近日,恒瑞医药(600276.SH;01276.HK)宣布,已与诺和诺德(Novo Nordisk)就HRS-1596达成许可协议。HRS-1596是一款已具备开展Ⅰ期临床试验条件的胰高血糖素样肽-1(GLP-1)和抑胃肽(GIP)双受体激动剂,有望实现每周一次口服给药。
美迪西助力
作为HRS-1596临床前研发服务伙伴,美迪西为该药物提供了药代动力学及安全性评价服务,支持其NMPA、FDA及OECDⅠ期临床试验申报。此次合作达成,不仅是中国创新药全球化BD的又一重要里程碑,也再次体现了美迪西在代谢疾病领域的专业赋能价值。
重磅出海
26亿美元潜在总额,HRS-1596全球许可落地
根据协议条款,诺和诺德获得在中国大陆、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HRS-1596的独家权利。该交易潜在总交易额最高可达26亿美元,包括3亿美元首付款,以及后续开发、注册和商业化里程碑付款;恒瑞医药还将有资格根据HRS-1596在授权区域内的净销售额收取销售提成。
该许可协议需根据美国《哈特-斯科特-罗迪诺反托拉斯改进法》获得相关监管机构批准,并满足其他惯例交割条件。交易预计于2026年第四季度完成交割。对中国创新药而言,这是一次高含金量的全球化合作;对代谢疾病治疗领域而言,则意味着一条具有差异化给药潜力的小分子多肽管线加速走向全球开发。
创新口服
GLP-1/GIP双受体激动剂HRS-1596
有望每周一次口服
恒瑞医药HRS-1596旨在通过抑制食欲、促进胰岛素分泌和改善胰岛素敏感性等多重机制,实现减重和改善血糖控制,具有用于肥胖症、2型糖尿病及其他代谢性疾病的潜力。
更值得关注的是,HRS-1596有望实现每周一次口服给药,与现有治疗选择相比,可显著减少用药频次并提升用药便利性。恒瑞医药已在中国获准开展HRS-1596用于体重管理和2型糖尿病的Ⅰ期临床试验。
美迪西赋能成果
22个GLP-1类药物获批临床,7个达成BD合作
依托GLP-1临床前研发服务体系,美迪西可一站式提供药物发现、药学、药效学、药代动力学、安全性评价服务。平台搭建成熟的糖尿病、肥胖代谢疾病动物模型,可满足多肽、小分子、多靶点激动剂、口服制剂等各类 GLP-1管线临床前开发,满足NMPA、FDA、OECD等国际申报标准,支持全球多国申报临床。
凭借稳定成熟的技术平台、标准化质量管控体系与丰富项目实战经验,持续助力本土药企管线价值兑现。目前,美迪西已助力22个GLP-1类药物成功获批临床,其中7个完成对外授权BD合作。
美迪西祝贺恒瑞医药与诺和诺德就HRS-1596达成独家许可协议,期待该药临床试验顺利推进,早日惠及全球代谢疾病患者。当下,GLP-1相关代谢疗法仍是全球新药研发的热点赛道,口服、多靶点、长效剂型是行业重要发展方向;美迪西将持续完善代谢疾病领域一站式临床前研发能力,支持更多创新管线加速临床开发与全球BD合作,持续助力中国创新药走向世界。
关于恒瑞医药
恒瑞医药(股票代码:600276.SH,01276.HK)创立于1970年,分别于2000年、2025年在上海证券交易所和香港联合交易所挂牌上市,成为“A+H”两地上市企业。作为一家专注研发、生产及推广高品质药物的创新驱动型国际化制药企业,恒瑞医药在五十多年的发展历程中,始终坚持“以患者为中心”的初心,聚焦肿瘤、代谢和心血管疾病、免疫和呼吸系统疾病以及神经科学等领域,持续攻坚药物研发,为了攻克疾病、改善生活质量和延长生命,公司不断拓展可能的疆域,致力于运用科技的力量造福全球患者。
恒瑞医药连续8年上榜美国《制药经理人》杂志公布的全球制药企业TOP50榜单;国际知名咨询机构Citeline发布全球TOP25管线规模制药公司榜单,恒瑞连续5年上榜,自研管线数量位居全球第二。
关于美迪西
美迪西(股票代码:688202.SH)成立于2004年,专注于为全球制药企业、研究机构及科研工作者提供全方位的临床前新药研发服务。公司构建了覆盖药物发现、药学研究至临床前研究的一站式综合研发平台,并在ADC、核酸、多肽、CGT、PROTAC、抗体等前沿领域搭建了服务平台。公司建立了符合国际规范的质量体系,已获得中国NMPA、美国FDA、欧盟OECD等GLP认证以及AAALAC国际认证。目前,公司在国内外拥有约9.2万平方米研发实验室。至2026年6月末,公司已为全球超2000家客户提供药物研发服务,参与研发完成的新药项目已有691件IND获批临床,携手国内外合作伙伴共同推动药物创新突破。美迪西将继续立足全球,聚力创新,为人类健康贡献力量!欢迎访问公司官网 www.medicilon.com.cn 了解更多详情。
Powering Another GLP?1/GIP Dual Receptor Agonist for Global Expansion! Medicilon Congratulates Hengrui Pharma on Exclusive License Agreement with Novo Nordisk for HRS?1596
Hengrui Pharma (600276.SH; 01276.HK) recently announced that it has entered into a license agreement with Novo Nordisk for HRS?1596. HRS?1596 is a GLP?1/GIP dual receptor agonist ready for Phase I clinical trials, with potential for once?weekly oral administration.
As the preclinical research partner for HRS?1596, Medicilon provided pharmacokinetic and safety evaluation services to support the drug’s Phase I clinical trial filings with NMPA, FDA and OECD.
Major Global Out-Licensing
HRS?1596 Worldwide License Secured with Up to USD 2.6 Billion Total Potential Value
Under the terms of the agreement, Novo Nordisk obtains exclusive rights to develop, manufacture and commercialize HRS?1596 globally, excluding Greater China. The transaction carries a total potential value of up to USD 2.6 billion, including a USD 300 million upfront payment plus subsequent development, regulatory and commercial milestone payments. Hengrui Pharma will also be eligible to receive tiered royalties on net sales of HRS?1596 within the licensed territories.
The license agreement is subject to regulatory approval under the US Hart?Scott?Rodino Act and other customary closing conditions. Closing is expected in Q4 2026. This represents a high-impact global collaboration for Chinese novel drugs. For metabolic therapeutics, it accelerates the global development of a small-molecule peptide candidate with differentiated oral dosing potential.
Innovative Oral Candidate
HRS?1596, a GLP?1/GIP Dual Agonist, with Potential Once?Weekly Oral Dosing
Hengrui Pharma’s HRS?1596 works through multiple mechanisms including appetite suppression, enhanced insulin secretion and improved insulin sensitivity to facilitate weight loss and glycemic control. It is being investigated for obesity, type 2 diabetes and other metabolic disorders.
Notably, HRS?1596 is designed for potential once?weekly oral administration. Compared with existing therapies, this could drastically reduce dosing frequency and improve patient convenience. Hengrui Pharma has obtained approval in China to initiate Phase I clinical trials of HRS?1596 for weight management and type 2 diabetes.
Medicilon’s Track Record in Enabling GLP?1 Programs
22 GLP?1 Candidates Cleared for Clinical Trials, 7 Secured BD Out-Licensing Deals
Medicilon offers one-stop preclinical GLP?1 services spanning drug discovery, pharmaceutical development, pharmacodynamics, pharmacokinetics and safety assessment. Medicilon’s platform features well-established animal models for diabetes and obesity, supporting preclinical development of diverse GLP?1 modalities including peptides, small molecules, multi-target agonists and oral formulations. All studies comply with international standards required for NMPA, FDA and OECD submissions to enable clinical trial applications across the globe.
Backed by robust technical platforms, standardized quality systems and extensive project experience, Medicilon helps global biopharma unlock the value of their pipelines. To date, Medicilon has supported 22 GLP?1 candidates to receive clinical trial approvals, of which 7 have completed out-licensing BD transactions.
Medicilon congratulates Hengrui Pharma on the exclusive license agreement with Novo Nordisk for HRS?1596. We look forward to smooth progress of clinical studies and hope this therapy will benefit patients with metabolic diseases worldwide.
GLP?1-based metabolic therapies remain one of the hottest areas in global drug discovery. Oral delivery, multi-target activity and long-acting formulations are key industry trends. Medicilon will continue to strengthen the preclinical capabilities for metabolic diseases, accelerating clinical development and global BD partnerships for more innovative pipelines.
About Medicilon
From its inception in 2004, Shanghai Medicilon Inc. (SHA: 688202)has been committed to providing comprehensive R&D services to pharmaceutical companies, research institutions, and any organizations working in the preclinical space. Medicilon has built an integrated one-stop R&D platform covering drug discovery, CMC and preclinical studies, and has established service platforms in cutting-edge fields such as ADC, nucleic acids, peptides, CGT, PROTAC, and antibodies. Medicilon has established a quality system in compliance with international standards and has obtained GLP certifications from China's NMPA, the US FDA, the EU OECD,as well as AAALAC accreditation. Currently, Medicilon has nearly 92,000 square meters of R&D laboratories.
By the end of June 2026, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 691 new drugs projects that have been approved for clinical trials with IND applications. For more information, please visit the company's official website at www.medicilon.com.
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