新华制药11月27日公告，公司近日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《药品补充 申请批准通知书》，该药品通过仿制药质量和疗效一致性评价。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。 ...

Core Viewpoint - The announcement indicates that the company has received approval from the National Medical Products Administration for its epinephrine injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1: Company Developments - The company submitted the application materials in February 2024 and received acceptance, with approval granted in November 2025 [1] - The epinephrine injection is indicated for severe respiratory distress and anaphylactic shock, classified as a Category A drug under medical insurance [1] Group 2: Market Insights - The estimated sales of epinephrine in Chinese public medical institutions is approximately 270 million yuan in 2024 [1] - The successful evaluation is expected to enhance the company's market competitiveness, although drug sales are subject to uncertainties influenced by policies and market conditions [1]

Core Viewpoint - The approval of the acetate prednisolone raw material drug by the National Medical Products Administration is expected to enhance the company's product line and competitiveness in the hormone drug market [1] Group 1: Company Developments - The company received the approval notice for the acetate prednisolone chemical raw material drug application from the National Medical Products Administration [1] - The application for this raw material drug was submitted in March 2024 and has been accepted for review [1] - The approval is anticipated to enrich the company's hormone product line [1] Group 2: Market Context - The acetate prednisolone is primarily used for allergic and autoimmune inflammatory diseases [1] - The estimated sales revenue for acetate prednisolone formulations in Chinese public medical institutions is approximately 100 million yuan in 2024 [1] - The sales of the drug may be influenced by industry policies and market conditions, indicating potential uncertainties [1]

智通财经APP讯，新华制药(000756.SZ)公告，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《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。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。 ...

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） | ...