Core Insights - Lijun Pharmaceutical has received the acceptance notice from the National Medical Products Administration for the domestic production registration of JP-1366 tablets, an innovative potassium ion competitive acid blocker (P-CAB) [1] - JP-1366 tablets effectively inhibit gastric acid secretion, promote esophageal mucosal healing, and improve reflux symptoms by blocking the K(+) channel of the H(+), K(+)-ATPase [1] - The company has initiated a Phase III clinical study comparing JP-1366 tablets with Esomeprazole magnesium enteric-coated tablets in Chinese patients with reflux esophagitis, with results expected to confirm non-inferiority in esophageal mucosal healing rates [2] Group 1 - The National Medical Products Administration has approved the acceptance of the registration application for JP-1366 tablets [1] - JP-1366 tablets can rapidly increase gastric pH and maintain it above 4 for an extended period, effectively addressing nighttime acid breakthrough [1] - The Phase III clinical study will include 362 Chinese patients and is expected to complete by June 2025 [2] Group 2 - The clinical study aims to demonstrate that JP-1366 tablets achieve esophageal mucosal healing rates that are non-inferior to those of Esomeprazole [2] - JP-1366 tablets significantly improve symptoms such as heartburn and reflux [2] - Based on the Phase III clinical study results, the company has submitted a marketing authorization application for JP-1366 tablets for the indication of reflux esophagitis to the drug evaluation center [2]
丽珠医药：JP-1366片注册上市许可申请获受理