Latest news with #Hengrui
Daily Mail
28-07-2025
- Business
- Daily Mail
GSK strikes £370m deal with Chinese rival Jiangsu Hengrui to develop up to a dozen new medicines
GSK has struck a £370million deal with a Chinese rival to develop up to a dozen medicines, including a promising candidate for a chronic lung condition. The deal with Jiangsu Hengrui Pharmaceuticals comes as GSK focuses on growing its pipeline to negate declining revenues from top drugs and vaccines amid slowing demand and rising competition. Under the deal, GSK will gain an exclusive licence to Hengrui's HRS-9821, which is being studied as a treatment for chronic obstructive pulmonary disease. GSK shares rose 0.4 per cent, or 5.5p, to 1398p.
Yahoo
16-07-2025
- Health
- Yahoo
Hengrui and Kailera report positive data from Phase III obesity treatment trial
Hengrui Pharma and Kailera Therapeutics have reported positive topline data from the former's Phase III trial (HRS9531-301) of subcutaneous injections of HRS9531 once per week in those with obesity or who are overweight in China. The HRS9531-301 study targeted adults with obesity or who were overweight and had a minimum of one weight-related comorbidity, excluding those with diabetes. Subjects were randomly assigned and given HRS9531 at doses of 2mg, 4mg, 6mg, or a placebo for a 48-week period. Out of the 567 enrolees, 531 completed the study. The double-blind, randomised, placebo-controlled multi-centre trial has met its primary endpoints. Participants who received the dual glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide (GLP-1/GIP) receptor agonist, HRS9531, at these doses experienced significantly more weight loss than those who took a placebo during the 48-week timeframe. The 567 individuals in the trial had a mean baseline body weight of 93kg. The primary analysis showed that those treated with HRS9531 achieved a mean weight loss of up to 17.7%, with the placebo-adjusted figure being 16.3%. In addition, the trial showed that up to 88% of those treated with HRS9531 lost at least 5% of their body weight, and 44.4% achieved a weight reduction of at least 20%. A pre-specified supplementary analysis showed a mean weight loss of up to 19.2%, with a placebo-adjusted figure of 17.7%. The safety profile of HRS9531 was favourable, aligning with GLP-1-based therapies and consistent with previous Phase II clinical data. Hengrui is now preparing to submit a new drug application in China for chronic weight management while Kailera is set to expand the therapy, as KAI-9531, into worldwide trials. Kailera Therapeutics CEO and president Ron Renaud said: 'We commend our colleagues at Hengrui for these impressive Phase III clinical results, building on the strong momentum behind HRS9531 (KAI-9531). 'As Kailera prepares to advance KAI-9531 into a global clinical programme, we look forward to evaluating both higher doses and longer duration of treatment to expand on KAI-9531's best-in-class potential.' HRS9531 is under development to treat type 2 diabetes and conditions related to obesity. Earlier this year, both companies reported encouraging topline data from a Phase II obesity trial involving an 8mg dose of HRS9531. "Hengrui and Kailera report positive data from Phase III obesity treatment trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Mint
16-07-2025
- Business
- Mint
Lilly's Zepbound faces a potential weight-loss rival. It's made by a Chinese biotech
A new late stage trial of a promising weight loss drug is one more sign of the impending disruption the booming Chinese biotech industry could bring to US biopharma. A Chinese-developed weight loss shot looked almost as good as Eli Lilly's megablockbuster Zepbound in late-stage trial results rolled out Tuesday morning, in one more sign of the impending disruption that the booming Chinese biotech industry could bring to U.S. biopharma. The Jiangsu, China-based company Hengrui Pharma and its privately held U.S. partner Kailera Therapeutics said early Tuesday that patients lost an average of 18% of their weight over 48 weeks on Hengrui's drug, HRS9531. Using a statistical measure that only takes into account patients who completed the trial, their average weight loss was 19%. That's still not quite as good as Zepbound, which led to 21% weight loss in a late-stage trial. But the Zepbound trial was longer, and Hengrui and Kailera say that patients were still losing weight when the Hengrui trial ended. What's more, the latest Hengrui trial didn't study HRS9531 at its highest dose level. Hengrui plans to seek regulatory approval for the shot in China only 'as soon as possible" based on the new results. The drug won't pose a threat to Lilly anytime soon, if ever. But Kailera, the U.S. company that licensed the rights to HRS9531 outside of China, thinks they may be able to show it works better than Zepbound in their own trials, which have yet to start, and which are aimed at getting global approvals for the drug. 'Today's treatments are pretty much capped at about 20%" weight loss, said Kailera's chief commercial officer, Jamie Coleman, in an interview Tuesday with Barron's. 'Our goal is to maximize that efficacy, go beyond that." Even if Kailera eventually does show that HRS9531 can help patients lose more weight than Zepbound, the drug is years from U.S. approval, and would likely launch later than retatrutide, a follow-up medicine from Lilly that already works better than Zepbound. Lilly's hold on the weight loss market seems secure at least until the end of the decade, if not longer. Still, the promising data on HRS9531 is a hint at the challenges that Chinese biotech is increasingly posing for U.S. biopharma. As Barron's reported in June, U.S. drugmakers have spent tens of billions of dollars in recent months acquiring rights to experimental medicines invented by Chinese companies, in a sign of the growing quality and efficiency of the Chinese biotech sector. HRS9531 is one of a big group of Chinese-developed weight loss assets licensed by U.S. companies. Merck licensed an oral GLP-1 for $112 million up front in December of last year from Hansoh Pharma, and Regeneron licensed a GLP-1/GIP from the same company in June for $80 million up front. AstraZeneca, Lilly, and Novo Nordisk also have similar deals with other companies. It all adds complexity for investors trying to forecast the shape of the obesity market over the long term. And it's a potential threat to the U.S. biotech ecosystem, which relies on big pharma cash going to U.S. biotechs to fund development of new drugs. HRS9531, which Kailera calls KAI-9531, is very similar to Lilly's Zepbound: Both are dual GLP-1/GIP receptor agonists, and both are injectable peptides. In an earlier trial, also conducted by Hengrui, patients on a higher dose of HRS9531 lost 22.8% of their weight after 36 weeks. 'Generally speaking, what we've seen out of China so far, this data looks very similar to tirzepatide," said Coleman, using Zepbound's chemical name. 'We can go to higher doses without trading off tolerability, and we'll study it longer." Though the latest study was a Phase 3 trial, it only enrolled 567 patients, far fewer than would be needed in a U.S. Phase 3. Kailera launched in October with $400 million in private funding. It owns the rights outside of China to four Hengrui drugs including HRS9531. The question for Kailera is what the market would be for a drug that may be similar or a bit better than Zepbound, and how the biotech could ramp up manufacturing. Making significant quantities of the drug has been a challenge for Lilly, which has invested many billions of dollars in expanding its manufacturing capacity. Coleman, who was vice president, U.S. brand leader for Zepbound at Lilly before coming to Kailera, said that Kailera is already talking to contract manufacturers, and that more contract manufacturing capacity is available because Lilly and its competitor Novo Nordisk have brought much of their manufacturing in-house. 'We intend to focus and compete where weight loss matters the most, and where there are unmet needs in the market," Coleman said. 'There's a high level of unmet need in people that need to lose more than what tirzepatide today is providing. And there are very few molecules that are really set up to deliver higher efficacy, especially with a mechanism that is well-known, well-understood, and a tolerability profile that's pretty well accepted." Write to Josh Nathan-Kazis at
Business Wire
08-07-2025
- Health
- Business Wire
眼科领域迎来重大突破！Hengrui的Heng Qin®（全氟己基辛烷滴眼液）获批成为首个治疗睑板腺功能障碍(MGD)相关干眼症的药物
中国江苏、德国海德堡和马萨诸塞州剑桥--(BUSINESS WIRE)--(美国商业资讯)-- 专注于科技创新的全球性制药企业Jiangsu Hengrui Pharmaceuticals Co., Ltd. ('Hengrui Pharma')与专注于研发基于独特EyeSol ® 无水技术的同类首创及最佳眼科疗法的生物制药公司Novaliq GmbH ('Novaliq')今日宣布，中国国家药品监督管理局(NMPA)已批准Heng Qin ® （全氟己基辛烷滴眼液）用于治疗与睑板腺功能障碍(MGD)相关的干眼症(DED)。Heng Qin ® 是首个且目前唯一获批用于治疗MGD相关干眼症的药物，未来数月将在中国面向患者上市。 根据《2023年中国MGD诊断与治疗专家共识》，目前尚无直接针对MGD的治疗药物 1 。《干眼诊断与治疗临床指南》显示，中国干眼症的发病率为21%-30% 2 。流行病学研究表明，69%-86%的干眼症患者属于蒸发过强型干眼症，而这一最常见的亚型主要由MGD引发 3,4 。Hengrui致力于满足临床对安全有效的MGD相关干眼症治疗药物的迫切且普遍的需求。 Heng Qin ® （全氟己基辛烷滴眼液）基于EyeSol ® 研发而成，该技术是全球首个不含水、辅料和防腐剂的药物技术 5,6 。凭借低表面张力的特性 5 ，它可以在眼表快速扩散 7 ，改善泪膜脂质层、抑制泪液蒸发并促进角膜上皮修复 8,9 。此外，全氟己基辛烷可补充脂质层中的非极性脂质，增加泪膜厚度并改善睑板腺功能 8,9 。 国家药品监督管理局对Heng Qin ® 的批准基于一项在中国患者中开展的多中心、随机、对照、双盲关键Ⅲ期临床试验 8 。研究显示，与活性对照药0.6%氯化钠溶液相比，Heng Qin ® 分别早在用药2周和第29天时显著改善了MGD相关干眼症患者的临床症状和体征。这一疗效持续至研究结束的第57天。研究结果表明，Heng Qin ® 安全性良好，耐受性佳，滴眼后眼部给药部位不良反应的发生率较低，与对照药相当。 2019年，Hengrui Pharma与Novaliq宣布达成战略合作，Hengrui Pharma获得全氟己基辛烷（研发代号：SHR8058滴眼液）在中国的独家研发、生产及商业化权利。全氟己基辛烷眼用溶液分别于2023年5月和2024年9月在美国和加拿大获批用于干眼症治疗。 关于Hengrui Pharma Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma)是一家创新型全球性制药企业，致力于高品质药物的研发和商业化，以应对未获满足的临床需求。Hengrui Pharma拥有由14个研发中心和5500余名专业人员组成的全球研发团队，重点关注肿瘤、代谢及心血管疾病、免疫及呼吸系统疾病、神经科学等治疗领域。截至目前，Hengrui已在中国上市23个新分子实体药物和4个其他创新药物。Hengrui Pharma成立于1970年，秉持以患者为中心的核心理念，始终致力于通过科技力量攻克疾病、改善健康、延长生命，为人类健康事业贡献力量。 关于 Novaliq Novaliq是一家私营生物制药公司，专注于同类首创及最佳眼科治疗药物的开发。Novaliq开发的EyeSol ® 是一种新型无水外用眼科药物。两款基于EyeSol ® 技术的干眼症治疗药物Miebo ® 和Vevye ® 已获得美国食品药品管理局批准并在美国上市，为患者护理带来革新。Novaliq的研发管线为眼科和视网膜疗法提供了多种发展机会。Novaliq总部位于德国海德堡，在美国马萨诸塞州剑桥设有办事处。其长期唯一股东是dievini Hopp BioTech holding GmbH & Co. KG，该公司是生命和健康科学公司的活跃投资者。更多信息请访问 。 参考文献 亚洲干眼学会中国分会、海峡两岸医药卫生交流协会眼科专业委员会眼表与泪液疾病学组、中国医师协会眼科医师分会眼表与干眼学组（2023年）。《中华眼科杂志》。2023年11月11日；59(11), 880–887。doi: 10.3760/ 《干眼诊断与治疗临床指南》。ISBN：9787523506189 Jie Y、Xu L、Wu YY、Jonas JB。《北京眼病研究中中国成年人干眼症患病率》(Prevalence of dry eye among adult Chinese in the Beijing Eye Study)。《眼科学（伦敦）》。2009年3月；23(3):688–693。doi: 10.1038/ Lemp MA、Crews LA、Bron AJ、Foulks GN、Sullivan BD。《基于临床患者队列的水液缺乏型与蒸发过强型干眼症分布情况：一项回顾性研究》(Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study)。《角膜》。2012年5月；31(5):472-8。doi: 10.1097/ICO.0b013e318225415a。 Tsagogiorgas C、Otto M。《半氟化烷烃作为新型药物载体——潜在医学及临床应用概述》(Semifluorinated Alkanes as New Drug Carriers-An Overview of Potential Medical and Clinical Applications)。《药剂学》。2023年4月11日；15(4):1211。doi: 10.3390/pharmaceutics15041211。 Sheppard JD等。莫哈韦研究组。《NOV03用于治疗睑板腺功能障碍相关干眼症的症状和体征：随机Ⅲ期莫哈韦研究》(NOV03 for Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction: The Randomized Phase 3 MOJAVE Study)。《美国眼科学杂志》。2023年8月；252:265-274。doi: 10.1016/ Agarwal P等。《评估半氟化烷烃对眼表和泪液动力学影响的临床前研究》(Preclinical studies evaluating the effect of semifluorinated alkanes on ocular surface and tear fluid dynamics)。《眼表》。2019年4月；17(2):241-249。doi: 10.1016/ Vittitow J等。《全氟己基辛烷（一种干眼症滴眼液）的体外蒸发抑制作用》(In Vitro Inhibition of Evaporation with Perfluorohexyloctane, an Eye Drop for Dry Eye Disease)。《当代治疗研究（临床与实验）》。2023年5月12日；98:100704。doi: 10.1016/ Steven P等。《半氟化烷烃滴眼液治疗睑板腺功能障碍所致干眼症》(Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease Due to Meibomian Gland Disease)。《眼科药物与治疗杂志》。2017年11月；33(9):678-685。doi: 10.1089/jop.2017.0042。 Tian L等。《全氟己基辛烷滴眼液治疗中国患者的睑板腺功能障碍相关干眼症：一项随机临床试验》(Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients: A Randomized Clinical Trial)。《美国医学会眼科杂志》。2023年4月1日；141(4):385-392。doi: 10.1001/jamaophthalmol.2023.0270。 任何产品/品牌名称和/或标识均为各自所有者的商标。© 2025 Jiangsu Hengrui Pharmaceuticals Co., Ltd.和德国海德堡Novaliq GmbH版权所有。保留所有权利。 免责声明：本公告之原文版本乃官方授权版本。译文仅供方便了解之用，烦请参照原文，原文版本乃唯一具法律效力之版本。
Yahoo
16-06-2025
- Business
- Yahoo
Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics Announce Clinical Data Presentations at the American Diabetes Association 85th Scientific Sessions
– Hengrui to present six abstracts highlighting clinical progress of GLP-1/GIP dual receptor agonist HRS9531 (KAI-9531) and GLP-1 receptor agonist HRS-7535 (KAI-7535) in type 2 diabetes and obesity – JIANGSU, China and BOSTON, June 16, 2025 (GLOBE NEWSWIRE) -- Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui), a global pharmaceutical company focused on scientific and technological innovation, and Kailera Therapeutics, Inc. (Kailera), a clinical-stage biopharmaceutical company focused on advancing a broad pipeline of next-generation therapies for the treatment of obesity and related conditions, today announced the presentation of six abstracts at the 85th Scientific Sessions of the American Diabetes Association (ADA), taking place June 20-23, 2025, in Chicago, IL. The presentations will highlight the breadth of the companies' metabolic disease portfolio, including data from several clinical-stage injectable and oral therapies. Data presented will cover results from clinical trials sponsored and conducted by Hengrui for an injectable GLP-1/GIP receptor dual agonist HRS9531 (in development as KAI-9531 outside of Greater China), an oral small molecule GLP-1 receptor agonist HRS-7535 (KAI-7535), and an oral formulation of HRS9531 (KAI-9531). The following abstracts were submitted by Hengrui and accepted for presentation: HRS9531Oral presentation: Friday, June 20, 5:45-6:00 p.m. CT Phase 2 clinical trial of HRS9531 in participants with type 2 diabetes up to 32 weeks Abstract 126-OR: Efficacy and Safety of a Novel Dual GLP-1/GIP Receptor Agonist in Participants with Type 2 Diabetes Mellitus Up to 32 Weeks Posters: Sunday, June 22, 12:30-1:30 p.m. CT Phase 1 clinical trial of HRS9531 (oral peptide) in healthy participants Abstract 797-P: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 Tablet, an Oral Dual GLP-1/GIP Receptor Agonist, in Healthy Participants: A Phase 1 Study Phase 2 clinical trial of HRS9531 in adults with obesity without diabetes up to 52 weeks Abstract 853-P: Efficacy and Safety of a Novel Dual GLP-1/GIP Receptor Agonist (HRS9531), in Obese Adults without Diabetes: Up to 52-Week Treatment Phase 2 clinical trial of HRS9531 high dose (8 mg) in adults with obesity or overweight without diabetes Abstract 874-P: Efficacy and Safety of a Novel Dual GLP-1/GLP Receptor Agonist in Chinese Overweight or Obese Adults without Diabetes HRS-7535Posters: Sunday, June 22, 12:30-1:30 p.m. CT Phase 2 clinical trial of HRS-7535 in adults with type 2 diabetes Abstract 837-P: Efficacy and Safety of a Novel Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist (HRS-7535) in Type 2 Diabetes Mellitus Patients Inadequately Controlled by Metformin Phase 2 clinical trial of HRS-7535 in adults with obesity without diabetes Abstract 865-P: Efficacy and Safety of a Novel Oral Small Molecule GLP-1RA in Chinese Obese Adults without Diabetes All abstracts will be published online in the journal Diabetes® and presentations will be accessible on the Scientific Publications section of the Kailera website following the congress. Additional information can be found on the ADA website. About Hengrui PharmaJiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. With a global R&D team that includes 14 R&D centers and more than 5,500 professionals, Hengrui Pharma's therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. To date, Hengrui has commercialized 23 new molecular entity drugs and 4 other innovative drugs in China. 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 Kailera TherapeuticsKailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions. Kailera's most advanced program, KAI-9531 (being developed in China as HRS9531), is an injectable GLP-1/GIP receptor dual agonist that has demonstrated positive results in Phase 2 trials in obesity and type 2 diabetes in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery, including oral administration. Kailera's mission is to develop next-generation weight management therapies that give people the power to transform their lives and elevate their overall health. The Company is based in Waltham, MA and San Diego, CA. For more information, visit and follow us on LinkedIn and X. Contact Information for Hengrui PharmaDGA Grouphengrui@ Contact Information for KaileraMaura GavaghanVice President, Corporate Communications and Investor
