Core Viewpoint - 百克生物 has received approval for its trivalent influenza virus split vaccine (BK-01 adjuvant) from the National Medical Products Administration, which is expected to enhance immune response in the elderly population, marking a significant step in flu prevention for this vulnerable group [1][2]. Group 1: Vaccine Development - The trivalent influenza virus split vaccine (BK-01 adjuvant) is specifically designed for individuals aged 60 and above, aiming to stimulate a stronger immune response compared to traditional vaccines [2]. - The company has developed a product matrix for adjuvanted influenza vaccines, including both trivalent and quadrivalent options, with the quadrivalent vaccine already receiving clinical trial approval [1][2]. - The World Health Organization has recommended the removal of the B/Yamagata strain from the Northern Hemisphere flu vaccine components, highlighting the importance of the trivalent vaccine in flu epidemic control [1]. Group 2: Impact on Company - If the trivalent vaccine successfully completes clinical trials and receives market approval, it will enhance the company's vaccine development pipeline and provide new vaccination options for the elderly, thereby expanding its market reach [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 85.5 million yuan and 13.83% in the same period last year [4]. - The company is focusing on a diverse pipeline of 13 vaccine products and 3 monoclonal antibodies for infectious disease prevention, with strategies including upgrades, filling domestic gaps, and technological breakthroughs [4].

Investment Rating - The industry investment rating is maintained at "Overweight" [3][11]. Core Views - The vaccine industry is currently experiencing a transition from scale expansion to innovation-driven growth, facing short-term pain due to supply-demand imbalance and homogenized competition, but the long-term positive outlook remains unchanged [10][11]. - The industry is under pressure in Q2 2025, with performance still in a bottoming process due to high Me-too pipeline ratios leading to intense competition and price declines, alongside weak demand and market education [9][10]. - The focus is on innovation and international market expansion, with companies actively adjusting their pipeline layouts to enhance competitive advantages [10][11]. Summary by Sections Industry Performance - The vaccine sector has shown a relative performance decline of -7% over the past month and -29% over the past year compared to the CSI 300 index [5]. - The vaccine sector's absolute return is -5% for the past month and -12% for the past year [5]. Market Review - The vaccine sector rose by 0.72% last week, with a cumulative decline of -2.35% since the beginning of 2025 [6]. - Notable companies in the vaccine sector include Lianoning Chengda, Hualan Biological, and Wantai Biological, while companies like Olin Biological and CanSino have underperformed [7]. Valuation - The vaccine sector's PE (ttm) is 103.74X, with a year-on-year maximum of 111.89X and a minimum of 27.99X [8]. - The PB (lf) stands at 1.91X, with a maximum of 2.29X and a minimum of 1.69X over the past year [8]. Investment Recommendations - The vaccine industry is advised to focus on companies with high technical barriers and differentiated pipeline layouts to find alpha opportunities amid industry differentiation [11][28]. - Companies with strong R&D innovation and technical advantages, such as CanSino and Kanghua Biological, are recommended for investment [11][28].

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Baike Biotechnology Co., Ltd. (referred to as "Baike Biotechnology"), received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for its acellular pertussis-diphtheria-tetanus combined vaccine with Hib [1] Group 1 - The approved vaccine, referred to as "DTP-Hib combined vaccine," is designed to simultaneously prevent whooping cough, diphtheria, tetanus, and infections caused by Haemophilus influenzae type b [1] - The target recipients of the vaccine are infants aged 2 months and older, and it is intended to stimulate the immune response to prevent invasive infections caused by these pathogens [1]

Core Viewpoint - The company, Baike Biological, has received approval from the National Medical Products Administration for a clinical trial of its combined vaccine for pertussis, diphtheria, and influenza type B [2] Group 1 - Baike Biological announced the receipt of the clinical trial approval notice for its acellular pertussis, diphtheria, and influenza type B vaccine [2]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Baike Biotechnology Co., Ltd., received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for its adsorbed acellular DTPa-Hib combined vaccine [1] Group 1 - The approved Hib vaccine is in a lyophilized form, which, when used in conjunction with the liquid form of the DTPa vaccine, reduces the number of injections required [1] - This combination aims to improve vaccination compliance among infants and young children [1]

Core Viewpoint - Changchun High-tech announced that Changchun Baike Biotechnology Co., Ltd. received the clinical trial approval notice from the National Medical Products Administration for its combined vaccine against whooping cough, diphtheria, tetanus, and invasive infections caused by Haemophilus influenzae type b, indicating progress in vaccine development and potential market impact [1] Group 1 - The combined vaccine aims to reduce the number of doses required and improve vaccination rates, which is a significant advantage in public health [1] - The vaccine is currently in the clinical trial phase, highlighting ongoing research and development efforts in the biotechnology sector [1]

Core Viewpoint - Changchun High-tech's subsidiary, Baike Biological, has received approval from the National Medical Products Administration for clinical trials of an adsorbed acellular combined vaccine for whooping cough, diphtheria, tetanus, and invasive infections caused by Haemophilus influenzae type b [1] Group 1 - The approved vaccine aims to prevent infections caused by whooping cough, diphtheria, tetanus, and Haemophilus influenzae type b [1] - Currently, there are no approved adsorbed acellular combined vaccines from domestic manufacturers in the market [1]

长春高新公告，子公司百克生物近日收到国家药品监督管理局对其吸附无细胞百白破b型流感嗜血杆菌 联合疫苗下发的《药物临床试验批准通知书》。该疫苗用于预防百日咳、白喉、破伤风和b型流感嗜血 杆菌引起的侵袭性感染。百克生物的吸附无细胞百白破疫苗（三组分）和冻干b型流感嗜血杆菌结合疫 苗（Hib疫苗）是百白破-Hib联合疫苗的基础和核心。此次获批将有助于完善公司联合疫苗研发管线， 优化产品结构，为公司业绩创造新的增长点。但后续临床试验的开展存在不确定性，对公司近期业绩不 会产生重大影响。 ...

Core Viewpoint - The company, Baike Biotechnology (688276.SH), has received approval from the National Medical Products Administration for the clinical trial of its combined vaccine, which targets whooping cough, diphtheria, tetanus, and Haemophilus influenzae type b [1] Group 1 - The approved vaccine is referred to as the "acellular combined whooping cough-diphtheria-tetanus and Hib vaccine" [1] - This vaccine is designed for infants aged 2 months and older, aiming to stimulate immune responses to prevent invasive infections caused by the targeted diseases [1] - The vaccine provides simultaneous protection against whooping cough, diphtheria, tetanus, and invasive infections from Haemophilus influenzae type b [1]

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]