Medigen Biotechnology Corp. (Medigen), in collaboration with Changhua Christian Hospital (CCH), submitted a cell therapy application titled “Autologous Gamma-Delta T (Megicell-GDT) Cell Therapy for Stage I–III Solid Tumors” to the Ministry of Health and Welfare (MOHW) on July 17, 2024, in accordance with the “Regulation Governing the Application of Specific Medical Examination Technique and Medical Device” (hereinafter as “Regulations of Special Medical Techniques”). The application has been accepted for review.
The approval of application will allow patients with Stage I–III solid tumors—specifically lung, breast, gastric, liver, pancreatic, renal, prostate, endometrial, or colorectal cancers—who have not responded to standard treatments to consult with CCH about autologous Gamma-Delta T cell therapy, and to choose treatment with Megicell®-GDT cells manufactured at Medigen's CPU (cell processing unit).
This is the first time Medigen has sought to expand the application of its proprietary cell therapy technology from Stage IV solid tumor patients to Stage I–III patients unresponsive to standard treatments. Upon approval, Medigen expects to offer more options of treatments to cancer patients. Depending on the progress of plan, Medigen will collaborate with hospitals in Taiwan to submit more applications for using Megicell®-NK or Megicell®-GDT cell therapy, aiming to provide options for Stage I–III solid tumor patients who do not respond to standard treatments.
The technology for Megicell®-GDT has been exclusively licensed to Medigen by MEDINET Co., Ltd., a publicly listed company in Japan. The collaborating hospital, Changhua Christian Hospital, is a medical center located in Changhua City and has been a long-term partner of Medigen in cell therapy.
The approval of application will allow patients with Stage I–III solid tumors—specifically lung, breast, gastric, liver, pancreatic, renal, prostate, endometrial, or colorectal cancers—who have not responded to standard treatments to consult with CCH about autologous Gamma-Delta T cell therapy, and to choose treatment with Megicell®-GDT cells manufactured at Medigen's CPU (cell processing unit).
This is the first time Medigen has sought to expand the application of its proprietary cell therapy technology from Stage IV solid tumor patients to Stage I–III patients unresponsive to standard treatments. Upon approval, Medigen expects to offer more options of treatments to cancer patients. Depending on the progress of plan, Medigen will collaborate with hospitals in Taiwan to submit more applications for using Megicell®-NK or Megicell®-GDT cell therapy, aiming to provide options for Stage I–III solid tumor patients who do not respond to standard treatments.
The technology for Megicell®-GDT has been exclusively licensed to Medigen by MEDINET Co., Ltd., a publicly listed company in Japan. The collaborating hospital, Changhua Christian Hospital, is a medical center located in Changhua City and has been a long-term partner of Medigen in cell therapy.