间苯三酚三甲醚主要用于制备间苯三酚注射液，其主要用于治疗消化系统和胆道功能障碍引起的急性痉 挛疼痛;急性痉挛性尿道、膀胱、肾绞痛;及妇科痉挛性疼痛。诚如本公司日期为2024年8月27日的公告 所载，本集团已取得国家药监局有关间苯三酚注射液的药品生产注册批件。 盐酸多巴酚丁胺主要用于制备盐酸多巴酚丁胺注射液，其主要用于器质性心脏病时心肌收缩力下降引起 的心力衰竭，包括心脏直视手术后所致的低排血量综合症。 石四药集团(02005)发布公告，本集团的间苯三酚三甲醚及盐酸多巴酚丁胺已获中国国家药品监督管理 局(国家药监局)批准登记成为在上市制剂使用的原料药。 ...

盐酸多巴酚丁胺主要用于制备盐酸多巴酚丁胺注射液，其主要用于器质性心脏病时心肌收缩力下降引起 的心力衰竭，包括心脏直视手术后所致的低排血量综合症。 间苯三酚三甲醚主要用于制备间苯三酚注射液，其主要用于治疗消化系统和胆道功能障碍引起的急性痉 挛疼痛;急性痉挛性尿道、膀胱、肾绞痛;及妇科痉挛性疼痛。诚如本公司日期为2024年8月27日的公告 所载，本集团已取得国家药监局有关间苯三酚注射液的药品生产注册批件。 智通财经APP讯，石四药集团(02005)发布公告，本集团的间苯三酚三甲醚及盐酸多巴酚丁胺已获中国国 家药品监督管理局(国家药监局)批准登记成为在上市制剂使用的原料药。 ...

间苯三酚三甲醚主要用于制备间苯三酚注射液，其主要用于治疗(i)消化系统和胆道功能障碍引起的急性 痉挛疼痛；(ii)急性痉挛性尿道、膀胱、肾绞痛；及(iii)妇科痉挛性疼痛。集团已取得国家药监局有关间 苯三酚注射液的药品生产注册批件。 格隆汇2月9日丨石四药集团(02005.HK)公告，集团的间苯三酚三甲醚及盐酸多巴酚丁胺已获中国国家药 品监督管理局("国家药监局")批准登记成为在上市制剂使用的原料药。 盐酸多巴酚丁胺主要用于制备盐酸多巴酚丁胺注射液，其主要用于器质性心脏病时心肌收缩力下降引起 的心力衰竭，包括心脏直视手术后所致的低排血量综合症。 ...

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 ...

Core Points - Chengyi Pharmaceutical has received approval from the National Medical Products Administration for its supplemental drug application for the production of Dopamine Hydrochloride Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approval signifies a significant milestone for Chengyi Pharmaceutical in the generic drug market [1] - The successful evaluation enhances the company's product portfolio and may lead to increased market competitiveness [1]

Core Viewpoint - Chengyi Pharmaceutical (603811.SH) has received approval from the National Medical Products Administration for its supplementary application, confirming that its product, Dobutamine Hydrochloride Injection, has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approved product, Dobutamine Hydrochloride Injection, is primarily used for heart failure caused by decreased myocardial contractility in organic heart disease, including low cardiac output syndrome following cardiac surgery, serving as a short-term supportive treatment [1]

Core Viewpoint - Chengyi Pharmaceutical (603811.SH) has received approval from the National Medical Products Administration for its supplemental drug application, indicating that its product, Dobutamine Hydrochloride Injection, has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approved product, Dobutamine Hydrochloride Injection, is primarily used for heart failure caused by decreased myocardial contractility in organic heart disease [1] - The drug is also indicated for short-term support treatment in cases of low cardiac output syndrome following cardiac surgery [1]

Core Viewpoint - Chengyi Pharmaceutical has received approval from the National Medical Products Administration for its hydrochloride dobutamine injection, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval - The hydrochloride dobutamine injection is primarily used for heart failure caused by decreased myocardial contractility in organic heart disease [1] - It is indicated for short-term supportive treatment, including cases of low cardiac output syndrome following cardiac surgery [1]

Group 1 - The company announced that its product, Dopamine Hydrochloride Injection, has passed the consistency evaluation for generic drug quality and efficacy [1] - This drug is primarily used for heart failure caused by decreased myocardial contractility in organic heart disease, including low cardiac output syndrome after cardiac surgery, serving as a short-term supportive treatment [1] - As of the announcement date, there are a total of 31 manufacturers that have passed the consistency evaluation for Dopamine Hydrochloride Injection by the National Medical Products Administration [1]

Group 1 - Shanghai Municipal Medical Procurement Management Office has suspended the procurement qualifications for two drugs due to non-compliance with price adjustment requirements: hydrochloride dobutamine injection produced by Anhui Changjiang Pharmaceutical Co., Ltd. and hydrochloride arginine injection produced by Jilin Huinan Changlong Biochemical Pharmaceutical Co., Ltd [1] - Both drugs are classified as shortage drugs, with multiple companies having obtained approval numbers for these products in China [1] - The national average price for hydrochloride dobutamine injection (2ml:20mg) is reported at 3.53 yuan per unit, while hydrochloride arginine injection (20ml:5g) is at 11.68 yuan per unit [1] Group 2 - The management mechanism for shortage drugs in China is improving, with the State Council issuing opinions in 2019 to ensure the supply and price stability of these drugs [2] - The average delivery rate for drugs on the national shortage list has increased from approximately 60% before 2019 to 90% currently [2] - New issues have emerged, including some companies creating artificial shortages to justify price increases, particularly at the local level [2] Group 3 - In August 2024, several national departments issued a notice to strengthen monitoring of production reserves for shortage drugs and those selected for centralized procurement [3] - A total of 109 shortage drug formulations, 60 raw materials, and 240 nationally selected drugs are under production reserve monitoring, with dynamic adjustments to the monitoring list [3] - The National Medical Insurance Administration has issued guidelines for risk management of shortage drug prices, focusing on price information disclosure, analysis, and monitoring [3]