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永泰生物-B(06978)接获aT19注射液新药研究申请的受理通知

Yongtai Biotech B (06978) Receives Notice of Acceptance of New Drug Research Application for At19 Injection

Zhitong Finance ·  Nov 24, 2023 06:20

According to the Zhitong Finance App, Yongtai Biotech B (06978) issued an announcement. The company has received an acceptance notice from the State Drug Administration regarding the study of new AT19 injectable drugs (acceptance number: CXSL2300808). AT19 injection is an injection that targets CD19 chimeric antigen receptor T cells (CAR-T cells) that target CD19 and is used sequentially after treating acute lymphocytic leukemia (B-ALL) derived from recurrent refractory B cells to prevent recurrent CD19 positive recurrence. The goal of this injection is to address the pain points of possible recurrence of CD19 positivity after B-ALL treatment with CD19-targeted CAR-T cells.

It is reported that the active component of the company's AT19 injection product being developed is genetically modified autologous T cells to express CD19. The gene introduced here is a coding gene structure that can express the human CD19 protein. Injecting AT19 injection after injecting Car-t-19 may reactivate CAR-T cells, restart the proliferation of CAR-T cells, and induce more immune memory cells, thereby increasing the chance of killing trace amounts of CD19-positive tumor cells and preventing recurrence. Through repeated stimulation of the CD19 antigen, the number of CAR-T cells with immune memory function will also increase, thereby extending the immune monitoring time of CAR-T cells and reducing the probability of recurrence of CD19-positive tumors.

AT19 injection has several commonalities with the company's CarT-19 injection products currently being developed (they are all products based on genetically modifying T cells through lentiviral vectors), so the previous process can be applied to pharmaceutical process development, thereby shortening the product development cycle.

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