Securities code: 002603 securities abbreviation: Yiling pharmaceutical Announcement No.: 2020-018
About Shijiazhuang Yiling Pharmaceutical Co., Ltd
Announcement on the consistency evaluation of Captopril Tablets
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without any false record, misleading statement or major omission.
Recently, Shijiazhuang Yiling Pharmaceutical Co., Ltd. (hereinafter referred to as "the company" or "the company") received the approval document for supplementary drug application of captopril tablets approved and issued by the State Drug Administration, which passed the quality and efficacy consistency evaluation of generic drugs (hereinafter referred to as "consistency evaluation"). The details are as follows:
1、 Basic information of drugs
Drug name: Captopril Tablets
Dosage form: tablet
Specification: 25mg
Registration classification: Chemicals
Application content: consistency evaluation application, change of prescription process; increase of direct contact medicine: silica gel desiccant in solid medical paper bag.
Approval No.: 2020b02381
Drug approval No.: gyzz h20057883
Applicant: Shijiazhuang Yiling Pharmaceutical Co., Ltd
Approval conclusion: according to the provisions of the drug administration law of the people's Republic of China, the opinions of the State Council on reforming the review and approval system of pharmaceutical medical devices (GF [2015] No. 44) and the announcement on issues related to the conformity evaluation of quality and efficacy of generic drugs (2017 No. 100), after examination, the product passed the conformity evaluation of quality and efficacy of generic drugs. At the same time, it is agreed to change the prescription and process of the product, and add silica gel desiccant in solid medical paper bags in the packaging materials directly contacting the drugs. The quality standard of this product is attached and is valid for 18 months. In the future, if the commercial production needs to scale up the batch, please pay attention to the corresponding scale-up research and verification, and if necessary, make a supplementary application for the scale-up of production.
2、 Other relevant information of drugs
Captopril tablet is an ACE inhibitor. Its clinical indications are hypertension and heart failure. It is widely used in people. It belongs to category A of national medical insurance catalogue (2019 version) and essential drug catalogue (2018 version). At present, a total of 7 domestic product specifications have passed the consistency evaluation of captopril tablets.
3、 Impact on the company and risk tips
According to the relevant national policies and regulations, for the drug varieties passing the consistency evaluation, appropriate support shall be given in the aspect of medical insurance payment; medical institutions shall give priority to purchase and select in clinical practice; meanwhile, the products passing the consistency evaluation will have the qualification to participate in the centralized purchase of national drugs. Through the consistency evaluation, this product is conducive to expanding the market sales of products, improving the market competitiveness, having a positive impact on the company's business performance, and accumulating valuable experience for the company's ongoing consistency evaluation of other products.
The future production and sale of the product may be affected by some uncertain factors. The company will perform the obligation of information disclosure in a timely manner according to the follow-up progress. We sincerely invite investors to make prudent decisions and take precautions against investment risks.
It is hereby announced.
Shijiazhuang Yiling Pharmaceutical Co., Ltd
Board of directors
February 28, 2020
Securities code: 002603 securities abbreviation: Yiling pharmaceutical Announcement No.: 2020-019
Shijiazhuang Yiling Pharmaceutical Co., Ltd
2019 performance express
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without any false record, misleading statement or major omission.
Special tips:
The financial data of 2019 contained in this announcement is only the preliminary accounting data, which has been audited by the internal audit department of the company and has not been audited by the accounting firm, and may be different from the final data disclosed in the annual report. Please pay attention to the investment risk.
1、 Main financial data and indicators in 2019
Unit: Yuan
Exergy
2、 Statement of business performance and financial position
1. In 2019, the company achieved a total operating revenue of 5851.9801 million yuan, a year-on-year increase of 21.55%, mainly due to the increase in sales revenue of the company's main products during the reporting period.
2. In 2019, the company realized an operating profit of 723.6791 million yuan, a year-on-year increase of 0.66%; in 2019, the total profit of the company was 721.0415 million yuan, a year-on-year increase of 2.86%; in 2019, the net profit attributable to the shareholders of the listed company was 601.7097 million yuan, a year-on-year increase of 0.42%. The operation of the company is normal and meets the expectation.
3. The owner's equity attributable to the shareholders of the listed company is 7939.6361 million yuan, an increase of 5.01% compared with the beginning of the period, which is mainly due to the increase of profits and the repurchase of shares of the company during the reporting period.
3、 Description of difference from previous performance forecast
Prior to the disclosure of this performance express, the company did not predict and disclose its business performance in 2019 according to relevant regulations.
4、 Documents for future reference
1. Comparative balance sheet and profit statement signed and sealed by the company's legal representative, person in charge of accounting work and person in charge of accounting organization (person in charge of Accounting);
2、 The internal audit report signed by the head of the internal audit department of the company.
It is hereby announced.
Shijiazhuang Yiling Pharmaceutical Co., Ltd
Board of directors
February 28, 2020