Recently, Guizhou Provincial Drug Administration issued the notice on the results of drug production supervision and inspection in 202, which determined that Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) Pharmaceutical Co., Ltd. (hereinafter referred to as " Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical") did not meet the drug production quality management standards, and suspended the production and sales of glimepiride tablets of the enterprise according to law. Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical has become the first pharmaceutical enterprise that is implementing the national centralized procurement and selection agreement and has not passed the inspection of the drug administration department.
The national organization drug joint procurement office then issued an announcement to cancel the qualification of Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical for the selection of glimepiride tablets, list the enterprise in the list of violations, start the substitution procedure and supply it by other selected enterprises.
Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical is a wholly-owned subsidiary of Guizhou Salvage Pharmaceutical Co.Ltd(600227) ( Guizhou Salvage Pharmaceutical Co.Ltd(600227) 600227). Glimepiride tablets are the selected products in the centralized procurement of drugs organized by the second batch of countries. At present, it is also the product of Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical that has passed the consistency evaluation of generic drug quality and efficacy.
To make matters worse, on January 29, Guizhou Salvage Pharmaceutical Co.Ltd(600227) issued an announcement on the advance loss of annual performance in 2021. The company's performance in 2021 is expected to lose 45 million yuan to 65 million yuan.
Affected by the above news, the share price of Guizhou Salvage Pharmaceutical Co.Ltd(600227) fell by the limit on February 7 and closed on February 11, with an increase of - 2.46%. On February 7, on the e interactive platform of Shanghai Stock Exchange, some investors asked the Secretary of Guizhou Salvage Pharmaceutical Co.Ltd(600227) about the disqualification of glimepiride tablets, pre loss of performance and loss of accounts receivable, but received no reply.
current violations of winning drugs
A total of 8 diabetes mellitus drug glimepiride in China has been evaluated by the consistency of quality and efficacy of generic drugs. The Glimepiride Tablets pharmaceutical company Guizhou Salvage Pharmaceutical Co.Ltd(600227) (Sheng Ping) published the notification list of the results of the national drug centralized procurement announced in January 21, 2020 with the first rank. The successful selection results will be implemented from April 2020, and the agreement period is 3 years. At present, the supply agreement for the second procurement year is being implemented.
During the flight inspection of Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical carried out by the inspection center of the State Food and Drug Administration from December 23 to 25, 2021, it was found that Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical had serious defects in plant maintenance, equipment cleaning and stability inspection, which did not meet the drug production quality management specifications.
On January 27, 2022, Guizhou Provincial Drug Administration issued a notice of suspension of production and sales to Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical, requiring Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical to immediately suspend the production and sales of glimepime tablets after receiving the notice, seriously rectify the existing problems, and carry out risk assessment and judgment, And submit the rectification report and risk assessment report before February 20, 2022.
In this regard, Guizhou Salvage Pharmaceutical Co.Ltd(600227) announced that Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical immediately started the rectification of relevant production lines, took the way of no rest during the Spring Festival, and seized the time to promote specific rectification projects, strive to complete the rectification work in the shortest time, pass the inspection of the drug administration department and confirm that it complies with the drug production quality management specifications, and strive to resume normal production and sales in mid March.
Guizhou Salvage Pharmaceutical Co.Ltd(600227) said that the bid winning areas for centralized purchase of glimepiride tablets are seven provinces (cities) of Shanxi, Shanghai, Jiangsu, Fujian, Guangdong, Guangxi and Hainan, with a total purchase volume of 698032800 tablets in three years. At present, 775394200 tablets have been supplied, which has exceeded the supply of centralized purchase, and the rectification will not affect the promised supply of centralized purchase.
However, in accordance with the spirit of the opinions of the general office of the State Council on promoting the normalization and institutionalization of centralized drug procurement, relevant members of the state organized joint drug procurement office believe that Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical violated the commitments made in the application materials and the relevant provisions of the national document on centralized drug procurement (gy-yd2019-2). On January 29, the joint procurement office decided to cancel its qualification for the selection of glimepiride tablets, list Guizhou Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical in the "list of violations", and suspend the application qualification of the enterprise to participate in the centralized drug procurement activities organized by the state from January 29, 2022 to July 28, 2023.
In response to a reporter's question, the head of the joint procurement office said that although no unqualified products were found in the sampling inspection of the enterprise's production site and circulation links, and no abnormalities were found in the adverse reaction monitoring, the drug regulatory department comprehensively determined that the enterprise did not meet the drug production quality management specifications, and took risk control measures according to the "four strictest" requirements, The medical insurance department also quickly punished and replaced the supply in time.
unpredictable performance impact
The main business of Guizhou Salvage Pharmaceutical Co.Ltd(600227) company is made up of two parts: chemical industry and medicine. In 2021, half year report showed that the pharmaceutical business of the company belongs to the pharmaceutical manufacturing industry, and the total sales of chemical drugs mainly based on diabetes accounted for more than 80% of the pharmaceutical sector. Its pharmaceutical manufacturers are Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceuticals based on the production of diabetes drugs, and Glimepiride Tablets is one of the main sources of sales revenue for Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceuticals.
According to the report of the third quarter of 2021, Guizhou Salvage Pharmaceutical Co.Ltd(600227) from the beginning of the year to the third quarter of the year, the revenue and net profit increased year-on-year, and the net profit increased by 184.27%. However, the annual performance of 2021 announced a loss in advance, with an estimated loss of 45 million yuan to 65 million yuan; After deducting non recurring gains and losses, the performance is expected to lose 50 million yuan to 70 million yuan.
For the reasons for the decline in performance, Guizhou Salvage Pharmaceutical Co.Ltd(600227) announced that during the performance forecast period, the operating income of pharmaceutical business decreased significantly. After the implementation of the "national procurement" policy, only glimepiride tablets are qualified for bidding and the bid winning price is low. Other mainstream varieties of the company are not qualified for bidding because they fail to pass the consistency evaluation, resulting in a year-on-year decline in the company's sales volume and price, resulting in an expected year-on-year decline of 158 million yuan in the company's net profit of the pharmaceutical sector.
Guizhou Salvage Pharmaceutical Co.Ltd(600227) another main chemical business is expected to have an inventory falling price reserve of 25 million yuan due to the rise in the cost of coal as the main raw material and the decrease in the market price of urea and methanol products. In addition, the company conducts a comprehensive inspection of receivables and accrues bad debt reserves, which is expected to affect the net profit of 76 million yuan in 2021.
At the same time, Guizhou Salvage Pharmaceutical Co.Ltd(600227) there may be uncertain factors affecting the accuracy of the performance forecast, including the rise in the cost of coal, the main raw material of the company's chemical products, the decrease in the market price of urea and methanol products, and the provision for inventory falling price is expected. Excluding the above uncertainties, the net profit attributable to the shareholders of the listed company is expected to be - 21 million yuan to - 31 million yuan. The net profit attributable to shareholders of listed companies after deducting non recurring profits and losses is - 26 million yuan to - 36 million yuan.
This time, the production and sales of Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical glimepiride tablets were suspended and the qualification of national mining was cancelled, which made the operation of Guizhou Salvage Pharmaceutical Co.Ltd(600227) uncertain this year.
After receiving the punishment of suspension of production and sales of glimepiride tablets, Guizhou Salvage Pharmaceutical Co.Ltd(600227) announced that in 2021, Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical glimepiride tablets had an operating revenue of 2006.3 million yuan (Unaudited), accounting for 16.43% of the company's pharmaceutical business revenue and 0.93% of the company's total operating revenue. If the rectification is successfully completed and production is resumed in time, it will not have a significant impact on the company's performance in 2022; If the rectification fails to meet the expectation and the production is not resumed in time, it will have a certain impact on the company's performance in 2022.
However, the subsequent disqualification of glimepiride tablets and the suspension of participation in national centralized procurement for 18 months are more serious penalties. Guizhou Salvage Pharmaceutical Co.Ltd(600227) on February 7, it was announced that the company's production and sales of glimepiride tablets were suspended and included in the "list of violations", and the national organization drug joint procurement office suspended the company's Application qualification to participate in the national organization drug centralized procurement activities from January 29, 2022 to July 28, 2023, which will have a certain impact on the company's business performance from 2022 to 2023.
Some insiders pointed out that the suspension of the core products of Guizhou Salvage Pharmaceutical Co.Ltd(600227) pharmaceutical business for a limited period of time will bring a chain reaction. Although it can also participate in the centralized purchase of local drugs, the violations should affect its credit evaluation, and the competition from the industry will also intensify. In this regard, the reporter of Huaxia times contacted to interview the Guizhou Salvage Pharmaceutical Co.Ltd(600227) Secretary of the board of directors. As of press time, no reply has been received.
