Hengrui’s Heng Yi wins China approval as second EyeSol-based dry eye therapy

Edited by Robert McTiernan··3 min read

China’s National Medical Products Administration (NMPA) has approved Heng Yi (cyclosporine ophthalmic solution 0.1%) for the treatment of dry eye disease, marking the second approval in China based on Germany-based Novaliq’s water-free EyeSol platform. Hengrui Pharma, which holds exclusive China rights under a 2019 licensing agreement with Novaliq, will commercialize the product. The same formulation is marketed in the US as Vevye (approved by the US FDA in May 2023) and received EU approval in September 2024.

Heng Yi combines cyclosporine at 0.1% concentration with perfluorobutylpentane, a semifluorinated alkane 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. The 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 NMPA approval was supported by the Phase III SHR8028-301 trial (NCT05841043), a multicenter, randomized, double-blind, vehicle-controlled study enrolling 206 adults with moderate-to-severe dry eye disease in China. The co-primary endpoints were improvements in total corneal fluorescein staining (tCFS) score and eye dryness visual analogue scale score at Day 29. Heng Yi demonstrated a statistically significant reduction in tCFS score at Day 29 (treatment group: −4.8 versus control: −3.0; P<0.0001), with separation from vehicle observed as early as Day 15. The 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, with 71.6% of patients achieving a clinically meaningful improvement of ≥3 grades in total corneal staining within four weeks.

The approval reinforces the EyeSol platform’s regulatory credibility across multiple jurisdictions. Heng Yi is the second EyeSol-based product approved in China, following Heng Qin (perfluorohexyloctane ophthalmic solution) in 2025, which targets the evaporative subtype of dry eye through a distinct anti-evaporative mechanism. Together, the two products position Hengrui to address both the aqueous-deficient and evaporative disease subtypes — the two predominant pathophysiological categories — within a single commercial portfolio.

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China’s prescription dry eye market remains relatively underpenetrated compared with the US, with cyclosporine emulsions representing the principal immunomodulatory option. Heng Yi differentiates itself through Novaliq’s water-free EyeSol vehicle, while Kanghong’s investigational lifitegrast would introduce a distinct LFA-1/ICAM-1 mechanism if approved.

Kanghong Pharmaceutical’s lifitegrast candidate KH632 has completed Phase III evaluation in Chinese patients and, if approved, would introduce a mechanistically distinct LFA-1/ICAM-1 antagonist to the market. The broader dry eye regulatory environment — including recent NMPA ophthalmic approvals in adjacent ocular surface indications — suggests growing regulatory appetite for differentiated topical therapies. The challenges facing other dry eye candidates in demonstrating efficacy underscore the clinical bar that Heng Yi’s Phase III data have cleared.

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.

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