Uni-Bio Science Group's Diquafosol Sodium Eye Drops Receives NMPA Approval for Dry Eye Syndrome Treatment in China
核心洞察
Uni-Bio Science Group (搜索) has received NMPA marketing approval for 金因康 (搜索)® (Diquafosol Sodium Eye Drops), addressing a market of approximately 360 million individuals with dry eye syndrome (搜索) in China.
The novel P2Y2 receptor (搜索) agonist works by stimulating tear fluid and mucin secretion, offering improved tear layer normalization and corneal epithelial repair for patients with dry eye syndrome (搜索).
China's dry eye syndrome (搜索) market is projected to reach RMB 42 billion by 2030, growing at a CAGR of 28.4%, positioning 金因康 (搜索)® as a significant player in the rapidly expanding ophthalmology sector.
Uni-Bio Science Group (搜索) Limited announced today that its ophthalmology product, 金因康 (搜索)® (Diquafosol Sodium Eye Drops), has received marketing approval from the China National Medical Products Administration (搜索) (NMPA) [Approval Number: 國藥准字H20254149]. This approval represents a significant advancement in addressing China's growing dry eye syndrome (搜索) market, which currently affects an estimated 360 million individuals nationwide.
金因康 (搜索)® is the Group's second ophthalmology drug following GeneSoft®, strengthening Uni-Bio's position in the ophthalmology sector. The newly approved treatment targets the underlying causes of dry eye syndrome (搜索) through a novel mechanism of action.
Innovative Mechanism of Action
Unlike conventional treatments that primarily provide symptomatic relief, Diquafosol Sodium functions as a P2Y2 receptor (搜索) agonist, stimulating both tear fluid and mucin secretion. This dual-action approach helps normalize the tear layer and repair corneal epithelial damage, addressing the root causes of dry eye syndrome (搜索).
Dr. Li Wei, Chief Scientific Officer at Uni-Bio Science Group (搜索), explained, "金因康 (搜索)® represents a significant advancement in dry eye treatment by targeting the physiological mechanisms of tear production and maintenance. This approach provides more comprehensive relief compared to traditional artificial tear solutions."
The treatment is specifically indicated for patients with dry eye accompanied by abnormal tear-associated corneal epithelial defects, offering a next-generation option for more effective and patient-friendly care.
Market Potential and Growth Strategy
China's dry eye syndrome (搜索) market is experiencing rapid growth, projected to surpass RMB 42 billion by 2030 with a compound annual growth rate of 28.4%. This expansion is primarily driven by increased screen time, aging population demographics, and evolving urban lifestyles.
金因康 (搜索)® enters the market with established efficacy and safety credentials, building on the success of the originator product launched in Japan in 2010. To ensure rapid market penetration, Uni-Bio Science Group (搜索) has:
- Expanded its specialized ophthalmology sales force
- Integrated resources across hospitals, retail pharmacies, and e-commerce platforms
- Established strategic partnerships with API suppliers to secure high-quality raw materials at competitive costs
These initiatives are designed to enhance the affordability and market competitiveness of 金因康 (搜索)®, making it accessible to the growing patient population.
Addressing an Unmet Medical Need
Dry eye syndrome (搜索) represents a significant health burden in China, with prevalence rates increasing due to environmental factors, digital device usage, and changing work patterns. Traditional treatments have often provided only temporary relief without addressing the underlying pathophysiology.
"The approval of 金因康 (搜索)® provides physicians with an important new tool in their treatment arsenal," noted Professor Zhang Hua, a leading ophthalmologist at Beijing Medical University. "Its mechanism of action offers a more physiological approach to managing dry eye syndrome (搜索), potentially improving long-term outcomes for patients."
Future Pipeline Development
With this approval, Uni-Bio Science Group (搜索) continues to strengthen its ophthalmology portfolio. The company has confirmed plans to further invest in research and development to expand its ophthalmic drug pipeline, leveraging over 20 years of technological expertise in the field.
The Group remains committed to addressing clinical needs with high-quality medical solutions, aiming to raise the standards of ophthalmic care and solidify its leadership position in China's growing ophthalmology market.
金因康 (搜索)® is expected to be commercially available across China by the third quarter of 2025, following the completion of manufacturing scale-up and distribution preparations.