Qilu Pharmaceutical's Irsogladine Maleate Tablets Receive Supplementary Approval for Consistency Evaluation as China's First Generic Entrant

On December 16, the official website of the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical’s supplemental application for consistency evaluation of Irsogladine Maleate Tablets had been approved. Irsogladine Maleate Tablets are a gastric mucosal protective agent, and Qilu Pharmaceutical is the first company to pass the consistency evaluation for this product. To date, Qilu Pharmaceutical has had 45 products approved through consistency evaluation.

Irsogladine Maleate Tablets are a gastric mucosal protective agent, commonly used in clinical practice for the treatment of gastric ulcers. They exert their mucosal defense effect by strengthening the junctions between gastric mucosal epithelial cells, inhibiting the detachment and exfoliation of epithelial cells as well as the widening of intercellular spaces, enhancing the intrinsic stability of mucosal cells, and thereby preventing the penetration of harmful substances through the mucosa.

The original manufacturer of Isoladine is Nippon Shinyaku Co., Ltd. of Japan. The product has been marketed in China under the brand name Gaisalong. There are five domestic generic manufacturers for this product, namely Qilu Pharmaceutical, Wansheng Pharmaceutical, Jiangxi Pharmaceutical, Sanofi, and Tianlong Pharmaceutical.

Manufacturer of Irasolidine Maleate Tablets

Source: Menet MID Drug Index Comprehensive Database

Data from Menet shows that in 2019, the sales of isolatidine at terminal outlets of China’s public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—amounted to RMB 14.59 million, with Nippon Shinyaku Co., Ltd. holding an 83.37% market share.

As of now, Qilu Pharmaceutical has 45 products (80 specifications) that have passed or are deemed to have passed the consistency evaluation. Notably, no other generic drug manufacturers have submitted supplementary applications for the consistency evaluation of Isoridine Maleate Tablets, nor have any companies submitted marketing authorization applications under the new registration classification. As the sole company with approval for this product, Qilu Pharmaceutical is poised to expand its sales market by leveraging policies that prioritize procurement and selection.

Source: Menet Database, NMPA