Product Center
Ab&B Bio-Tech Co., Ltd. JS Quadrivalent Influenza Virus Subunit Vaccine Marketing Application Has Been Accepted by the National Medical Products Administration!
- Categories:Company news
- Author:
- Origin:
- Time of issue:2022-03-21
- Views:
(Summary description)Recently, Ab&B Bio-Tech Co., Ltd. JS's independently developed market application for the unadjuvanted quadrivalent influenza virus subunit vaccine for individuals aged 3 and above was accepted by the National Medical Products Administration (NMPA) of China. This is the first market application for a quadrivalent influenza virus subunit vaccine accepted by the NMPA.
Ab&B Bio-Tech Co., Ltd. JS Quadrivalent Influenza Virus Subunit Vaccine Marketing Application Has Been Accepted by the National Medical Products Administration!
(Summary description)Recently, Ab&B Bio-Tech Co., Ltd. JS's independently developed market application for the unadjuvanted quadrivalent influenza virus subunit vaccine for individuals aged 3 and above was accepted by the National Medical Products Administration (NMPA) of China. This is the first market application for a quadrivalent influenza virus subunit vaccine accepted by the NMPA.
- Categories:Company news
- Author:
- Origin:
- Time of issue:2022-03-21 16:16
- Views:
Recently, Ab&B Bio-Tech Co., Ltd. JS's independently developed market application for the unadjuvanted quadrivalent influenza virus subunit vaccine for individuals aged 3 and above was accepted by the National Medical Products Administration (NMPA) of China. This is the first market application for a quadrivalent influenza virus subunit vaccine accepted by the NMPA.
Source: CDE Website
The Ab&B Bio-Tech Co., Ltd. JS quadrivalent influenza virus subunit vaccine is a component vaccine containing a new antigen form, characterized by high purity, low vaccination side effects, and good safety. In 2016, the company applied for clinical trials of the quadrivalent influenza virus subunit vaccine using its own patented technology. In 2017, the company obtained clinical approval for two Class 1 biological new drugs in adult and pediatric dosage forms. From 2018 to 2021, the Phase I/III clinical trial was successfully completed, and all relevant trial results reached clinical endpoints, showing significant positive results in immunogenicity and safety.
The clinical results show that the full-dose unadjuvanted (0.5ml) quadrivalent influenza virus subunit vaccine for individuals aged 3 and above, which has been accepted for the company's marketing application, is a safe and effective influenza vaccine that can provide broader and sufficient protection against seasonal influenza viruses. This vaccine is expected to serve as an important member of the influenza prevention strategy and contribute to China's efforts in the global prevention and control of influenza virus outbreaks and infections.
Relevant information
-
The Launch Meeting of Phase I/II Clinical Trial for Recombinant Herpes Zoster Vaccine (CHO Cell) was successfully heldRecently, the Phase I/II clinical trial launch meeting for the recombinant herpes zoster vaccine (CHO cell), co-developed by Ab&B Bio-Tech CO., LTD. JS. and Yither Biotech (Shanghai) Co., Ltd., was successfully held in Henan, and the first-in-human (FIH) dosing was successfully completed. - Ab&B Bio and Yither Bio Have Both Obtained Qualification Certification! 12-30
- Kickoff Meeting for Clinical Research on Quadrivalent Influenza Virus Subunit Vaccine in Children with Nephrotic Syndrome Successfully Held 12-25
- IND Application for Influenza Virus Subunit Vaccine (Adjuvanted) Approved 10-30
- The Application for the Marketing of Trivalent Influenza Virus Subunit Vaccine has been Accepted! 10-08
Got a project? Contact us today !
At Ab&B Bio, our mission is to care for life and protect health by developing globally innovative vaccines.
Contact
E-mail:haixin.zhang@yitherbiotech.com
Add:No. 32, Xinglin Road, Medical High-tech Zone, Taizhou City
Quick view
Follow us
