Hengrui's Heng Yi Wins NMPA Approval as China's First Water-Free Cyclosporine Ophthalmic Solution for Dry Eye Disease
核心洞察
Hengrui Pharma and Novaliq announced NMPA approval of Heng Yi (0.1% cyclosporine ophthalmic solution) on June 23, 2026, for the treatment of dry eye disease (搜索).
Heng Yi is the first and only water-free cyclosporine ophthalmic solution in China, based on Novaliq's EyeSol platform, and the second EyeSol-based product approved in the country.
The Phase III SHR8028-301 bridging trial met its primary endpoint, demonstrating a statistically significant reduction in total corneal fluorescein staining score at Day 29 (treatment: −4.8 vs control: −3.0; P<0.0001).
China's National Medical Products Administration (NMPA) has approved Heng Yi (0.1% cyclosporine ophthalmic solution) for the treatment of dry eye disease (搜索), Hengrui Pharma and Germany-based Novaliq GmbH jointly announced on June 23, 2026. Heng Yi becomes the first and only water-free cyclosporine ophthalmic solution available in China and marks the second approval in the country based on Novaliq's proprietary EyeSol water-free platform technology, following the 2025 approval of Heng Qin (perfluorohexyloctane ophthalmic solution).
The approval grants Hengrui Pharma, which secured exclusive China rights under a 2019 licensing agreement with Novaliq, the ability to commercialize a differentiated immunomodulatory therapy in a market where dry eye disease (搜索) prevalence is reported to range from approximately 21.0% to 52.4%. The same formulation is marketed in the United States as Vevye, approved by the FDA in May 2023, and received centralized EU approval in September 2024.
A Water-Free Delivery Platform
Heng Yi combines cyclosporine at a 0.1% concentration with perfluorobutylpentane (搜索), a semifluorinated alkane (SFA) vehicle that enables water-free delivery. The vehicle's spreading properties reduce ocular surface friction and are reported to enhance drug bioavailability compared with conventional aqueous emulsions. This formulation is distinct from Sinqi Pharmaceutical's Zirun, a 0.05% cyclosporine emulsion that has been marketed in China since 2020 and represents the established incumbent in this mechanism class.
The EyeSol platform's regulatory credibility now spans three major jurisdictions — the US, EU, and China — reinforcing the technology's clinical validation across diverse patient populations.
Phase III Evidence
The NMPA approval was supported by the Phase III SHR8028-301 trial (NCT05841043), a multicenter, randomized, double-blind, vehicle-controlled bridging study enrolling 206 adults with moderate-to-severe dry eye disease (搜索) in China. Led by Professor Hong Jing at Peking University Third Hospital, the trial randomized subjects in a 1:1 ratio to receive either SHR8028 or vehicle twice daily.
The co-primary endpoints were improvements in total corneal fluorescein staining (tCFS) score and eye dryness visual analogue scale (VAS) score at Day 29. Heng Yi demonstrated a statistically significant reduction in tCFS score at Day 29, with the treatment group achieving −4.8 compared to −3.0 in the control group (P<0.0001). Separation from vehicle was observed as early as Day 15, where the treatment group recorded −4.0 versus −2.8 in the control group (P=0.008). The product demonstrated a favorable safety and tolerability profile.
The SHR8028-301 trial was designed as a bridging study to the US pivotal ESSENCE-2 trial (NCT04043179), which enrolled 834 patients and met its primary sign endpoint. In ESSENCE-2, 71.6% of patients achieved a clinically meaningful improvement of ≥3 grades in total corneal staining within four weeks, with effect on tCFS score observed as early as Day 15 (treatment: −3.5 vs control: −3.0, P=0.002). Long-term data from the ESSENCE-2 open-label extension study (NCT04180109) showed that over 80% of patients achieved a significant improvement of ≥3 points in tCFS score after four weeks, which was maintained over the 12-month study period.
Portfolio Strategy and Market Context
Together with Heng Qin, which targets the evaporative subtype of dry eye through an anti-evaporative mechanism, Heng Yi positions Hengrui to address both the aqueous-deficient and evaporative disease subtypes — the two predominant pathophysiological categories — within a single commercial portfolio. This dual approach addresses what the companies describe as a significant unmet medical need in dry eye disease (搜索) management, where current treatment strategies often fall short of meeting combined requirements for efficacy, safety, and suitability for long-term use.
China's prescription dry eye market remains relatively underpenetrated compared with the US, with cyclosporine emulsions representing the principal immunomodulatory option. Kanghong Pharmaceutical (搜索)'s investigational lifitegrast candidate KH632 has completed Phase III evaluation in Chinese patients and, if approved, would introduce a mechanistically distinct LFA-1/ICAM-1 (搜索) antagonist to the market.
For Hengrui, the approval adds an ophthalmic asset to a portfolio more commonly associated with oncology and metabolic disease, and extends the company's track record as a licensing partner capable of executing local clinical development programs for globally originated molecules.