辽宁成大生物股份有限公司 关于冻干人用狂犬病疫苗（人二倍体细胞）获得药品注册证书的公告

Core Viewpoint - The company has received a drug registration certificate for its lyophilized human rabies vaccine (human diploid cells) from the National Medical Products Administration, marking a significant advancement in its vaccine product portfolio and competitive position in the rabies vaccine market [1][3]. Group 1: Drug Information - The drug is a lyophilized human rabies vaccine (human diploid cells) with an injection form, and each bottle contains 1.0ml, with a minimum potency of 2.5 IU per dose [1]. - The vaccine is classified as a preventive biological product and has been approved for domestic production, with a registration number valid until February 9, 2031 [1]. - Rabies is a highly fatal infectious disease with a near 100% mortality rate once symptoms appear, affecting approximately 60,000 people globally each year [1]. Group 2: Product Features and Competitive Advantage - The vaccine utilizes the MRC-5 human diploid cell line, recommended by the World Health Organization, ensuring excellent safety, immunogenicity, and durability, particularly for vulnerable populations such as the elderly and children [2]. - It is the first domestic human diploid cell rabies vaccine to include three immunization schedules: "simple 4-dose," "2-1-1," and "5-dose," enhancing adaptability for different exposure levels and patient compliance [2]. - The approval of the "simple 4-dose" immunization schedule represents a breakthrough in the adaptability of the vaccine, potentially increasing the completion rate of immunizations and optimizing post-exposure prevention strategies [2]. Group 3: Impact on the Company - The approval of the human diploid rabies vaccine will enhance the company's vaccine product layout, strengthen its core competitiveness, and solidify its market position in the rabies vaccine sector, providing new growth momentum for future development [3].