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Zhifei Biotech annonce de nouveaux progrès dans deux projets de R&D autonomes
来源:环球网
近日,智飞生物在疫苗创新研发领域接连取得重要进展。
Recently, Zhifei Biological has made important progress in the field of vaccine innovation and research and development.
旗下全资子公司北京智飞绿竹自主研发的吸附无细胞百白破(组分)b型流感嗜血杆菌(结合)联合疫苗(以下简称“组分百白破-Hib四联疫苗”)已启动Ⅰ期临床研究,
Its wholly-owned subsidiary, Beijing Zhifei Green Bamboo, has independently developed an adsorbed acellular DTP (component) type B Haemophilus influenzae (combined) vaccine (hereinafter referred to as the “component DTP-Hib quadrivalent vaccine”) and has initiated Phase I clinical trials,
自主研发的吸附破伤风疫苗已启动Ⅰ/Ⅲ期临床研究。
and the independently developed adsorbed tetanus vaccine has initiated Phase I/III clinical trials.
两项进展标志着企业在多联疫苗及破伤风应急疫苗领域的技术布局迈出关键步伐。
These two advancements mark a key step in the company’s technological layout in the fields of multi-valent vaccines and emergency tetanus vaccines.
图:智飞生物北京研产基地
Image: Zhifei Biological Beijing Research and Production Base
组分百白破-Hib四联疫苗在广西开展Ⅰ期临床试验。
The component DTP-Hib quadrivalent vaccine is conducting Phase I clinical trials in Guangxi.
百日咳、白喉、破伤风及Hib感染在婴幼儿及儿童中具有较高的发病率和死亡率,严重威胁儿童健康。
Pertussis, diphtheria, tetanus, and Hib infections have high morbidity and mortality rates among infants and children, seriously threatening children’s health.
智飞生物自主研发的组分百白破-Hib四联疫苗采用了新一代“组分纯化”工艺,
The component DTP-Hib quadrivalent vaccine independently developed by Zhifei Biological adopts a new generation of “component purification” technology,
抗原成分纯度高,含量精准,批间一致性好,能够有效预防上述四种疾病,
with high purity of antigen components, precise content, and good consistency between batches, effectively preventing the aforementioned four diseases,
还可减少接种针次,增强预防接种的依从性。
and can also reduce the number of vaccinations, enhancing compliance with preventive vaccinations.
项目将与企业在研多联疫苗形成协同效应,助力夯实多联疫苗领域的核心产品矩阵,
The project will create a synergistic effect with the company’s research and development of multi-valent vaccines, helping to solidify the core product matrix in the multi-valent vaccine field,
若顺利上市,可为民众健康提供高效、便捷的预防方案。
if successfully launched, it could provide efficient and convenient prevention solutions for public health.
吸附破伤风疫苗在重庆正式启动Ⅰ/Ⅲ期临床入组。
The adsorbed tetanus vaccine has officially initiated Phase I/III clinical enrollment in Chongqing.
破伤风作为严重急性感染性疾病,可通过免疫接种有效预防,但我国非新生儿破伤风的问题依然严峻。
Tetanus, as a serious acute infectious disease, can be effectively prevented through immunization, but the problem of non-neonatal tetanus in our country remains severe.
智飞生物该款疫苗采用柱层析法纯化有效抗原,相较于传统盐析法纯化的抗原纯度更高,
This vaccine from Zhifei Biological uses column chromatography to purify effective antigens, achieving higher purity compared to antigens purified by traditional salt precipitation methods,
免疫原性更优,可满足成人及外伤高风险人群的暴露后预防需求。
with superior immunogenicity, meeting the post-exposure prevention needs of adults and high-risk groups for injuries.
该项目的推进,填补了企业在百白破系列产品管线中暴露后免疫处置领域的产品空白,
The advancement of this project fills the product gap in the post-exposure immunization management field in the DTP series product pipeline of the company,
若顺利上市,将与现有百白破系列疫苗形成从儿童基础免疫到成人及高危人群应急预防的全场景防护闭环。
if successfully launched, it will form a complete protection loop from basic immunization for children to emergency prevention for adults and high-risk populations with the existing DTP series vaccines.
近年来,智飞生物坚持创新驱动发展,持续加码研发投入与技术攻关,
In recent years, Zhifei Biological has adhered to innovation-driven development, continuously increasing investment in research and development and tackling technological challenges,
目前已布局预防类在研管线34项,其中25项处于申报、开展临床试验及申请注册阶段。
and has currently laid out 34 projects in the preventive research pipeline, with 25 projects at the stages of application, clinical trials, and registration.
此次两大自主研发项目接连取得临床进展,
The recent clinical advancements of these two independently developed projects,
既是企业研发实力的集中体现,也是践行健康中国战略、守护全民健康的务实行动。
not only reflect the concentrated strength of the company’s research and development but also represent a practical action to implement the Healthy China strategy and safeguard public health.
智飞生物相关负责人表示,企业将继续践行“防未病治已病,守护人类健康”的使命,
A relevant person in charge of Zhifei Biological stated that the company will continue to uphold the mission of “preventing disease before it occurs and treating diseases that have occurred, safeguarding human health,”
不断强化从实验室研发到上市应用的技术转化能力,
continuously strengthening the technical transformation capabilities from laboratory research and development to market application,
以高质量创新成果助力疾病防控体系建设。
and using high-quality innovative results to support the construction of disease prevention and control systems.
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