Securities code: Hainan Poly Pharm.Co.Ltd(300630) securities abbreviation: Hainan Poly Pharm.Co.Ltd(300630) Announcement No.: 2022048 bond Code: 123099 bond abbreviation: Puli convertible bond
Hainan Poly Pharm.Co.Ltd(300630)
Announcement on obtaining drug registration approval for sodium nitroprusside injection
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 ” Hainan Poly Pharm.Co.Ltd(300630) ” or “the company”) has recently received the drug registration approval of sodium nitroprusside injection issued by the State Drug Administration. The relevant information is hereby announced as follows:
1、 Basic information of drugs
(I) drug name: sodium nitroprusside injection
(II) dosage form: injection
(III) specification: 2ml: 50mg
(IV) registration category: new registration classification of chemical drugs: Category 3
(V) listing Permit Holder: Hainan Poly Pharm.Co.Ltd(300630)
(VI) manufacturer: Hainan Poly Pharm.Co.Ltd(300630)
(VII) approval conclusion: approve production
(Ⅷ) name of API for related review: sodium nitroprusside
(IX) API manufacturer: Hainan Poly Pharm.Co.Ltd(300630)
(x) registration status: a
2、 Other relevant information of drugs
Sodium nitroprusside injection is a vasodilator, which is mainly used to immediately reduce the blood pressure of adult and pediatric patients in hypertensive crisis; Control blood pressure during operation to reduce bleeding; Treatment of acute congestive heart failure. After successfully developing generic drugs for sodium nitroprusside injection, the company has successively submitted registration applications from many countries outside China. At the same time, this variety is also an integrated variety of raw materials and preparations of the company. The product was approved by FDA in August 2020 and Health Canada in October 2020. Recently, the company received the approval notice from the State Drug Administration, and the registration status of API (Registration No.: y2019 China Vanke Co.Ltd(000002) 0) has been changed to a.
The company’s sodium nitroprusside injection has been approved for listing in Category 3 of the new registration classification of chemical drugs, which indicates that this product is deemed to have passed the consistency evaluation of generic injection. As an exclusive dosage form and self-produced raw material in China, it is of great significance to Hainan Poly Pharm.Co.Ltd(300630) and will not only improve the market competitiveness of the drug, but also have a positive impact on the business performance of the company.
The registration of the company’s sodium nitroprusside injection in Germany and other markets is still continuing.
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-tech, 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
April 17, 2022
