Announcement on the issuance of veterinary drug (Stock Certificate No.: 6898-8098) and the announcement on the issuance of veterinary drug (stock certificate) of Shanghai Pharmaceutical Co., Ltd. (Stock Code: 6898}
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 company recently received the veterinary drug GMP certificate and veterinary drug production license issued by Shanghai Agricultural and Rural Committee. The details are as follows:
1、 Relevant information of veterinary drug GMP certificate and veterinary drug production license
1. Veterinary drug GMP certificate
Certificate No.: (2022) veterinary drug GMP certificate No. 09001
Company name: Shanghai Shen Lian Biomedical Corporation(688098) Pharmaceutical (Shanghai) Co., Ltd
Production address: No. 48, Jiangchuan East Road, Minhang District, Shanghai
Acceptance scope: immunological diagnostic products (Class A) and molecular biological diagnostic products (class B). Validity period: January 26, 2022 to January 25, 2027
2. Veterinary drug production license
Certificate No.: (2022) veterinary drug production certificate Zi No. 09029
Company name: Shanghai Shen Lian Biomedical Corporation(688098) Pharmaceutical (Shanghai) Co., Ltd
Registered address: No. 48, Jiangchuan East Road, Minhang District, Shanghai
Production address: No. 48, Jiangchuan East Road, Minhang District, Shanghai
Production scope: immunological diagnostic products (Class A) and molecular biology diagnostic products (class B). Validity period: January 26, 2022 to January 25, 2027
2、 Production lines and planned products that have passed the acceptance this time
The immunological diagnostic products (Class A) production line that has passed the acceptance this time can be used to produce immunological diagnostic products such as diagnostic kit of enzyme-linked immunosorbent assay for antibody to VP1 structural protein of porcine foot-and-mouth disease virus, diagnostic kit of enzyme-linked immunosorbent assay for antibody to VP1 structural protein of bovine and sheep foot-and-mouth disease virus, etc; The accepted molecular biology diagnostic products (class B) production line can be used to produce molecular biology diagnostic products such as African classical swine fever virus fluorescent PCR nucleic acid detection kit.
At present, the company has completed the trial production of the diagnostic kit for antibody enzyme-linked immunosorbent assay against the VP1 structural protein of porcine foot-and-mouth disease virus and the African swine fever virus fluorescent PCR nucleic acid detection kit, which are in the application stage of product approval number. The company will actively promote the application of other relevant product approval numbers.
3、 Market situation of similar products
The product category represents the market sales of other major manufacturers of products
Structure of porcine foot-and-mouth disease virus VP1
Immunology Diagnostic protein antibody enzyme linked immunosorbent assay Co., Ltd
Broken product (a) test diagnostic kit
(class I) cattle and sheep foot-and-mouth disease virus VP1 junction company failed to obtain the attached test diagnostic kit from other companies in the industry from the public constitutive protein antibody enzyme-linked immunosorbent assay
Physical sales of Zhengzhou Zhongdao biotechnology. Molecular biology African classical swine fever virus fluorescent PCR Co., Ltd., Beijing tomorrow
Class diagnostic products nucleic acid detection kit Technology Development Co., Ltd
(class B) division, etc
Note: the information of main manufacturers comes from China veterinary drug information network.
4、 Impact on the company and risk tips
The original veterinary drug GMP certificate and veterinary drug production license related to the above production lines of the company expired in February 2022. According to the veterinary drug administration regulations and veterinary drug production quality management specifications, the company submitted the application for renewal of the two licenses in time, and the relevant production lines passed the veterinary drug GMP acceptance and obtained the new veterinary drug GMP certificate and veterinary drug production license. The timely acquisition of new certificates ensures the normal development of the company’s veterinary diagnostic products business. After the listing of relevant products, it will enrich the company’s product categories, expand the company’s business scale and enhance the company’s competitiveness in the veterinary biological products industry.
The products corresponding to the above production lines have not obtained the veterinary drug product approval number, and the acquisition of veterinary drug GMP certificate and veterinary drug production license this time is not expected to have a significant impact on the company’s business performance this year. Due to administrative approval and other reasons, the time when relevant products obtain product approval number is uncertain. Investors are reminded to invest carefully and pay attention to investment risks.
It is hereby announced.
Board of directors of Shanghai Shen Lian Biomedical Corporation(688098) Pharmaceutical (Shanghai) Co., Ltd. February 7, 2022
