本次公司获批临床的吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)(以下简称"青少年及成人百 白破疫苗")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，接种后可刺激机体产生免疫应答，用于预防百日咳、白喉、破伤风引起的侵袭性感染。 智通财经APP讯， 百克生物(688276.SH)发布公告，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》。 ...

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]

格隆汇10月30日丨百克生物(688276.SH)发布三季报，2025年前三季度实现营业总收入4.74亿元，同比下 降53.76%；归属母公司股东净利润-1.58亿元，上年同期净利润为2.44亿元；基本每股收益为-0.38元。 ...

Core Insights - The company, Baike Biotech (688276), focuses on innovative product research and development as its primary growth driver, leveraging over 20 years of technical expertise to establish a well-structured and diverse R&D pipeline [1] - Since 2025, Baike Biotech has reported significant progress in key projects, driven by a high proportion of R&D investment, contributing to the advancement of China's vaccine industry [1] R&D Strategy - Baike Biotech has established a tiered R&D strategy centered on "upgrading, filling gaps, and breakthroughs," aiming to create a product matrix that meets the health needs of the entire population [2] - The company focuses on optimizing mature products through process innovations to enhance safety and applicability, such as the acellular DTP vaccine, which reduces adverse reaction risks compared to traditional vaccines [2] - Baike Biotech targets unmet clinical needs in China with self-developed vaccines, like the "Ganwei" varicella-zoster virus vaccine, breaking the import monopoly and aiming to increase vaccination rates [2] - The company is also pursuing cutting-edge technologies with products like HSV-2 mRNA vaccine and Alzheimer's therapeutic vaccine, aligning with the national "Healthy China" strategy [2] Development Model - To ensure steady progress in its R&D strategy, Baike Biotech has implemented a "production, R&D, and reserve" model, covering the entire chain from mature product production to cutting-edge technology reserves [3] - Core products like varicella vaccine and nasal spray flu vaccine support the company's growth, while products in clinical stages include acellular DTP vaccine and adjuvanted flu vaccines [3] - The company has built a dual innovation system of "independent R&D + collaborative win-win," enhancing its technical strength through partnerships with universities and research institutions [3] Diverse Pipeline - Baike Biotech has established a diverse R&D pipeline with 13 vaccine projects and 3 monoclonal antibodies for infectious disease prevention, supported by five core technology platforms [4] - The company has achieved breakthroughs in traditional live attenuated vaccines and is advancing in mRNA vaccines and adjuvant technologies, with its self-developed adjuvant already applied in several vaccines [4] Key Projects - The company has developed a matrix of flu vaccines, including the nasal spray flu vaccine, which is the first and only one of its kind in China, offering significant advantages over traditional injected vaccines [5][6] - The "Ganwu" nasal spray flu vaccine has been approved for production and is undergoing clinical trials to expand its application to a broader age group [6] - Baike Biotech has also developed adjuvanted flu vaccines for elderly populations, enhancing immune response and safety [6] Innovative Vaccines - The HSV-2 mRNA vaccine aims to address the public health issue of genital herpes, currently in Phase I clinical trials, with no similar products available globally [7] - The DTP-Hib combined vaccine offers a "one shot, multiple protections" advantage, reducing the number of injections required for infants while ensuring high purity and consistency [8] - The Alzheimer's therapeutic vaccine is in preclinical research, showing promising safety and immunogenicity, with potential applications for early-stage patients [9]