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重组带状疱疹ZFA01佐剂疫苗(CHO细胞)
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智飞生物(300122.SZ):重组带状疱疹ZFA01佐剂疫苗(CHO细胞)获得临床试验批准
智通财经网· 2026-02-09 09:24
Core Viewpoint - The company Zhifei Biological (300122.SZ) has received approval from the National Medical Products Administration for clinical trials of its recombinant herpes zoster vaccine ZFA01 in individuals aged 40 and above, marking a significant advancement in its vaccine development efforts [1] Group 1: Vaccine Development - The recombinant herpes zoster vaccine ZFA01, developed by the company's wholly-owned subsidiary Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd., has been granted a clinical trial approval notice (Notice No. 2026LP00366) [1] - The vaccine utilizes a novel adjuvant developed in-house, which is expected to stimulate both cellular and humoral immune responses, potentially enhancing the vaccine's protective efficacy [1] Group 2: Market Position and Product Portfolio - As of the announcement date, there are only two approved herpes zoster vaccines available in the domestic market, indicating a competitive opportunity for the company [1] - The approval of the clinical trial application is a result of the company's focus on innovation and strengthening its core technology, which may enrich its adult vaccine offerings and enhance its market position [1]
智飞生物:重组带状疱疹ZFA01佐剂疫苗(CHO细胞)临床试验申请获受理
Mei Ri Jing Ji Xin Wen· 2025-11-19 09:51
Core Viewpoint - The announcement highlights that Zhifei Biological's subsidiary, Zhifei Longkema, has received the clinical trial application acceptance notice from the National Medical Products Administration for its recombinant herpes zoster vaccine ZFA01, which utilizes a novel adjuvant to enhance immune responses [1] Company Summary - Zhifei Biological's subsidiary, Zhifei Longkema, is developing the recombinant herpes zoster vaccine ZFA01 [1] - The vaccine is designed to prevent diseases caused by herpes zoster infection [1] - The new adjuvant developed by the company aims to stimulate both cellular and humoral immune responses, potentially improving the vaccine's protective efficacy [1] Industry Summary - The vaccine development is part of the broader pharmaceutical industry efforts to enhance vaccine effectiveness through innovative adjuvants [1] - The acceptance of the clinical trial application indicates progress in the regulatory pathway for new vaccine candidates in the market [1]
智飞生物(300122.SZ):重组带状疱疹ZFA01佐剂疫苗(CHO细胞)临床试验申请获受理
智通财经网· 2025-11-19 09:43
智通财经APP讯,智飞生物(300122.SZ)公告,公司全资子公司安徽智飞龙科马生物制药有限公司(简 称"智飞龙科马")研发的重组带状疱疹ZFA01佐剂疫苗(CHO细胞)获得国家药品监督管理局药物临床试验 申请受理通知书。自受理之日起60日内,未收到药审中心否定或质疑意见的,智飞龙科马可以按照提交 的方案开展临床试验。 ...