XINHUA PHARM(000756)
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新华制药:子公司获得克拉霉素干混悬剂《药品注册证书》
Xin Lang Cai Jing· 2025-08-26 09:32
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]
山东新华制药股份(00719)获得米诺地尔搽剂《药品注册证书》
智通财经网· 2025-08-26 09:30
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]
山东新华制药股份公布中期业绩 归母净利为约2.24亿元 同比减少15.69%
Zhi Tong Cai Jing· 2025-08-26 09:29
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]
山东新华制药股份(00719.HK):上半年净利润为2.24亿元 同比减少15.69%
Ge Long Hui· 2025-08-26 09:29
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。 ...
山东新华制药股份(00719.HK)获得米诺地尔搽剂《药品注册证书》
Ge Long Hui· 2025-08-26 09:29
Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Minoxidil topical solution, which is intended for the treatment of male pattern baldness and alopecia areata [1] Company Summary - The company submitted the application for the marketing authorization of Minoxidil topical solution to the Center for Drug Evaluation (CDE) in October 2023, which was accepted [1] - The drug registration certificate was granted in August 2025, with the evaluation conclusion being approval for registration [1] Industry Summary - The estimated sales revenue for Minoxidil in public medical institutions in China is approximately RMB 2.36 billion in 2024 [1]
山东新华制药股份(00719)公布中期业绩 归母净利为约2.24亿元 同比减少15.69%
智通财经网· 2025-08-26 09:28
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]
山东新华制药股份(00719) - 海外监管公告-关於子公司获得克拉霉素干混悬剂《药品註册证书》的公...


2025-08-26 09:26
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) | ...
山东新华制药股份(00719) - 海外监管公告-关於获得沙库巴曲纈沙坦钠片《药品註册证书》的公告


2025-08-26 09:25
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 ...
山东新华制药股份(00719) - 海外监管公告-关於获得米诺地尔搽剂《药品註册证书》的公告


2025-08-26 09:24
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《關於獲得米諾地爾搽劑〈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: 一、基本情况 | 執行董事: | | 獨立非執行董事: | | --- | --- | --- | | 賀同慶先生(董事長) ...
山东新华制药股份(00719) - 建议修订公司章程及相关议事规则


2025-08-26 09:23
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,概不對因本公告全部或任何部份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) 建議修訂公司章程及相關議事規則 此公告乃山東新華製藥股份有限公司(「本公司」)根據香港聯合交易所有限公司證券上 市規則第13.51(1)條發出。 本公司董事會(「董事會」)特此公告,為遵守以下相關法律法規及監管要求:(一) 2024年7月1日生效的《中華人民共和國公司法》;(二)《關於新〈公司法〉配套制度規 則實施相關過渡期安排》;(三)中國證券監督管理委員會發佈的《上市公司章程指引 (2025年修訂)》;(四)行政管理機構企業登記管理審批系統對經營範圍的分類規則進 行了調整;以及(五)其他相關法律、法規、規範性文件和監管要求,公司擬對現行章程 及相關議事規則進行修訂,以落實以下內容(「建議修訂」): 建議修訂公司章 ...