Latest news with #JiangsuHengruiPharmaceuticalsCo.
Business Wire
08-07-2025
- Health
- Business Wire
Breakthrough in Ophthalmology! Hengrui's Heng Qin® (Perfluorohexyloctane Eye Drops) Approved as First Treatment for Dry Eye Disease Associated with MGD
JIANGSU, China & HEIDELBERG, Germany & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jiangsu Hengrui Pharmaceuticals Co., Ltd. ('Hengrui Pharma'), a global pharmaceutical company focused on scientific and technological innovation, and Novaliq GmbH ('Novaliq'), a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol ® water-free technology, announce today that the China National Medical Products Administration (NMPA) has approved Heng Qin ® (Perfluorohexyloctane Eye Drops) for the treatment of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Heng Qin ® is the first and only drug approved to treat DED associated with MGD and will be available to patients in China in the coming months. According to the Chinese Expert Consensus on MGD: Diagnosis and Treatment in 2023, there is no drug that directly targets the treatment of MGD 1. The incidence rate of DED in China is 21%-30% according to the Clinical Guidelines for Diagnosis and Treatment of Dry Eye 2. Epidemiology studies show that 69%-86% of DED patients suffer from evaporative DED, the most common disease subtype resulting from MGD 3,4. Hengrui aims to address the urgent and common clinical need for an effective and safe treatment for the treatment of DED associated with MGD. Heng Qin ® (Perfluorohexyloctane Eye Drops) is based on EyeSol ®, the world's first water-, excipient-, and preservative-free drug technology 5,6. Due to its low surface tension 5, it rapidly spreads over the ocular surface 7. It improves the tear lipid layer, inhibits tear evaporation, and promotes corneal epithelial healing 8,9. In addition, perfluorohexyloctane supplements nonpolar lipids in the lipid layer, increases tear film thickness and improves Meibomian gland function 8,9. The NMPA approval of Heng Qin ® was based on a multi-center, randomized, controlled, double-blind, pivotal phase 3 clinical study in Chinese patients 8. The study demonstrated that Heng Qin ® compared with an active comparator, 0.6% saline solution, significantly improved the clinical signs and symptoms of patients with DED associated with MGD as early as 2 weeks and at day 29, respectively. The effects were maintained through day 57, the end of the study. According to the study findings, Heng Qin ® is safe and well-tolerated. The incidence of instillation site reactions following administration of the eye drops is low and comparable to the study comparator. In 2019, Hengrui Pharma and Novaliq announced a strategic collaboration under which Hengrui Pharma secured exclusive rights to develop, manufacture, and commercialize perfluorohexyloctane (development name: SHR8058 eye drops) in China. Perfluorohexyloctane ophthalmic solution was approved as dry eye drug therapy in the United States and in Canada in May 2023 and September 2024, respectively. About Hengrui Pharma Jiangsu 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 Novaliq Novaliq is a private biopharmaceutical company focusing on the development of first- and best-in-class ocular therapeutics. Novaliq developed EyeSol ®, a novel drug category of water-free topical eye medicines. Two FDA-approved EyeSol ® medicinal products for dry eye disease – Miebo ® and Vevye ® – are on the market in the United States revolutionizing patient care. The Novaliq R&D pipeline provides multiple development opportunities in ophthalmology and retina therapies. Novaliq is headquartered in Heidelberg, Germany and has an office in Cambridge, MA, USA. The long-term single shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on Reference Chinese Branch of the Asian Dry Eye Society, Ocular Surface and Tear Film Diseases Group of Ophthalmology Committee of Cross‑Straits Medicine Exchange Association, & Ocular Surface and Dry Eye Group of Chinese Ophthalmologist Association (2023). [Zhonghua yan ke za zhi] Chinese journal of ophthalmology. 2023 Nov 11; 59(11), 880–887. doi: 10.3760/ Clinical Guidelines for Diagnosis and Treatment of Dry Eye. ISBN: 9787523506189 Jie Y, Xu L, Wu YY, Jonas JB. Prevalence of dry eye among adult Chinese in the Beijing Eye Study. Eye (Lond). 2009 Mar;23(3):688–693. doi: 10.1038/ Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012 May;31(5):472-8. doi: 10.1097/ICO.0b013e318225415a. Tsagogiorgas C, Otto M. Semifluorinated Alkanes as New Drug Carriers-An Overview of Potential Medical and Clinical Applications. Pharmaceutics. 2023 Apr 11;15(4):1211. doi: 10.3390/pharmaceutics15041211. Sheppard JD, et al. MOJAVE Study Group. NOV03 for Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction: The Randomized Phase 3 MOJAVE Study. Am J Ophthalmol. 2023 Aug;252:265-274. doi: 10.1016/ Agarwal P, et al. Preclinical studies evaluating the effect of semifluorinated alkanes on ocular surface and tear fluid dynamics. Ocul Surf. 2019 Apr;17(2):241-249. doi: 10.1016/ Vittitow J, et al. In Vitro Inhibition of Evaporation with Perfluorohexyloctane, an Eye Drop for Dry Eye Disease. Curr Ther Res Clin Exp. 2023 May 12;98:100704. doi: 10.1016/ Steven P, et al. Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease Due to Meibomian Gland Disease. J Ocul Pharmacol Ther. 2017 Nov;33(9):678-685. doi: 10.1089/jop.2017.0042. Tian L, et al. Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Apr 1;141(4):385-392. doi: 10.1001/jamaophthalmol.2023.0270. Any product/brand names and/or logos are trademarks of their respective owners. © 2025 Jiangsu Hengrui Pharmaceuticals Co., Ltd. and Novaliq GmbH, Heidelberg, Germany. All rights reserved.
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
Bloomberg
15-05-2025
- Business
- Bloomberg
Hengrui Pharma Seeks Up to $1.3 Billion in Hong Kong Listing
Jiangsu Hengrui Pharmaceuticals Co. has started taking investor orders for a Hong Kong listing that could raise as much as HK$9.9 billion ($1.3 billion), the latest significant deal to boost the financial hub's share-sale recovery. The Chinese drugmaker is offering 225 million shares at HK$41.45 to HK$44.05 apiece, according to its listing document on Thursday. Versus Hengrui's last close in Shanghai on Wednesday, that's a discount of as much as 28% — roughly in line with what Hong Kong shares trade at relative to their mainland China-listed stocks.
Bloomberg
28-04-2025
- Business
- Bloomberg
Hengrui Pharma Gets China Regulator's Nod for Hong Kong Share Sale
Jiangsu Hengrui Pharmaceuticals Co. received the green light from China's securities regulator for its Hong Kong listing, putting the Chinese drugmaker a step closer to a share sale that may fetch as much as $2 billion. The Shanghai-listed company plans to issue up to 815 million shares in Hong Kong, Hengrui said in an exchange filing Monday. The sale could occur as soon as this year, people familiar with the matter have said.
