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 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.
For more information please visit, www.novaliq.com.
