Securities code: 688575 securities abbreviation: Shenzhen Yhlo Biotech Co.Ltd(688575) Announcement No.: 2022-020 Shenzhen Yhlo Biotech Co.Ltd(688575)
Announcement on voluntary disclosure of New Coronavirus antigen test kit to Japan’s PMDA certification
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 New Coronavirus antigen detection kit, Shenzhen Yhlo Biotech Co.Ltd(688575) (hereinafter referred to as “company”), Japan Medical partner’s Institute (English: Medical & Biological Laboratories Co., Ltd. hereinafter referred to as “MBL”) was obtained from Beijing PMDA in February 10, 2022. The production and sales license of in vitro diagnostic products (i.e. Japan PMDA certification) issued by Japan’s independent administrative legal person comprehensive organization of pharmaceutical products and medical devices. The details of this certification have also been publicized on the official website of Japan’s Ministry of health, labor and welfare on the same day. The company is designated manufacturer of MBL New Coronavirus antigen detection kit. After obtaining the PMDA certification, the product will be sold in Japan, and can be used for medical testing and home self testing. The following are the specific cases:
1、 Basic information of PMDA certification in Japan
Product name applicant certificate number intended use
Gline-2019-medical 30400ezx00 of Co., Ltd. This product aims to quickly and qualitatively detect sars-cov-2 antigen in 012000 samples of ncov Ag キット Institute of biology of human nasal swab.
2、 Impact on the company
This MBL New Coronavirus antigen test kit has obtained the PMDA certification from Japan. As a designated manufacturer of MBL, the company has obtained the qualification of supply in the Japanese market on behalf of the New Coronavirus antigen detection kit, which is conducive to further expanding the Japanese market and enhancing the international competitiveness of the company’s New Coronavirus testing products. It will have a positive impact on the company’s future operation.
3、 Risk tips
As a designated manufacturer of MBL New Coronavirus antigen detection kit, the company’s sales performance in Japan will depend largely on MBL’s sales ability and order status in Japan. Up to now, many enterprises have obtained PMDA certification for similar reagent products in Japan, with fierce market competition and unpredictable risk of epidemic development. At present, the company cannot predict the impact of this event on the company’s future business performance. Please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Shenzhen Yhlo Biotech Co.Ltd(688575) board of directors February 11, 2022
