Securities code: 300318 securities abbreviation: Beijing Bohui Innovation Biotechnology Group Co.Ltd(300318) Announcement No.: pro 2022-003
Beijing Bohui Innovation Biotechnology Group Co.Ltd(300318)
With regard to the announcement that the holding subsidiary obtained the notice of approval for supplementary drug application, the company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Hebei Da’an Pharmaceutical Co., Ltd. (hereinafter referred to as “Hebei Da’an”), a holding subsidiary of Beijing Bohui Innovation Biotechnology Group Co.Ltd(300318) (hereinafter referred to as “the company”), recently received the notice of approval for supplementary drug application for hepatitis B human immunoglobulin issued by the State Drug Administration and agreed to “change the production process” of the above products. The details are as follows:
Drug name: general name of drug: hepatitis B human immunoglobulin
English name / Latin name: human hepatitis B immunoglobulin
Dosage form: injection
Registration classification: therapeutic biological products
Specification: each bottle contains anti HBS 200iu (2ml)
Original drug approval No.: gyzz s20063001
Drug registration Standard No.: bs02010420
Application content: change of production process
Approval conclusion: according to the drug administration law of the people’s Republic of China and relevant regulations, after examination, the essence of this application is to change the production process, and it is agreed to produce this product according to the new production process. The attached inspection procedures, quality standards, instructions and labels shall be followed. With regard to the use of recycled ethanol in production, enterprises are requested to control the quality and risk of recycled ethanol in strict accordance with the standards of medicinal ethanol, and discard unqualified recycled ethanol in time. Listing Permit Holder: Name: Hebei Da’an Pharmaceutical Co., Ltd
Address: No. 6, Qingshan Road, Lvdao Torch Development Zone, Luquan, Shijiazhuang
Manufacturer: Hebei Da’an Pharmaceutical Co., Ltd
Address: No. 6, Qingshan Road, Lvdao Torch Development Zone, Luquan, Shijiazhuang
Acceptance No.: cxss1800016
Notice No.: 2022b00712
Changing the production process of the above products is conducive to improving the product quality.
Securities code: 300318 securities abbreviation: Beijing Bohui Innovation Biotechnology Group Co.Ltd(300318) Announcement No.: pro 2022-003
It is hereby announced.
Beijing Bohui Innovation Biotechnology Group Co.Ltd(300318) board of directors
February 26, 2022
