Recently, our company’s ocular formulation, “Diquafosol Sodium Eye Drops,” has received the “Drug Registration Certificate” approved and issued by the National Medical Products Administration. The approval number is: National Drug Approval No. H20234037. This product is classified as a Class 4 chemical drug and comes in a specification of 3% (5 ml: 150 mg). This marks our company’s second ophthalmic product to be launched on the market, following the approval we obtained in May for 0.1% Sodium Hyaluronate Eye Drops (5 ml: 5 mg). Meanwhile, the active pharmaceutical ingredient “Diquafosol Sodium,” which our company is also responsible for registering, has also been approved. Review and filing registration number: Y20210000404.

Sodium Pilocarpine is a P2Y2 receptor agonist that acts on the P2Y2 receptors located on the conjunctival epithelial and goblet cell membranes. By increasing intracellular calcium ion concentration, it promotes the secretion of both water and mucin, thereby bringing the tear film back to a normal state in both quality and quantity. This enhances the eye’s natural moisturizing capacity, which in turn helps repair damage to the corneal and conjunctival epithelium and effectively alleviates symptoms of dry eye.

China’s potential market for dry eye disease medications is vast and has been growing rapidly in recent years. According to the “Clinical Consensus on Diagnosis and Treatment of Dry Eye (2020)” and existing epidemiological studies in China, the global prevalence of dry eye ranges from approximately 5.5% to 33.7%, while in China, the prevalence is estimated at around 21% to 30%. With the prolonged use of smartphones and computers, as well as factors such as air pollution, the number of dry eye patients is increasing dramatically. The number of dry eye patients in China reached 240 million in 2020. According to data from Sullivan, the dry-eye drug market is projected to reach RMB 6.9 billion and RMB 18 billion by 2025 and 2030, respectively. The compound annual growth rates from 2020 to 2025 and from 2025 to 2030 are expected to be 18.2% and 21.2%, respectively.

Diquafosol sodium eye drops, a novel dry-eye treatment with a unique mechanism of action, have experienced rapid growth in recent years. According to data from Menet, among the top 20 ophthalmic drug products sold at public hospitals in key provinces and cities from Q1 to Q3 2022, Diquafosol sodium eye drops have already risen to the 11th position. Diquafosol sodium eye drops were first launched in Japan in December 2010 and received approval for import into China in October 2017. Currently, the market is still dominated by the imported product, Senko. As the patent protection for the original research product expires and generic versions gradually enter the market, the market size is expected to expand further, potentially becoming a blockbuster product worth hundreds of millions of yuan.

The successful approval of Diclofenac Sodium further enriches the company’s ophthalmic product pipeline. Under the Marketing Authorization Holder (MAH) system, this product will be manufactured by the Group’s holding subsidiary—Beijing Huien NORTHLAND Pharmaceutical Co., Ltd.—fully leveraging the Group’s resource advantages, actively expanding into the ophthalmic drug segment, and enhancing our competitiveness in the ophthalmology field. Currently, the Group already holds registration approvals for seven ophthalmic drugs, including sodium hyaluronate eye drops (in two specifications), olopatadine hydrochloride eye drops (a centrally procured product), brimonidine tartrate eye drops, moxifloxacin hydrochloride eye drops, diclofenac sodium eye drops, and balanced salt solution. These products cover a wide range of indications, including dry eye syndrome, glaucoma, anti-allergy, antibacterial treatment, and irrigation solutions for ophthalmic surgeries. The company is actively preparing for the launch and sales of new products and is comprehensively initiating efforts to attract investment. As NORTHLAND’s first commercially launched product, the company will kick off its commercialization journey with ophthalmic drug sales, establishing and perfecting a pharmaceutical marketing system, building a sales team, and laying the foundation for the future launch of biopharmaceutical products.