Core Viewpoint - Changchun High-tech announced that its subsidiary, Baike Biotech, received the Clinical Trial Approval Notice from the National Medical Products Administration for its trivalent influenza virus split vaccine, allowing clinical trials to prevent influenza caused by related strains of the virus [1] Group 1 - The vaccine is targeted at individuals aged 60 and above [1] - The vaccine utilizes a split virus technology route and is combined with a self-developed adjuvant to ensure safety while enhancing immunogenicity [1] - Successful completion of clinical trials and subsequent approval for market launch will further enhance the company's influenza vaccine research pipeline and expand its coverage among the population [1]

证券代码：688276 证券简称：百克生物 公告编号：2025-038 长春百克生物科技股份公司 关于自愿披露三价流感病毒裂解疫苗（BK-01 佐剂） 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 管理局下发的三价流感病毒裂解疫苗（BK-01 佐剂）的《药物临床试验批准通知书》。 2、本次获批临床试验的三价流感病毒裂解疫苗（BK-01 佐剂）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： 受理号：CXSL2500608 通知书编号：2025LP02679 药品名称：三价流感病毒裂解疫苗（BK-01 佐剂） 结论：同意开展预防疫苗相关型别流感病毒引起的流行性感冒的临床试验。 批准日期：2025 年 10 月 13 日 二、三价流感病毒裂解疫苗（BK-01 佐剂）的简介 流感是由流感病毒引起的一种急性呼吸道传染 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for its trivalent influenza virus split vaccine (BK-01 adjuvant), targeting individuals aged 60 and above, which aims to enhance immune response [1] Group 1: Vaccine Development - The trivalent influenza virus split vaccine (BK-01 adjuvant) is developed in-house by the company, utilizing a split virus technology route combined with a self-developed adjuvant to ensure safety while improving immunogenicity [1] - Compared to traditional split influenza vaccines, this new vaccine is designed to stimulate a higher level of protective antibodies, providing effective protection for the elderly population [1] Group 2: Market Implications - If the vaccine successfully completes clinical trials and receives market approval, it will enhance the company's influenza vaccine development pipeline, offering new vaccination options for individuals aged 60 and above [1] - This development is expected to expand the company's coverage in the influenza vaccine market, optimize product structure, and contribute to the overall growth of its main business, thereby strengthening long-term profitability [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its trivalent influenza virus split vaccine (BK-01 adjuvant), targeting the prevention of influenza caused by specific virus strains in individuals aged 60 and above [1] Group 1 - The vaccine is designed to stimulate a stronger immune response in the target population [1] - The approval allows the company to proceed with clinical trials, which is a significant step in the vaccine development process [1]

Group 1 - The core viewpoint of the news is that Baike Biological experienced a slight increase in stock price and notable trading activity, with significant financing and margin trading data indicating a mixed sentiment among investors [1] Group 2 - As of October 9, Baike Biological's stock price rose by 0.91%, with a trading volume of 46.96 million yuan. The financing buy-in amount was 8.80 million yuan, while the financing repayment was 9.24 million yuan, resulting in a net financing buy of -0.43 million yuan [1] - The total margin trading balance for Baike Biological reached 261 million yuan, with the financing balance accounting for 2.85% of the circulating market value, indicating a high level compared to the past year [1] - On the margin trading side, there were no shares repaid on October 9, with 9,399 shares sold short, amounting to 0.21 million yuan at the closing price. The short selling balance was 71,980 yuan, which is below the 30th percentile level over the past year, indicating a low level of short interest [1] Group 3 - As of June 30, Baike Biological had 10,100 shareholders, an increase of 0.40% from the previous period, with an average of 40,980 circulating shares per shareholder, a decrease of 0.40% [2] - For the first half of 2025, Baike Biological reported operating revenue of 285 million yuan, a year-on-year decrease of 53.93%, and a net profit attributable to shareholders of -73.57 million yuan, a decline of 153.47% [2] - Since its A-share listing, Baike Biological has distributed a total of 235 million yuan in dividends, with 194 million yuan distributed over the past three years [2] - As of June 30, 2025, among the top ten circulating shareholders, the Southern CSI 1000 ETF was the newest addition, holding 1.52 million shares, while the China National Bio-Medical Index A and Southern CSI 500 ETF exited the top ten list [2]

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]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Baike Biological, has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for its acellular combined vaccine for whooping cough, diphtheria, tetanus, and invasive infections caused by Haemophilus influenzae type b [1] Group 1: Product Development - The vaccine is intended to prevent whooping cough, diphtheria, tetanus, and invasive infections caused by Haemophilus influenzae type b [1] - Baike Biological's acellular combined vaccine (three-component) and lyophilized Haemophilus influenzae type b conjugate vaccine (Hib vaccine) are the foundation and core of the combined vaccine [1] Group 2: Business Impact - The approval will help enhance the company's combined vaccine research and development pipeline and optimize its product structure [1] - This development is expected to create new growth points for the company's performance [1] - However, there is uncertainty regarding the subsequent clinical trial process, and it will not have a significant impact on the company's recent performance [1]