1受体激动剂。结果显示：在超重/肥胖和2型糖尿病患者中每2周给药一次；用药24周后显示出显著的减重、降糖效应；同时改善了心脏-肾-代谢指标，安全性和耐受性良好。八、华东医药：口服小分子GLP-1受体激动剂conveglipron华东医药口服小分子GLP-1受体激动剂conveglipron（HDM1002）的Ib期研究显示：在28天治疗期内，200mg及以上剂量组平均体重变化范围为-4.3kg~-6.1kg，百分比变化为-4.9%~-6.8%；药代动力学显示剂量依赖性增加；最常见不良事件为恶心（54.0%）和呕吐（30.0%），均为轻度至中度。中国药企在2025年ADA大会上凸显了其GLP-1疗法的三大差异化创新路径，直指依从性、安全性与疗效瓶颈。多靶点激动剂平台（信达玛仕度肽、博瑞BGM0504、恒瑞HRS9531）通过协同激活多个受体（如GCGR/GLP-1R, GIPR/GLP-1R），显著提升减重幅度（最高达21.1%），展现超越单靶点产品的下一代疗法潜力。口服给药系统（恒瑞HRS-7535、华东conveglipron、箕星/闻泰CX11）则成功突破注射依赖，其显著减重效果（如16周9.7%）为患者提供免注射的高依从性选择。长效制剂（甘李博凡格鲁肽/GZR18双周制剂、GZR4周制剂胰岛素、众生RAY1225双周制剂）通过延长给药间隔（如每两周一次），在维持疗效的同时大幅优化患者体验和生活质量。这些创新共同推动了中国在代谢疾病治疗领域的全球竞争力。2025年ADA大会见证了中国代谢药物研发从“中国新”到“全球新”的质变过程。凭借强大的临床数据、差异化的技术平台和清晰的全球化战略，中国药企将在全球GLP-1市场分得可观份额，也会为全球亿万代谢疾病患者提供更安全、更有效、更便捷的治疗选择。参考来源:[1]https://www.prnewswire.com/news-releases/the-american-diabetes-association-demonstrates-its-commitment-to-curbing-the-obesity-epidemic-with-obesity-standards-of-care-302486601.html[2]https://bydrug.pharmcube.com/news/detail/edbbd30a882d77bba61084ae5d05bd12[3]https://www.phirda.com/artilce_39218.html[4]https://news.futunn.com/post/57445054/lilly-announces-details-of-presentations-at-american-diabetes-association-s药事纵横投稿须知：稿费已上调，欢迎投稿

2025年6月19日，德睿智药宣布小分子GLP-1受体激动剂MDR-001的2b期临床取得成功，不同剂量组治疗24周减重8.2%-10.3%，绝对减重7.4-9.2kg，安慰剂组为2.4kg（p＜0.00001）。同时，MDR-001在改善多个代谢和心血管疾病相关参数表现出色，包括腰围、血脂、血压等指标，有望带来全面临床获益。安全性方面，MDR-001试验期间无药物治疗相关SAE，研究入组20%肝功能异常和转氨酶升高的受试者，各组均未观察到转氨酶升高的趋势，且相比于安慰剂组，MDR-001治疗组的转氨酶较基线具有明显降低。此外，心脏安全性良好，未观察到心率升高的风险，仅有2例（0.8%）因TEAE终止治疗，远低于同类药物15-50%的终止率。辉瑞、礼来为小分子GLP-1受体激动剂开发的先驱，引领了整个赛道的发展。2023年6月，辉瑞放弃开发小分子GLP-1受体激动剂Lotiglipron，原因是其在早期临床中出现的转氨酶升高的安全性信号，而这一问题当时在第一代的Danuglipron中则没有发现。2025年4月，辉瑞宣布终止开发每日一次小分子GLP-1受体激动剂Danuglipron，因1例患者经历严重肝损伤，停药后缓解，经过考虑后辉瑞决定终止开发Danuglipron。礼来的Orforglipron则在今年宣布糖尿病三期临床成功。礼来Orforglipron在安全性方面与注射类GLP-1药物相当，无患者达到Hy's law标准的肝损伤。Orforglipron治疗期间，ALT、AST均值有所下降。Orforglipron在减重二期临床中，治疗36周减重幅度为12.5%-14.7%（安慰剂2.3%）。国内主要竞品中，恒瑞医药HRS-7535在今年ADA会议上公布了及那种二期临床数据，治疗26周减重2.99-9.36%，安慰剂组为-2.5%。安全性方面，未观察到肝酶升高趋势。华东医药HDM1002的1b期临床数据在今年ADA会议上公布，治疗4周减重6.8%、5.1%、4.9%，未观察到肝酶升高相关AE。闻泰/箕星药业VCT220的减重二期临床数据在今年ADA会议上公布，治疗16周减重5.8-9.5%，安慰剂组为1.6%。安全性方面，未发现肝脏毒性相关安全性信号。总结小分子GLP-1的先驱，辉瑞因肝脏毒性而终止开发，礼来则率先在三期临床撞线，且ALT、AST均有降低趋势。国产竞品中，恒瑞医药、闻泰医药、华东医药已经推进到三期临床，德睿智药此次2b期临床表现出优异的疗效与安全性，很快也将推进到三期临床。对于关键的肝脏安全性，几家企业均未披露具体数据，恒瑞医药的描述是“未观察到肝酶升高趋势”，闻泰医药的描述是“未发现肝脏毒性相关安全性信号”，华东医药的描述为“未报告肝酶升高相关AE”（较早期数据，1b期治疗4周数据）。德睿智药则描述“转氨酶较基线明显降低”。MDR-001有望成为小分子GLP-1赛道又一个有力竞争者。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

Patients treated with CX11 (also designated as VCT220) achieved a 9.7% and 9.4% decrease in body weight from baseline after 16 weeks (p≤0.001) in the 160 mg fast and slow titration cohorts, respectively.Results suggest a favorable tolerability profile, with no drug-induced liver injury observed. BERKELEY HEIGHTS, N.J. and SHANGHAI, June 23, 2025 (GLOBE NEWSWIRE) -- Corxel Pharmaceuticals Limited (CORXEL), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world, in collaboration with its partner, Chengdu Vincentage Pharma Co., Ltd. (Vincentage), announced the positive China Phase 2 clinical results for its oral small molecule once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA) CX11/VCT220, presented via poster presentation at the American Diabetes Association’s (ADA) 85th Scientific Sessions. The abstract will also be published online on the Diabetes® journal’s website. The Phase 2 randomized, double-blind, placebo-controlled clinical trial was conducted by Vincentage to investigate the efficacy, safety and tolerability of CX11/VCT220 in nondiabetic adults with obese or overweight conditions in China. The China Phase 2 trial evaluated 250 adults with a BMI greater than or equal to 28 kg/m2, or between 24 kg/m2 and 28 kg/m2 accompanied by at least one obesity-related comorbidity, randomized 3:1 to 80 mg, 120 mg, or 160 mg cohorts to receive CX11/VCT220 or matching placebo. The 160 mg cohort was further divided (1:1) into fast or slow titration groups. The primary endpoint was percentage change from baseline to week 16 in body weight (BW). Results Summary: At baseline, mean BW was 91.76 kg, mean BMI was 32.03 kg/m2, and 93.6% of participants had a BMI greater than or equal to 28 kg/m2. At week 16, the mean percentage change from baseline in BW ranged from −5.8% to −9.7% across the CX11/VCT220 dose cohorts and was −1.6% in the placebo group. Weight reduction was significantly greater at all CX11/VCT220 doses compared to placebo. A weight reduction of at least 5% by week 16 occurred in 55% to 90% of the participants who received CX11/VCT220, as compared to 13% who received placebo. (Figure). Treatment with CX11/VCT220 was associated with improvement in all weight-related and cardiometabolic metrics that were measured, including liver enzymes (ALT, AST) and blood pressure. Most reported adverse events were GI-related and mild to moderate (95.8%) in severity. No liver toxicity safety signal was identified. No drug-related serious adverse events were reported. The data presentation at ADA marks the first time CX11/VCT220's clinical results are showcased on a global stage. “We are pleased with the data presented at ADA that demonstrated robust efficacy results and favorable tolerability of CX11/VCT220,” said Dr. Bo Liang, Senior Vice President, Head of Clinical Development – Metabolic at CORXEL. “With the solid scientific foundation built by Vincentage, we have initiated the Phase 2 trial in the U.S. for CX11 with the first patient enrolled last week. We believe the Phase 2 trial in the U.S. has the potential to improve upon the weight reduction and tolerability results observed in the Phase 2 clinical trial of CX11/VCT220 in China.” “We are excited to see CX11/VCT220 gain international attention,” said Dr. Ben Li, Chief Executive Officer of Vincentage. “The Phase 3 registrational trial in China was initiated in November 2024 and we look forward to supporting CORXEL in their global development efforts.” About CX11 CX11 is an investigational oral small molecule GLP-1 RA designed to address cardiometabolic conditions, with a primary focus on obese and overweight patients. With global ex-China rights acquired by CORXEL from Vincentage in December 2024, CX11 aims to overcome limitations of current injectable GLP-1 RAs by offering convenient, once-daily oral administration, and weight reduction comparable to injectable GLP-1 RAs. CX11 presents favorable tolerability results, scalability and accessibility as a small molecule product candidate. Clinical data from Vincentage’s Phase 2 trial in China demonstrated competitive weight loss with a favorable safety and tolerability profile. CX11 is currently advancing into a Phase 2 trial in the U.S. conducted by CORXEL and through a Phase 3 registrational trial in China conducted by Vincentage, positioning it as a potentially leading oral therapy for management of obese and overweight conditions. About CORXEL CORXEL is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world. CORXEL is led by an experienced management team that has a strong track record of identifying, in-licensing and developing attractive clinical product candidates directed at validated targets with proven mechanisms of action (MoAs). CORXEL’s diverse portfolio of clinical-stage product candidates has the potential to redefine treatment standards and address key limitations of current therapies for multiple cardiometabolic indications. CORXEL is developing selective small molecule compounds across the cardiometabolic spectrum with the lead product candidate CX11, an oral GLP-1 receptor agonist (GLP-1 RA) for obese and overweight patients, JX10, a thrombolytic and anti-inflammatory agent for acute ischemic stroke (AIS) and JX09, a highly selective aldosterone synthase inhibitor (ASI) for hypertension. For further information about CORXEL, please visit www.corxelbio.com   Contact: media@corxelbio.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e5ddca94-9e35-420d-93da-1f4a84bab329