华兰疫苗: 关于冻干b型流感嗜血杆菌结合疫苗获得药物临床试验批准通知书的公告

Core Viewpoint - The approval of the clinical trial for the freeze-dried Hib vaccine marks a significant milestone in the company's product development strategy, enhancing its position in the domestic vaccine market and supporting sustainable growth in its vaccine business [1][2]. Group 1: Clinical Trial Approval - The company has received the clinical trial approval notice for the freeze-dried Hib vaccine from the National Medical Products Administration [1]. - The vaccine is classified as a Class 3.3 preventive biological product and is intended to prevent invasive infections caused by Haemophilus influenzae type b, including meningitis, pneumonia, and sepsis [1]. Group 2: Product Information - 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 recipients [2]. - The company is also developing a combination vaccine based on the DTP (diphtheria, tetanus, and pertussis) framework, with the Hib vaccine as one of its components [2]. Group 3: Significance of Approval - The approval of the freeze-dried Hib vaccine is a strategic success for the company, enriching its product portfolio and representing a crucial step towards developing multi-component vaccines [2]. - This development is expected to strengthen the company's position in the domestic second-class vaccine sector and contribute to the sustainable development of its vaccine business [2].