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].
丽珠医药集团股份有限公司 关于JP-1366片注册上市许可申请获受理的提示性公告