Securities code: Jiangsu Hengrui Medicine Co.Ltd(600276) securities abbreviation: Jiangsu Hengrui Medicine Co.Ltd(600276) Announcement No.: pro 2022028 Jiangsu Hengrui Medicine Co.Ltd(600276)
Announcement on obtaining drug registration certificate
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear individual and joint liabilities for the authenticity, accuracy and completeness of its contents. Recently, Jiangsu Hengrui Medicine Co.Ltd(600276) (hereinafter referred to as “the company”) received the drug registration certificate approved and issued by the State Drug Administration (hereinafter referred to as “the State Drug Administration”). The relevant information is hereby announced as follows: I. Basic information of drugs
Drug name: Gadolinium butoxide injection
Dosage form: injection
Specification: 7.5ml: 4.5354g
Registration classification: chemical drugs category 4
Acceptance No.: cyhs2000331
Certificate No.: 2022s00219
Prescription drugs / over-the-counter drugs: prescription drugs
Approval conclusion: according to the drug administration law of the people’s Republic of China and relevant regulations, after examination, this product meets the relevant requirements of drug registration. The registration is approved and a drug registration certificate is issued. 2、 Other information about drugs
Gadolinium butoxide injection is a paramagnetic contrast agent for magnetic resonance imaging (MRI). It was first developed by bayerschering company with the trade name of Gadovist. It was approved to be listed in Switzerland in 1999 and later in many countries including China. Gadolinium butoxide injection is suitable for adults and children of all ages (including full-term newborns). It is only used for intravenous administration. It is used for diagnosis: contrast-enhanced magnetic resonance imaging (CE-MRI) of lesions in all parts of the body (including brain and spinal cord); Contrast enhanced magnetic resonance angiography (CE-MRA) was performed in all parts of the body. So far, in addition to the original research, only gadolinium butoxide injection of the company in China has been approved for listing, which is deemed to have passed the consistency evaluation of the quality and efficacy of generic drugs.
After inquiry, the global sales of gadolinium butoxide injection in 2020 was about 307 million US dollars. Up to now, about 27.38 million yuan has been invested in research and development of gadolinium butoxide injection related projects. 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. After obtaining the approval, the production and sales of drugs are vulnerable to some uncertain factors. Please make careful decisions and pay attention to preventing investment risks.
It is hereby announced.
Jiangsu Hengrui Medicine Co.Ltd(600276) board of directors March 27, 2022
