NMPA in China approves Heng Yi cyclosporine drop

Second EyeSol approval in China

China's National Medical Products Administration approved Heng Yi (0.1% cyclosporine ophthalmic solution) for dry eye disease (DED) on June 23, 2026, according to a joint announcement from Hengrui Pharma and Novaliq.¹ Heng Yi is the first water-free 0.1% cyclosporine formulation cleared in China and the second dry eye product approved there on Novaliq's EyeSol platform, following Heng Qin (perfluorohexyloctane ophthalmic solution) in 2025.¹ Hengrui holds exclusive China development and commercialization rights under a 2019 agreement with Novaliq.¹

DED affects an estimated 21% to 52.4% of the population in China, a range reported in a 2024 Chinese expert consensus statement.¹ The condition stems from a self-perpetuating cycle of tear film instability and inflammation, producing dryness, burning, and foreign body sensation alongside ocular surface damage.¹ Existing treatment options in China have not fully addressed efficacy, safety, and long-term use requirements together, leaving room for additional therapies.¹

Bridging trial supports approval

The China approval rests on SHR8028-301, a randomized, double-blind, vehicle-controlled Phase 3 trial led by Hong Jing, MD, at Peking University Third Hospital, enrolling 206 subjects in a 1 to 1 ratio to twice-daily SHR8028 or vehicle.¹ The formulation significantly improved total corneal fluorescein staining score by Day 15, with the treatment group showing a 4.0-point reduction versus 2.8 for vehicle.¹ By Day 29, the treatment group reduction reached 4.8 points versus 3.0 for vehicle, and the study reported a favorable safety and tolerability profile.¹

SHR8028-301 served as a bridging study to ESSENCE-2, Novaliq's earlier multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial conducted in the United States under the development name CyclASol.² ESSENCE-2 enrolled 834 subjects and met its primary sign end point, with 71.6% of treated patients achieving a clinically meaningful improvement of at least 3 grades in corneal staining within 4 weeks.² A follow-on open-label extension study, enrolling 202 subjects who completed ESSENCE-2, found more than 80% sustained a 3-point or greater improvement in staining score over 12 months of continued twice-daily use.¹

Already marketed in US, EU

The same 0.1% cyclosporine formulation is marketed in the United States as Vevye, which the FDA approved in May 2023 as the first cyclosporine ophthalmic solution indicated for the signs and symptoms of DED.³ The European Medicines Agency centrally approved the formulation in September 2024 for adults with moderate to severe DED.¹ Heng Yi combines cyclosporine with perfluorobutylpentane, a semifluorinated alkane vehicle designed to spread across the ocular surface and reduce friction without added water or preservatives.¹

Novaliq's EyeSol platform now supports 2 approved dry eye therapies in China, Heng Yi for aqueous-deficient dry eye and Heng Qin for the meibomian gland dysfunction-associated form of the disease.¹ Hengrui Pharma will handle commercialization of Heng Yi across the Chinese market following the NMPA decision.¹ No launch timeline or pricing details were included in the announcement.¹

The approval does not change prescribing access for US optometrists, who can already prescribe the same formulation under the Vevye brand.³ For ODs following global dry eye pipelines, the bridging-trial pathway used for Heng Yi illustrates how Chinese regulators are accepting supplemental local data alongside larger international Phase 3 programs rather than requiring fully independent trials.¹ Clinicians managing patients with ties to China may see questions about regional availability as Hengrui begins its rollout.¹

References:

1. Hengrui's Heng Yi approved in China as an innovative cyclosporine ophthalmic solution for the treatment of dry eye disease. Hengrui Pharma; Novaliq GmbH. June 30, 2026. Accessed July 8, 2026. https://www.novaliq.com/press-releases/2026/06/30/hengruis-heng-yi-approved-in-china-as-an-innovative-cyclosporine-ophthalmic-solution-for-the-treatment-of-dry-eye-disease/

2. 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

3. Novaliq announces FDA approval of VEVYE (cyclosporine ophthalmic solution) 0.1%, for the treatment of the signs and symptoms of dry eye disease. Novaliq GmbH. June 8, 2023. Accessed Accessed July 8, 2026. https://www.novaliq.com/press-releases/2023/06/08/novaliq-announces-fda-approval-of-vevye-cyclosporine-ophthalmic-solution-0-1-for-the-treatment-of-the-signs-and-symptoms-of-dry-eye-disease/