Hengrui Pharma and Novaliq GmbH have received approval from China's National Medical Products Administration (NMPA) for Heng Yi (0.1 percent cyclosporine ophthalmic solution) for the treatment of Dry Eye Disease (DED). The therapy is indicated to increase tear secretion in patients with reduced tear production and improve the clinical signs of the disease.

The approval marks the launch of China's first and only water-free 0.1 percent cyclosporine ophthalmic solution and the second dry eye treatment approved in the country based on Novaliq's proprietary EyeSol water-free platform technology, following the approval of Heng Qin (perfluorohexyloctane ophthalmic solution) in 2025.

Dry eye disease affects an estimated 21 percent to 52.4 percent of the Chinese population and is characterised by disruption of tear film homeostasis, leading to persistent inflammation, ocular surface damage and symptoms such as dryness, burning sensation and foreign body sensation. Existing treatment options often fail to provide the desired balance of efficacy, safety and long-term disease management.

Heng Yi combines the anti-inflammatory agent cyclosporine with perfluorobutylpentane, a water-free semifluorinated alkane vehicle designed to improve drug delivery and reduce friction on the ocular surface. Hengrui Pharma secured exclusive rights in 2019 to develop, manufacture and commercialise the therapy in China under a strategic collaboration with Novaliq.

The approval is supported by results from the Phase 3 SHR8028-301 clinical trial, a multicentre, randomised, double-blind, vehicle-controlled study involving 206 patients with moderate-to-severe dry eye disease. The study demonstrated statistically significant improvements in total Corneal Fluorescein Staining (tCFS), a key marker of ocular surface damage, as early as Day 15, with further improvement observed at Day 29 compared with the control group. The therapy also demonstrated a favourable safety and tolerability profile.

The product is based on CyclASol, which received approval from the US Food and Drug Administration in 2023 for the treatment of the signs and symptoms of dry eye disease. It was subsequently approved by the European Commission in 2024 for the treatment of adults with moderate-to-severe dry eye disease.

Clinical evidence supporting the therapy also includes the global Phase 3 ESSENCE-2 trial, which enrolled 834 patients and met its primary efficacy endpoint. More than 80 percent of patients achieved clinically meaningful improvements in corneal staining after four weeks of treatment, with benefits maintained throughout the 12-month study period, supporting its potential for long-term management of the chronic condition.

With the addition of Heng Yi alongside Heng Qin, Hengrui Pharma now offers a broader treatment portfolio targeting multiple underlying causes of dry eye disease, strengthening its position in China's ophthalmology market.