Securities code: 300630 securities abbreviation: Hainan Poly Pharm.Co.Ltd(300630) Announcement No.: 2022-012
Bond Code: 123099 bond abbreviation: Puli convertible bond
Hainan Poly Pharm.Co.Ltd(300630)
Announcement on metformin hydrochloride sustained release tablets obtaining marketing license in the Netherlands
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.
Hainan Poly Pharm.Co.Ltd(300630) (hereinafter referred to as “Haipu”) recently received the marketing license of metformin hydrochloride sustained-release tablets issued by the Dutch drug evaluation committee (hereinafter referred to as “CBG”), and now the relevant information is announced as follows:
First, the basic situation of drugs (I): drug name: Metformin Hydrochloride Sustained Release Tablets (II) indications: treatment of adults with type 2 diabetes, especially for diet and exercise alone is not enough to control the level of blood sugar overweight patients. Adults: metformin hydrochloride sustained release tablets can be used as monotherapy or in combination with other oral hypoglycemic drugs or insulin. It has been shown that the use of metformin as a first-line treatment for type 2 diabetes and overweight adults after diabetes failure can reduce diabetic complications. (III) dosage form: tablet (IV) specification: 500mg (V) manufacturer: Hainan Poly Pharm.Co.Ltd(300630) (VI) license issuing authority: Dutch drug evaluation committee
2、 Other relevant information and follow-up progress of drugs
Metformin hydrochloride is used as an adjunctive therapy for diet and exercise to improve glycemic control in adults and children with type II diabetes. Metformin can also be used with sulfonylureas or insulin to improve blood glucose control in adults. Metformin hydrochloride (Glucophage) is an oral oral antidiabetic drug developed by Merck Sante SA and Shi Guibao BMS (Sumitomo), which is jointly sold by Sumitomo Dainippon Pharma and Daewoong. Metformin is the first choice for diabetic patients. It has hypoglycemic effect and insulin resistance. The main dosage form listed outside China is tablets, and sustained-release tablets can significantly reduce the adverse reactions of gastrointestinal tract after taking drugs, and reduce the times of taking drugs every day, from 2-3 times a day to once a day, so as to improve the safety and compliance of drugs.
The company’s metformin hydrochloride sustained-release tablets were first approved for listing by the State Drug Administration on July 14, 2004, with the approval number of gyzz h20040971. On May 6, 2021, it obtained the approval document of supplementary application for consistency evaluation issued by the State Drug Administration.
In addition, the company actively responded to the strategy of industrial upgrading, improving product quality and going global called by the State Council and the National Drug Administration, and launched the application for European listing license of metformin hydrochloride sustained-release tablets (500mg). Recently, it received the listing license issued by CBG in the Netherlands, which indicates that Hainan Poly Pharm.Co.Ltd(300630) has the qualification to sell metformin hydrochloride sustained-release tablets in the Netherlands, which will have a positive impact on the company’s expansion of the market in that country. The European marketing license of metformin hydrochloride sustained-release tablets is conducive to improving the brand image of the products. At the same time, it has accumulated very valuable experience for the company to carry out the follow-up international marketing application of slow-release and controlled-release drugs.
3、 Risk tips
The company attaches great importance to drug research and development, and strictly controls the quality and safety of drug research and development, manufacturing and sales. Due to the characteristics of high technology, high risk and high added value of pharmaceutical products, not only the early research and development of drugs and the long cycle and many links of products from research and development, clinical trial approval to production, but also the production and sales of drugs after obtaining approval are vulnerable to some uncertain factors. The company will timely fulfill the obligation of information disclosure according to the follow-up progress. Please make careful decisions and pay attention to preventing investment risks.
4、 Documents for future reference
(I) supporting documents
It is hereby announced.
Hainan Poly Pharm.Co.Ltd(300630) board of directors
January 24, 2022
