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重酒石酸去甲肾上腺素注射液
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湖南华纳大药厂股份有限公司 自愿披露关于子公司原料药获得上市申请批准通知书的公告
Core Points - The company has received approval from the National Medical Products Administration for the production of two chemical raw materials: Isoproterenol Hydrochloride and Dexamethasone Tartrate [1][2][3] - The approval indicates that these raw materials meet the national drug review technical standards and will enhance the company's product line and core competitiveness [5] Raw Material Registration Information - **Isoproterenol Hydrochloride**: - Registration Number: Y20240000173 - Application: Domestic production of chemical raw materials - Packaging Specifications: 0.1kg, 0.2kg, 0.5kg, 1kg, 2kg, 3kg, 5kg [1] - Production Company: Hunan Warner Pharmaceutical Chiral Drugs Co., Ltd. - Production Address: Changsha City, Hunan Province [1] - Approval Conclusion: Complies with drug registration requirements [1][4] - **Dexamethasone Tartrate**: - Registration Number: Y20240000250 - Application: Domestic production of chemical raw materials - Packaging Specifications: 100g, 200g, 500g, 1kg, 2kg, 3kg [2] - Production Company: Hunan Warner Pharmaceutical Chiral Drugs Co., Ltd. - Production Address: Changsha City, Hunan Province [2] - Approval Conclusion: Complies with drug registration requirements [2][4] Drug Information - **Isoproterenol Hydrochloride**: Used for treating cardiogenic or infectious shock and complete atrioventricular block, cardiac arrest [4] - **Dexamethasone Tartrate**: Used for blood pressure control in acute hypotensive states and as an adjunct in cardiac arrest and severe hypotension [5]
华纳药厂再获两款急救药原料药批件,年内累计已达8个
Core Insights - Warner Pharmaceutical's subsidiary has received approval for two chemical raw materials, indicating compliance with national drug review standards and enhancing the company's product line and core competitiveness [1][2] Group 1: Regulatory Approvals - Warner Pharmaceutical's subsidiary, Hunan Warner Pharmaceutical, received approval for isoproterenol hydrochloride and racemic norepinephrine raw materials, marking the 7th and 8th raw material approvals in 2023 [1] - The company now has a total of 72 raw material varieties, with 55 approved for use in formulations [1] Group 2: Product Applications - Isoproterenol hydrochloride is used in injection form for treating cardiogenic or infectious shock and complete atrioventricular block [1] - Racemic norepinephrine is utilized for blood pressure control in acute hypotensive states and as an adjunct treatment for cardiac arrest and severe hypotension [1] Group 3: Market Relevance - Both isoproterenol hydrochloride and racemic norepinephrine injections are common emergency medications and are included in the "clinically essential and easily short-supplied drugs" list [1] - Racemic norepinephrine injection has been included in the 10th batch of national centralized procurement [1]
9月2日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-03 05:04
Group 1 - Huazhong Securities has been approved to issue subordinate corporate bonds with a total face value of no more than 10 billion yuan [1] - Jinbei Automotive plans to invest 240 million yuan to establish an automotive industry investment fund focusing on electrification, intelligence, and low carbon [1] - Linyang Energy is expected to win a bid for a 244 million yuan metering equipment project from Southern Power Grid [1][2] Group 2 - Renfu Pharmaceutical's subsidiary has received drug registration certificates for two products, including a medication for acute hypotension [3][4] - Nanjing Steel plans to distribute a cash dividend of 0.1186 yuan per share [5][6] - Pairui Co. has signed a strategic cooperation agreement with Xi'an Power Electronics Research Institute to develop power devices [7][8] Group 3 - Haixing Electric is expected to win a bid for a 214 million yuan metering equipment project from Southern Power Grid [9][10] - Kuangda Technology is planning a change in control, leading to a continued suspension of its stock [11][12] - Samsung Medical is expected to win a bid for a 274 million yuan metering equipment project from Southern Power Grid [13][14] Group 4 - Jiukang Bio has obtained a medical device registration certificate for a specific diagnostic kit [15][16] - Hechuan Technology's minority shareholder plans to transfer a 13% stake in a subsidiary [17][18] - DiAo Micro has launched a new eUSB2 repeater product for various electronic applications [19][20] Group 5 - David Medical's electric surgical table registration application has been accepted [21][22] - Hangxin Technology plans to apply for a total of 280 million yuan in bank credit [23][24] - Liyuan Technology's non-independent director has resigned [25][26] Group 6 - Ningbo Construction's subsidiary has won a construction project bid worth 729 million yuan [27][28] - Huaren Pharmaceutical's subsidiary has received approval for a raw material drug [29][30] - Suwen Electric plans to distribute a cash dividend of 1 yuan per 10 shares [31][32] Group 7 - Solar Energy has received 1.692 billion yuan in renewable energy subsidies [33][34] - Wangli Security has obtained a patent for a new lock structure [35][36] - Zhejiang Energy's vice chairman has resigned due to age reasons [37][38] Group 8 - Beilu Pharmaceutical's subsidiary has passed GMP certification in Brazil [39][40] - Zhejiang Communications has a subsidiary that is expected to win a highway project bid [41][42] - Xinzhi Group has received a government subsidy of 11.1978 million yuan [43][44] Group 9 - Dong'an Power's engine sales in August increased by 3.44% year-on-year [45][46] - Baiyun Mountain's subsidiary has passed the consistency evaluation for two generic drugs [47][48] - Yipin Hong's subsidiary has received a drug registration certificate for a specific injection [49][50] Group 10 - Far East Holdings' subsidiary has won multiple contracts totaling 1.689 billion yuan [51][52] - Good Housekeeping's shareholder plans to reduce holdings by up to 3.5 million shares [53][54] - Guanghong Technology's shareholders have set a transfer price of 23.33 yuan per share [55][56] Group 11 - Keli Sensor plans to acquire 45% of Huahong Technology's shares for 122 million yuan [57][58] - Jianmin Group's furosemide oral solution has been approved for market launch [59][60] - Jinghua Laser's directors plan to reduce their holdings by up to 143,420 shares [61][62] Group 12 - Zhuyue Group is planning a share transfer that will change its controlling shareholder [63][64] - Terid has pre-bid for two projects totaling approximately 698 million yuan [65][66] - Zhonghuan Hailu is planning a change in control, leading to a continued suspension of its stock and convertible bonds [67][68] Group 13 - Great Wall Motors reported August sales of 115,600 vehicles, a year-on-year increase of 22.33% [69][70] - Guizhou Tire's controlling shareholder has committed not to reduce holdings for 12 months [71][72] - San Da Membrane's shareholder plans to reduce holdings by up to 1% of the company's shares [73][74] Group 14 - Chint Electric has decided to terminate the spin-off of its subsidiary for listing [75][76] - Jusaylong's shareholder plans to reduce holdings by up to 1% of the company's shares [77][78]
人福医药集团股份公司 关于二十碳五烯酸乙酯软胶囊获得 药品注册证书的公告
Group 1 - Company received drug registration certificate for Eicosapentaenoic Acid Ethyl Ester Soft Capsules from the National Medical Products Administration [1][2] - The product is indicated for lowering triglyceride levels in adult patients with severe hypertriglyceridemia and for reducing cardiovascular event risks in patients with cardiovascular diseases or diabetes [2][3] - Cumulative R&D investment for the product is approximately RMB 6 million, with projected national sales of around RMB 5 million for 2024 [2] Group 2 - Company also received drug registration certificate for Levophed Injection, which is used for blood pressure control in acute hypotensive states [6][7] - Cumulative R&D investment for Levophed Injection is approximately RMB 5 million, with projected national sales of around RMB 2.1 billion for 2024 [7] - Both products enhance the company's product line and are expected to have a positive impact on sales, although future sales may be influenced by industry policies and market conditions [3][7]
人福医药: 人福医药关于重酒石酸去甲肾上腺素注射液获得药品注册证书的公告
Zheng Quan Zhi Xing· 2025-09-02 16:15
Core Viewpoint - The approval of the drug registration certificate for heavy tartrate norepinephrine injection marks a significant milestone for the company, enhancing its product line and enabling it to sell the drug in the domestic market, which is expected to have a positive impact on the company's performance [1][2]. Group 1: Drug Registration Details - The drug name is heavy tartrate norepinephrine injection, with a specification of 4ml:8mg [1]. - The drug registration certificate number is 2025S02573, valid until August 25, 2030 [1]. - The drug is classified as a chemical drug category 3 and is approved for domestic production [3]. Group 2: Drug Application and Market Potential - The drug is intended for controlling blood pressure in acute hypotensive states and as an auxiliary treatment for cardiac arrest and severe hypotension [2]. - The total R&D investment for this project has reached approximately RMB 5 million [2]. - According to market data, the projected national sales for heavy tartrate norepinephrine injection in 2024 is estimated to be around RMB 500 million [2]. Group 3: Future Plans and Market Considerations - The company plans to arrange for the production and market launch of the drug based on market demand [2]. - The future sales performance of the product may be influenced by industry policies and market conditions, indicating potential uncertainties [2].
人福医药:关于重酒石酸去甲肾上腺素注射液获得药品注册证书的公告
Zheng Quan Ri Bao· 2025-09-02 14:11
Group 1 - The core point of the article is that Yichang Renfu Pharmaceutical Co., Ltd., a subsidiary of Renfu Pharmaceutical, has received the drug registration certificate for heavy tartrate deoxycorticosterone injection from the National Medical Products Administration [2] Group 2 - Renfu Pharmaceutical holds an 80% stake in Yichang Renfu Pharmaceutical Co., Ltd. [2] - The approval of the drug registration certificate indicates a significant regulatory milestone for the company [2] - This development may enhance the company's product portfolio and market position in the pharmaceutical industry [2]
人福医药:子公司两款药品获药品注册证书
Core Viewpoint - The company has received regulatory approval for two new pharmaceutical products, indicating a positive development in its product pipeline and potential revenue growth [1] Group 1: Product Approvals - The company's subsidiary, Yichang Renfu Pharmaceutical, has been granted a drug registration certificate for the injection of heavy tartrate de-norepinephrine, which is used for blood pressure control in certain acute hypotensive states [1] - The company's wholly-owned subsidiary, Renfu Puke Pharmaceutical, has received approval for ethyl eicosapentaenoate soft capsules, aimed at reducing triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL) in conjunction with dietary control [1]
人福医药:子公司重酒石酸去甲肾上腺素注射液获得药品注册证书
Xin Lang Cai Jing· 2025-09-02 09:16
Core Viewpoint - The announcement indicates that the company has received regulatory approval for a new medication, which could enhance its product portfolio and market position in the pharmaceutical industry [1] Company Summary - The company, Renfu Pharmaceutical, announced on September 2 that its subsidiary, Yichang Renfu Pharmaceutical, has received a drug registration certificate from the National Medical Products Administration for a new injectable medication [1] - The newly approved drug, heavy tartrate deactivated epinephrine injection, is intended for use in managing acute hypotensive states and as an adjunct treatment for cardiac arrest and severe hypotension [1] Industry Summary - The approval of this medication reflects ongoing regulatory support for new pharmaceutical products, which may lead to increased competition and innovation within the industry [1] - The drug's application in critical care scenarios highlights the growing demand for effective treatments in emergency medicine, potentially impacting market dynamics [1]
人福医药:重酒石酸去甲肾上腺素注射液获药品注册证书
Xin Lang Cai Jing· 2025-09-02 09:16
Core Viewpoint - The approval of the drug by the National Medical Products Administration signifies the company's qualification to sell the product in the domestic market, enhancing its product line and potential revenue streams [1] Group 1: Company Developments - Yichang Renfu Pharmaceutical, a subsidiary of Renfu Pharmaceutical, has received the drug registration certificate for Dexamethasone Injection from the National Medical Products Administration [1] - The drug is indicated for the control of blood pressure in certain acute hypotensive states, as well as for the auxiliary treatment of cardiac arrest and severe hypotension [1] - The projected national sales for the drug in 2024 are approximately 2.1 billion yuan [1]
人福医药(600079.SH):重酒石酸去甲肾上腺素注射液获得药品注册证书
智通财经网· 2025-09-02 09:08
Core Viewpoint - The approval of the drug registration certificate for heavy tartrate norepinephrine injection by the National Medical Products Administration marks a significant milestone for the company, allowing it to sell the product in the domestic market and enhancing its product line [1] Group 1 - The company’s subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., holds 80% of the shares and has received the drug registration certificate [1] - The approval signifies the company’s qualification to market the drug in China, which is expected to have a positive impact on its business [1] - The addition of this product to the company's portfolio will further enrich its offerings in the pharmaceutical market [1]