Hengrui’s Heng Yi® Approved in China for Dry Eye Disease Treatment
Hengrui Pharma and Novaliq GmbH have announced that China’s National Medical Products Administration (NMPA) has approved Heng Yi® (0.1% cyclosporine ophthalmic solution) for the treatment of patients with dry eye disease (DED). The approval, granted on June 23, 2026, marks an important milestone for both companies and expands treatment options for millions of patients in China who experience chronic symptoms associated with reduced tear production and ocular surface inflammation.
The newly approved therapy is designed to increase tear secretion in patients with diminished tear production while improving the clinical signs of dry eye disease. The approval also highlights the continued adoption of Novaliq’s proprietary EyeSol® water-free technology platform, which has been developed to improve the delivery of ophthalmic medications.
First Water-Free Cyclosporine Ophthalmic Solution
Heng Yi® becomes the first and only water-free 0.1% cyclosporine ophthalmic solution approved in China. The product also represents the second dry eye treatment in the country utilizing the EyeSol® technology platform. It follows the 2025 approval of Heng Qin® (perfluorohexyloctane ophthalmic solution), another innovative therapy jointly associated with the collaboration between Hengrui Pharma and Novaliq.
Unlike conventional cyclosporine eye drops that rely on water-based formulations, Heng Yi® uses a unique water-free delivery system. This formulation is intended to improve the distribution of the medication across the eye’s surface while reducing friction, potentially enhancing patient comfort and therapeutic effectiveness.
The approval further strengthens Hengrui Pharma’s ophthalmology portfolio and demonstrates the company’s continued investment in innovative therapies addressing unmet medical needs in China.
Growing Burden of Dry Eye Disease in China
Dry eye disease has emerged as one of the most common ocular disorders worldwide, and its prevalence in China continues to be particularly high. According to published studies, between 21% and 52.4% of the Chinese population may experience some form of dry eye disease, making it a significant public health concern.
DED is recognized as a multifactorial disease characterized by disruption of the normal tear film that protects and lubricates the eye. When tear film stability is compromised, inflammation develops and perpetuates a cycle of ocular surface damage and worsening symptoms.
Patients commonly report symptoms such as:
- Persistent eye dryness
- Burning or stinging sensations
- Foreign body sensation
- Eye irritation
- Blurred or fluctuating vision
- Increased sensitivity to light
- Eye fatigue during reading or screen use
Beyond physical discomfort, dry eye disease can significantly impair daily activities including driving, computer work, reading, and other tasks requiring sustained visual attention. In many cases, the condition negatively affects quality of life and workplace productivity.
Despite numerous treatment options currently available, physicians continue to face challenges in identifying therapies that combine sustained efficacy, acceptable safety, patient comfort, and suitability for long-term treatment.
Innovative EyeSol® Technology
A distinguishing feature of Heng Yi® is its use of Novaliq’s proprietary EyeSol® water-free platform technology.
Traditional ophthalmic formulations frequently encounter challenges when delivering hydrophobic drugs such as cyclosporine because these compounds dissolve poorly in water. EyeSol® addresses this limitation by utilizing a water-free formulation that enables efficient delivery of the active pharmaceutical ingredient without requiring conventional emulsions.
Heng Yi® combines:
- Cyclosporine, a well-established anti-inflammatory agent used to reduce inflammation associated with dry eye disease.
- Perfluorobutylpentane, a semifluorinated alkane (SFA) serving as the water-free carrier vehicle.
The semifluorinated alkane possesses excellent spreading properties across the ocular surface, allowing the medication to form a thin, uniform layer. By reducing friction between the eyelid and corneal surface, the formulation may contribute not only to improved drug delivery but also to enhanced patient comfort.
The technology represents an innovative approach to overcoming many of the formulation challenges traditionally associated with cyclosporine eye treatments.
Strategic Collaboration Between Hengrui and Novaliq
The approval is also the result of a long-term strategic collaboration established between Hengrui Pharma and Novaliq.
In 2019, the two companies entered into an agreement granting Hengrui Pharma exclusive rights to develop, manufacture, and commercialize the 0.1% cyclosporine ophthalmic solution in mainland China.
The partnership combines Novaliq’s proprietary ophthalmic formulation technology with Hengrui Pharma’s expertise in clinical development, manufacturing, regulatory approvals, and commercialization within the Chinese pharmaceutical market.
Since initiating their collaboration, both companies have successfully introduced multiple EyeSol®-based therapies into China, expanding treatment choices for ophthalmologists and patients alike.
Phase III Trial Demonstrated Clinical Benefits
The Chinese approval was supported by data from the randomized, double-blind, vehicle-controlled Phase III clinical trial SHR8028-301.
The study was led by Professor Hong Jing and her research team at Peking University Third Hospital, one of China’s leading medical institutions.
The trial evaluated the efficacy and safety of Heng Yi® in patients diagnosed with dry eye disease.
One of the primary efficacy measures was the total corneal fluorescein staining (tCFS) score, an established clinical indicator used to assess damage to the ocular surface.
Clinical findings demonstrated that patients receiving Heng Yi® experienced statistically significant improvements compared with the control group.
Notably:
- By Day 15, patients treated with Heng Yi® showed a reduction in total corneal fluorescein staining score of 4.0 points, compared with 2.8 points in the control group, representing a statistically significant difference.
- By Day 29, the treatment group achieved an average reduction of 4.8 points, compared with 3.0 points in the control arm, with highly significant statistical results.
These findings suggest that Heng Yi® can provide relatively rapid improvement in clinical signs of dry eye disease while continuing to demonstrate increasing benefits over the treatment period.
Favorable Safety and Tolerability
In addition to demonstrating efficacy, the Phase III study showed that Heng Yi® exhibited a favorable safety and tolerability profile.
Safety remains an essential consideration for dry eye therapies because many patients require treatment for extended periods or even throughout their lifetime.
The clinical trial findings indicate that the water-free cyclosporine formulation was generally well tolerated, supporting its potential use as a long-term therapeutic option for patients with chronic disease.
The combination of efficacy and tolerability may provide physicians with greater confidence when prescribing the therapy for ongoing disease management.
International Recognition of CyclASol®
The formulation approved in China was originally developed internationally under the name CyclASol®.
The product has already received regulatory approvals in several major healthcare markets.
In 2023, the U.S. Food and Drug Administration (FDA) approved CyclASol® for the treatment of the signs and symptoms of dry eye disease, making it the world’s first approved water-free cyclosporine ophthalmic solution. The therapy was subsequently launched in the United States.
The product also received approval from the European Medicines Agency (EMA) in September 2024, allowing its use throughout the European Union for the treatment of adults with moderate to severe dry eye disease.
These international regulatory milestones provided additional validation of both the clinical performance of the therapy and the underlying EyeSol® platform technology.
The Chinese approval now expands the therapy’s global footprint and enables patients in one of the world’s largest pharmaceutical markets to access the innovative treatment.
Expanding Dry Eye Treatment Options
With Heng Yi® joining Heng Qin® in Hengrui Pharma’s ophthalmology portfolio, the company now offers therapies targeting different underlying mechanisms of dry eye disease.
While Heng Yi® primarily addresses the inflammatory component of the disease through cyclosporine’s immunomodulatory effects, Heng Qin® provides an anti-evaporative mechanism designed to stabilize the tear film and reduce excessive tear evaporation.
Because dry eye disease often arises from multiple overlapping causes, having therapies that address distinct disease pathways may enable ophthalmologists to better tailor treatment according to individual patient needs.
The broader portfolio positions Hengrui Pharma to play a significant role in advancing dry eye management in China, where the demand for effective, long-term therapies continues to grow. By combining innovative formulation technology with clinically validated treatments, Hengrui and Novaliq aim to improve outcomes for millions of patients living with this common yet frequently debilitating ocular condition.
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