The board of directors of the Immunotech Biopharm Ltd. announced that the Company has received the acceptance notice for the Investigational New Drug Application for the Denocabtagene Ciloleucel Injection from the National Medical Products Administration (acceptance no.: CXSL2200619GUO). Denocabtagene Ciloleucel Injection, originally known as CAR-T-19-D2, CAR-T-19-DNR and RC19D2, targets immunosuppressive molecule TGF-ß, it is an injection for the treatment of patients with relapsed and refractory diffuse large B-cell lymphoma (‘DLBCL'). The injection has the goal of overcoming chimeric antigen receptor T cells' (‘CAR-T cells') pain points in terms of the lack of persistence, the lack of efficacy in the treatment of solid tumours, and in the prevention of tumour recurrence.

Based on the current progress, the Company expects to obtain the approval of clinical trial for the Denocabtagene Ciloleucel Injection in the first half of 2023.