Securities code: Hainan Poly Pharm.Co.Ltd(300630) securities abbreviation: Hainan Poly Pharm.Co.Ltd(300630) Announcement No.: 2022079 bond Code: 123099 bond abbreviation: Puli convertible bond
Hainan Poly Pharm.Co.Ltd(300630)
About the approval of iopanol injection by the Dutch drug evaluation committee (CBG)
Announcement of listing license
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 marketing license of iodophor injection issued by the Dutch drug evaluation committee (hereinafter referred to as "CBG"). The relevant information is hereby announced as follows:
1、 Basic information of drugs
(I) drug name: iodopanol injection
(II) indications: for neuroradiology, including lumbar vertebrae, thoracic vertebrae and cervical vertebrae, as well as CT myelography.
(III) dosage form: injection
(IV) specification: 408 mg / ml
(V) manufacturer: Hainan Poly Pharm.Co.Ltd(300630)
2、 Other relevant information of drugs
Iopamidol was first developed by Bracco as a non-ionic, low permeability iodized contrast agent. It is widely used in various diagnostic fields such as lumbar and cervical myelography, CT and CT enhancement. Iodophor injection was first approved for listing in France in May 1981. Since then, it has been approved for listing in other European countries, including Italy, Germany, the Netherlands and the United Kingdom. It was approved for listing in the United States in December 1985 and in China in July 2002.
Iodophor injection is the first generic contrast agent developed by our company. After successfully developing the generic iodophor injection, the company submitted the application for generic registration in China, Europe and the United States respectively, which is a collinear product. Recently, the company has received the listing permission from the Dutch drug evaluation committee, which indicates that Hainan Poly Pharm.Co.Ltd(300630) has the qualification to sell iodophor injection in the Netherlands, and also indicates that Hainan Poly Pharm.Co.Ltd(300630) has successfully entered the field of contrast agents, which will have a positive impact on the company's market expansion.
3、 Risk tips
The company attaches great importance to drug R & D, production and sales. In the whole process of drug life cycle management, strictly abide by the relevant quality management norms for drug R & D, production and sales in foreign markets to ensure drug quality and safety. Due to the technical complexity and high-risk characteristics of pharmaceutical products, the technology of products from development, clinical trial approval to production is complex, with long cycle and many links. After the approval of drugs, the production and sales are also vulnerable to some uncertain factors in the policy and market. 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
May 22, 2022
