October 26, 2022
Hangzhou, Zhejiang, China
The IND application of novel coronavirus mRNA vaccine booster project (hereinafter referred to as HC009) independently developed by Zhejiang Haichang Biotech Co., Ltd. was approved by the US FDA (IND:28424) and it is the first mRNA vaccine project approved by the US FDA in China.
The COVID-19 mRNA vaccine booster product will be used to prevent infection of various variants, including Omicron, and is intended for use in population vaccinated with COVID-19 vaccine as well as the unvaccinated population. QTsomeTM, a technology under global independent intellectual property right by Haichang Biotech, is used as the delivery system of HC009. Haichang Biotech intends to establish an internationally leading platform for the industrialization of mRNA vaccine together with the partners in various links of the industry chain.
Dr. Zhao Xiaobin, president of Haichang Biotech said: “The rapidly occurring mutation in novel coronavirus poses a huge challenge to vaccine development. mRNA vaccine delivers such advantages as precise targeting, simplified design and persistent immunoprotection, therefore, it is one of the most effective means against breakthrough infections. We will accelerate our overall arrangement in advancing both domestic and overseas clinical trials so that we can better respond to the epidemic change by providing more effective solutions. Furthermore, we will also step up our efforts in the setup of appropriate mRNA technology platform, give full play to the advantages of QTsomeTM delivery system and increase our input in the development of additional innovative products like preventive vaccines and tumor vaccines.