LIVZON PHARMA (01513) announced that the company has received an "Acceptance Notice" (Acceptance No.: CYHS2502991) approved and issued by the National Medical Products Administration (NMPA). The company's application for domestic production drug registration of JP-1366 tablets has been accepted by the NMPA.

JP-1366 tablets are an innovative potassium-competitive acid blocker (P-CAB) that can competitively block the K+ channels of H+/K+-ATPase (proton pump), preventing K+ from binding to the proton pump and inhibiting gastric acid secretion, thereby promoting esophageal mucosal healing and improving reflux symptoms. JP-1366 tablets demonstrate rapid elevation of intragastric pH levels and can maintain intragastric pH >4 for extended periods, effectively addressing nocturnal acid breakthrough.

The company initiated a multicenter, randomized, double-blind, positive parallel-controlled Phase III clinical study comparing JP-1366 tablets with Nexium (esomeprazole magnesium enteric-coated tablets) in Chinese patients with reflux esophagitis. The first patient was enrolled in December 2024, and the last patient completed the final visit at the end of June 2025. The study enrolled a total of 362 Chinese patients with reflux esophagitis, and results confirmed that JP-1366 tablets achieved esophageal mucosal healing rates within 8 weeks of administration that were non-inferior to Nexium. Additionally, JP-1366 tablets significantly improved symptoms such as heartburn and reflux.

Based on the results of this Phase III clinical study, the company submitted a marketing authorization application for JP-1366 tablets for the indication of reflux esophagitis to the Center for Drug Evaluation (CDE) of the National Medical Products Administration.