Zheng Quan Zhi Xing·2025-08-15 08:07Core Viewpoint - Lijun Pharmaceutical Group has received acceptance from the National Medical Products Administration for the domestic production registration of JP-1366 tablets, an innovative potassium ion competitive acid blocker for the treatment of reflux esophagitis [1][2]. Group 1: Drug Registration and Approval - The drug name is JP-1366 tablets, with a specification of 20mg, aimed at treating reflux esophagitis [1]. - The application for domestic production registration has been officially accepted by the National Medical Products Administration [1]. Group 2: Drug Development and Clinical Trials - JP-1366 tablets are designed to inhibit gastric acid secretion by blocking the K(+) channel of the H(+), K(+)-ATP enzyme, promoting esophageal mucosal healing and improving reflux symptoms [1]. - A Phase III clinical study comparing JP-1366 tablets with Esomeprazole magnesium enteric-coated tablets has been initiated, with the first subject enrolled in December 2024 and the last visit completed by June 2025 [2]. - The study aims to demonstrate that the mucosal healing rate of JP-1366 tablets is non-inferior to that of Esomeprazole, while also significantly improving symptoms like heartburn and reflux [2]. Group 3: Market Situation - Proton pump inhibitors (PPIs) and potassium ion competitive acid blockers (P-CABs) are recognized as first-line treatment options for gastroesophageal reflux disease in clinical guidelines [2]. - The estimated domestic terminal sales of P-CABs in 2024 are approximately RMB 1,248.12 million, reflecting a year-on-year growth of 81.22% compared to 2023 [2]. - The introduction of JP-1366 tablets will enhance the company's product pipeline in the gastrointestinal field, providing more comprehensive treatment options for clinical use [2].