Core Viewpoint - Lijun Pharmaceutical Group has received acceptance for the registration application of JP-1366 tablets, an innovative potassium ion competitive acid blocker (P-CAB) aimed at treating gastroesophageal reflux disease (GERD) [1][2]. Group 1: Drug Registration and Approval - The National Medical Products Administration (NMPA) has issued an acceptance notice for the domestic production registration of JP-1366 tablets [1]. - The drug is designed to inhibit gastric acid secretion, promoting esophageal mucosal healing and alleviating reflux symptoms [2]. - The application for market approval is based on a Phase III clinical study involving 362 patients, demonstrating non-inferiority in mucosal healing compared to a standard treatment [2]. Group 2: Clinical Research and Development - The Phase III clinical trial for JP-1366 tablets commenced with the first patient enrolled in December 2024, and the last visit completed by June 2025 [2]. - The total research and development expenditure for JP-1366 tablets has reached approximately RMB 185.21 million [4]. Group 3: Market Situation - Proton pump inhibitors (PPIs) and P-CABs are recognized as first-line treatment options for gastroesophageal reflux disease in clinical guidelines [6]. - The domestic sales of P-CABs are projected to reach approximately RMB 1.25 billion in 2024, reflecting an 81.22% year-on-year growth [6]. - In the first quarter of 2025, P-CAB sales are estimated at around RMB 394.35 million, marking an 81.63% increase compared to the same period in 2024 [6].

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]