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亿立舒国内外累计发货超50万支 亿帆医药国内销售里程碑条款望触发
Quan Jing Wang· 2025-12-31 13:26
12月31日,亿帆医药(002019)通过官方微信公众号披露核心经营数据,公司核心创新药亿立舒2025年 国内外累计发货量突破50万支,同比增幅超80%,放量趋势显著。其中,国内市场发货规模预计达到销 售里程碑条款的会计确认阈值,有望将对公司当期业绩形成实质性提振;海外市场方面,美国终端定价 达4600美元/支,发货量超4.6万支,国际化布局成效凸显。与此同时,公司另一款创新药易尼康同样表 现亮眼,2025年累计发货量实现同比超200%的高速增长,创新药管线多点开花的格局逐步成型。 2025年是中国创新药企全球化突围的关键之年,对外授权(BD)交易市场迎来爆发式增长,全年对外 授权总金额突破1000亿美元,首付款规模达81亿美元,印证中国创新药的全球临床价值与商业化潜力获 得国际市场高度认可,更成为中国医药产业从规模扩张的医药大国向创新驱动的医药强国加速转型的核 心注脚。 为统筹推进各事业部产品交易执行、跨境商务谈判、联盟生态管理及全球化与区域市场拓展等核心职 能,亿帆医药于2025年上半年正式组建全球BD中心。全球BD中心通过重塑BD业务定位、整合内外部 资源,强化战略合作纽带,旨在为亿帆医药持续引入高价值 ...
华纳药厂:重酒石酸去甲肾上腺素注射液获批注册
Zheng Quan Ri Bao Wang· 2025-12-25 12:13
证券日报网讯12月25日,华纳药厂发布公告称,公司近日获国家药监局核准签发重酒石酸去甲肾上腺素 注射液药品注册证书,规格4ml:8mg,用于急性低血压及心跳骤停辅助治疗,按化学药品3类获批并视 同通过一致性评价。 ...
华纳药厂获得重酒石酸去甲肾上腺素注射液药品注册证书
Zhi Tong Cai Jing· 2025-12-25 10:16
重酒石酸去甲肾上腺素注射液用于急性低血压状态的血压恢复;也可用于心跳骤停的辅助治疗和心跳骤 停复苏后的血压维持。对血容量不足导致的休克,本品作为急救时补充血容量的辅助治疗,以使血压回 升,暂时维持脑与冠状动脉灌注,直到补充血容量治疗发生作用。公司重酒石酸去甲肾上腺素注射液按 新注册分类化学药品3类获得药品注册证书,视同通过一致性评价。 华纳药厂(688799.SH)发布公告,近日,公司收到国家药品监督管理局核准签发的重酒石酸去甲肾上腺 素注射液《药品注册证书》。 ...
华纳药厂(688799.SH)获得重酒石酸去甲肾上腺素注射液药品注册证书
智通财经网· 2025-12-25 10:16
智通财经APP讯,华纳药厂(688799.SH)发布公告,近日,公司收到国家药品监督管理局核准签发的重 酒石酸去甲肾上腺素注射液《药品注册证书》。 重酒石酸去甲肾上腺素注射液用于急性低血压状态的血压恢复;也可用于心跳骤停的辅助治疗和心跳骤 停复苏后的血压维持。对血容量不足导致的休克,本品作为急救时补充血容量的辅助治疗,以使血压回 升,暂时维持脑与冠状动脉灌注,直到补充血容量治疗发生作用。公司重酒石酸去甲肾上腺素注射液按 新注册分类化学药品3类获得药品注册证书,视同通过一致性评价。 ...
华纳药厂(688799.SH):重酒石酸去甲肾上腺素注射液获得药品注册证书
Ge Long Hui A P P· 2025-12-25 10:08
格隆汇12月25日丨华纳药厂(688799.SH)公布,公司收到国家药品监督管理局核准签发的重酒石酸去甲 肾上腺素注射液《药品注册证书》,重酒石酸去甲肾上腺素注射液用于急性低血压状态的血压恢复;也 可用于心跳骤停的辅助治疗和心跳骤停复苏后的血压维持。对血容量不足导致的休克,本品作为急救时 补充血容量的辅助治疗,以使血压回升,暂时维持脑与冠状动脉灌注,直到补充血容量治疗发生作用。 ...
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].