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石四药集团:间苯三酚三甲醚及盐酸多巴酚丁胺已获国家药监局批准登记成为在上市制剂使用的原料药
Zhi Tong Cai Jing· 2026-02-09 11:27
Core Viewpoint - The company Shijiazhuang Four Medicines Group (02005) has received approval from the National Medical Products Administration of China for its active pharmaceutical ingredients, including m-aminophenol dimethyl ether and dobutamine hydrochloride, for use in marketed formulations [1] Group 1: Product Approvals - The m-aminophenol dimethyl ether is primarily used for the preparation of m-aminophenol injection, which treats acute spasm pain caused by digestive system and biliary dysfunction, acute spasmodic urethral, bladder, and renal colic, as well as gynecological spasmodic pain [1] - The company has obtained the production registration certificate for m-aminophenol injection from the National Medical Products Administration, as stated in its announcement dated August 27, 2024 [1] Group 2: Therapeutic Applications - Dobutamine hydrochloride is mainly used for the preparation of dobutamine hydrochloride injection, which is indicated for heart failure caused by decreased myocardial contractility in organic heart disease, including low cardiac output syndrome following cardiac surgery [1]
石四药集团(02005):间苯三酚三甲醚及盐酸多巴酚丁胺已获国家药监局批准登记成为在上市制剂使用的原料药
智通财经网· 2026-02-09 10:35
Core Viewpoint - The company Shijiazhuang Pharmaceutical Group has received approval from the National Medical Products Administration of China for two active pharmaceutical ingredients, which are now registered for use in marketed formulations [1] Group 1: Product Approvals - The active pharmaceutical ingredient, isopropyl phenol trimethyl ether, is primarily used to prepare isopropyl phenol injection, which treats acute spasm pain caused by digestive system and biliary dysfunction, acute spasmodic urethral, bladder, and renal colic, as well as gynecological spasmodic pain [1] - The company has obtained the production registration certificate for isopropyl phenol injection from the National Medical Products Administration, as stated in the announcement dated August 27, 2024 [1] Group 2: Additional Product Information - The active pharmaceutical ingredient, hydrochloride dobutamine, is mainly used to prepare hydrochloride dobutamine injection, which is indicated for heart failure caused by decreased myocardial contractility in organic heart disease, including low cardiac output syndrome following cardiac surgery [1]
石四药集团(02005.HK):间苯三酚三甲醚及盐酸多巴酚丁胺获国家药监局批准登记成为在上市制剂使用的原料药
Ge Long Hui· 2026-02-09 10:33
Core Viewpoint - The company Shijiazhuang Pharmaceutical Group has received approval from the National Medical Products Administration of China for two active pharmaceutical ingredients, which will be used in their respective injectable formulations [1] Group 1: Product Approvals - The active pharmaceutical ingredient isomeric phenol trimethyl ether has been approved for use in injectable formulations, primarily for treating acute spasmodic pain caused by digestive system and biliary dysfunction, acute spasmodic urethral, bladder, and renal colic, as well as gynecological spasmodic pain [1] - The company has also obtained the production registration certificate for isomeric phenol injection from the National Medical Products Administration [1] - The active pharmaceutical ingredient dopamine hydrochloride has been approved for use in injectable formulations, mainly for heart failure caused by decreased myocardial contractility in organic heart disease, including low cardiac output syndrome after cardiac surgery [1]
石四药集团(02005) - 自愿公告 - 產品开发的最新进展
2026-02-09 10:27
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,概不會就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。 本公告為本公司自願發佈,目的是使股東及潛在投資者瞭解本集團最新業務發展情況。 石四藥集團有限公司(「本公司」,連同其附屬公司,「本集團」)董事局(「董事局」)欣然公告, 本集團的間苯三酚三甲醚及鹽酸多巴酚丁胺已獲中國國家藥品監督管理局(「國家藥監局」)批 准登記成為在上市製劑使用的原料藥。 間苯三酚三甲醚主要用於製備間苯三酚注射液,其主要用於治療(i)消化系統和膽道功能障礙引 起的急性痙攣疼痛;(ii)急性痙攣性尿道、膀胱、腎絞痛;及(iii)婦科痙攣性疼痛。誠如本公司 日期為二零二四年八月二十七日之公告所載,本集團已取得國家藥監局有關間苯三酚注射液的 藥品生產註冊批件。 鹽酸多巴酚丁胺主要用於製備鹽酸多巴酚丁胺注射液,其主要用於器質性心臟病時心肌收縮力 下降引起的心力衰竭,包括心臟直視手術後所致的低排血量綜合症。 自願公告 產品開發的最新進展 承董事局命 執行董事兼公司秘書 周興揚 香港,二零二六年 ...