Core Viewpoint - Lijun Group's JP-1366 tablet has received acceptance for its domestic production drug registration application, indicating progress in its development pipeline for treating gastroesophageal reflux disease [1][2] Company Announcements - Lijun Group's JP-1366 tablet registration application was accepted by the National Medical Products Administration, with a cumulative R&D investment of approximately RMB 185.21 million [1] - The company has initiated a Phase III clinical study for JP-1366, involving 362 patients, showing non-inferiority in esophageal mucosal healing rates compared to the control drug, Naisan [2] Market Performance - As of August 15, 2025, Lijun Group's stock closed at RMB 40.1, a 0.25% increase from the previous week, with a total market capitalization of RMB 36.254 billion [1] - The stock reached a weekly high of RMB 40.75 and a low of RMB 39.26, ranking 15th in the chemical pharmaceutical sector and 453rd among A-shares [1] Sales Projections - According to IQVIA data, the domestic terminal sales for P-CABs are projected to reach approximately RMB 1.248 billion in 2024, reflecting a year-on-year growth of 81.22%, with Q1 2025 sales estimated at RMB 394.35 million, up 81.63% year-on-year [2]

Group 1 - The core point of the announcement is that the company’s subsidiary, Lijun Pharmaceutical Group Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for the domestic production registration of JP-1366 tablets, which are indicated for gastroesophageal reflux disease [1][2] Group 2 - JP-1366 tablets are an innovative potassium-competitive acid blocker (P-CAB) that effectively inhibits gastric acid secretion, promoting esophageal mucosal healing and improving reflux symptoms [2][3] - A Phase III clinical study has been initiated to compare JP-1366 tablets with Esomeprazole magnesium enteric-coated tablets in Chinese patients with gastroesophageal reflux disease, involving 362 patients [2] - The clinical study results indicate that JP-1366 tablets achieve a mucosal healing rate comparable to Esomeprazole within 8 weeks and significantly improve symptoms such as heartburn and reflux [2][3] Group 3 - The market for P-CABs in China is projected to reach approximately RMB 1.25 billion in 2024, reflecting a year-on-year growth of 81.22% from 2023 [4] - The first quarter of 2025 is expected to see P-CAB sales of around RMB 394.35 million, marking an 81.63% increase compared to the first quarter of 2024 [4] - The introduction of JP-1366 tablets will enhance the company’s product pipeline in the gastrointestinal field, providing more comprehensive treatment options [4]

Core Viewpoint - Lijun Pharmaceutical Group Co., Ltd. has received a notice of 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 gastroesophageal reflux disease [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 accepted by the National Medical Products Administration, indicating a positive step towards market entry [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(+)-ATPase, effectively promoting esophageal mucosal healing and alleviating reflux symptoms [2]. - A Phase III clinical trial involving 362 patients with reflux esophagitis has been initiated, with results showing that JP-1366 tablets achieve a mucosal healing rate comparable to the existing treatment, Esomeprazole [2][3]. Group 3: Financial Investment in R&D - The total research and development investment for JP-1366 tablets has reached approximately RMB 185.21 million [4]. Group 4: 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 [5]. - The estimated domestic terminal sales for P-CABs in 2024 are approximately RMB 1.25 billion, reflecting a year-on-year growth of 81.22% [5][6]. - In the first quarter of 2025, the estimated domestic terminal sales for P-CABs are around RMB 394.35 million, showing an increase of 81.63% compared to the same period in 2024 [6].

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]