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 - Hualan Biological's revenue increased by 68.77% in the first half of 2025, despite a challenging environment for the vaccine industry, primarily driven by significant sales of rabies vaccines and a doubling of flu vaccine revenue [1][2][3]. Revenue Performance - Hualan Biological achieved a revenue of 59.96 million yuan in the first half of 2025, marking a year-on-year growth of 68.77% [1]. - The company's net profit attributable to shareholders was 20.80 million yuan, a decrease of 17.71% compared to the previous year [1]. - The flu vaccine revenue grew by 132.94%, contributing approximately 40% to the total revenue [2][3]. Market Dynamics - The domestic vaccine industry is undergoing a deep adjustment period due to price wars, particularly in the HPV vaccine segment, which has led to significant revenue declines for several companies [2]. - Hualan Biological's proactive sales efforts and increased market promotion have resulted in a notable rise in sales, especially for rabies vaccines [1][3]. Sales and Marketing Strategy - Sales expenses increased by 30.78% to 28.99 million yuan, reflecting the company's efforts to enhance market penetration and awareness [4]. - Hualan Biological's sales network covers over 30 provincial regions and more than 2,500 disease control centers, achieving a coverage rate of over 70% [4]. Future Growth Prospects - The company is focusing on expanding its product pipeline, with ongoing clinical trials for new vaccines, including a freeze-dried Hib vaccine and mRNA vaccines for flu and RSV [5]. - Hualan Biological aims to increase the sales revenue and market share of its rabies vaccine while enhancing public awareness of flu vaccination [5].

Group 1: Financial Performance - The company's operating revenue for the first half of 2025 was ¥59,961,774.27, representing a year-on-year increase of 68.77% [3] - The net profit attributable to shareholders decreased by 17.71% to ¥20,797,156.80 [3] - The net profit after deducting non-recurring gains and losses was -¥12,784,853.85, showing a year-on-year increase of 40.04% [3] - As of the end of the reporting period, total assets amounted to ¥6,912,395,737.39, with net assets attributable to shareholders at ¥5,918,534,037.40 [3] Group 2: Dividend Policy - The 2024 dividend plan is to distribute ¥2 per 10 shares, with a total cash dividend of ¥8 per 10 shares for 2025 [4] - The average annual net profit attributable to shareholders over the past three years was ¥5.284 billion, with cumulative cash dividends of ¥706.4 million, resulting in a payout ratio of 133.69% [4] - The company aims to enhance the stability and predictability of cash dividends while increasing the average payout ratio [4] Group 3: Vaccine Industry Insights - The global human vaccine market grew from $27.7 billion in 2017 to $46 billion in 2021, with a compound annual growth rate (CAGR) of 13.5%, projected to reach $83.1 billion by 2025 and exceed $131 billion by 2030 [4] - In China, the overall vaccination rate for influenza vaccines is approximately 3%, significantly lower than the rates in developed countries [5] - The CDC reported that the vaccination rates for the 2023-2024 flu season in the U.S. were 55.4% for ages 6 months to 17 years, 44.9% for adults, and 69.7% for seniors aged 65 and above [5] Group 4: Market Strategy and Future Growth - The company has established a sales network covering over 2,500 disease control centers across more than 30 provinces, achieving over 70% coverage [5] - To improve accessibility and market competitiveness, the company adjusted the price of its quadrivalent influenza vaccine starting June 5, 2024 [6] - Future growth points include the development of rabies and tetanus vaccines, with the company also advancing clinical trials for new products like mRNA vaccines [6]

谈及此次获得临床批件的意义，华兰疫苗表示，"冻干Hib疫苗"的获批是公司产品研发战略布局阶段性 的成功，不仅丰富公司产品布局，也是实现公司研发多联多价产品的重要一步，既有利于巩固公司在国 内二类疫苗领域的行业地位，又有利于公司疫苗业务的可持续发展。 审批结论显示，Hib疫苗符合药品注册的有关要求，同意开展预防由b型流感嗜血杆菌引起的侵袭性感染 (包括脑膜炎、肺炎、败血症、蜂窝织炎、关节炎、会厌炎等)的临床试验。 本报讯(记者肖艳青)8月13日晚间，华兰生物（002007）疫苗股份有限公司(以下简称"华兰疫苗 （301207）")公告称，公司近日收到国家药品监督管理局核准签发的关于冻干b型流感嗜血杆菌结合疫 苗(以下简称"Hib疫苗")的《药物临床试验批准通知书》。 ...

Core Viewpoint - Hualan Vaccine has received approval from the National Medical Products Administration for clinical trials of its Hib vaccine, which targets invasive infections caused by Haemophilus influenzae type b [1] Group 1: Company Developments - Hualan Vaccine announced on August 13 that it has obtained the clinical trial approval notice for its freeze-dried Hib vaccine [1] - The Hib vaccine is intended to prevent invasive infections such as meningitis, pneumonia, sepsis, cellulitis, arthritis, and epiglottitis caused by Haemophilus influenzae type b [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of its Hib vaccine, which targets Haemophilus influenzae type b, a major pathogen causing acute lower respiratory infections in children [1] Group 1: Vaccine Development - The Hib vaccine is developed using purified Hib capsular polysaccharide combined with tetanus toxoid protein, and it is expected to induce an immune response against Hib, providing protection to the vaccinated individuals [1] - The company is also developing a combination vaccine based on the DTP (Diphtheria, Tetanus, Pertussis) framework, with the Hib vaccine as one of its components [1] Group 2: Clinical Trial and Regulatory Process - The Hib vaccine, as an unapproved single vaccine, requires the accumulation of clinical data to complete its registration application for market approval [1] - Successful registration of the Hib single vaccine will support future registration applications for the combination vaccine based on the DTP framework [1]

Core Viewpoint - Hualan Vaccine has received approval from the National Medical Products Administration for the clinical trial of its lyophilized Haemophilus influenzae type b (Hib) vaccine, marking a significant step in the company's product development strategy [2] Group 1: Company Developments - The approval of the Hib vaccine is an important milestone for Hualan Vaccine, as it will enrich the company's product line [2] - The Hib vaccine is classified as a Class 3.3 preventive biological product, aimed at preventing invasive infections caused by Haemophilus influenzae type b [2] - The company plans to support future registration applications for combination vaccines based on the Hib vaccine and DTP (Diphtheria, Tetanus, Pertussis) [2] Group 2: Industry Context - The development of vaccines typically involves long research and development cycles, and the company must conduct clinical trials in accordance with national regulations [2] - The company faces potential risks associated with the vaccine development process, including the possibility of research and development failures [2]