2021-036 Yan'an Pharmaceutical: Announcement on the company's wholly-owned subsidiary drugs passing the generic drug consistency evaluation
classification： Investor relations
Recently, Shanghai Yan’an Pharmaceutical Co., Ltd. (hereinafter referred to as “Yan’an Pharmaceutical”), a wholly-owned subsidiary of Shanghai Yan’an Pharmaceutical Yangpu Co., Ltd. (hereinafter referred to as the “Company”), received “Notice of Supplemental Application Approval” (notice number: 2021B03755) on Norfloxacin Capsules (hereinafter referred to as “the drug”) approved and issued by the Bureau"), and approved the drug to pass the generic drug quality and efficacy consistency evaluation ( Hereinafter referred to as "consistency evaluation"). The relevant situation is announced as follows:
1. The basic situation of the drug
1. Drug name: Norfloxacin Capsules
2. Dosage form: capsule
3. Specification: 0.1g
4. Registration classification: chemical drugs
5. Holder of the marketing license: Shanghai Yan'an Pharmaceutical Co., Ltd.
6. Manufacturer: Shanghai Yan'an Pharmaceutical Co., Ltd.
7. The original drug approval number: National Medicine Standard H20056314
8. Approval conclusion: According to the "Drug Administration Law of the People's Republic of China", "Opinions of the State Council on Reforming the Review and Approval System of Drugs and Medical Devices" (Guo Fa  No. 44) and "Regarding the Quality and Efficacy Consistency Evaluation of Generic Drugs" According to the “Announcement on Related Matters” (No. 100 of 2017), after review, this product is deemed to have passed the quality and efficacy consistency evaluation of generic drugs.
2. Related information of the drug
Norfloxacin Capsules is a marketed product of Yan'an Pharmaceutical, with approved specifications of 0.1g. The drug has carried out a study on the consistency evaluation of the quality and efficacy of the generic drug. The original product is used as the reference preparation. After the prescription, process redevelopment, improvement of quality standards and clinical trials of bioequivalence in healthy humans, the quality and efficacy of this drug are comparable to those of the original research. The product is consistent. The medicine is mainly used to treat urinary tract infections, gonorrhea, prostatitis, intestinal infections, typhoid fever and other salmonella infections caused by sensitive bacteria. At present, a total of 561 domestic companies hold the approval for the production of the drug, and 3 companies other than our company have passed the consistency evaluation.
Three, risk warning
The consistency evaluation of the company's products will help improve the market competitiveness of the drug, and at the same time, it has accumulated valuable experience for the company's subsequent product consistency evaluation work. Since pharmaceutical products have the characteristics of high technology, high risk, high added value, etc., and the sales of pharmaceuticals are easily affected by many unpredictable factors such as national policies and market environment, there are uncertainties. Investors are advised to make cautious decisions and pay attention to investment risk.
Shanghai Yan'an Pharmaceutical Yangpu Co., Ltd.
Board of Directors
November 2 2021