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质子泵抑制剂(PPI)
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健康元药业集团股份有限公司 关于药品注册上市许可申请获受理的提示性公告
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]