Core Viewpoint - Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the listing of Acetate Prednisolone as a chemical raw material drug, indicating a significant advancement in its product portfolio and potential market opportunities [1] Company Summary - The company submitted the registration application for Acetate Prednisolone to the National Medical Products Administration's CDE in March 2024, which was accepted [1] - The approval notification for the listing was granted in November 2025, with the review conclusion being a registration approval [1] - Acetate Prednisolone is primarily used for allergic and autoimmune inflammatory diseases, including active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, nephrotic syndrome, and others [1] Industry Summary - The sales revenue of Acetate Prednisolone-related formulations in Chinese public medical institutions is estimated to be approximately RMB 100 million in 2024 [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Acetate Prednisolone, indicating a significant advancement in its product portfolio and potential revenue growth in the pharmaceutical market [1] Company Summary - The company submitted the registration application for Acetate Prednisolone to the National Medical Products Administration's CDE in March 2024, which was accepted [1] - The approval notification for the marketing application was granted in November 2025, with the review conclusion being a registration approval [1] Industry Summary - Acetate Prednisolone is primarily used for allergic and autoimmune inflammatory diseases, including active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, nephrotic syndrome, thrombocytopenic purpura, granulocytopenia, various adrenal cortical insufficiencies, severe dermatitis, and acute leukemia, among others [1] - The sales revenue of Acetate Prednisolone-related formulations in Chinese public medical institutions is estimated to be approximately RMB 100 million in 2024 [1]

本品主要适用于因支气管痉挛所致严重呼吸困难，可迅速缓解药物等引起的过敏性休克，亦可用于延长 浸润麻醉用药的作用时间，是各种原因引起的心脏骤停进行心肺复苏的主要抢救用药。 格隆汇11月27日丨山东新华制药股份(00719.HK)公布，近日，公司收到国家药品监督管理局核准签发的 盐酸肾上腺素注射液(以下简称"本品")《药品补充申请批准通知书》，本品通过仿制药质量和疗效一致 性评价。 ...

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Acetate Prednisolone, which is primarily used for allergic and autoimmune inflammatory diseases [1] Group 1: Product Approval - The company has been granted a marketing approval notification for Acetate Prednisolone, indicating a significant regulatory milestone [1] - This product is mainly utilized for various conditions including active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, nephrotic syndrome, thrombocytopenic purpura, neutropenia, adrenal insufficiency, severe dermatitis, and acute leukemia [1] - Acetate Prednisolone is also used in the comprehensive treatment of certain infections, showcasing its versatility in therapeutic applications [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 11 月 28 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得醋酸潑尼松龍化學原料藥上市申請批准通知 書的公告》,茲載列有關文檔之中文版，以供參閱。 山東新華製藥股份有限公司 承董事會命 关于获得醋酸泼尼松龙化学原料药上市申请批准通知书的公告 賀同慶 董事長 中國 淄博 2025年11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： | | ...

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 11 月 28 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於鹽酸腎上腺素註射液通過仿製藥一致性評價的公 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11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） | ...

Market Performance - The Shandong state-owned enterprise reform sector rose by 0.45% compared to the previous trading day, with Xinhua Pharmaceutical leading the gains [1] - The Shanghai Composite Index closed at 3864.18, down 0.15%, while the Shenzhen Component Index closed at 12907.83, up 1.02% [1] Stock Highlights - Xinhua Pharmaceutical (000756) closed at 18.15, up 5.77% with a trading volume of 877,900 shares and a transaction value of 1.595 billion [1] - Inspur Information (000977) closed at 63.56, up 5.74% with a trading volume of 995,400 shares and a transaction value of 6.266 billion [1] - Other notable stocks include Jiri Co. (002083) up 3.50%, Shantui Co. (000680) up 3.02%, and Haizhu Co. (301262) up 3.01% [1] Capital Flow - The Shandong state-owned enterprise reform sector saw a net inflow of 885 million in main funds, while retail investors experienced a net outflow of 449 million [2] - The main funds showed significant inflows into stocks like Inspur Information and Xinhua Pharmaceutical, while retail investors withdrew from several stocks [3] Individual Stock Capital Flow - Inspur Information had a main fund net inflow of 11.37 billion, while retail investors saw a net outflow of 6.40 billion [3] - Xinhua Pharmaceutical experienced a main fund net inflow of 68.2 million, with retail investors withdrawing 46.5 million [3] - Other stocks like Shandong Steel (600022) and Qingdao Food (001219) also showed varied capital flows, indicating differing investor sentiments [3]

Group 1 - Shandong Xinhua Pharmaceutical (000756) shares increased by over 4%, currently trading at 7.49 HKD with a transaction volume of 95.1843 million HKD [1] - The company received approval from the National Medical Products Administration for the registration of Lidocaine and Prilocaine Cream, which is expected to generate approximately 615 million CNY in sales for public medical institutions in China in 2024 [1] - The current season is seeing a rise in demand for flu medications such as Oseltamivir and Marbofloxacin, with sales of Oseltamivir increasing by 237% and Marbofloxacin by 180% over the past week [1] Group 2 - Xinhua Pharmaceutical is a significant global supplier of antipyretic and analgesic medications, with a product portfolio that includes Ibuprofen, Aspirin, and Meloxicam [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has seen its stock price increase by over 4%, currently trading at 7.49 HKD, following the approval of its drug registration certificate for a new compound anesthetic cream by the National Medical Products Administration of China [1] Company Summary - The newly approved drug, Lidocaine and Prilocaine Cream, is intended for local skin anesthesia and is projected to generate sales of approximately 615 million CNY in public medical institutions in China by 2024 [1] - Xinhua Pharmaceutical is a significant global supplier of antipyretic and analgesic medications, with a product portfolio that includes Ibuprofen, Aspirin, and Meloxicam [1] Industry Summary - The current season is marked by a surge in respiratory infectious diseases, leading to increased demand for antiviral medications such as Oseltamivir and Marbofloxacin, with sales growth rates of 237% and 180% respectively over the past week [1]

Core Viewpoint - Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of its drug, Lidocaine and Prilocaine Cream [1] Group 1 - Xinhua Pharmaceutical announced the receipt of the drug registration certificate for Lidocaine and Prilocaine Cream [1]