Core Viewpoint - The company, Huaren Health, announced that its wholly-owned subsidiary, Jiangsu Shenhua Pharmaceutical Co., Ltd., has received the acceptance notice for the drug registration application of Fumaric Acid Vonoprazan Tablets from the National Medical Products Administration [1] Group 1: Product Information - Fumaric Acid Vonoprazan Tablets are a new type of potassium ion competitive acid blocker (P-CAB) [1] - The drug can reversibly inhibit the H+/K+-ATPase on gastric parietal cells in a potassium ion competitive manner without relying on an acidic environment [1] - It is stable in highly acidic environments and can quickly, effectively, and durably suppress gastric acid secretion from gastric parietal cells, significantly reducing the occurrence of nighttime gastric acid elevation [1]

Core Viewpoint - The announcement highlights that Jiangsu Shenhua Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huaren Health, has received the acceptance notice for the drug registration application of Fumaric Acid Vonoprazan Tablets from the National Medical Products Administration of China, indicating a significant step towards market entry for this new medication [1] Group 1: Drug Information - Fumaric Acid Vonoprazan is a novel potassium-competitive acid blocker (P-CAB) that can reversibly inhibit the H+/K+-ATPase on gastric parietal cells in a potassium-competitive manner without relying on an acidic environment [1] - The drug is stable in highly acidic environments and can rapidly, effectively, and durably suppress gastric acid secretion from gastric parietal cells, significantly reducing the occurrence of nighttime gastric acid elevation [1] - It was officially approved for marketing in China on December 18, 2019, for the treatment of gastroesophageal reflux disease, making it the first P-CAB to enter the Chinese market [1]

Core Viewpoint - Lijun Group's JP-1366 tablet has received acceptance for its domestic production drug registration application, indicating progress in its development pipeline for treating gastroesophageal reflux disease [1][2] Company Announcements - Lijun Group's JP-1366 tablet registration application was accepted by the National Medical Products Administration, with a cumulative R&D investment of approximately RMB 185.21 million [1] - The company has initiated a Phase III clinical study for JP-1366, involving 362 patients, showing non-inferiority in esophageal mucosal healing rates compared to the control drug, Naisan [2] Market Performance - As of August 15, 2025, Lijun Group's stock closed at RMB 40.1, a 0.25% increase from the previous week, with a total market capitalization of RMB 36.254 billion [1] - The stock reached a weekly high of RMB 40.75 and a low of RMB 39.26, ranking 15th in the chemical pharmaceutical sector and 453rd among A-shares [1] Sales Projections - According to IQVIA data, the domestic terminal sales for P-CABs are projected to reach approximately RMB 1.248 billion in 2024, reflecting a year-on-year growth of 81.22%, with Q1 2025 sales estimated at RMB 394.35 million, up 81.63% year-on-year [2]

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]

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].

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].

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].

Core Insights - Lijun Pharmaceutical has received the acceptance notice from the National Medical Products Administration for the domestic production registration of JP-1366 tablets, an innovative potassium ion competitive acid blocker (P-CAB) [1] - JP-1366 tablets effectively inhibit gastric acid secretion, promote esophageal mucosal healing, and improve reflux symptoms by blocking the K(+) channel of the H(+), K(+)-ATPase [1] - The company has initiated a Phase III clinical study comparing JP-1366 tablets with Esomeprazole magnesium enteric-coated tablets in Chinese patients with reflux esophagitis, with results expected to confirm non-inferiority in esophageal mucosal healing rates [2] Group 1 - The National Medical Products Administration has approved the acceptance of the registration application for JP-1366 tablets [1] - JP-1366 tablets can rapidly increase gastric pH and maintain it above 4 for an extended period, effectively addressing nighttime acid breakthrough [1] - The Phase III clinical study will include 362 Chinese patients and is expected to complete by June 2025 [2] Group 2 - The clinical study aims to demonstrate that JP-1366 tablets achieve esophageal mucosal healing rates that are non-inferior to those of Esomeprazole [2] - JP-1366 tablets significantly improve symptoms such as heartburn and reflux [2] - Based on the Phase III clinical study results, the company has submitted a marketing authorization application for JP-1366 tablets for the indication of reflux esophagitis to the drug evaluation center [2]

Core Viewpoint - Lijun Pharmaceutical Group has received 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 reflux esophagitis [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 officially accepted by the National Medical Products Administration [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(+)-ATP enzyme, promoting esophageal mucosal healing and improving reflux symptoms [1]. - A Phase III clinical study comparing JP-1366 tablets with Esomeprazole magnesium enteric-coated tablets has been initiated, with the first subject enrolled in December 2024 and the last visit completed by June 2025 [2]. - The study aims to demonstrate that the mucosal healing rate of JP-1366 tablets is non-inferior to that of Esomeprazole, while also significantly improving symptoms like heartburn and reflux [2]. Group 3: 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 [2]. - The estimated domestic terminal sales of P-CABs in 2024 are approximately RMB 1,248.12 million, reflecting a year-on-year growth of 81.22% compared to 2023 [2]. - The introduction of JP-1366 tablets will enhance the company's product pipeline in the gastrointestinal field, providing more comprehensive treatment options for clinical use [2].