HRS-9531

In recent news from Yaozh.com, Hengrui Pharmaceuticals, a leading player in the pharmaceutical industry, has taken a significant step forward in the development of domestic weight loss drugs. With the initiation of Phase III clinical trials for their GLP-1R/GIPR dual agonist, HRS9531, intended for obesity treatment, Hengrui aims to complete the study by July 2025. This move comes amidst the submission of a market application for a GLP-1R/GCGR dual agonist, Masidupeptide, by Xinda Biotechnology, positioning it as a potential pioneer in the field of domestically produced dual-target weight loss drugs.  Hengrui Pharmaceuticals: Pioneering Innovations Hengrui Pharmaceuticals has established a strong presence in the field of metabolic disorders, including diabetes and obesity, in addition to their focus on oncology. With nine innovative drug pipelines dedicated to metabolic diseases, Hengrui has developed a range of drugs targeting various points such as DPP-IV, metformin, SGLT2, and insulin/GLP-1. Notably, three of their pipelines involve GLP-1 targeting, including HR17031, a drug for type 2 diabetes, and two promising GLP-1 weight loss drugs, HRS-7535 and HRS9531. The GLP-1 weight loss drug market is highly competitive, with newcomers needing to demonstrate distinctive advantages to gain market share from established giants like Lilly and Novo Nordisk. Hengrui's strategy involves developing an orally administered small molecule GLP-1 receptor agonist, HRS-7535. This formulation offers improved portability and ease of use compared to injectable forms, enhancing patient compliance. Furthermore, HRS-7535 holds the advantage of being the first oral small molecule GLP-1 drug without any existing global competitors. Currently, HRS-7535 is in Phase II clinical trials for both type 2 diabetes and weight loss indications. Initial results from Phase I studies indicate its favorable safety, tolerability, pharmacokinetic profile, and potential to reduce weight by 4.38 kg after four weeks of treatment, with notable hypoglycemic effects. Xinda Biotechnology: The Dual-Target Approach Xinda Biotechnology has taken a significant stride in the development of dual-target weight loss drugs with its GLP-1R/GCGR dual agonist, Masidupeptide. Having received acceptance for market application by the National Medical Products Administration (NMPA) in February of this year, Masidupeptide is poised to become the first domestically produced dual-target weight loss drug. The results from Phase II clinical studies demonstrate an average percentage change in weight reduction of -15.4% compared to the placebo group, with a weight loss of 14.7 kg after 24 weeks of treatment. In clinical studies primarily conducted on the Chinese population, Masidupeptide has shown superior weight reduction efficacy (18.6%) compared to Lilly's dulaglutide and Novo Nordisk's semaglutide. Hengrui's HRS9531: A Promising Contender Following closely behind Xinda Biotechnology, Hengrui Pharmaceuticals has initiated Phase III clinical trials for their GLP-1R/GIPR dual agonist, HRS9531, designed for obesity treatment. The study is expected to be completed by July 2025. Initial results from Phase I studies indicate weight reductions ranging from 4.3-7.7 kg (6.7%-9.3%) after four weeks of treatment with HRS9531 at doses ranging from 0.9-5.4 mg. The greatest weight reduction (8.0 kg, 10.0%) was observed on the 36th day in the 5.4 mg dose group. Although Hengrui's research and development progress slightly lags behind Xinda Biotechnology, their strong sales and marketing capabilities make the ultimate sales performance of these two contenders difficult to predict. The Competitive Landscape for Domestic Players Time is of the essence for domestic pharmaceutical companies in the Chinese market. Both Novo Nordisk's semaglutide and Lilly's dulaglutide, with weight loss indications, have already submitted market applications and are expected to be approved for sale in the near future, setting the stage for intense competition in the GLP-1 weight loss drug market. Moreover, there is a significant level of competition among domestic players in this field. Dozens of GLP-1 pipelines are currently in various stages of clinical development. Apart from Xinda Biotechnology and Hengrui Pharmaceuticals, other listed pharmaceutical companies, such as Huadong Medicine, Hanson Pharmaceutical, and Borui Medicine, are alsoactively pursuing the development of GLP-1 weight loss drugs. The race to develop domestically produced weight loss drugs in China has reached a critical milestone with Hengrui Pharmaceuticals' initiation of Phase III clinical trials for their GLP-1R/GIPR dual agonist, HRS9531. Alongside Xinda Biotechnology's market application for their GLP-1R/GCGR dual agonist, Masidupeptide, the domestic weight loss drug market is poised for intense competition. Hengrui's innovative pipeline, including the orally administered GLP-1 receptor agonist, HRS-7535, showcases their commitment to providing patients with effective and convenient treatment options. However, success in this market will depend on factors such as production capacity, marketing strategies, and ongoing research and development efforts. As the journey progresses, various domestic pharmaceutical companies, including Hengrui and Xinda, are taking significant steps forward, aiming to claim their share of the weight loss drug market and improve the health and well-being of individuals struggling with obesity.

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。今年一季度业绩纷纷出炉，GLP-1领域“双雄”在减重领域的表现也浮出水面。诺和诺德和礼来两家公司大单品司美格鲁肽和替尔泊肽持续放量。根据财报，诺和诺德2024年第一季度总营收653.49亿丹麦克朗（折合当前汇率约94.17亿美元），按固定汇率同比增长24%。三款适应症及剂型不同的司美格鲁肽产品均保持了两位数及以上的增速，其中减重注射剂Wegovy销量约为93.77亿丹麦克朗（折合当前汇率约13.51亿美元），同比增长106%；降糖注射剂Ozempic销量约为278.10亿丹麦克朗，同比增长43%，减重注射销量的大幅增长进一步推动公司在该领域的布局，长效剂型则能进一步提升产品的便利性和患者的依从性。口服降糖产品Rybelsus销售额为50.13亿丹麦克朗(7.28亿美元)，同比增长17%。GLP-1领域另一巨头礼来制药的财报数据也极为亮眼。财报显示，今年一季度，礼来的明星产品替尔泊肽（英文名称：Tirzepatide）为其贡献了23.24亿美元，占总营收的比重约为26%；其中，降糖版替尔泊肽 Mounjaro销量暴涨217%，已达18.07亿美元，另一款肥胖药物Zepbound在2023年11月获得FDA批准上市后，其销售额也呈现出爆发式增长。尽管在上市初期面临严重的缺货状态，但Zepbound在2024年第一季度的销售额仍然达到了5.17亿美元。分析人士预测，Zepbound上市第一年的销售额有望超过10亿美元，这使其有可能成为有史以来销售额最高的药物。当前，随着减肥药市场需求旺盛，甚至出现了供应短缺的情况，对此，诺和诺德和礼来这两家头部也准备积极扩产。2024年4月，礼来宣布从Nexus Pharmaceuticals收购一家制药厂，旨在进一步扩大GLP-1药物生产网络。2024年2月，诺和诺德宣布，计划收购原属于Catalent的3家无菌灌装工厂，以增加司美格鲁肽产能。以司美格鲁肽、替尔泊肽为代表的GLP-1类药物市场正持续扩容，随着更多药企的入局，未来市场前景广阔。开源证券研报显示，截至2024年4月底，国内共有7款GLP-1类新药获批上市、5款新药处于新药上市申请阶段；海外共有7款新药获批上市、5款新药处于Ⅲ期临床阶段。国内也有几家药企在积极提升产能，以提高竞争力。此前，药明康德在2024Q1种表示，公司计划在泰兴扩建新的多肽产能。4月22日，凯莱英发布公告表示，公司将加快多肽商业化产能建设，以支撑持续开拓多肽商业化生产外包业务。业内人士认为，GLP-1类药物市场持续扩容，有望推动上游原材料及合同研发生产服务（CDMO）需求提升。具有技术平台优势、合规药品生产质量管理规范（GMP）产能、项目交付经验丰富的相关公司有望受益。根据Frost&Sullivan预测，2030年我国GLP-1类药物市场规模将达515亿元。在其带动下，国内多家企业积极布局以GLP-1（胰高血糖素样肽-1）为靶点的药物管线，加速布局海内外市场。日前，恒瑞医药（600276.SH）公布了其GLP-1R/GIPR双重激动剂HRS9531的进展。据clinicaltrials官网信息显示，恒瑞医药启动了GLP-1R/GIPR双重激动剂HRS9531治疗肥胖的多中心、随机、双盲III期临床研究（NCT06396429；HRS9531-301），旨在评估HRS9531对比安慰剂在超重或肥胖受试者中持续48周的有效性和安全性，试验计划招募540例受试者，预计将于5月20日开始，于2025年7月30日结束。4月22日，华东医药全资子公司中美华东宣布其HDM1005注射液获美国FDA批准开展1期临床试验，适应症为成人超重或肥胖人群的体重管理。HDM1005注射液一款多肽类人胰高血糖素样肽-1（GLP-1）受体和葡萄糖依赖性促胰岛素多肽（GIP）受体的双靶点长效激动剂。同时，公司也指出其旗下司美格鲁肽注射液糖尿病适应证目前也已经完成III期临床研究全部受试者入组，预计2024年Q4获得主要终点数据。4月3日，CDE网站显示，九源基因的生物类似药司美格鲁肽注射液上市申请获得受理，用于成人2型糖尿病患者的血糖控制。2月7日，信达生物玛仕度肽注射液的上市申请获得NMPA受理，用于治疗肥胖症患者，这是全球首款GLP-1R/GCGR双靶点激动剂。预计玛仕度肽将于2024年底或2025年初获批上市。总结国外市场GLP-1药物供不应求，持续处于FDA药物短缺名单中，带动API需求，国内市场2026年专利到期且后续药物储备丰富， GLP-1药物市场有望快速打开，届时对于原料药CDMO及上游需求也会随之增长。参考资料：各公司官网-END-药事纵横投稿须知：稿费已上调，欢迎投稿各位朋友好，觉得本文对您有帮助，请随手点一下下方的在看，以便让你的朋友也能看到哦。