Priority review! Sanofi PCSK9 inhibitors will enter the domestic market!

On February 19, according to CDE news, Sanofi (China) Investment Co., Ltd applied for the import listing of alizumab injection to be included in the priority review Photo source: CDE alirocumab, jointly developed by Sanofi and regeneron, was approved by the US Food and Drug Administration (FDA) on July 24, 2015, and listed by the European Drug Administration (EMA) on September 23, 2015 It was jointly sold by Sanofi and regeneron in the US and European markets under the name of praluent Alirocumab is the first FDA approved PCSK9 inhibitor By binding PCSK9 and inhibiting the binding of circulating PCSK9 to low density lipoprotein receptor (LDLR), PCSK9 mediated degradation of LDLR was prevented The drug is used to treat adult heterozygous familial hypercholesterolemia and clinical atherosclerotic cardiovascular disease (such as heart disease or stroke requiring low-density cholesterol reduction) At present, there are 101 patents in the global distribution of the drug, and its main type is new use Data source: as a new target of attention for lipid-lowering circle after statins, yaozhitongpcsk9 has not only arizumab, but also evolocumab Evolocumab was approved by the European Drug Administration (EMA) on July 17, 2015, and approved by the U.S Food and Drug Administration (FDA) on August 28, 2015, and sold by Amgen in the U.S and European markets under the trade name repatha At present, iloximab has been approved by the State Food and Drug Administration on July 31, 2018, becoming the first PCSK9 inhibitor new drug to be listed in China, and the commercial name is ribea Approved for the treatment of homozygous familial hypercholesterolemia (hofh) in adults or adolescents over 12 years old Familial hypercholesterolemia is one of the first 121 rare diseases in China This time, if the application for import of alizhumab is approved, it will open up the domestic competition pattern In 2017, the global sales of ilojumab was RMB 2.154 billion, while that of arizumab was RMB 1.305 billion Source of sales data of alizumab: statement of drug sales database: the viewpoint of this article only represents the author, not the position of drug network, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.