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丽珠医药(01513):JP-1366片注册上市许可申请获受理
Zhi Tong Cai Jing· 2025-08-15 10:57
Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of JP-1366 tablets, an innovative potassium-competitive acid blocker (P-CAB) aimed at treating gastroesophageal reflux disease [1][2]. Group 1: Product Development - JP-1366 tablets work by competitively blocking the H(+), K(+)-ATP enzyme's K(+) channel, inhibiting gastric acid secretion, and promoting esophageal mucosal healing [1]. - The product is designed to rapidly increase gastric pH levels and maintain a pH greater than 4, effectively addressing nighttime acid breakthrough [1]. Group 2: Clinical Trials - The company has initiated a Phase III clinical study comparing JP-1366 tablets with Esomeprazole magnesium enteric-coated tablets in patients with reflux esophagitis in China [2]. - The study will enroll 362 patients, with the first subject enrolled in December 2024 and the last visit completed by June 2025 [2]. - Results from the study indicate that JP-1366 tablets achieve a non-inferior esophageal mucosal healing rate compared to Esomeprazole after 8 weeks of treatment, while also significantly improving symptoms such as heartburn and reflux [2].