NEWS & MEDIA

HOT-1030 Injection Obtained FDA IND Approval for Phase I Clinical Trial

2020-09-25 816

Recently, Shanghai Huaota Biopharmaceutical Co., Ltd. (aka Huata) and its subsidiary Huabo Biopharm(Shanghai) Co., Ltd. (aka Huabo) received ‘investigational new drug approval notice’ from the NMPA of their HOT1030 injection. Huaota and Huabo submitted their investigational new drug application to the NMPA and the application was accepted in July 2020. Recently, the NMPA approved HOT1030 for clinical trial. HOT-1030 injection is a monoclonal antibody targeting CD137 (4-1BB), intended to treat advanced malignant solid tumors. CD137, also known as 4-1BB, is a member of the Tumor Necrosis Factor Receptor Superfamily 9 (TNFRSF9). It is mainly expressed on activated T cells, NK cells and dendritic cells and other tumor immune cells. The ligand CD137L is mainly expressed in activated APC. After T cells receive the MHC molecular complex signal presented by APC, 4-1BB is transiently expressed. When there is a continuous antigen signal, the expression of 4-1BB is prolonged. 4-1BB is induced to aggregate by trimerized 4-1BBL, and TRAF1 and TRAF2 is recruited, and then up-regulate members of the anti-apoptotic gene family, down-regulate the pro-apoptotic molecule Bim, and promote the signal transduction cascade of mitogen-related protein kinases, thereby effectively promoting the proliferation and differentiation of CD8+ cells and reducing activation-induced cell death, maintaining The survival status of CD8+ T cells can kill tumor cells and exert anti-tumor effect.