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–The United Laboratories International Holdings Limited (TUL) and Novo Nordisk A/S (Novo Nordisk) today announced that Novo Nordisk and TUL’s wholly-owned subsidiary The United Bio-Technology (Hengqin) Co., Ltd. (United Biotechnology), have entered into an exclusive license agreement for UBT251, a triple agonist of the receptors for GLP-1, GIP, and glucagon in early-stage clinical development for the treatment of obesity, type 2 diabetes, and other diseases..
联邦制药国际(TUL)与诺和诺德公司(Novo Nordisk)今日宣布,诺和诺德与TUL的全资子公司联合生物技术(横琴)有限公司(United Biotechnology)就UBT251达成了独家许可协议。UBT251是一种针对GLP-1、GIP和胰高血糖素受体的三重激动剂,目前正处于早期临床开发阶段,用于治疗肥胖症、2型糖尿病及其他疾病。
Under the license agreement, Novo Nordisk will obtain exclusive worldwide rights (excluding Chinese mainland, Hong Kong, Macau, and Taiwan) to develop, manufacture, and commercialize UBT251. United Biotechnology will retain the rights for UBT251 in Chinese mainland, Hong Kong, Macau, and Taiwan. United Biotechnology is eligible to receive an upfront payment of 200 million US dollars and potential milestone payments of up to 1.8 billion dollars from Novo Nordisk, as well as tiered royalties on net sales outside of Chinese mainland, Hong Kong, Macau, and Taiwan..
根据许可协议,诺和诺德将获得UBT251在全球范围内(不包括中国大陆、香港、澳门和台湾)的独家开发、生产和商业化权利。联合生物技术公司将保留UBT251在中国大陆、香港、澳门和台湾的权利。联合生物技术公司有资格从诺和诺德获得2亿美元的首付款和高达18亿美元的潜在里程碑付款,以及在大陆、香港、澳门和台湾以外地区净销售额的分级特许权使用费。
“Novo Nordisk is dedicated to providing improved treatment options for people living with obesity, type 2 diabetes, and other cardiometabolic diseases. The addition of a candidate targeting glucagon, as well as GLP-1 and GIP, will add important optionality to our clinical pipeline, as we look to develop a broad portfolio of differentiated treatment options that cater to the diverse needs of people living with these highly prevalent diseases,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk.
诺和诺德致力于为肥胖、2型糖尿病和其他心代谢疾病患者提供更佳的治疗选择。添加一种针对胰高血糖素以及GLP-1和GIP的候选药物,将为我们的临床管线增添重要的灵活性。我们旨在开发一系列多样化的治疗方案,以满足这些高发疾病患者的多样化需求。
“We look forward to building on United Biotechnology’s scientific work and further exploring the potential best-in-class properties of UBT251 across cardiometabolic disease indications.”.
“我们期待在联合生物技术公司的科学研究基础上,进一步探索UBT251在心代谢疾病适应症中的潜在最佳特性。”
United Biotechnology recently completed a randomized, double-blind, placebo-controlled phase 1b trial in China designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple subcutaneous injections of UBT251 in people with overweight or obesity.
联合生物技术公司最近在中国完成了一项随机、双盲、安慰剂对照的1b期试验,旨在评估UBT251多次皮下注射在超重或肥胖人群中的安全性、耐受性、药代动力学和药效学。
A total of 36 patients were enrolled in three different dose groups (1mg, 1mg/3mg, 1mg/3mg/6mg). Each group adopted a dose titration method, with subcutaneous injection once a week for 12 consecutive weeks.
共有36名患者被分配到三个不同的剂量组(1mg、1mg/3mg、1mg/3mg/6mg),每组采用剂量递增法,每周一次皮下注射,连续12周。
The safety profile of UBT251 was consistent with incretin-based therapies. The most common adverse events were gastrointestinal and the vast majority were mild to moderate in severity. In the highest dose group, the average weight of the people who completed the trial decreased by 15.1% from baseline, while the average weight of people in the placebo group increased by 1.5% from baseline..
UBT251 的安全性与基于肠促胰岛素的疗法一致。最常见的不良事件是胃肠道反应,绝大多数为轻至中度。在最高剂量组中,完成试验的人平均体重较基线下降了 15.1%,而安慰剂组的平均体重较基线增加了 1.5%。
“We are pleased to announce our exclusive license agreement with Novo Nordisk for UBT251. As a leading global biopharmaceutical company, Novo Nordisk holds a strong position in the treatment of chronic diseases,” said Mr. Tsoi Hoi Shan, the Chairman of TUL. “TUL is committed to strengthening its presence in the treatment of chronic diseases, including endocrine and metabolic disorders, while actively expanding its footprint in global markets.
“我们很高兴宣布与诺和诺德就UBT251达成独家许可协议。作为全球领先的生物制药公司,诺和诺德在慢性疾病的治疗领域占据重要地位,”TUL董事长蔡海山先生表示,“TUL致力于加强其在包括内分泌和代谢紊乱在内的慢性疾病治疗领域的影响力,同时积极拓展其在全球市场的布局。
We believe that Novo Nordisk’s expertise will play a key role in accelerating the global development of UBT251.”.
我们认为,诺和诺德的专业知识将对加速UBT251的全球开发起到关键作用。
This collaboration represents a pivotal milestone in TUL’s ongoing efforts to establish a global strategic presence and demonstrates its commitment to innovation-driven transformation. TUL will continue to foster scientific innovation, advance high-quality and sustainable development, and accelerate the establishment of a globally competitive framework for manufacturing, R&D, and commercialization..
这一合作代表着TUL在建立全球战略布局过程中一个关键的里程碑,也彰显了其对创新驱动转型的坚定承诺。TUL将继续推动科技创新,促进高质量与可持续发展,并加速构建具有全球竞争力的制造、研发和商业化体系。
The closing of this transaction is subject to applicable regulatory clearance and other customary closing conditions.
本交易的完成取决于适用的监管批准和其他惯例的成交条件。
About UBT251
关于UBT251
UBT251 is a long-acting synthetic peptide triple agonist targeting the receptors for GLP-1 (glucagon-like peptide-1), GIP (glucose-dependent insulinotropic polypeptide) and glucagon. It has demonstrated potent activity on all three receptors in a preclinical setting.
UBT251 是一种长效合成肽三重激动剂,靶向 GLP-1(胰高血糖素样肽-1)、GIP(葡萄糖依赖性促胰岛素多肽)和胰高血糖素的受体。它在临床前研究中已表现出对所有三种受体的强大活性。
UBT251 is categorized as a Class 1 innovative drug in China, being developed by United Biotechnology for multiple indications. To date, UBT251 has been approved for clinical trials in China in adult type 2 diabetes, overweight or obesity, metabolic dysfunction-associated fatty liver disease (MAFLD), and chronic kidney disease (CKD), and for clinical trials in the United States in adult type 2 diabetes, overweight or obesity, and CKD..
UBT251 被列为中国的 1 类创新药,由联合生物技术公司开发用于多种适应症。迄今为止,UBT251 已在中国获准用于成人 2 型糖尿病、超重或肥胖、代谢功能障碍相关脂肪肝病 (MAFLD) 和慢性肾病 (CKD) 的临床试验,并在美国获准用于成人 2 型糖尿病、超重或肥胖和 CKD 的临床试验。
United Biotechnology recently initiated a phase 2 trial for UBT251 in people with overweight or obesity in China.
联合生物技术公司最近在中国启动了UBT251针对超重或肥胖人群的二期试验。
About TUL and United Biotechnology
关于TUL和联合生物技术
Founded in 1990, TUL (HKEX: 3933) is mainly engaged in the research and development, production and sales of pharmaceuticals, and ranks among the leading integrated pharmaceutical companies in China. TUL currently boasts seven production bases, covering intermediate products, bulk medicine , finished products, veterinary drugs, empty capsule casings, and medical devices, with the sales networks dotted across nearly 80 countries and regions.
成立于1990年的联邦制药(港交所:3933)主要从事药品的研发、生产与销售,位列中国领先的综合性制药企业。目前,联邦制药拥有七个生产基地,涵盖中间体、原料药、成品药、兽药、空心胶囊、医疗器械等领域,销售网络遍布近80个国家和地区。
United Biotechnology, located in the Guangdong-Macao In-Depth Cooperation Zone in Hengqin, serves as the biopharmaceutical R&D headquarter of TUL. United Biotechnology focuses on the development of high-end biopharmaceuticals to treat major chronic diseases. For more information, please visit www.tul.com.cn..
位于横琴粤澳深度合作区的联合生物制药(珠海)股份有限公司是TUL的生物制药研发中心,专注于治疗重大慢性病的高端生物制药开发。更多信息,请访问www.tul.com.cn。
About Novo Nordisk
关于诺和诺德
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease.
诺和诺德是一家全球领先的医疗保健公司,成立于1923年,总部位于丹麦。我们的宗旨是推动变革以战胜严重的慢性疾病,这一使命植根于我们在糖尿病领域的深厚积淀。我们通过开创科学突破、扩大药品的可及性,并致力于疾病的预防与最终治愈来实现这一目标。
Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. For more information, visit .
诺和诺德在80个国家拥有约76,300名员工,并在大约170个国家销售其产品。欲了解更多信息,请访问 。