智通财经APP讯,康希诺生物(06185)公布,该公司研发的吸附破伤风疫苗的新药上市申请已于近日获得中华人民共和国国家药品监督管理局出具的受理通知书。
破伤风是由破伤风杆菌感染机体导致的一种急性感染性疾病,破伤风杆菌产生的一种外毒素即破伤风痉挛毒素,是破伤风的致病因子,可引起全身骨骼肌强直性收缩和阵发性痉挛。重症破伤风患者可并发喉痉挛、窒息、肺部感染和器官功能衰竭,病死率高达30%-50%,在无医疗干预的情况下病死率接近100%,是一种极为严重的潜在致命性疾病。
公司研发的破伤风疫苗采用无动物源培养基进行发酵,更加安全,已确定产业化规模工艺,工艺稳定。该款疫苗主要用于非新生儿破伤风预防,将丰富公司产品管线,提升公司核心竞争力。
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