24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)
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康希诺:24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)获批临床试验
智通财经网· 2026-01-05 09:09
公司PCV24覆盖当前肺炎球菌主要流行血清型,采用多糖抗原与蛋白载体共价结合的方式,以及双载体 技术,拟适用于2月龄(最小6周)及以上人群接种,以预防由24种肺炎球菌血清型引起的感染性疾病。该 产品完成了24种血清型纯化多糖、多糖蛋白结合物原液生产工艺、成品处方的开发与确认。截止公告披 露日,24价肺炎球菌多糖结合疫苗在国内外均无上市产品。 智通财经APP讯,康希诺(688185.SH)发布公告,公司于近日收到国家药品监督管理局核准签发的关于 24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)(简称"PCV24")的《药物临床试验批准通知书》, 同意开展预防由本品所含24种肺炎球菌血清型引起的感染性疾病的临床试验。 ...
康希诺(688185.SH):24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)获批临床试验
智通财经网· 2026-01-05 09:04
智通财经APP讯,康希诺(688185.SH)发布公告,公司于近日收到国家药品监督管理局核准签发的关于 24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)(简称"PCV24")的《药物临床试验批准通知书》, 同意开展预防由本品所含24种肺炎球菌血清型引起的感染性疾病的临床试验。 公司PCV24覆盖当前肺炎球菌主要流行血清型,采用多糖抗原与蛋白载体共价结合的方式,以及双载体 技术,拟适用于2月龄(最小6周)及以上人群接种,以预防由24种肺炎球菌血清型引起的感染性疾病。该 产品完成了24种血清型纯化多糖、多糖蛋白结合物原液生产工艺、成品处方的开发与确认。截止公告披 露日,24价肺炎球菌多糖结合疫苗在国内外均无上市产品。 ...
康希诺:PCV24获得药物临床试验批准通知书
Zheng Quan Shi Bao Wang· 2026-01-05 08:23
人民财讯1月5日电,康希诺(688185)1月5日公告,公司于近日收到国家药品监督管理局核准签发的关于 24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)(简称"PCV24")的《药物临床试验批准通知书》。 公司PCV24覆盖当前肺炎球菌主要流行血清型,采用多糖抗原与蛋白载体共价结合的方式,以及双载体 技术,拟适用于2月龄(最小6周)及以上人群接种,以预防由24种肺炎球菌血清型引起的感染性疾病。截 止本公告披露日,24价肺炎球菌多糖结合疫苗在国内外均无上市产品。 ...
康希诺(688185.SH):24价肺炎球菌多糖结合疫苗(CRM197/破伤风类毒素)获得药物临床试验批准通知书
Ge Long Hui A P P· 2026-01-05 08:12
Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of its 24-valent pneumococcal polysaccharide conjugate vaccine, which addresses a significant public health issue caused by Streptococcus pneumoniae [1][2] Group 1: Product Development - The 24-valent pneumococcal polysaccharide conjugate vaccine (PCV24) targets the major circulating serotypes of pneumococcus and is designed for use in individuals aged 2 months and older [1] - The vaccine employs a covalent binding method of polysaccharide antigens with protein carriers, utilizing dual carrier technology [1] - The product has completed the development and confirmation of the production process for purified polysaccharides from 24 serotypes and the formulation of the final product [1] Group 2: Market Context - Pneumococcal diseases are a major cause of morbidity and mortality among infants and the elderly in China, with over 100 identified serotypes capable of causing disease [1] - The World Health Organization has classified pneumococcal diseases as a condition that requires "high priority" for vaccine prevention [1] - As of the announcement date, there are no existing products for the 24-valent pneumococcal polysaccharide conjugate vaccine available in domestic or international markets [2]