Hengrui’s Heng Yi ® Approved in China as an Innovative Cyclosporine Ophthalmic Solution for the Treatment of Dry Eye Disease

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 its unique EyeSol^® water-free platform technology, announce today that on June 23, 2026, the China National Medical Products Administration (NMPA) has approved Heng Yi^® (0.1% cyclosporine ophthalmic solution) for the treatment of patients with dry eye disease, aiming to increase tear secretion in patients with reduced tear production and improve the sign of the disease.

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Heng Yi^® is the first and only water-free 0.1% cyclosporine ophthalmic solution and the second dry eye disease drug product approved in China based on the EyeSol^® platform technology, following the approval of Heng Qin^® (perfluorohexyloctane ophthalmic solution) in 2025.

Dry eye disease (DED) affects a substantial proportion of the population in China, with reported prevalence ranging from approximately 21.0% to 52.4% ¹. DED is a multifactorial disorder driven by disruption of tear film homeostasis and a self-perpetuating vicious cycle of inflammation ^1,2,3. This vicious circle results in subjective symptoms - such as dryness, foreign body sensation and burning - and clinical signs of ocular surface damage, impairing visual function and quality of life ³. Current treatment strategies remain limited, often falling short of meeting the combined requirements for efficacy, safety, and suitability for long-term use, highlighting a significant unmet medical need in DED management.

Heng Yi^® combines the proven anti-inflammatory drug cyclosporine with the vehicle perfluorobutylpentane, a semifluorinated alkane (SFA) designed to overcome the drug’s usual limitations. The spreading properties of the water-free vehicle reduce friction and thereby contribute to the efficacy ⁴. In 2019, Hengrui Pharma and Novaliq announced a strategic collaboration under which Hengrui Pharma secured exclusive rights to develop, manufacture, and commercialize 0.1% cyclosporine ophthalmic solution in China.

The approval in China is based on a randomized, double-blind, vehicle-controlled Phase III clinical trial (Study SHR8028-301) led by the team of Professor Hong Jing at Peking University Third Hospital ⁵. Results showed that Heng Yi^® significantly improved total corneal fluorescein staining (tCFS) score as early as Day 15 (treatment group: -4.0 vs control group: -2.8, P=0.008). At Day 29, treatment with Heng Yi^® significantly reduced tCFS score (treatment group: -4.8 vs control group: -3.0, P<0.0001). The product demonstrated a favorable safety and tolerability profile ⁶. This novel cyclosporine ophthalmic solution (development name CyclASol^®) was approved by the U.S. Food and Drug Administration (FDA) and launched in the United States in 2023 as the world's first cyclosporine ophthalmic solution “indicated for the treatment of signs and symptoms of dry eye disease" ⁷. In Europe, the product was reviewed by the European Medicines Agency (EMA) and centrally approved in the European Union in September 2024 “for the treatment of adults with moderate to severe dry eye disease.”

Together with Heng Qin^® (perfluorohexyloctane ophthalmic solution), having an anti-evaporative mode-of-action, Hengrui Pharma is uniquely positioned to offer an innovative and comprehensive treatment portfolio for patients across the most common disease root causes of dry eye disease in China.

About the SHR8028-301 Study

The SHR8028-301 clinical trial is a multicenter, randomized, double-blind, vehicle-controlled Phase III trial (NCT05841043) conducted by Hengrui Pharma in China, designed to evaluate the efficacy and safety of 0.1% cyclosporine ophthalmic solution (development code: SHR8028) in adult patients with moderate-to-severe DED. A total of 206 subjects were enrolled and randomized in a 1:1 ratio to receive either SHR8028 or vehicle twice daily. The primary endpoints were improvements in tCFS score and eye dryness VAS score in dry eye patients at Day 29 with SHR8028 compared with vehicle. SHR8028-301 is a bridging study in China of the ESSENCE-2 clinical trial.

About the ESSENCE-2 Study

The ESSENCE-2 (NCT04043179) clinical trial is a multicenter, randomized, double-blind, vehicle-controlled Phase III trial sponsored by Novaliq, conducted in the US across multiple regions, designed to evaluate the efficacy and safety of 0.1% cyclosporine ophthalmic solution (development name: CyclASol^®, SHR8028 in China) in adult patients with moderate-to-severe DED. ESSENCE-2 enrolled 834 subjects, who were randomized in a 1:1 ratio to receive either 0.1% cyclosporine ophthalmic solution or vehicle twice daily. The primary endpoints were improvements in tCFS score and eye dryness VAS score in dry eye patients at Day 29 (Week 4) with CyclASol^® compared to vehicle. ESSENCE-2met its primary sign endpoint. The effect on tCFS score was observed as early as Day 15 (treatment group: -3.5 vs control group: -3.0, P=0.002). Importantly, 71.6% of patients responded within four weeks with a clinically meaningful improvement of ≥3 grades in total corneal staining.

About the ESSENCE-2 OLE Study

The ESSENCE-2 OLE clinical trial is a multicenter, open-label, single-arm trial (NCT04180109) initiated by Novaliq, designed to evaluate the long-term efficacy, safety, and tolerability of CyclASol^® in adult patients with DED. The study enrolled 202 subjects who had completed treatment in the ESSENCE-2 clinical trial. All subjects received CyclASol^® twice daily for 12 months. The primary endpoints were to assess the safety of CyclASol^® during long-term administration and to observe the long-term improvements in corneal and conjunctival staining scores and dry eye symptom scores in patients with DED.

In the study, over 80% of patients achieved a significant improvement of ≥3 points in tCFS score after 4 weeks in the study which was maintained over the 12 months study period, making it well-suited for long-term management of DED as a chronic disease.

About Hengrui Pharma

Hengrui Pharma is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Driven by a patient-focused philosophy since its founding in 1970, 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. For more information, visit us at Hengrui.com and follow us on LinkedIn.

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.

Hengrui Pharma Cautionary Statement Regarding Forward-Looking Statements

This press release contains statements that reflect Hengrui Pharma’s beliefs or expectations about the future or future events as of the respective dates indicated therein (“forward-looking statements”). These forward-looking statements are based on a number of assumptions about Hengrui Pharma’s operations, its future development plans, market (financial and otherwise) conditions and growth prospects, and are subject to significant risks, uncertainties and other factors beyond Hengrui Pharma’s control, and accordingly, actual results may differ materially from those contemplated by these forward-looking statements. No reliance should be placed on such statements, which reflect the view of the management of Hengrui Pharma as at the date of this press release. Hengrui Pharma does not undertake any obligation to update these forward-looking statements for events or circumstances that occur subsequent to such dates.

Reference

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2. Chinese expert consensus on the diagnosis and treatment of dry eye (2013). Chin J Ophthalmol, 2013, 49(1):73-75. doi: 10.3760/cma.j.issn.0412-4081.2013.020
3. Stapleton F, Argüeso P, Asbell P, et al. TFOS DEWS III: Digest. Am J Ophthalmol. 2025;279:451-553. doi:10.1016/j.ajo.2025.05.040
4. Agarwal P, Epitropoulos A, Gaddie I, Galor A, Karpecki P, Schmidt E. All eyes on semifluorinated alkanes: a comprehensive review of the influence of semifluorinated alkane eyedrops on tear film stabilization and drug delivery in dry eye disease. Expert Opin Drug Deliv. 2025;22(9):1359-1374. doi:10.1080/17425247.2025.2522947
5. Peng R, Jie Y, Long Q, et al. Water-Free Cyclosporine Ophthalmic Solution vs Vehicle for Dry Eye Disease: A Randomized Clinical Trial. JAMA Ophthalmol. 2024;142(4):337-343. doi:10.1001/jamaophthalmol.2024.0101
6. Heng Yi^® label
7. Harrow VEVYE^® website
8. Akpek EK, Wirta DL, Downing JE, et al. Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease: The ESSENCE-2 Randomized Clinical Trial. JAMA Ophthalmol. 2023;141(5):459-466. doi:10.1001/jamaophthalmol.2023.0709

Any product/brand names and/or logos are trademarks of their respective owners. © 2026 Jiangsu Hengrui Pharmaceuticals Co., Ltd. and Novaliq GmbH, Heidelberg, Germany. All rights reserved.

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