Securities code: Shanghai Rightongene Biotechnology Co.Ltd(688217) securities abbreviation: Shanghai Rightongene Biotechnology Co.Ltd(688217) Announcement No.: 2022009 Shanghai Rightongene Biotechnology Co.Ltd(688217)
Announcement on voluntary disclosure of medical device registration certificate obtained by wholly-owned subsidiaries
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear legal responsibility for the authenticity, accuracy and integrity of its contents according to law.
The product of Suzhou Yuntai Biomedical Technology Co., Ltd., a wholly-owned subsidiary of Shanghai Rightongene Biotechnology Co.Ltd(688217) (hereinafter referred to as the “company”), the detection kit of 15 fusion genes related to leukemia (fluorescent RT-PCR method) recently obtained the medical device registration certificate issued by the State Drug Administration. The details are hereby announced as follows:
1、 Main contents of certificate
Name of registrant: Suzhou Yuntai Biomedical Technology Co., Ltd
Product Name: detection kit for 15 fusion genes related to leukemia (fluorescent RT-PCR method)
Registration category: Category III
Registration Certificate No.: gxzz 20223400290
Intended use: this kit is used to detect bcr-abl, sil-tal1, e2a-hlf, TEL-AML1, mll-af4, E2A-Pbx1, AML1-ETO, MLL-AF9 and PML-RAR in bone marrow samples of patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (all), other mixed phenotype leukemia and leukemia whose early diagnosis is not clear α、 MLL-AF6 、MLL-AF10、MLL-ELL、MLL-ENL、CBF β- There are 15 leukemia related fusion genes in myh11 and DEK-CAN, so as to timely assist in the clinical diagnosis of leukemia, the selection of clinical drugs and the evaluation of disease prognosis.
2、 Impact on the company
Obtaining the medical device registration certificate for the above products is conducive to enriching the company’s product types, expanding the company’s product layout in the field of molecular diagnosis, continuously meeting the diversified market demand and further enhancing the company’s core competitiveness.
3、 Risk tips
The acquisition of the above registration certificate only means that the relevant products of the company have obtained the Chinese market access qualification. The actual sales situation of the products after listing depends on the promotion effect of the future market. At present, it is impossible to predict the specific impact of the above products on the future performance of the company. The company will timely perform the corresponding information disclosure business in strict accordance with relevant regulations.
Please invest carefully and pay attention to investment risks.
It is hereby announced.
Shanghai Rightongene Biotechnology Co.Ltd(688217) board of directors March 12, 2022
