BGI Gino was approved for "targeted neonatal antigen autoimmune T cell injection"
Release date: 2020-01-09 Views: 0
On January 8th, the column of CDE clinical implied permission updated the data. Among them, Wuhan Huada Genenoin Biotechnology Co., Ltd.'s tumor neonatal antigen cell therapy drug "targeted neoantigen autoimmune T cell injection" obtained clinical implied permission. For neonatal antigen positive patients with advanced solid tumors.
Tumor neoantigen treatment drugs are a truly personalized treatment plan. When normal cells transform into cancer cells, and as they grow, the cells undergo a series of DNA mutations. These mutations, on the one hand, can help tumor cells gain advantages such as growth advantages or drug resistance. But at the same time, these DNA mutations also cause changes in cancer cell proteins, which are displayed on the surface of tumor cells and recognized and killed by T cells. These mutated protein fragments are called tumor neoantigens. They are only found in tumor cells and are ideal targets for drugs and treatments.
Because the mutations in the tumors of each patient are not the same, deep sequencing is needed to find the mutations unique to each patient, and according to this, a personalized treatment plan is designed. It is therefore called tumor neoantigen therapy.
It is reported that the tumor neonatal antigen cell therapy drug submitted by BGI Genenoy is the first domestic tumor immunogenic antigen-based immunotherapy product that has been approved by the State Food and Drug Administration in China. Products of the Authority.
Neoantigen therapy represents a new direction for tumor immunotherapy, marking the first time that truly personalized precision medicine has entered the clinical stage in China.
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