Workflow
治疗用卡介苗
icon
Search documents
智飞生物自研速度加快 三款重磅产品获关键进展
自研加速,智飞生物(300122)于4月8日晚间连发三条公告,该上市公司旗下四价流脑结合疫苗、治疗 用卡介苗及双价痢疾结合疫苗已进入关键研发阶段,其技术突破与市场布局引发行业高度关注。 资料显示,引起细菌性痢疾的志贺菌主要包括4种菌群:痢疾志贺菌、福氏志贺菌、鲍氏志贺菌和宋内 氏志贺菌,全球以福氏、宋内氏志贺菌感染为主,占总发病数的90%以上。2024年,世界卫生组织将志 贺菌列入细菌重点病原体清单(WHO BPPL),凸显志贺菌在疾病负担方面的全球影响力。 公告指出,由智飞生物研发的产品主要针对福氏、宋内氏志贺菌2种菌群;截至目前,全球暂无同类疫 苗获批上市。根据智飞生物收到孟加拉国药品管理总局签发的III期临床试验批件,双价痢疾结合疫苗拟 在孟加拉国开展的III期临床试验,将采用随机、盲法、安慰剂对照评价该疫苗针对6月龄至5周岁婴幼儿 的有效性、免疫原性和安全性。此外,智飞生物该疫苗产品的国内III期临床试验已于2021年12月开展, 若在孟加拉国开展的III期临床试验进展顺利,将进一步充实智飞生物申请双价痢疾疫苗生产注册的临床 数据,加速推动项目进展。 再看第三则临床消息,来自于智飞生物全资子公司安徽智 ...
智飞生物多款重磅疫苗研发取得突破性进展
Jin Rong Jie· 2025-04-08 13:56
Core Viewpoint - The company, Zhifei Biological, has made significant advancements in vaccine development, including a quadrivalent meningococcal vaccine, a therapeutic BCG vaccine for bladder cancer, and a bivalent shigella vaccine, indicating a strategic focus on infectious disease prevention and cancer treatment [1][5]. Group 1: Quadrivalent Meningococcal Vaccine - The quadrivalent meningococcal polysaccharide conjugate vaccine has completed its Phase III clinical trial, demonstrating good immunogenicity and safety, meeting the predefined clinical trial goals [2][5]. - If approved, this vaccine will complement existing meningococcal vaccines, enhancing the company's market position in the meningitis vaccine sector [2][5]. Group 2: Therapeutic BCG Vaccine - The therapeutic BCG vaccine has entered Phase III clinical trials aimed at preventing recurrence in non-muscle invasive bladder cancer patients, with the first subject treated in Hunan Province [3][5]. - This product could become the company's first oncology therapeutic biological product, addressing the high recurrence rates of bladder cancer [3][5]. Group 3: Bivalent Shigella Vaccine - The bivalent shigella vaccine is set to initiate Phase III trials in Bangladesh, targeting bacterial dysentery caused by Shigella flexneri and Shigella sonnei, with the potential to fill a significant market gap as no similar vaccines are currently approved globally [4][5]. - The trial will assess the vaccine's efficacy and safety in infants aged 6 months to 5 years, contributing to the global fight against dysentery, particularly in developing countries [4][5].