格隆汇2月24日丨康希诺生物(06185.HK)宣布，公司已获得中国国家药监局出具的《药品补充申请批准 通知书》，根据该通知书，国家药监局已批准公司的ACYW135群脑膜炎球菌多糖结合疫苗(CRM197载 体)(「MCV4」，商品名称：曼海欣®)的适用人群年龄范围由「3月龄到3周岁(47月龄)儿童」扩大至「3 月龄到6周岁(83月龄)儿童」的补充申请。 公司的曼海欣®为我国首个脑膜炎球菌四价结合疫苗产品，其上市缩小了我国在该领域与发达国家的差 距，填补了我国在该领域缺乏高端疫苗的空白，为我国6周岁及以下儿童流脑疾病的预防提供了更优解 决方案。曼海欣®凭借其创新优势，展现出强劲的市场表现力，实现了市场占有率的不断攀升。 ...

Moderna's stock was surging after the FDA said it would review the biotech's flu-vaccine candidate, a week after it had refused to do so. ...

Core Viewpoint - The company, CanSino Biologics, is expected to turn a profit in 2025, with significant advancements in vaccine development and ongoing expansion into international markets [1][2]. Financial Performance - The company forecasts revenue between 1.04 billion to 1.08 billion yuan for 2025, representing a year-on-year growth of 22.88% to 27.61%. Net profit attributable to shareholders is projected to be between 24.5 million to 29 million yuan, indicating a turnaround from previous losses. The audited annual report is scheduled for release in 2026 [2]. Product Development Progress - The self-developed DTPa vaccine has completed Phase III clinical trials and is expected to receive market approval in the first half of 2026, potentially replacing imported products and expanding into the high-end vaccine market. The 24-valent pneumococcal polysaccharide conjugate vaccine (PCV24) has been approved for clinical trials by the National Medical Products Administration of China, marking it as the first 24-valent pneumonia vaccine to enter clinical trials globally [3]. Business Expansion - The company is actively expanding into overseas markets in Southeast Asia, the Middle East, North Africa, and South America. For instance, the Manhaixin vaccine has received halal certification in Indonesia and has begun exports, with potential for deeper local partnerships and technology transfers [4]. Future Development - Other research pipeline updates include the prioritization of the DTPa vaccine for infants, acceptance of the application for the Tetanus vaccine, and international support for the recombinant poliovirus vaccine (VLP-Polio). The clinical and approval progress of these products may significantly impact the company's long-term development [5].

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 ...