According to the statistics of pharmaceutical cloud studio, this week (December 6, 2020 – December 12, 2020), 31 new varieties passed the consistency evaluation, 10 of which were the first in China to pass the evaluation
Chengdu Shengnuo Bio: the first over evaluation of etibatide injection
Etibatide is a receptor antagonist of platelet glycoprotein Ⅱ B / Ⅲ a. The ischemic state caused by thrombosis can be reversed through the final common pathway of selective and reversible inhibition of platelet aggregation. It is suitable for the treatment of patients with acute coronary syndrome.
Etibatide injection was initially developed by cor therapeutics, Inc. it was approved to be listed in the United States in May 1998, and now it is sold by Merck. It was approved to be listed in Europe in July 1999, and now it is sold by GlaxoSmithKline. Its trade name is Integrilin. At present, it has been widely sold in the world. However, the original products have not yet entered China.
In 2014, Haosen pharmaceutical became the first domestic enterprise approved to produce etibatide injection; then in 2016, Shenzhen Hanyu pharmaceutical became the second domestic enterprise, but the sales volume of the drug has been tepid. Until 2017, etibatide injection entered into medical insurance through negotiation, and the market began to expand.
According to minet.com, the sales volume of sample hospitals in 2018 was 9.07 million yuan, with a year-on-year growth of 814.78%; from Q1 to Q3 in 2020, the sales volume has risen to 32.14 million yuan, with potential to be released.
According to insight database, at present, a total of 5 companies including sinobio have submitted listing applications for etibatide injection, 1 company has submitted supplementary application for consistency evaluation, and 1 company is in be trial.