The first company to pass the evaluation, Hengrui Medicine's contrast agent ioverol injection passed the consistency evaluation of generic drugs

September 04, 2021

On September 2, Hengrui Medicine announced that it had received the "Drug Supplementary Application Approval Notice" approved and issued by the National Medical Products Administration, approving the company's ioverol injection to pass the generic drug quality and efficacy consistency evaluation. In addition to the original products in China, only Hengrui Medicine's ioverol injection has been approved for production and passed the consistency evaluation of generic drugs.

Contrast agents are products that are injected/taken into human tissues or organs to enhance the effect of image observation, and are essential diagnostic and differential diagnostic drugs for medical imaging disciplines. In recent years, as the application of medical imaging in clinical diagnosis has become more and more extensive, medical imaging technology has been transformed from the previous "assisted examination method" to one of the most important clinical diagnosis and differential diagnosis methods in modern medicine. Ioverol injection is a new type of non-ionic, low-permeability, water-soluble, radiopaque contrast agent for transvascular administration. Like other non-ionic contrast agents, ioverol injection has no significant effect on blood coagulation and does not have the anticoagulant function of ionic contrast agents. This product is mainly used for various vascular radiology examinations. The indications include: (1) Angiography of the entire cardiovascular system in adults: The scope of use includes cerebral arteries, coronary arteries, peripheral arteries, visceral and renal arteriography, and aortic angiography And left ventricular angiography; (2) enhanced CT scan of the head and body and excretory urography; (3) cardiovascular angiography, enhanced CT scan of the head and body, and excretory urography in children one year or older. Hengrui Medicine's ioverol injection 50ml:16g(I) was approved for marketing in 2006, and the application for consistency evaluation of generic drugs was accepted in February 2020. In addition to the original products in China, only Hengrui Medicine's ioverol injection has been approved for production and passed the consistency evaluation of generic drugs. As an innovative national pharmaceutical company, Hengrui Pharmaceuticals has always been committed to making it accessible and affordable for the common people. Up to now, the company has a total of 21 products passed the consistency evaluation, 19 products are deemed to have passed the consistency evaluation, 12 products have been submitted for approval, and 3 products are under development.

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Ms. Yi

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