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
Shang Hai Zheng Quan Bao·2026-02-24 17:05

Core Viewpoint - The company has received a drug registration certificate for its lyophilized human rabies vaccine (human diploid cells), marking a significant advancement in its vaccine product portfolio and enhancing its market position in the rabies vaccine sector [1][5]. Group 1: Drug Information - The drug is a lyophilized human rabies vaccine (human diploid cells) with an injection form, where each bottle contains 1.0ml, and the efficacy must not be less than 2.5 IU per dose [1][2]. - The vaccine is classified as a preventive biological product, with the approval number valid until February 9, 2031 [2]. Group 2: Market Context - Rabies has a high mortality rate, with nearly 100% fatality once symptoms appear, resulting in approximately 60,000 deaths globally each year, posing a significant threat to public health [2]. - The vaccine utilizes human diploid cells (MRC-5) for cultivation, which is recognized for its excellent immunogenicity and safety, particularly suitable for individuals with weaker immune systems [3]. Group 3: Competitive Advantage - The vaccine is the first in China to include three immunization schedules: "simple 4-dose," "2-1-1," and "5-dose," providing flexibility for different exposure levels and patient compliance [3]. - This diverse immunization approach is expected to improve overall vaccination completion rates and optimize post-exposure prevention strategies, enhancing the company's competitive edge in the market [3]. Group 4: Company Impact - The approval of the human diploid rabies vaccine will enhance the company's vaccine product layout and strengthen its core competitiveness, injecting new growth momentum into its ongoing development [5].

JINYU-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 - Reportify