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On August 12, 2024, Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. (Zhonghui Biotechnology) and its subsidiary Yihui Biotechnology (Shanghai) Co., Ltd. (Yihui Biotechnology) jointly applied for an IND application for a Class I new drug, 'Recombinant Herpes zoster Vaccine (CHO Cells)', which was approved by the Drug Evaluation Center (CDE) of the China National Medical Products Administration..
2024年8月12日,江苏中汇元通生物技术有限公司(中汇生物技术)及其子公司一汇生物技术(上海)有限公司(一汇生物技术)共同申请了一类新药“重组带状疱疹疫苗(CHO细胞)”的IND申请,该申请经中国国家医药产品管理局药物评估中心(CDE)批准。。
Herpes zoster (HZ) is a kind of infectious diseases that mainly affects nerves and skin caused by reactivation of Varicella zoster virus (VZV). The main characteristic is clustered blisters distributed in a band shape, accompanied by obvious neuropathic pain, which becomes more severe with age. This disease is common in elderly, immunocompromised, and immunocompromised patients, and has a certain recurrence rate.
带状疱疹(HZ)是一种主要影响神经和皮肤的传染病,由水痘带状疱疹病毒(VZV)的再激活引起。主要特征是成簇的水泡呈带状分布,伴有明显的神经性疼痛,随着年龄的增长,这种疼痛会变得更加严重。这种疾病在老年人,免疫功能低下和免疫功能低下的患者中很常见,并且有一定的复发率。
At present, there is no effective treatment for shingles, and vaccination is the preferred and effective means of preventing shingles..
目前,带状疱疹尚无有效的治疗方法,疫苗接种是预防带状疱疹的首选和有效手段。。
The recombinant herpes zoster vaccine (CHO cells) approved this time utilizes the company's multiple independent intellectual property innovative technologies and officially authorized high expression cell matrix, especially the independently developed and screened innovative adjuvant system, which has obvious advantages and eliminates dependence on foreign adjuvant technology.
此次获批的重组带状疱疹疫苗(CHO细胞)利用了公司多项自主知识产权创新技术和官方授权的高表达细胞基质,特别是自主研发和筛选的创新佐剂系统,优势明显,消除了对国外佐剂技术的依赖。
Preclinical studies have shown that this product can induce the production of high levels of specific antibodies and CD4+T cell responses simultaneously, with high immunogenicity and safety. At the same time, the R&D team has optimized the production process to make it easier to scale up and achieve higher protein production, making subsequent commercial production more convenient and efficient..
临床前研究表明,该产品可以同时诱导产生高水平的特异性抗体和CD4+T细胞应答,具有高免疫原性和安全性。同时,研发团队优化了生产流程,使其更容易扩大规模,实现更高的蛋白质产量,使后续的商业生产更加方便高效。。
Recently, the company's drug production license change has been approved by the Jiangsu Provincial Drug Administration, adding the production scope of 'influenza virus subunit vaccine', marking the company's successful acquisition of the production license for trivalent influenza virus subunit vaccine.
最近,该公司的药品生产许可证变更已获得江苏省药品监督管理局的批准,增加了“流感病毒亚单位疫苗”的生产范围,标志着该公司成功获得了三价流感病毒亚单位疫苗的生产许可证。
This is an unremitting effort made by the company in response to the WHO's recommendation this year that influenza vaccines should no longer include B/Yamagata lineage components. The company acted quickly to meet market demand and achieve the early launch of trivalent influenza virus subunit vaccines, scientifically respond to influenza prevention and control, and provide multiple influenza vaccine options for society!.
这是该公司为回应世卫组织今年提出的流感疫苗不应再包括B/Yamagata谱系成分的建议而做出的不懈努力。公司迅速采取行动,满足市场需求,实现三价流感病毒亚单位疫苗的早期推出,科学应对流感防控,为社会提供多种流感疫苗选择!。