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新华制药:盐酸肾上腺素注射液通过一致性评价
Zhi Tong Cai Jing· 2025-11-27 08:52
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。 ...
山东新华制药股份获得醋酸泼尼松龙化学原料药上市申请批准通知书
Zhi Tong Cai Jing· 2025-11-27 08:47
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]
山东新华制药股份(00719)获得醋酸泼尼松龙化学原料药上市申请批准通知书
智通财经网· 2025-11-27 08:45
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]
山东新华制药股份(00719.HK):盐酸肾上腺素注射液通过仿制药一致性评价
Ge Long Hui· 2025-11-27 08:41
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。 ...
山东新华制药股份(00719.HK):获得醋酸泼尼松龙化学原料药上市申请批准通知书
Ge Long Hui· 2025-11-27 08:41
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]
山东新华制药股份(00719) - 海外监管公告-关於获得醋酸泼尼松龙化学原料药上市申请批准通知书的...
2025-11-27 08:32
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: | | ...
山东新华制药股份(00719) - 海外监管公告-关於盐酸肾上腺素註射液通过仿製药一致性评价的公告
2025-11-27 08:31
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) | ...
智通AH统计|11月27日
智通财经网· 2025-11-27 08:18
Core Insights - The article highlights the top and bottom AH premium rates for various stocks as of November 27, with Northeast Electric (00042) leading with a premium rate of 864.29% [1] - The article also lists the stocks with the highest and lowest deviation values, indicating significant discrepancies between A-shares and H-shares [1] AH Premium Rate Rankings - The top three stocks with the highest AH premium rates are: - Northeast Electric (00042): 864.29% - Hongye Futures (03678): 269.82% - Sinopec Oilfield Service (01033): 264.86% [1] - The bottom three stocks with the lowest AH premium rates are: - Ningde Times (03750): -5.40% - China Merchants Bank (03968): -1.65% - Heng Rui Medicine (01276): -0.38% [1] Deviation Value Rankings - The stocks with the highest deviation values are: - Vanke Enterprises (02202): 30.48% - Dazhong Public Utilities (01635): 24.57% - Shandong Xinhua Pharmaceutical (00719): 22.88% [1] - The stocks with the lowest deviation values are: - Sairis (09927): -17.06% - China National Airlines (00753): -13.21% - China Life (02628): -13.18% [1] Additional Insights - The article provides detailed tables showing the premium rates and deviation values for the top and bottom AH stocks, indicating market trends and potential investment opportunities [2]
山东国企改革板块11月26日涨0.45%,新华制药领涨,主力资金净流入8.85亿元
Sou Hu Cai Jing· 2025-11-26 09:37
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]
智通AH统计|11月26日
Zhi Tong Cai Jing· 2025-11-26 08:32
Core Insights - The article highlights the top and bottom AH premium rates for various stocks, indicating significant discrepancies between H-shares and A-shares [1][2][3] Group 1: Top AH Premium Rates - Northeast Electric (00042) leads with an AH premium rate of 831.03%, followed by Sinopec Oilfield Service (01033) at 267.57% and Hongye Futures (03678) at 266.67% [1][2] - Other notable stocks with high premium rates include Zhejiang Shibao (01057) at 263.21% and Fudan Zhangjiang (01349) at 237.83% [2] Group 2: Bottom AH Premium Rates - The stocks with the lowest AH premium rates include Ningde Times (03750) at -4.42%, China Merchants Bank (03968) at -1.39%, and Hengrui Medicine (01276) at 1.55% [1][2] - Additional stocks with low premium rates are WuXi AppTec (02359) at 5.00% and Weichai Power (02338) at 6.47% [2] Group 3: Top Deviation Values - The highest deviation values are seen in China Shipbuilding Defense (00317) at 27.44%, Shandong Xinhua Pharmaceutical (00719) at 22.88%, and Guanghetong (00638) at 22.39% [1][3] - Other stocks with significant deviation values include Nanjing Panda Electronics (00553) at 16.09% and Vanke Enterprises (02202) at 15.80% [3] Group 4: Bottom Deviation Values - Northeast Electric (00042) has the lowest deviation value at -25.74%, followed by Longpan Technology (02465) at -16.99% and Air China (00753) at -13.49% [1][3] - Additional stocks with low deviation values include Jiangsu Ninghu Expressway (00177) at -12.27% and China Life (02628) at -11.52% [3]