Qilu Pharmaceutical Submits NDA for Diquafosol Sodium Eye Drops as Second Domestic Applicant

On December 9, the CDE website showed that Qilu Pharmaceutical submitted a marketing application for its Class 4 generic drug "Diquafosol Sodium Eye Drops," which was accepted. Previously, only Hengrui had filed for production of this drug, and it has not yet been approved for market launch.

Diquafosol sodium is a P2Y2 receptor agonist that acts on P2Y2 receptors located on the membranes of conjunctival epithelial cells and goblet cells. By upregulating intracellular calcium ion concentration, it promotes the secretion of water and mucins, thereby improving the symptoms of dry eye disease.

This drug was developed by Santen Pharmaceutical after obtaining licensing from Inspire Pharmaceuticals (a subsidiary of Merck). It was first approved in Japan in October 2010 for the treatment of dry eye disease, under the brand name Diquas®, with a specification of 3% (5 mL). It was approved for import into China in October 2017, under the brand name Li’aisi. Public data shows that sales of this drug in public medical institutions in China amounted to approximately RMB 35 million in 2019.

Insight database shows that Hengrui's Diquafosol Sodium was submitted for marketing approval in July this year and is currently awaiting review.

Source: Insight Database (http://db.dxy.cn/v5/home/)