Group 1 - Shandong Xinhua Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has received the drug registration certificate for Clarithromycin suspension from the National Medical Products Administration [1] - The application for the marketing authorization of Clarithromycin suspension was submitted in December 2023 and accepted, with the registration certificate granted in August 2025 [1] - The approval of Clarithromycin suspension will enhance the company's portfolio of anti-infective drugs and improve its overall competitiveness [2] Group 2 - Clarithromycin is indicated for treating infections caused by pathogens sensitive to it, including upper respiratory infections, lower respiratory infections, skin and soft tissue infections, and acute otitis media [2] - The estimated sales of Clarithromycin in public medical institutions in China for 2024 is approximately RMB 1.123 billion [2]

本品作为血管紧张素II拮抗剂的复方药物，属于《国家基本医疗保险、工伤保险和生育保险药品目录 (2025年)》乙类品种。根据相关统计数据，2024年中国公立医疗机构沙库巴曲缬沙坦钠片销售额约为人 民币49亿元。 新华制药的沙库巴曲缬沙坦钠片于2025年8月取得药品注册证书，有利于丰富本公司心血管疾病治疗药 物，提升公司综合竞争优势。 智通财经APP讯，山东新华制药股份(00719)发布公告，近日，山东新华制药股份有限公司(以下简称"新 华制药"或"本公司")收到国家药品监督管理局核准签发的沙库巴曲缬沙坦钠片(以下简称"该产品")《药 品注册证书》。 沙库巴曲缬沙坦钠片用于射血分数降低的慢性心力衰竭(NYHA Ⅱ-Ⅳ级，LVEF≤40%)成人患者，降低心 血管死亡和心力衰竭住院的风险。沙库巴曲缬沙坦钠片可代替血管紧张素转化酶抑制剂(ACEI)或血管紧 张素Ⅱ受体拮抗剂(ARB)，与其他心力衰竭治疗药物合用。沙库巴曲缬沙坦钠片也可用于治疗原发性高 血压。 ...

Core Viewpoint - The announcement indicates that the company's subsidiary has received regulatory approval for a new drug, which is expected to enhance its product portfolio and market presence in the pharmaceutical industry [1] Group 1 - The full subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has been granted a drug registration certificate for Clarithromycin dry suspension by the National Medical Products Administration [1] - Clarithromycin is indicated for the treatment of infections caused by pathogens sensitive to the drug, including upper respiratory infections, lower respiratory infections, skin and soft tissue infections, and acute otitis media [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Minoxidil lotion, which is expected to enhance the company's product portfolio and overall competitiveness [1] Company Summary - The Minoxidil lotion received its registration certificate, which is a significant milestone for the company [1] - The approval date for the Minoxidil lotion is set for August 2025, indicating a future expansion in product offerings [1] Industry Summary - The approval of new pharmaceutical products like Minoxidil lotion contributes to the diversification of product categories within the pharmaceutical industry [1] - Enhanced product offerings are likely to improve competitive positioning in the market [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. reported a decline in revenue and net profit for the first half of 2025, indicating challenges in the market despite some growth in specific segments [1] Financial Performance - The company's operating revenue was approximately 4.639 billion yuan, a year-on-year decrease of 1.98% [1] - Net profit attributable to shareholders was about 224 million yuan, down 15.69% year-on-year [1] - Basic earnings per share stood at 0.32 yuan [1] Product Development and Market Position - The company launched 10 new formulation products in the first half of the year [1] - A total of 19 products across 25 specifications were awarded national procurement bids [1] - The formulation processing and export business maintained stable growth, with significant development in self-operated formulation exports [1] Production and Innovation - The company focused on cost reduction and leveraged its production advantages in key raw materials, resulting in increased production of 11 key raw materials such as ibuprofen and aspirin, thereby expanding market share [1] - Sales of specialty raw materials experienced rapid growth [1] - In the first half of the year, the company obtained 21 drug approvals, including 19 new formulation products and 2 raw material drug approvals [1] - The company initiated Phase II clinical work for a Class I innovative drug OAB-14 for Alzheimer's treatment [1] - The company received 18 authorized patents, including 8 invention patents [1] - One project was awarded the Shandong Province 2024 Science and Technology Progress Award, and another was included in the 2025 provincial major science and technology innovation project [1]

格隆汇8月26日丨山东新华制药股份(00719.HK)发布公告，集团2025年半年度按《中国企业会计准则》 计算，实现营业收入为人民币46.39亿元，同比减少1.98%；归属于上市公司股东的净利润为人民币2.24 亿元，同比减少15.69%。公司董事会建议不派发2025年半年度股息，不送红股，不以公积金转增股 本。 ...

2023年10月，新华制药向国家药品监督管理局药品审评中心(CDE)递交米诺地尔搽剂上市许可申报资料 并获受理，2025年8月获得《药品注册证书》，审评结论为：批准注册。本品用于治疗男性型脱发和斑 秃。根据有关统计数据，2024年中国公立医疗机构米诺地尔销售额约为人民币23.6亿元。 格隆汇8月26日丨山东新华制药股份(00719.HK)公告，近日，山东新华制药股份有限公司(以下简称"新 华制药"或"公司")收到国家药品监督管理局核准签发的米诺地尔搽剂(以下简称"本品")《药品注册证 书》，批准本品注册。 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. reported a decline in revenue and net profit for the first half of 2025, indicating challenges in the market despite some growth in specific areas [1] Financial Performance - The company's operating revenue was approximately 4.639 billion yuan, a year-on-year decrease of 1.98% [1] - Net profit attributable to shareholders was about 224 million yuan, down 15.69% year-on-year [1] - Basic earnings per share stood at 0.32 yuan [1] Product Development and Market Position - The company launched 10 new formulation products in the first half of the year [1] - A total of 19 products with 25 specifications were awarded national procurement bids by the end of the reporting period [1] - The formulation processing and export business maintained stable growth, with significant development in self-operated formulation exports [1] Raw Material Production and Innovation - The company leveraged its production advantages in key raw materials, achieving increased production of 11 key raw materials including ibuprofen and aspirin, thereby expanding market share [1] - Sales of specialty raw materials experienced rapid growth [1] - The company obtained 21 drug approvals in the first half of the year, including 19 new formulation products and 2 raw material drug approvals [1] - It initiated Phase II clinical trials for a Class 1 innovative drug OAB-14 for Alzheimer's treatment [1] - The company received 18 authorized patents, including 8 invention patents [1] Recognition and Future Projects - One project was awarded the Shandong Province 2024 Science and Technology Progress Second Prize [1] - Another project was included in the 2025 provincial major scientific and technological innovation engineering projects [1]

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之內容概不負責，對其準確性或完整性亦不發表任何 聲明，並明確表示概不就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之任何損失承擔任何責任。 山東新華製藥股份有限公司 Shandong Xinhua Pharmaceutical Company Limited （於中華人民共和國註冊成立之股份有限公司） （股份代碼：00719） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條作出。 山 東 新 華 製 藥 股 份 有 限 公 司 （ 「 本 公 司 」 ） 將 於 2025 年 8 月 27 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於子公司獲得克拉黴素幹混懸劑〈藥品註冊證書〉 的公告》,茲載列有關文檔之中文版，以供參閱。 承董事會命 山東新華製藥股份有限公司 賀同慶 董事長 中國 淄博 2025年8月26日 於本公告日期，本公司董事會之成員如下： | 執行董事： | | 獨立非執行董事： | | --- | --- | --- | | 賀同慶先生（董事長） | ...

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之內容概不負責，對其準確性或完整性亦不發表任何 聲明，並明確表示概不就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之任何損失承擔任何責任。 山 東 新 華 製 藥 股 份 有 限 公 司 （ 「 本 公 司 」 ） 將 於 2025 年 8 月 27 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得沙庫巴曲纈沙坦鈉片〈藥品註冊證書〉的公 告》,茲載列有關文檔之中文版，以供參閱。 承董事會命 山東新華製藥股份有限公司 賀同慶 董事長 中國 淄博 2025年8月27日 於本公告日期，本公司董事會之成員如下： | 執行董事： | | 獨立非執行董事： | | --- | --- | --- | | 賀同慶先生（董事長） | | 潘廣成先生 | | 徐文輝先生 | | 朱建偉先生 | | 侯 | 寧先生 | 凌沛學先生 | | | | 張菁菁女士 | 非執行董事： 徐 列先生 張成勇先生 山東新華製藥股份有限公司 Shandong Xinhua Pharmaceutical Company Limi ...