By Fineline Cube Shandong Luoxin Pharmaceutical Group Stock Co., Ltd (SHE: 002793), a leading China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a filing for another indication approval for its potassium-competitive acid blocker (P-CAB), tegoprazan. The drug is being reviewed for the treatment of duodenal ulcers, expanding its therapeutic applications beyond its previously approved use for reflux esophagitis (RE) in China.
Clinical Study and Efficacy
The filing is supported by a multi-center, randomized, double-blind, double-simulation, parallel-grouping, active-controlled Phase III clinical study. This study was designed to evaluate the efficacy and safety of tegoprazan in treating duodenal ulcers. A total of 400 patients were enrolled in the trial. The results confirmed that the cumulative healing rate of endoscopic ulcers in Chinese patients treated with tegoprazan 50mg once a day for 6 weeks was not inferior to that of lansoprazole 30mg. This treatment significantly alleviated gastrointestinal symptoms with good safety and tolerance.
Mechanism of Action and Licensing History
Tegoprazan achieves acid secretion control by competitively binding to the potassium ion binding site of H+/K+-ATPase (proton pump) in parietal cells. Unlike traditional proton pump inhibitors, P-CAB directly inhibits H+/K+-ATPase without requiring activation in a strong acid environment. Luoxin Pharmaceutical secured a licensing deal with South Korea-based HK inno.N Corporation in October 2015, obtaining exclusive development, manufacturing, and commercialization rights to the drug in China. Tegoprazan was originally developed by Japanese firm RaQualia Pharma, which licensed exclusive rights to the drug to HK inno.N in a 2010 deal.
Market and Development Outlook
Tegoprazan is included on the National Reimbursement Drug List (NRDL) and has previously obtained clinical trial approval for use in the eradication of Helicobacter pylori (Hp) infection when combined with appropriate antimicrobial therapy. The company is also developing an injectable version of tegoprazan, which has no similar product currently marketed anywhere in the world. This development positions Luoxin Pharmaceutical at the forefront of innovation in the treatment of gastrointestinal disorders.-Fineline Info & Tech