Statement
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1.Date of occurrence of the event:2024/07/04
2.Company name:Medigen Biotechnology Crop. (Medigen)
3.Relationship to the Company (please enter "head office" or
"subsidiaries"):head office
4.Reciprocal shareholding ratios:N/A
5.Cause of occurrence:
Medigen, in collaboration with Taipei Municipal Wanfang Hospital- Managed
by Taipei Medical University, has applied for the Autologous
Gamma-Delta T Cell (Magicell-GDT) cell therapy project. On July 04, 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 Taipei Municipal Wanfang Hospital.
6.Countermeasures:
The announcement was released in accordance with the approval letter of
the Ministry of Health and Welfare
7.Any other matters that need to be specified(the information
disclosure also meets the requirements of Article 7, subparagraph 9
of the Securities and Exchange Act Enforcement Rules, which brings
forth a significant impact on shareholders rights or the price of
the securities on public companies.):
(1) Details on the approved items in the abovementioned Taipei Municipal
Wanfang 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 2024/07/03 to 2026/02/02
(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)
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