2023-06-07 13:13:56
Tianming Pharmaceutical (6659) announced that the cell preparation site of the GTP laboratory has applied for the approval of the cell preparation site in accordance with the “Administrative Measures for the Implementation or Use of Specific Medical Technology Inspection and Testing Medical Instruments”, and has been approved by the Ministry of Health and Welfare (Accreditation Number: TP112C032).
Date: 2023/6/7
Author: Genet
No. 1 Speech Date 112/06/07 Speech Time 15:39:08
Spokesperson Zhang Wenchang Spokesperson Title Financial Manager Spokesperson Telephone 02-85218883
Subject:It is announced that the cell preparation site of the company’s GTP laboratory has applied for the approval of the cell preparation site in accordance with the “Administrative Measures for the Implementation or Use of Specific Medical Technology Inspection and Inspection of Medical Instruments”, and has been approved by the Ministry of Health and Welfare (Accreditation Number: TP112C032).
Fact date 112/06/07
illustrate
1. Date of actual occurrence: 112/06/07
2. Causes:
On June 7, 2012, the company received a letter from the Ministry of Health and Welfare to approve the cell preparation site of the company’s GTP laboratory, which complies with the good practice of human cell tissue (GTP). The cell preparation place of the company’s GTP laboratory is Zhongshan Hospital, a legal person of Zhongshan Medical Association. According to the “Special Medical Technology Inspection and Inspection Medical Instrument Implementation or Use Management Measures” (Special Management Measures), apply to the Ministry of Health and Welfare for autologous immune cells (NK ) The cell preparation site for the implementation plan of the “fourth stage of solid cancer” treatment.
3. Countermeasures: release this important information.
4. Other items that should be stated:
Zhongshan Hospital, a legal person of Zhongshan Medical Association, has approved the following items for the pre-application plan:
(1) Cell therapy technology project: autologous immune cell therapy (NK).
(2) Indications: Phase IV of solid cancer; Cancer types: lung cancer, liver cancer, colorectal cancer, ovarian cancer, breast cancer, gastric cancer, kidney cancer, esophagus cancer, head and neck cancer (including nasopharyngeal cancer), prostate cancer, pancreatic cancer.
(3) Cell preparation site: Tianming Precision Cell Preparation Center.
(4) The validity period of the plan: from June 2, 2012 to June 1, 115.
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