Diquafosol

For patients with dry eye, traditional artificial tears can only relieve symptoms in the short term and cannot improve tear secretion disorders from the root cause. The advent of diquafosol has filled this clinical gap. As an ophthalmic active pharmaceutical ingredient (API) of the P2Y2 receptor agonist class, it can activate the P2Y2 receptors on ocular surface epithelial cells and goblet cells to promote the secretion of water, electrolytes and mucin, and rebuild a stable tear film. It is indicated for moderate to severe dry eye patients who have poor response to artificial tear treatment, and especially delivers significant clinical benefits to people with insufficient tear secretion and mucin deficiency.

The current global prevalence of dry eye ranges from 5.5% to 33.7%, and the number of dry eye patients in China exceeds 290 million, which drives the continuous expansion of the diquafosol market. In 2023, the market size of domestic diquafosol-related preparations exceeded 1.1 billion yuan, with a compound annual growth rate of 27.2% in the recent 3 years. In terms of the competitive landscape, the originator product still accounts for approximately 62% of the market share. With the expiration of core patents, generic drugs from 3 domestic enterprises have been approved for marketing, and centralized procurement will further boost the clinical penetration rate of this drug.

The originator enterprise of diquafosol is Santen Pharmaceutical Co., Ltd. of Japan, with the originator brand name "Diquas". Its core compound patent will expire in China in 2025. The originator dosage form is eye drops, with the mainstream specification of 3% (5ml:150mg). This originator product has been included in the Reference Listed Drug Catalogue for Chemical Drugs issued by the NMPA. As of September 2024, the CDE API Registration Platform has included a total of 6 registration entries for diquafosol sodium (the medicinal form of diquafosol is sodium salt), among which 3 are in Status A and can be used for associated domestic preparation declaration. At present, 4 generic diquafosol sodium eye drops have been approved for marketing in China. (Data as of September 2024, please refer to the official CDE website for the latest information.)

CATO provides a full set of diquafosol impurity reference standards, which can cover the whole process requirements of impurity qualification, quantification and release testing. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable support for pharmaceutical enterprises in API R&D, quality control and declaration work.