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].
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