Breakthrough in Ophthalmology! Hengrui’s Heng Qin® (Perfluorohexyloctane Eye Drops) Approved as First Treatment for Dry Eye Disease Associated with MGD

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.

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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 tension⁵, it rapidly spreads over the ocular surface⁷. 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 www.novaliq.com.

Reference

1. 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/cma.j.cn112142-20230822-00054.
2. Clinical Guidelines for Diagnosis and Treatment of Dry Eye. ISBN: 9787523506189
3. 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/sj.eye.6703101.
4. 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.
5. 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.
6. 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/j.ajo.2023.03.008.
7. 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/j.jtos.2019.02.010.
8. 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/j.curtheres.2023.100704.
9. 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.
10. 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.

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