Core Viewpoint - Lijun Pharmaceutical Group 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] Group 1: Product Information - JP-1366 tablets work by competitively blocking the K(+) channel of the H(+), K(+)-ATPase (proton pump), inhibiting the binding of K(+) to the proton pump, thereby suppressing gastric acid secretion [1] - The product promotes esophageal mucosal healing and improves reflux symptoms, with a rapid increase in gastric pH and the ability to maintain gastric pH above 4 for an extended period, effectively addressing nighttime acid breakthrough [1] Group 2: Financial Investment - As of the announcement date, the total research and development expenses directly invested in JP-1366 tablets amount to approximately RMB 185.21 million [1]

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 announcement indicates that the company’s subsidiary, Lijun Pharmaceutical Group Co., Ltd., has received acceptance from the National Medical Products Administration for the domestic production registration of the drug JP-1366 tablets [1]. Group 1 - The company, Health元, announced on August 15 that its subsidiary, Lijun Pharmaceutical Group, received a notice of acceptance from the National Medical Products Administration [1]. - The acceptance number for the registration application of JP-1366 tablets is CYHS2502991 [1].

智通财经APP讯，丽珠医药(01513)发布公告，该公司收到国家药品监督管理局(药监局)核准签发的《受 理通知书》(受理号： CYHS2502991)，本公司申请的JP-1366片(本品)的境内生产药品注册获药监局受 理。 本公司启动了一项 JP-1366 片与耐信®(艾司奥美拉唑镁肠溶片)在中国反流性食管炎患者中的多中心、 随机、双盲、阳性平行对照的Ⅲ期临床研究。2024年12 月首例受试者入组，2025年6月末例受试者末次 访视完成。该研究共纳入362例中国反流性食管炎患者，结果证实JP-1366片在给药后8周内获得的食管 黏膜癒合率非劣于耐信®。同时，JP-1366片可明显地改善烧心和反流等症状。基于此Ⅲ 期临床研究的 结果，本公司向国家药品监督管理局药品审评中心(CDE)递交了JP-1366 片剂反流性食管炎适应症的上 市许可申请。 该信息由智通财经网提供 JP-1366 片是一款创新钾离子竞争性酸阻滞剂(P-CAB)，可以通过竞争性阻断 H(+)、K(+)-ATP 酶(质子 泵)的 K(+)通道，阻滞 K(+)与质子泵的结合，抑制胃酸的分泌，从而达到促进食管黏膜癒合和改善反流 症状的效果。JP-13 ...

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]

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 麗珠醫藥集團股份有限公司 呈交日期： 2025年8月15日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 01513 | 說明 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括庫存股份）數 目 | 佔有關事件 ...

JP-1366片註冊上市許可申請獲受理 近日，麗珠醫藥集團股份有限公司 Livzon Pharmaceutical Group Inc.*（「本公司」） 收到國家藥品監督管理局（「藥監局」）核准簽發的《受理通知書》（受理號： CYHS2502991），本公司申請的 JP-1366 片（「本品」）的境內生產藥品註冊獲 藥監局受理。現將有關詳情公告如下： 一、受理通知書的主要內容 藥物名稱：JP-1366 片 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完整性亦 不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任 何損失承擔任何責任。 自願公告 適應症：反流性食管炎 申請事項：境內生產藥品註冊上市許可 英文名/拉丁名：JP-1366 tablets 劑型：片劑 規格：20mg 申請人：麗珠醫藥集團股份有限公司 審批結論：根據《中華人民共和國行政許可法》第三十二條的規定，經審查，決 定予以受理。 1 二、藥品研發及相關情況 JP-1366 片是一款創新鉀離子競爭性酸阻滯劑（P-CAB），可以通過競爭性阻斷 H(+)、K(+)-ATP ...

Core Viewpoint - Lijun Pharmaceutical (01513) announced a share buyback plan, intending to repurchase approximately 110,300 A-shares at a cost of about 4.3939 million yuan by August 15, 2025 [1] Company Summary - The company plans to execute a buyback of A-shares, indicating a strategy to enhance shareholder value and potentially signal confidence in its financial health [1] - The total amount allocated for the buyback is approximately 4.3939 million yuan, which reflects the company's commitment to returning capital to shareholders [1] - The specific number of shares targeted for repurchase is 110,300, which may influence the stock's liquidity and market perception [1]

格隆汇8月15日丨丽珠医药(01513.HK)发布公告，2025年8月15日耗资439.39万元人民币回购11.03万股A 股。 ...

丽珠医药(01513)公布，2025年8月15日耗资约439.39万元回购11.03万股A股股份。 ...