Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Baike Biotechnology Co., Ltd., received approval from the National Medical Products Administration for clinical trials of a combined vaccine for the prevention of whooping cough, diphtheria, and tetanus [1] Group 1 - The approval pertains to the "Adsorbed Acellular Combined Vaccine (for Adults and Adolescents)" [1] - The clinical trials are aimed at evaluating the vaccine's effectiveness in preventing three diseases: whooping cough, diphtheria, and tetanus [1]

Group 1 - The core point of the article is that Baike Biotech has received approval from the National Medical Products Administration for a clinical trial of its combined vaccine for adults and adolescents [1] - Baike Biotech's revenue composition for the year 2024 is entirely from biopharmaceuticals, accounting for 100% [2] - As of the latest update, Baike Biotech has a market capitalization of 9.6 billion yuan [3]

证券代码：688276 证券简称：百克生物 公告编号：2025-043 长春百克生物科技股份公司 关于自愿披露吸附无细胞百（二组分）白破联合疫苗 （成人及青少年用）临床试验申请获得批准的公告 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、准确性和完整性依法承担法律责任。 重要内容提示： 1、长春百克生物科技股份公司（以下简称"公司"）近日收到国家药品监督 管理局下发的吸附无细胞百（二组分）白破联合疫苗（成人及青少年用）的《药物 临床试验批准通知书》。 2、本次获批临床试验的吸附无细胞百（二组分）白破联合疫苗（成人及青少 年用）后续临床试验的开展具有一定的不确定性，能否最终实现商业目的也存在一 定的不确定性。敬请广大投资者谨慎决策，注意防范投资风险。 现将相关情况公告如下： 一、《药物临床试验批准通知书》的主要信息 受理号：CXSL2500724 通知书编号：2025LP02992 药品名称：吸附无细胞百（二组分）白破联合疫苗（成人及青少年用） 结论：建议批准开展预防百日咳、白喉、破伤风的临床试验。 批准日期：2025 年 11 月 11 日 二、吸附无细 ...

Core Viewpoint - The approval of the clinical trial for the adolescent and adult combined vaccine by the National Medical Products Administration represents a significant advancement for the company in expanding its vaccine development pipeline and product offerings [1] Group 1: Vaccine Approval - The company has received the clinical trial approval notice for the acellular combined vaccine (DTPa) for adolescents and adults [1] - This vaccine aims to simultaneously prevent whooping cough, diphtheria, and tetanus in individuals aged 10 years and older [1] Group 2: Market Impact - Successful completion of the clinical trials and subsequent market approval will enhance the company's vaccine research and development pipeline [1] - The new vaccine will diversify the company's combined vaccine product matrix, optimizing its product structure and supporting comprehensive business development [1] - This development is expected to provide higher quality vaccination options for the public and create new growth points for the company's performance [1]

Core Viewpoint - The company, 百克生物 (Biokangtai), has received approval from the National Medical Products Administration for its acellular combined vaccine for adolescents and adults, which targets whooping cough, diphtheria, and tetanus [1] Group 1: Product Approval - The company has been granted a clinical trial approval notice for the acellular combined whooping cough, diphtheria, and tetanus vaccine for adolescents and adults [1] - This vaccine is designed to simultaneously prevent whooping cough, diphtheria, and tetanus in individuals aged 10 years and older [1] - The vaccine aims to stimulate an immune response to prevent invasive infections caused by these diseases [1]

百克生物公告，公司近日收到国家药品监督管理局下发的吸附无细胞百（二组分）白破联合疫苗（成人 及青少年用）的《药物临床试验批准通知书》。该疫苗是一种可以同时预防青少年及成人百日咳、白 喉、破伤风的疫苗，接种对象为10周岁及以上人群。若顺利完成临床试验并获批上市，将进一步完善公 司疫苗研发管线，丰富公司联合疫苗产品矩阵，有助于公司优化产品结构和主营业务的全面发展。 ...

Group 1 - The vaccine sector experienced a significant rise, with Gendik hitting the daily limit increase [1] - Other companies such as Watson Bio, Zhifei Bio, Kangtai Bio, Baike Bio, and Kangle Weishi also saw gains [1]

Core Viewpoint - The A-share market has seen a significant rise in flu-related stocks due to a noticeable increase in flu activity across China, with most provinces entering the flu epidemic period [1] Group 1: Stock Performance - Hendi Pharmaceutical has increased by over 14%, while Hualan Biological has risen by 11% [1] - Other notable performers include Peking University Pharmaceutical with a 10% increase, and Jinshi Yao with a rise of over 7% [1] - Several companies, including Teva Pharmaceutical, Erkang Pharmaceutical, and others, have also shown gains of over 5% [1] Group 2: Market Context - Recent data from the China CDC indicates that flu virus cases have surpassed other respiratory viruses, marking a significant shift in the current flu season [1] - Since mid-October, sales of related medications, such as Oseltamivir, have increased, with production running continuously [1]

Core Viewpoint - The company has developed a lyophilized nasal spray influenza vaccine suitable for individuals aged 3 to 17, which simulates natural infection and induces both systemic and local mucosal immunity with a validity period of 10 months [1] Group 1: Product Details - The lyophilized nasal spray influenza vaccine is the only nasal spray live attenuated influenza vaccine in China, significantly improving vaccination compliance among recipients [1] - The liquid nasal spray influenza vaccine received production approval in August 2025, representing an upgrade from the lyophilized form, eliminating the need for reconstitution during use [1] Group 2: Regulatory and Global Context - The lyophilized nasal spray influenza vaccine is part of the World Health Organization's (WHO) Global Action Plan for Influenza Vaccines (GAP) [1]

Group 1 - The core viewpoint of the article highlights that Changchun Gaoxin, as a leading local enterprise, is actively responding to the severe influenza situation in Changchun by promoting its vaccine products [2] - The company’s subsidiary, Baike Biological, currently has a nasal spray influenza vaccine (powder form) and has recently obtained production approval for a liquid nasal spray influenza vaccine [2] - Changchun Gaoxin is committed to advancing the production and sales of these related products to support local efforts against the influenza outbreak [2]