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Recombinant herpes zoster vaccine (CHO cells) IND application approved
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- Time of issue:2024-08-13
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(Summary description)On August 12, 2024,Ab&B Bio-Tech Co.,Ltd（Ab&B Bio） and its subsidiary Yither biotech (Shanghai) Co., Ltd (Yither Bio) 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.
Recombinant herpes zoster vaccine (CHO cells) IND application approved
(Summary description)On August 12, 2024,Ab&B Bio-Tech Co.,Ltd（Ab&B Bio） and its subsidiary Yither biotech (Shanghai) Co., Ltd (Yither Bio) 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.
- Categories:Company news
- Author:
- Origin:
- Time of issue:2024-08-13 16:38
- Views:
On August 12, 2024, Ab&B Bio-Tech Co., Ltd (hereinafter referred to as “Zhonghui Bio”) and its subsidiary Yither biotech (Shanghai) Co., Ltd (Yither Bio) 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.
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. At present, there is no effective treatment for shingles, and vaccination is the preferred and effective means of preventing shingles.
Source: Government Service Website of the Drug Evaluation Center of the National Medical Products Administration
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. 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.
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. 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!
Relevant information
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The application for the marketing of trivalent influenza virus subunit vaccine has been accepted!Recently, Ab&B Bio-Tech Co.,Ltd（Ab&B Bio）has received acceptance from the Drug Evaluation Center (CDE) of the China National Medical Products Administration for its application to market the "6-35 month old trivalent influenza virus subunit vaccine" and the "3-year-old and above trivalent influenza virus subunit vaccine". This acceptance marks the final sprint stage of the first domestic full dose trivalent influenza virus subunit vaccine for people aged 6 months and above, which is about to be launched! - Breaking through bottleneck technology, significant progress has been made in the research and development of new adjuvants 08-26
- Obtained recognition as one of the first offshore innovation centers for enterprises in Taizhou 08-14
- Recombinant herpes zoster vaccine (CHO cells) IND application approved 08-13
- IND application for quadrivalent influenza virus subunit vaccine (adjuvant) approved 07-30
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