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]

Core Viewpoint - 百克生物 is committed to innovation-driven development in the booming global biopharmaceutical industry, with a well-structured and diverse research pipeline that enhances its competitive edge [1][2]. R&D Strategy - The company has established a tiered R&D strategy focusing on "upgrading, filling gaps, and innovative breakthroughs," creating a product matrix that addresses health needs across all demographics [1][3]. - The R&D model includes a "production generation, R&D generation, and reserve generation" approach, ensuring a comprehensive layout from mature product production to cutting-edge technology reserves [2]. Key Products and Pipeline - Core products in the "production generation" include varicella vaccine, nasal spray influenza vaccine (both freeze-dried and liquid forms), and attenuated live vaccine for herpes zoster, which support the company's growth [2]. - "R&D generation" products, such as acellular DTP vaccine and adjuvanted influenza vaccines, are currently in clinical stages, while "reserve generation" products like HSV-2 mRNA vaccine and Alzheimer's therapeutic vaccine lay the foundation for long-term development [2]. Technological Platforms - The company has developed five core technology platforms: virus large-scale culture, formulation and adjuvant technology, genetic engineering, bacterial vaccine technology, and mRNA vaccine technology, supporting 13 vaccine projects and 3 monoclonal antibodies for infectious disease prevention [3]. - The company has achieved breakthroughs in mRNA vaccines and recombinant protein vaccines, with proprietary adjuvants already applied in various vaccine formulations [3]. Recent Achievements - In the first ten months of the year, the company received one production license for liquid nasal spray influenza vaccine and submitted five clinical trial applications for adjuvanted influenza vaccines, with four already approved [3][4]. - The company is developing a multi-component HSV-2 mRNA vaccine that enhances immune response and has initiated Phase I clinical trials, which could significantly enrich its product pipeline [4]. - The Alzheimer's therapeutic vaccine is in preclinical research, showing promising safety and immunogenicity, with potential applications for early treatment and prevention in at-risk populations [4].

Core Insights - The company reported a significant decline in revenue and profit for the first three quarters of 2025, with total revenue at 474 million yuan, down 53.76% year-on-year, and a net loss of 158 million yuan, a decrease of 164.76% compared to the previous year [1][2] Financial Performance - The basic earnings per share for the reporting period was -0.38 yuan, with a weighted average return on equity of -3.86% [2] - The company's gross margin for the first three quarters was 75.40%, down 10.09 percentage points year-on-year, while the net margin was -33.36%, a decline of 57.17 percentage points from the same period last year [2] - In Q3 2025, the gross margin was 70.94%, a year-on-year decrease of 10.89 percentage points but an increase of 1.69 percentage points from the previous quarter; the net margin was -44.67%, down 70.87% year-on-year but up 16.20 percentage points quarter-on-quarter [2] Expense Analysis - Total operating expenses for the period were 507 million yuan, a decrease of 67.43 million yuan year-on-year, with an expense ratio of 106.88%, up 50.88 percentage points from the previous year [2] - Sales expenses decreased by 24.96% year-on-year, while management expenses increased by 1.28%, R&D expenses rose by 18.92%, and financial expenses surged by 137.29% [2] Shareholder Information - As of the end of Q3 2025, the total number of shareholders was 10,800, an increase of 730 (7.23%) from the end of the previous half-year, while the average market value per shareholder decreased by 2.66% to 837,700 yuan [3] Company Overview - Changchun Baike Biotechnology Co., Ltd. is located in Changchun, Jilin Province, and was established on March 4, 2004, with its listing date on June 25, 2021; the company focuses on the research, production, and sales of human vaccines [3] - The main business revenue is derived from varicella vaccine (116.82%) and influenza vaccine (6.07%) [3] - The company belongs to the pharmaceutical and biological industry, specifically in the vaccine sector, and is associated with concepts such as monkeypox, vaccines, biopharmaceuticals, small-cap stocks, and margin financing [3]