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]

近日（7月23日），CDE官网显示，江苏和晨药业有限公司按化药注册分类4类申报的艾普拉唑肠溶片上市申请已获受理。摩熵医药显示，该品种院内市场规 模超15亿元，当前已有多家企业入局。 | 受理品种目录浏览 | | 在审品种目录浏览 | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 年 | 2025 | ▼ 药品类型: | रुकी | V | 申请类型: | V 仿制&已有国家标准 | 童间 | | 受理号: | 请输入受理号 | 药品名称: | 艾普拉唑肠溶片 | | 企业名称: | 请输入企业名称 | | | 序号 | 受聘号 | 药品名称 | 药品类型 | 申请类型 | 注册分类 | 企业名称 | 承办日期 | | CYHS2502667 | | 艾普拉唑肠溶片 | 化药 | 仿制 | য | 浙江皓格药业有限公 司;江苏和晨药业有限 公司; | 2025-07-23 다해줄[ | 截图来源：CDE官网 艾普拉唑（ilaprazole）是由丽珠集团丽珠制药研发的国产1.1类新药，属于不可逆型质子泵抑制剂（PPI），具有抑制胃酸分 ...