Securities code: 000597 securities abbreviation: Northeast Pharmaceutical Group Co.Ltd(000597) Announcement No.: 2022-008
Northeast Pharmaceutical Group Co.Ltd(000597)
Announcement on the subsidiary’s obtaining 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 material omissions.
Recently, Northeast Pharmaceutical Group Co.Ltd(000597) (hereinafter referred to as “the company”), a wholly-owned subsidiary of Northeast Pharmaceutical Group Shenyang first pharmaceutical Co., Ltd. (hereinafter referred to as “the first pharmaceutical”) received the notice of approval of supplementary drug application approved and issued by the State Drug Administration. The relevant information is hereby announced as follows:
1、 Basic information of supplementary application approval notice
Generic name of drug: fosfomycin tromethamine powder
Drug name
English name / Latin name: fosfomycin trometamol powder
Trade name fuanxin
Registration classification of dosage form powder chemical drugs
Specification 3G original drug approval No.: gyzz h10930155
Package specification: 1 bottle / box drug registration Standard No.: ybh00912022
Evaluation on the consistency of application contents, at the same time: 1 Improve quality standards; 2. Revise the instructions.
Name: Northeast Pharmaceutical Group Co.Ltd(000597) Group Shenyang first pharmaceutical Co., Ltd
Listing Permit Holder
Address: No. 8, Kunming Lake Street, Shenyang Economic and Technological Development Zone
Name: Northeast Pharmaceutical Group Co.Ltd(000597) Group Shenyang first pharmaceutical Co., Ltd
manufacturing enterprise
Address: No. 8, Kunming Lake Street, Shenyang Economic and Technological Development Zone
According to the provisions of the drug administration law of the people’s Republic of China, the opinions of the State Council on the reform of the review and approval system of drugs and medical devices (GF [2015] No. 44) and the announcement on matters related to the review and approval of the conclusion price of the quality and efficacy consistency of generic drugs (2017 No. 100), This product is deemed to have passed the consistency evaluation of quality and efficacy of generic drugs. The quality standards and instructions shall be implemented in accordance with the attached, and the validity period is 24 months.
2、 Other relevant information of drugs
Fosfomycin tromethamine powder is suitable for the treatment of sensitive Escherichia coli, Enterococcus faecalis and Klebsiella pneumoniae
Acute simple urinary tract infection caused by bacteria, Citrobacter, Enterobacter and Proteus mirabilis. The research shows that the quality of this product is stable and can reach the level consistent with the quality and curative effect of the reference preparation.
3、 Impact on the company
This time, fosfomycin aminobutanol powder, a subsidiary of the company, has passed the evaluation of the consistency between the quality and efficacy of generic drugs, which is conducive to improving the market competitiveness of the company, and its listing and sales will have a positive impact on the improvement of the company’s performance in the future.
As the production and sales of drugs are affected by factors such as changes in the market environment, there is a certain degree of uncertainty. Please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Northeast Pharmaceutical Group Co.Ltd(000597) board of directors February 11, 2022
