Core Viewpoint - The approval of the combined vaccine for whooping cough, diphtheria, tetanus, and Hib by the National Medical Products Administration represents a significant advancement for the company, potentially enhancing its product offerings and market position in the vaccine sector [1][2]. Group 1: Vaccine Development - The newly approved combined vaccine can simultaneously prevent whooping cough, diphtheria, tetanus, and Hib infections, targeting infants aged 2 months and older [1]. - The combined vaccine offers the advantage of "one shot for multiple protections," which can reduce the number of injections required, lower vaccination costs, and improve vaccination coverage [1]. - The combined vaccine is based on the company's existing vaccines, including the acellular whooping cough vaccine and the lyophilized Hib vaccine, which together enhance compliance among infants [1]. Group 2: Impact on Company - If the combined vaccine successfully completes clinical trials and receives market approval, it will enhance the company's vaccine development pipeline and contribute to the overall growth of its main business [2]. - The company has previously received approval for other vaccines, including a recombinant shingles vaccine and an influenza virus split vaccine, indicating a robust pipeline of vaccine candidates [2]. - The company reported a significant increase in R&D investment, amounting to 98.2 million yuan, which represents 34.47% of its revenue, compared to 13.83% in the previous year [3].

Core Viewpoint - The approval of the acellular combined vaccine for whooping cough, diphtheria, tetanus, and Haemophilus influenzae type b by the National Medical Products Administration represents a significant advancement for the company in its vaccine development pipeline [1] Group 1: Vaccine Approval - The company has received a clinical trial approval notice for the acellular combined vaccine from the National Medical Products Administration [1] - The vaccine is designed to prevent whooping cough, diphtheria, tetanus, and invasive infections caused by Haemophilus influenzae type b in infants aged 2 months and older [1] Group 2: Business Implications - Successful completion of clinical trials and subsequent market approval of the combined vaccine will enhance the company's vaccine development pipeline [1] - This development is expected to optimize the company's product structure and support comprehensive growth in its main business [1] - The introduction of this vaccine will provide the public with higher quality vaccination options and create new growth points for the company's performance [1]

Core Viewpoint - 百克生物 has received approval from the National Medical Products Administration for a clinical trial of a combined vaccine that prevents whooping cough, diphtheria, tetanus, and Haemophilus influenzae type b [1] Group 1 - The vaccine aims to provide a comprehensive preventive solution for multiple diseases, enhancing public health options [1] - Successful completion of clinical trials and subsequent market approval could improve the company's vaccine development pipeline and optimize its product structure [1] - There are uncertainties regarding the clinical trial process and the potential for commercial success of the vaccine [1]

证券代码：688185 证券简称：康希诺 公告编号：2025-004 康希诺生物股份公司 关于吸附无细胞百（组分）白破b型流感嗜血杆菌（结合） -ACYW135群脑膜炎球菌（结合）联合疫苗获得 药物临床试验批准通知书的公告 申请事项：境内生产药品注册临床试验 申请人：康希诺生物股份公司 一、通知书基本情况 产品名称：吸附无细胞百（组分）白破 b 型流感嗜血杆菌（结合）-ACYW135 群脑膜炎球菌（结合）联合疫苗 注册分类：预防用生物制品 1.4 类 通知书编号：2025LP00435 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，经审査，DTcP-Hib-MCV4 联合疫苗符合药品注册的有关要求， 建议批准开展临床试验。 二、产品相关情况 随着中国上市疫苗品种的不断增加，越来越多剂次疫苗使用，给家长、孩子 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、准确性和完整性依法承担法律责任。 康希诺生物股份公司（以下简称"公司"）于近日收到国家药品监督管理局 核准签发的关于吸附无细胞百（组分）白破b型流感嗜血杆菌（结合）- ...