The study is being conducted to compare the pharmacokinetics and safety of HRS-7535 in subjects with mild to moderate hepatic impairment and normal hepatic function.

开始日期2025-06-05

申办/合作机构

山东盛迪医药有限公司

NCT06904105

/ Active, not recruiting临床3期

A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HRS-7535 Tablets in Subjects With Overweight or Obesity

The study is being conducted to evaluate the efficacy and safety of HRS-7535 in subjects with overweight or obesity.

开始日期2025-04-09

申办/合作机构

山东盛迪医药有限公司

NCT06820099

/ Recruiting临床2期

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HRS-7535 in Subjects With Heart Failure With Preserved Ejection Fraction and Obesity

This is a multicenter, randomized, double-blind, placebo-controlled, parallel design phase II clinical trial, including a screening period of up to 2 weeks, a 40-weeks' treatment period, and a 1-week safety follow-up visit period.

开始日期2025-03-31

申办/合作机构

山东盛迪医药有限公司

100 项与 HRS-7535 相关的临床结果

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100 项与 HRS-7535 相关的转化医学

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100 项与 HRS-7535 相关的专利（医药）

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项与 HRS-7535 相关的文献（医药）

2024-03-01·Diabetes, obesity & metabolism

Safety, pharmacokinetics and pharmacodynamics of HRS‐7535, a novel oral small molecule glucagon‐like peptide‐1 receptor agonist, in healthy participants: A phase 1, randomized, double‐blind, placebo‐controlled, single‐ and multiple‐ascending dose, and food effect trial

Article

作者: Zhou, Renpeng ; Shu, Chang ; Wang, Quanren ; Fan, Yang ; Ye, Zi ; Zhang, Qian ; Qin, Huiling ; Du, Yijun ; Shen, Yu ; Feng, Sheng ; Zhang, Qin ; Hu, Wei ; Wu, Jingying ; Xu, Yimei

Abstract:

Aim:

To assess the safety, tolerability, pharmacokinetics (PKs) and pharmacodynamics of HRS‐7535, a novel glucagon‐like peptide‐1 receptor agonist (GLP‐1RA), in healthy participants.

Materials and Methods:

This phase 1 trial consisted of single‐ascending dose (SAD), food effect (FE) and multiple‐ascending dose (MAD) parts. In the SAD part, participants were randomized (6:2) to receive HRS‐7535 (at doses of 15, 60 and 120 mg; administered orally once daily) or placebo. In the FE part, participants were randomized (8:2) to receive a single dose of 90‐mg HRS‐7535 or placebo, in both fed and fasted states. In the MAD part, participants were randomized (18:6) to receive daily HRS‐7535 (120 mg [30/60/90/120‐mg titration scheme]) or placebo for 28 days. The primary endpoints were safety and tolerability.

Results:

Nausea and vomiting were the most frequently reported AEs across all three parts. In the SAD part, the median Tmax was 5.98‐5.99 hours and the geometric mean t1/2 was 5.28‐9.08 hours across the HRS‐7535 dosing range. In the MAD part, the median Tmax was 5.98‐10.98 hours and the geometric mean t1/2 was 6.48‐8.42 hours on day 28 in participants on HRS‐7535. PKs were approximately dose‐proportional. On day 29 in the MAD part, the mean (percentage) reduction in body weight from baseline was 4.38 kg (6.63%) for participants who received HRS‐7535, compared with 0.8 kg (1.18%) for those participants who received a placebo.

Conclusions:

HRS‐7535 exhibited a safety and tolerability profile consistent with other GLP‐1RAs and showed PKs suitable for once‐daily dosing. These findings support further clinical development of HRS‐7535 for type 2 diabetes.

162

项与 HRS-7535 相关的新闻（医药）

2025-09-08

·Biotech前瞻

君实三期成功，但IL-17A单抗国内竞争态势比PD-1单抗还卷

2025 【生物类似药内卷加速】【生物类似药内卷加速】处于技术前沿的制药领域的竞逐是惨烈的。首先是药物的研发极其消耗时间和金钱。其次，失败率很高。最后，上市以后的商业化运作也决定了一个药品的生命周期。随着畅销药品专利期进入到10年以内，全球仿制的速度必然就加快，进一步抢占原研产品的市场份额。相较于极度内卷的肿瘤赛道，自身免疫疾病领域的竞逐也在加剧。面对专利到期的各路诸侯围剿，诺华的司库奇尤单抗（secukinumab，商品名：Cosentyx）静脉注射剂获FDA批准上市，期望通过改变患者给药方式延长生命周期。但随着国产即将3家企业报产上司，更多企业进入到III期临床，集采成为大概率事件，则逼迫着诺华不得不加速产品迭代升级和创新管线的布局。而对于国内众多布局IL-17A的企业，应该聚焦如何在众多竞争者中差异化产品布局，实现逆袭。 2025 阅读指南 1、君实生物丨IL-17A单抗 2、丽珠医药丨IL-17A/IL-17F单抗 3、恒瑞医药丨夫那奇珠单抗 4、IL-17单抗丨竞逐激烈 5、总结君实生物丨IL-17A单抗 9月7日，君实生物宣布JS005治疗斑块状银屑病的关键注册性III期研究（JS005-005-III-PsO）取得阳性结果，共同主要研究终点和关键次要终点均具有统计学显著性和临床意义的改善。基于此，君实生物计划将于近期向监管部门递交该产品的上市许可申请。但整个国内已上市的IL-17A单抗已经足够多了。丽珠医药丨IL-17A/IL-17F单抗 2025年7月21日，丽珠医药旗下控股子公司丽珠单抗宣布，其从鑫康合生物引进的双特异性抗体 LZM012（又名 XKH004）在一项多中心、随机、双盲、对照的Ⅲ期临床试验中，表现优异：该试验以全球首款 IL‑17A 单抗司库奇尤单抗（商品名 Cosentyx®）为对照，入组中度至重度斑块型银屑病（plaque psoriasis）患者（部分合并银屑病关节炎）。研究采用 320 mg LZM012 每 4 周一次 vs. 300 mg 司库奇尤单抗每 4 周一次的给药方案，主要终点为第 12 周 Psoriasis Area and Severity Index 100（PASI 100，即皮损面积及严重度指数完全清除率）达标率。结果显示： PASI 100（12 周）：LZM012 组 49.5% vs. 司库奇尤组 40.2%，不仅达到非劣效标准，更实现优效优势； PASI 75（4 周）：LZM012 组 65.7% vs. 50.3%，体现更快的起效速度；持续疗效（52 周）：320 mg q4w 给药组 PASI 100 达 75.9%，而 320 mg q8w （每 8 周一次）组也达 62.6%，证明长期维持获益；安全性：LZM012 良好可耐受，不良事件发生率与对照组相当。司库奇尤单抗作为全球首个上市的 IL‑17A 单抗，2024 年全球销售额达 61.41 亿美元。LZM012 在同时靶向 IL‑17A 同源二聚体（A–A）、IL‑17F 同源二聚体（F–F）及 IL‑17A/F 异源二聚体的基础上，显示出更全面的作用机制。目前全球已有六款 IL‑17 靶向药物获批，其中仅 UCB 的比奇珠单抗（Bimekizumab）也是 IL‑17A/F 双抗；其他均为 IL‑17A 单抗。基于上述优势，丽珠医药已向国家药监局药品审评中心（CDE）提交上市许可申请前的沟通申请，推进 LZM012 尽快上市。丽珠医药，首当其冲面临市场竞争的国内药企是恒瑞医药。恒瑞丨夫那奇珠单抗 2025年4 月8 日，恒瑞「夫那奇珠单抗注射液」在国内获批新适应症，用于常规治疗疗效欠佳的活动性强直性脊柱炎成人患者（CXSS2400017/8 )。适应症获批是基于一项多中心、随机、双盲、安慰剂对照的适应性无缝II/Ⅲ期临床试验（SHR-1314-302）。研究表明，与安慰剂相比，夫那奇珠单抗注射液对活动性强直性脊柱炎具有统计学显著性和临床意义的改善。同时，SHR-1314注射液在活动性强直性脊柱炎患者中长期治疗的安全性、耐受性良好。截图来源：NMPA 官网 2024年8月27日，恒瑞的夫那奇珠单抗注射液获得NMPA审批上市，获批适应症为中重度斑块状银屑病。如此短的时间内，2项适应症获批上市，源自于恒瑞一以贯之的研发务实风格。且在肿瘤赛道极度内卷态势之下，恒瑞也积极拓展海外BD项目和非肿瘤赛道，以此补充单一肿瘤赛道占比较重的风险性。且从近期的公司高层人事变动上也可以管中窥豹。 4月2日晚间，恒瑞医药发布2024年财报后宣布重要人事调整：拥有30余年跨国药企经验的冯佶接棒总裁一职，纵览冯佶的履历，她主导过心血管、中枢神经、感染性疾病等多个战略业务单元的全球拓展。与此同时，恒瑞2024年财报披露的一组数据引发市场热议：恒瑞非肿瘤领域在研管线已达47项，首次超越肿瘤管线数量。其中，代谢性疾病板块的恒格列净（SGLT-2抑制剂）上市首年销售额突破8亿元，自免领域的艾玛昔替尼（JAK1抑制剂）在中重度特应性皮炎适应症中获批，填补国产创新药空白。更值得期待的是，其与默沙东达成的Lp(a)抑制剂合作创下2亿美元首付款纪录，这种针对心血管"隐形杀手"的创新药靶点，正是冯佶在阿斯利康时期重点布局的方向。分析人士指出，此次人事变动暗含战略重心转移。冯佶在慢病管理领域的深厚积淀，或将激活恒瑞在该赛道的资源禀赋。资料显示，其曾操盘阿斯利康全球中枢神经产品线，而恒瑞刚获批的用于阿尔茨海默病的HRS-7535（口服小分子GLP-1），恰好与该领域形成技术协同。这种跨界融合或催生"代谢+神经"的联合疗法，开辟百亿级蓝海市场。而如何在内卷同样激烈的自身免疫性疾病领域，尤其是同靶点生物类似药赛道，快人半步即是成功的门槛！ IL-17单抗丨竞逐激烈三生国健 2024年11 月 19 日，CDE 官网显示，三生国健的重组抗 IL-17A 人源化单克隆抗体注射液（研发代号：SSGJ-608）国内报上市（受理号：CXSS2400124），用于治疗成人中重度斑块状银屑病。Insight 数据库显示，这是国内第 6 款报上市的 IL-17A 单抗。截图来自：CDE官网智翔金泰 2024年8月27日，智翔金泰的赛立奇单抗注射液获得NMPA审批上市，获批适应症同样为银屑病。早在2024年2月15日，智翔金泰自主研发的赛立奇单抗注射液（GR1501注射液）针对中、重度斑块状银屑病Ⅲ期临床研究取得的积极结果在国际皮肤病学权威期刊British Journal of Dermatology（BJD）上正式发表。研究结果显示，赛立奇单抗对中国中、重度斑块状银屑病患者疗效显著，且安全性良好。康方生物 2023年12月1日，康方生物（9926.HK）宣布公司自主研发的新型人源化IL-17单克隆抗体古莫奇单抗（AK111）治疗中、重度斑块型银屑病的关键注册性Ⅲ期临床研究达到包括PASI100和sPGA0/1在内的全部疗效终点。2023年8月底，康方生物（9926.HK）宣布，自主研发的新型人源化白介素-17(IL-17）单克隆抗体古莫奇单抗注射液（AK111）治疗中重度斑块型银屑病的关键注册性Ⅲ期临床研究已完成患者入组。除了治疗中重度斑块型银屑病适应症之外，古莫奇单抗治疗中重度活动性强直性脊柱炎的关键注册性Ⅲ期临床研究正在筹备中。已获批上市IL-17靶向药在研IL-17靶向药 IL-17丨银屑病市场分析 IL17A和IL17F都属于白细胞介素17（IL17）家族成员，两者在IL17家族中同源性最高，主要由T辅助细胞Th17亚群产生，也可在其他T细胞和先天性免疫系统的某些细胞类型中产生。IL17A与IL17F在体内以同型二聚体IL17A-A、IL17F-F或异型二聚体IL17A-F形式存在，通过由IL17RA、IL17RC或IL17RD组成的二聚体受体传递信号，促进其他促炎细胞因子（如IL-6、IL-1β、IL-20家族细胞因子）以及效应蛋白的表达，并进一步导致中性粒细胞和巨噬细胞以及上皮细胞和成纤维细胞的活化，在许多自身免疫性疾病中发挥重要作用，包括银屑病、强直性脊柱炎和溃疡性结肠炎。银屑病是一种在多基因遗传背景下，由多种致病因子刺激机体免疫系统，而引起的以T细胞介导为主的自体免疫皮肤病，其中斑块状银屑病是银屑病中最为常见的一种类型。我国银屑病的发病率相对稳定，约占总人口的0.5%，因此中国银屑病患病人数将随着人口的增长而增加。据中华医学会皮肤性病学分会数据显示，中国银屑病患病人数由2014年的约643万人增长至2018年的约656万人，期间复合年增长率约0.5%。和弗若斯特沙利文预测2023年中国银屑病患病人数将达到约674万人，2018年至2023年复合年增长率约0.5%。来源：弗若斯特沙利文抗IL-17A单抗对于银屑病患者的治疗效果显著，获得医生和患者的认可，使其成为未来治疗银屑病的重要药物之一。未来，新研发的抗IL-17A单抗将会陆续上市，且随着国家医保目录的覆盖，患者对抗IL-17A单抗的可及性也会提高，预计我国抗IL-17A单抗药治疗银屑病市场将会快速发展，预计至2023年我国抗IL-17A单抗药将达到约23亿元，2019年至2023年复合年增长率约154.4%。总结面对专利到期的各路诸侯围剿，诺华的司库奇尤单抗（secukinumab，商品名：Cosentyx）静脉注射剂获FDA批准上市，期望通过改变患者给药方式延长生命周期。但随着国产即将3家企业报产，更多企业进入到III期临床，集采成为大概率事件，则逼迫着诺华不得不加速产品迭代升级和创新管线的布局。而对于国内众多布局IL-17A的企业，应该聚焦如何在众多竞争者中差异化产品布局，实现逆袭。近期发现，华博生物和华奥泰生物已经在国内启动了一项评价HB0017注射液治疗中重度斑块状银屑病的疗效和安全性的多中心、随机、双盲、安慰剂对照的3期临床研究。HB0017是华奥泰自主研发的IL-17A单克隆抗体，拟开发用于治疗中重度斑块状银屑病和强直性脊柱炎。在此前的1期临床研究中，该产品表现出半衰期方面的优势，有希望实现临床2~3月给药1次的维持期治疗方案，极大提高患者用药便利性。之所以聚焦长周期给药，也是鉴于自身免疫疾病患者的依从性是市场竞争中的一个优势。 ✦ • ✦ 【会员福利】随着运营内容的日渐丰富，Biotech前瞻公众号将为会员提供疾病基础知识幻灯的同时，ASCO和ESMO为代表的国际大会会后简版幻灯材料也会在会后一周左右时间发给会员。另外，上述所展示的幻灯，会员有专属价格获得可编辑无水印资料。研究设计小课堂和其他系列图表资料，不定期还有会员福利惊喜赠送或享限时优惠价格哦！早购买，早获益，意愿者请联系如下。【新版会员福利】按瘤种选择基础/进展幻灯，尽享研究设计/行研幻灯

临床3期专利到期上市批准生物类似药

2025-09-05

·PRNewswire

Hengrui Pharma and Braveheart Bio Enter Exclusive License Agreement for Cardiac Myosin Inhibitor HRS-1893

Collaboration highlights Hengrui Pharma's successful use of the NewCo model to achieve another out-licensing deal Agreement grants Braveheart Bio exclusive global rights to develop, manufacture and commercialize HRS-1893 outside of Mainland China, the Hong Kong SAR, the Macao SAR and Taiwan Region HRS-1893 currently in Phase 3 clinical trial in China for treatment of obstructive hypertrophic cardiomyopathy (oHCM) SHANGHAI, Sept. 5, 2025 /PRNewswire/ -- Hengrui Pharma (600276.SH；01276.HK), a leading innovative global pharmaceutical company focused on scientific and technological innovation, announced today that it has entered into an exclusive license agreement with Braveheart Bio for HRS-1893, a small-molecule inhibitor of cardiac myosin independently developed by Hengrui Pharma with best-in-class potential. Braveheart Bio is a newly launched, U.S.-based biotechnology company focused on cardiovascular disease with a consortium of lead investors that includes Forbion, OrbiMed, and others. Under the terms of the agreement, Hengrui Pharma has granted Braveheart exclusive rights to develop, manufacture and commercialize HRS-1893 worldwide, excluding Mainland China, the Hong Kong SAR, the Macao SAR, and Taiwan Region. Braveheart will make an upfront payment of $65 million (consisting of $32.5 million in cash and $32.5 million in Braveheart shares) and a near-term payment of up to $10 million upon technology transfer completion, totaling $75 million. Hengrui Pharma is eligible to receive potential development and commercial milestone payments of up to $1.013 billion, in addition to related royalties based on the net sales. "This marks the second time in less than 18 months that Hengrui Pharma has partnered with leading international investment institutions and leveraged the NewCo model in our efforts to ensure our innovation benefits patients worldwide," said Frank Jiang, MD, PhD, Executive Vice President and Chief Strategy Officer of Hengrui Pharma. "This agreement demonstrates the global competitiveness of our diversified, high-value R&D pipeline, and will accelerate the development of our innovative therapies for cardiovascular diseases, bringing more clinically valuable treatment options to patients around the world." "We're excited to partner with Hengrui to advance HRS-1893 into late-stage clinical development," said Braveheart Bio CEO Travis Murdoch, MD. "The recently presented Phase 1 data on HRS-1893 at ESC 2025 support our conviction in this molecule. We believe that it may confer best-in-class properties among cardiac myosin inhibitors. We are looking forward to further advancing its potential as a differentiated therapeutic for large and growing unmet needs in cardiovascular disease." In May 2024, Hengrui Pharma completed a landmark deal leveraging the NewCo model, out-licensing its portfolio of innovative GLP-1 class drugs (HRS-7535, HRS9531, HRS-4729) to Kailera Therapeutics, a newly established U.S.-based company backed by prominent investment institutions including Bain Capital Life Sciences, Atlas Venture, and RTW Investments, of which the total deal value, comprising upfront and milestone payments, could reach up to $6 billion; Hengrui also acquired a 19.9% equity stake in the new company. HRS-1893 is one of Hengrui Pharma's key innovative achievements in the heart disease space and recently entered Phase 3 clinical trials. Currently, the company has more than 10 innovative products in the cardiovascular disease field that have advanced to clinical research or beyond. Hengrui Pharma is also progressing investigational candidates for the treatment of heart disease, including SHR-6934, SHR-4658 and HRS-9057 in heart failure-related clinical studies. About Hypertrophic Cardiomyopathy (HCM) Hypertrophic cardiomyopathy (HCM), a primary cardiomyopathy characterized by left ventricular hypertrophy, is the most common genetic heart disease and the primary cause of sudden cardiac death in adolescents and athletes1,2. HCM is classified into obstructive HCM (oHCM) and non-obstructive HCM (nHCM) depending on whether the peak pressure difference of the left ventricular outflow tract at rest or after excitation are both less than 30mmHg1. Compared to patients with nHCM, those with oHCM have a lower survival rate. Relieving obstruction helps to reduce the risk of death. About HRS-1893 HRS-1893 is a highly selective small molecular myosin inhibitor independently developed by Hengrui that can specifically inhibit the activity of myosin ATPase, inhibit myocardial excessive contraction, reduce left ventricular hypertrophy and improve diastolic compliance. Multiple clinical trials for HRS-1893 have been conducted, with Phase 1 data recently presented at the European Society of Cardiology (ESC) Congress 2025. A phase 3 trial in oHCM has been initiated. About Hengrui Pharma Hengrui Pharma is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Founded in 1970 with the core principle of putting patients first, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology. About Braveheart Bio Braveheart Bio is a clinical-stage biotechnology company focused on developing precision therapies for cardiovascular disease. Braveheart is backed by world-class life science investors including Forbion and OrbiMed. Forbion is a leading European life sciences firm, active across stages and focused on bringing paradigm shifting innovation in medicine to patients around the globe. In addition, its newly-raised BioEconomy fund invests in planetary health solutions, "feeding and cleaning the planet." OrbiMed is one of the world's leading investors in healthcare, managing approximately $17 billion and aiming to help build world-class public and private healthcare companies. Reference: The Cardiomyopathy Specialty Alliance of National Center for Cardiovascular Diseases, Cardiovascular Precision Medicine Branch of China International Exchange and Promotive Association for Medical and Health Care. 2025 Chinese Guideline for the Management of Cardiomyopathies. Chinese Circulation Journal. 2025, 40 (5): 420-462. Zhaoxu Jia, Xin Du. Risk Assessment and Treatment of Sudden Death in Hypertrophic Cardiomyopathy. Journal of Clinical Internal Medicine. 2024, 41 (6): 370-374. SOURCE Jiangsu Hengrui Pharmaceuticals Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期引进/卖出临床3期

2025-09-05

·医药地理

10.88亿美元！恒瑞NewCo出海再下一城

9月5日，恒瑞医药宣布就其自主研发的心肌肌球蛋白（Myosin）小分子抑制剂HRS-1893与美国Braveheart Bio达成全球独家许可协议。此次交易采用的“NewCo”模式，通常指许可方将创新药项目授权给由境外资本或跨国药企共同新设的海外公司，以获取许可费及股权，并整合双方优势推进管线的开发与商业化。这是恒瑞继去年5月将GLP-1类创新药组合（HRS-7535、HRS9531、HRS-4729）有偿许可给Hercules后，再次采用NewCo模式实现对外授权。根据协议条款，恒瑞医药将HRS-1893在除中国大陆、香港特别行政区、澳门特别行政区及台湾地区以外的全球范围内开发、生产和商业化的独家权利有偿许可给Braveheart Bio。Braveheart Bio将向恒瑞医药支付6500万美元首付款（含3250万美元现金和等值3250万美元的Braveheart Bio公司股权）和完成技术转移后的1000万美元近期里程碑款，总计7500万美元。此外，恒瑞医药还将收取最高可达10.13亿美元的与临床开发和销售相关的里程碑付款，及相应的销售提成。恒瑞医药执行副总裁、首席战略官江宁军博士表示：“这是恒瑞再度携手国际资本，以NewCo模式推动全球医药创新。此次成功引入Forbion资本、OrbiMed等全球顶尖生命科学投资机构，不仅彰显了恒瑞多元化、高价值研发管线的国际竞争力，也将加速我们在心脏病领域创新疗法的全球开发进程，为全球患者提供更具临床价值的治疗新选择。” Braveheart Bio首席执行官Travis Murdoch医学博士表示：“我们非常高兴与恒瑞医药携手，推动HRS-1893进入后期临床开发阶段。近期在2025年欧洲心脏病学会（ESC）大会上公布的HRS-1893的Ⅰ期研究数据，进一步坚定了我们对该分子的信心，我们相信HRS-1893具备心肌肌球蛋白抑制剂同类最佳的潜质。心血管疾病领域存在大量且持续增长的未被满足需求，我们期待进一步挖掘该药物的潜力，使其成为一款具有差异化优势的治疗方案。” Myosin抑制剂：梗阻性HCM患者“心”希望肥厚型心肌病（HCM）是一种以左心室肥厚为突出特征的原发性心肌病，是最常见的遗传性心脏病，也是青少年和运动员发生心脏性猝死的首要原因。根据“静息时或激发后左室流出道的峰值压差是否均<30mmHg”，肥厚型心肌病分为梗阻性（obstructive）与非梗阻性（non-obstructive）。与非梗阻性HCM患者相比，梗阻性HCM患者生存率更低，而缓解梗阻有助于降低死亡风险。目前，对于梗阻性HCM的治疗，心肌肌球蛋白抑制剂已获得《中国心肌病综合管理指南2025》IB类推荐。 HRS-1893是恒瑞医药自主研发的一种高选择性的Myosin小分子抑制剂，可特异性抑制心肌肌球蛋白ATP酶活性，使心肌收缩性能正常化，减少左心室肥厚并改善舒张期顺应。 HRS-1893 已开展多项临床试验，其Ⅰ期临床试验数据近期已在2025年欧洲心脏病学会（ESC）大会上公布。此外，该产品针对梗阻性肥厚型心肌病的治疗已启动III期临床。 Pharma ONE药物研发大数据平台显示，目前国内仅有一款（按通用名记）针对肥厚型梗阻性心肌病适应症的药物获批上市，即全球首创心肌肌球蛋白抑制剂玛伐凯泰（Mavacamten，商品名：迈凡妥），自2024年4月获批后即被迅速纳入国家医保目录。随着恒瑞HRS-1893III期临床的推进，肥厚型梗阻性心肌病的治疗格局或将迎来关键拐点。肥厚型梗阻性心肌病药物全球获批情况数据来源：Pharma ONE药物研发大数据平台结语从肿瘤到代谢，再到如今的心血管，恒瑞医药用一次又一次的海外授权证明：中国创新药不仅能“走出去”，更能“走得好”“走得远”。HRS-1893的出海，不仅给恒瑞带来丰厚财务回报，更为全球梗阻性肥厚型心肌病患者送去新的希望。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

100 项与 HRS-7535 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
肥胖	临床3期	中国	山东盛迪医药有限公司	2025-04-09
2型糖尿病	临床3期	中国	山东盛迪医药有限公司	2024-09-25
2型糖尿病肾脏病	临床2期	中国	山东盛迪医药有限公司	2024-06-17
糖尿病肾病	临床2期	-	山东盛迪医药有限公司	2024-06-01

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05759897 (ADA 12025 \| ADA 22025 \| NEWS) 人工标引	临床2期	2型糖尿病	194	HRS-7535 15mg	網鬱蓋窪糧鑰繭鏇蓋願(構獵網鑰獵壓選簾醖觸) = 衊鏇選繭艱衊鹹壓憲構糧鑰膚鹹觸醖遞夢鬱鏇 (範艱壓廠觸淵簾廠鏇構 ) 更多	积极	2025-06-20
				HRS-7535 30mg	網鬱蓋窪糧鑰繭鏇蓋願(構獵網鑰獵壓選簾醖觸) = 構築廠鑰蓋積製蓋鹽構糧鑰膚鹹觸醖遞夢鬱鏇 (範艱壓廠觸淵簾廠鏇構 ) 更多
ADA 12025 \| ADA 22025	临床2期	肥胖	235	HRS-7535 30 mgHRS-7535 30 mg	積觸憲壓選繭築齋繭淵(壓網憲獵網鹹選網鑰網) = 糧鬱鏇觸鹹鹽築簾築廠醖鹽觸願衊齋艱選艱膚 (窪醖繭鏇獵齋觸築簾壓 ) 更多	积极	2025-06-20
				HRS-7535 60 mgHRS-7535 60 mg	積觸憲壓選繭築齋繭淵(壓網憲獵網鹹選網鑰網) = 簾鏇獵窪遞艱繭鏇襯齋醖鹽觸願衊齋艱選艱膚 (窪醖繭鏇獵齋觸築簾壓 )
CTR20240369 (NEWS) 人工标引	临床2期	超重 \| 肥胖	235	HRS-7535 30mg	衊膚構鹹簾鑰構糧廠艱(壓齋膚膚齋繭襯鏇壓鬱) = 鑰夢遞製衊製鹹顧膚獵顧積獵繭構遞鹹餘衊衊 (壓齋餘餘衊夢簾選廠壓 )	积极	2025-06-17
				HRS-7535 60mg	衊膚構鹹簾鑰構糧廠艱(壓齋膚膚齋繭襯鏇壓鬱) = 觸選艱構獵顧窪觸醖鑰顧積獵繭構遞鹹餘衊衊 (壓齋餘餘衊夢簾選廠壓 )
NCT05347758 (EASD2023)	临床1期	-	24	HRS-7535 15 mg	願衊選廠窪選鹽顧構齋(壓獵範淵衊構廠憲艱願) = Most common treatment-emergent adverse events in both SAD and MAD were nausea 膚願壓築鬱廠網鏇獵淵 (顧夢淵積願鹹網鹹壓壓 ) 更多	积极	2023-10-03
				HRS-7535 60 mg
NCT05347758 (ADA 12023 \| ADA 22023) 人工标引	临床1期	-	48	HRS-7535 (SAD)	繭願築製築淵繭鹽簾襯(鑰選餘膚齋構遞廠鏇獵) = Most common treatment-emergent adverse events in both SAD and MAD were nausea and vomiting; all TEAEs were mild in severity. 簾範衊遞繭製鹹餘憲獵 (壓淵衊鏇鏇獵簾夢鹽鑰 ) 更多	积极	2023-06-20
				HRS-7535 (MAD)