生物制药研发突破
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成大生物:冻干人用狂犬病疫苗(人二倍体细胞)获得药品注册证书
Ge Long Hui· 2026-02-24 07:41
公司本溪子公司研发的人用二倍体狂犬疫苗,采用世界卫生组织推荐的人二倍体细胞MRC-5为细胞基 质,该细胞源自健康人胚肺组织,产品安全性、免疫原性及免疫持久性表现优良,尤其适用于过敏体质 者、老年人、儿童等免疫力相对薄弱人群。该产品为国内首个同时涵盖"简易4针法"、"2‑1‑1"及"5针 法"三种免疫程序的人二倍体细胞狂犬病疫苗。本次"简易4针法"免疫程序获批,标志着我国人二倍体细 胞狂犬病疫苗在免疫程序适应性方面取得新突破。依托多样化免疫程序,产品可适配不同暴露等级、不 同时间安排及不同依从性人群,提供更科学、个性化的接种方案,有利于提升全程免疫完成率,优化暴 露后预防策略。人用二倍体狂犬疫苗具备差异化竞争优势,将进一步丰富公司产品梯队,同时能够更好 地满足临床需求。 格隆汇2月24日丨成大生物(688739.SH)公布,公司全资子公司成大生物(本溪)有限公司(以下简称"本溪 子公司")于近日收到国家药品监督管理局签发的冻干人用狂犬病疫苗(人二倍体细胞)(以下简称"人用二 倍体狂犬疫苗")《药品注册证书》。 ...
科兴制药:人干扰素α 1b吸入溶液纳入突破性治疗品种名单
Zhi Tong Cai Jing· 2025-09-23 08:15
Core Viewpoint - The announcement highlights that the company's subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., has developed an inhalation solution of human interferon α 1b, which has been included in the list of breakthrough therapeutic varieties by the National Medical Products Administration's Drug Review Center [1] Group 1: Product Development - The inhalation solution is a significant breakthrough in the antiviral field, specifically designed for children [1] - The product is administered via nebulization, allowing the active ingredient to reach the site of infection more quickly compared to injection [1] - The solution is indicated for pediatric respiratory syncytial virus lower respiratory tract infections, including pneumonia and bronchiolitis [1] Group 2: Advantages of the Product - The inhalation method eliminates the pain associated with injections, leading to higher acceptance and safety for pediatric patients [1] - The broad-spectrum antiviral, antitumor, and immune-regulating properties of interferon make it a key component of the body's natural immunity [1]
科兴制药(688136.SH):人干扰素α 1b吸入溶液纳入突破性治疗品种名单
智通财经网· 2025-09-23 08:12
Core Viewpoint - The announcement highlights that the inhalation solution of human interferon α 1b, developed by the company's wholly-owned subsidiary, has been included in the list of breakthrough therapies by the National Medical Products Administration [1] Group 1: Product Development - The human interferon α 1b inhalation solution is a significant breakthrough in the antiviral field for the company [1] - This medication is specifically designed for children and is administered via nebulization, allowing the active ingredient to reach the site of infection more quickly [1] - Compared to injectable forms, this inhalation solution offers higher acceptance and safety for pediatric patients, as they do not have to endure the pain of injections [1] Group 2: Indications and Applications - The indication for the human interferon α 1b inhalation solution is for pediatric respiratory syncytial virus (RSV) lower respiratory tract infections, including pneumonia and bronchiolitis [1]