Medigen Biotechnology Corporation in collaboration with Taichung Tzu Chi Hospital applied for the Autologous Gamma-Delta T (Magicell-GDT) cell therapy project. On January 11, 2024, Medigen received the approval letter from the competent authority, the Ministry of Health and Welfare, confirming that Medigen's Cell Processing Unit is compliant with Good Tissue Practice (GTP). In accordance with the regulations of the Regulations Governing the Application of Specific Medical examination technique and Medical Device, the Magicell-GDT cells produced at Medigen's Cell Processing Unit can be used for treating stage IV solid tumors at Taichung Tzu Chi hospital.

Countermeasures: The announcement was released in accordance with the approval letter of the Ministry of Health and Welfare .Any other matters that need to be specified: (1) Details on the approved items in the abovementioned Taichung Tzu Chi Hospital cell therapy project: A.Type of cell therapy: Autologous Gamma-Delta T cell (Magicell-GDT) B.Indication: Stage IV solid tumor; Lung cancer, breast cancer, kidney cancer, prostate cancer, pancreatic cancer, colorectal cancer C.Cell processing unit: Medigen?s cell processing unit D. Approval period: From January 9, 2024 to February 2, 2026 (2) The manufacturing technology of this approved Gamma-Delta T cell is exclusively licensed from the Japanese listed company MEDINET Co. Ltd. (please see Medigen?s announcement released on 7th October, 2019).