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广药集团旗下白云山生物冻干人用狂犬病疫苗(Vero细胞)获批生产
Xin Lang Cai Jing· 2025-12-26 04:18
本次获批的冻干人用狂犬病疫苗(Vero 细胞)是白云山生物自主研发的预防用生物制品,用于预防狂 犬病。该产品不含明胶、抗生素及防腐剂,具有中和抗体产生快、效价高、稳定性强等特点。临床试验 显示,该疫苗在10-60岁健康人群中分别采用5剂或4剂程序接种,均表现出良好的免疫原性。(智通财 经记者李科文) 12月26日,智通财经从广药集团获悉,广药集团旗下白云山生物获得国家药品监督管理局核准签发 的"冻干人用狂犬病疫苗(Vero细胞)"《药品注册证书》。 ...
广州白云山医药集团股份有限公司 关于广州白云山生物制品股份有限公司收到药品注册证书的公告
本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性承担法律责任。 近日,广州白云山医药集团股份有限公司(以下简称"本公司")合并报表范围内企业广州白云山生物制 品股份有限公司(以下简称"白云山生物")收到国家药品监督管理局核准签发关于冻干人用狂犬病疫苗 (Vero细胞)的《药品注册证书》。现将相关情况公告如下: 一、药品的基本情况 药品通用名称:冻干人用狂犬病疫苗(Vero细胞) 剂型:注射剂 证书编号:2025S03950 药品注册标准编号: 上市许可持有人:(1)名称:广州白云山生物制品股份有限公司;(2)地址:广州市经济技术开发区 连云路406号 生产企业:(1)名称:广州白云山生物制品股份有限公司;(2)地址:广州市番禺区万宝北街1号 受理号:CXSS2400079 药品批准文号:国药准字S20250069 药品批准文号有效期:至2030年12月21日 审批结论:根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》及有关规定,经审查, 本品符合药品注册的有关要求,批准注册,发给药品注册证书。 规格:复溶后每瓶0.5ml。每1次人 ...
12月26日重要公告一览
Xi Niu Cai Jing· 2025-12-26 02:37
Group 1 - 德方纳米 plans annual equipment maintenance to ensure efficient and stable operation, starting January 1, 2026, for one month, with no significant impact on 2026 performance [1] - 达意隆's subsidiary Tianjin Baolong faces a significant decline in OEM orders due to strategic adjustments from core customers, leading to plans to shut down production lines [2] - 天威视讯's subsidiary plans to transfer project assets for 604.3 million yuan to a related party, constituting a related transaction [3] Group 2 - 金龙羽 intends to sign a strategic cooperation framework agreement with an investment institution to establish an industrial merger fund with a planned scale of 1.5 billion yuan [4] - 紫光国微's subsidiary plans to establish a new company with multiple partners, including a subsidiary of CATL, with a registered capital of 300 million yuan [5] - 信隆健康's major shareholder plans to reduce its stake by up to 1% through trading [6] Group 3 - 龙建股份 wins a 612 million yuan EPC contract for a project, which represents approximately 3.27% of the company's audited revenue for 2024 [7] - 复旦张江 receives acceptance for a clinical trial application for a drug aimed at visualizing malignant lesions in lung cancer patients [9] - 博实股份's major shareholder plans to reduce its stake by up to 2.93% [10] Group 4 - 百纳千成 plans to acquire 100% of Zhonglian Century's shares to expand its marketing business and digital advertising solutions [11] - 天铁科技's major shareholder is under criminal detention, but the investigation is unrelated to the company's operations [12] - 海看股份's shareholder plans to reduce its stake by up to 3.6% [13] Group 5 - 智光电气's subsidiary signs a procurement contract worth 148 million yuan for a high-voltage energy storage system [14] - 西藏矿业's attempt to transfer 100% of a subsidiary's equity has not attracted qualified buyers, leading to automatic withdrawal from the trading platform [15] - 英诺激光's major shareholder plans to reduce its stake by up to 3% [16] Group 6 - 福鞍股份's major shareholder plans to reduce its stake by up to 3% [17] - 白云山 receives a drug registration certificate for a rabies vaccine [18] - 华电科工 signs a contract worth approximately 265 million yuan for a power plant project [19] Group 7 - 康弘药业 receives a drug registration certificate for a medication used to treat schizophrenia [20] - 西菱动力's actual controller plans to reduce their stake by 2% [21] - 海希通讯's actual controller plans to reduce their stake by 0.48% [22] Group 8 - 海南机场 plans to transfer 90% of a subsidiary's equity for approximately 500 million yuan, expecting a profit of about 200 million yuan from the transaction [23] - 森远股份 signs a contract for a computing cluster integration project worth 26.78 million yuan [24] - 丽珠集团's subsidiary receives acceptance for a drug registration application for a new treatment for psoriasis [25] Group 9 - 郑州银行 plans to acquire a village bank and convert it into a branch [26] - 方正证券 announces a cash dividend distribution plan for the third quarter of 2025 [27] - 金陵体育 announces a cash dividend distribution plan for the first three quarters of 2025 [29] Group 10 - 紫金银行 announces a mid-term profit distribution plan for 2025 [30] - *ST建艺's major shareholder waives 1.4 billion yuan in debt and donates 400 million yuan to support the company [31] - 万朗磁塑's major shareholder plans to reduce their stake by up to 3% [32] Group 11 - 艾力斯's core product is included in a list of potential breakthrough therapies for lung cancer [33] - 富创精密's shareholder plans to transfer 918.63 million shares [34] - 东阳光's subsidiary plans to increase capital and introduce investors [35] Group 12 - 侨银股份 plans to acquire a 16.67% partnership in a venture capital fund [36] - 尤夫股份 receives a government subsidy of 4.04 million yuan for a technical improvement project [37] - 倍轻松 and its actual controller are under investigation for information disclosure violations [38] Group 13 - 万润新能 plans to reduce production on some lines for maintenance, expecting a reduction of 5,000 to 20,000 tons in lithium iron phosphate output [39]
广州白云山医药集团股份有限公司关于广州白云山生物制品股份有限公司收到药品注册证书的公告
广州白云山医药集团股份有限公司 证券代码:600332 证券简称:白云山公告编号:2025-094 关于广州白云山生物制品股份有限公司收到 药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性承担法律责任。 近日,广州白云山医药集团股份有限公司(以下简称"本公司")合并报表范围内企业广州白云山生物制 品股份有限公司(以下简称"白云山生物")收到国家药品监督管理局核准签发关于冻干人用狂犬病疫苗 (Vero细胞)的《药品注册证书》。现将相关情况公告如下: 一、药品的基本情况 药品通用名称:冻干人用狂犬病疫苗(Vero细胞) 剂型:注射剂 规格:复溶后每瓶0.5ml。每1次人用剂量为0.5ml,狂犬病疫苗效价应不低于2.5IU。 注册分类:预防用生物制品 证书编号:2025S03950 药品注册标准编号: 上市许可持有人:(1)名称:广州白云山生物制品股份有限公司;(2)地址:广州市经济技术开发区 连云路406号 生产企业:(1)名称:广州白云山生物制品股份有限公司;(2)地址:广州市番禺区万宝北街1号 受理号:CXSS240007 ...
国产首个!信达生物CTLA-4单抗获批上市
Xin Lang Cai Jing· 2025-12-25 12:40
12月25日,国家药监局(NMPA)官网显示,信达生物的伊匹木单抗N01注射液(商品名:达伯欣)获批上市,联合信迪利单抗用于可手术切除的IIB-III 期微卫星高度不稳定型或错配修复缺陷(MSI-H/dMMR)结肠癌患者的新辅助治疗。该药是中国首个获批国产抗CTLA-4单抗,也是全球首个获批的用于 结肠癌新辅助治疗的抗CTLA-4单抗。 信达生物制药集团肿瘤管线首席研发官周辉博士表示:"目前国内可根治性手术切除的MSI-H/dMMR结肠癌新辅助治疗存在巨大未满足临床需求。 NeoShot-III研究的期中分析达到了预设的主要研究终点,对该治疗领域具有重要意义。我们很高兴在信达生物高质量高效的临床开发推动下,伊匹木单抗 N01注射液)作为中国首个本土创新的抗CTLA-4抑制剂成功获批上市,为中国可手术切除MSI-H/dMMR结肠癌患者提供新的治疗选择。" Copyright © 2025 PHARMCUBE. All Rights Reserved. 免责申明:本微信文章中的信息仅供一般参考之用,不可直接作为决策内容,医药魔方不对任何主体 因使用本文内容而导致的任何损失承担责任。 12月25日,国家药监局(NM ...
白云山:冻干人用狂犬病疫苗(Vero细胞)获药品注册证书
人民财讯12月25日电,白云山(600332)12月25日公告,公司合并报表范围内企业广州白云山生物制品股 份有限公司收到国家药监局核准签发关于冻干人用狂犬病疫苗(Vero细胞)的《药品注册证书》。 转自:证券时报 ...
白云山:白云山生物收到冻干人用狂犬病疫苗药品注册证书
Di Yi Cai Jing· 2025-12-25 10:18
(本文来自第一财经) 白云山公告,公司合并报表范围内企业广州白云山生物制品股份有限公司收到国家药品监督管理局核准 签发关于冻干人用狂犬病疫苗(Vero细胞)的《药品注册证书》。截至目前,白云山生物在冻干人用狂 犬病疫苗(Vero 细胞)研发项目上已投入研发费用合计约人民币20509万元(未经审计)。 ...
白云山:旗下生物制品公司获冻干人用狂犬病疫苗注册证书
Mei Ri Jing Ji Xin Wen· 2025-12-25 09:57
每经AI快讯,12月25日,白云山(600332)(600332.SH)公告称,公司合并报表范围内企业白云山生物 收到国家药品监督管理局核准签发的冻干人用狂犬病疫苗(Vero细胞)的《药品注册证书》。该疫苗用 于预防狂犬病,白云山生物已投入约2.05亿元研发费用。 ...
花310元打的狂犬病疫苗却是80元的!官方通报
Xin Lang Cai Jing· 2025-12-21 21:44
12月20日,贵州桐梓县卫生健康局发布情况通报:2025年12月18日,有群众在网上反映"在桐梓县海校 街道社区卫生服务中心医院打狂犬疫苗,医院私自更换药品"的信息,事情发生后,海校街道社区卫生 服务中心主任马某因护士扫错码一事,主动向赵某某家属诚恳道歉。根据调查情况,该局对海校街道社 区卫生服务中心主任马某、副主任刘某通报批评,分别惩扣1个月绩效工资,对当班护士冯某、令狐某 分别给予批评教育、惩扣3个月绩效工资。 详情如下 ↓↓↓ 海校街道社区卫生服务中心 12月17日共3 人接种狂犬病疫苗。经核查,山东亦度生物技 术有限公司生产的冻干人用狂犬病疫苗12月16 日库存67剂次,12月17日10时14分接种袁 某、10时18分接种成某某共2剂次,17日库存 65 剂次;成都康华生物制品股份有限公司生产 的冻干人用狂犬病疫苗12月16日库存9剂次, 17日14时48分接种赵某某1剂次,17日库存8 剂次。海校街道社区卫生服务中心不存在更换 药品情况。赵某某实际注射疫苗为成都康华生 物制品股份有限公司生产的冻干人用狂犬病疫 苗(人二倍体细胞), 价格 310元/剂次。 此前报道>>> "我们买的是310元的疫苗, ...
复星医药拟联合华润系等设立10亿私募 复星安特金拟分拆上市
Chang Jiang Shang Bao· 2025-10-30 05:41
Core Viewpoint - Fosun Pharma is planning to spin off its subsidiary, Fosun Antigen, for a listing on the Hong Kong Stock Exchange amid fluctuating performance and increasing debt levels [2][4]. Financial Performance - For the first three quarters of 2025, Fosun Pharma reported a revenue of 29.393 billion yuan, a decrease of 4.91% year-on-year, while net profit increased by 25.50% to 2.523 billion yuan [12]. - In 2023, Fosun Pharma's revenue was 41.4 billion yuan, down 5.81% year-on-year, and net profit fell by 36.04% to 2.386 billion yuan [11]. - The company has experienced a decline in revenue over the past few years, with 2022 revenue at 43.952 billion yuan, a 12.66% increase, but net profit decreased by 21.10% [9]. Debt and Cash Flow - As of the end of Q3 2025, Fosun Pharma had cash and cash equivalents of 11.478 billion yuan and short-term borrowings of 16.447 billion yuan, indicating tight cash flow [12]. - Fosun Antigen's debt ratio increased from 33.87% at the end of 2024 to 43.72% by mid-2025, reflecting a rise of approximately 10 percentage points in just six months [7]. Spin-off Details - The spin-off of Fosun Antigen aims to enhance its governance and sustainable development, thereby maximizing shareholder value [4]. - Fosun Antigen focuses on the research, production, and sales of human vaccines and has developed several vaccines that have been approved for sale in China [6]. Investment Initiatives - Fosun Pharma's subsidiary plans to establish a target fund with a total fundraising goal of 1 billion yuan, with Fosun Pharma contributing 100 million yuan [13]. - The fund aims to leverage partnerships with various investors to expand in innovative drugs, biopharmaceuticals, and high-end medical devices [13].