Hanyu pharmaceutical's new drug enkephalin and injection enter the site for inspection

According to the website of the State Food and Drug Administration (CFDA) on April 11, Hanyu pharmaceutical's heavyweight new drug, enkephalin and enkephalin injection, has entered the site for inspection, which means that the drug only needs to pass the inspection link of production environment and production process to impact the domestic first imitation Enkephalin injection has the effect of anti platelet aggregation It was first listed in the United States in 1998 In 2007, the sales amount of the product in the United States reached 332 million US dollars At present, there is no domestic enterprise to produce the product Hanyu pharmaceutical declared the clinical approval documents of enkephalin API and injection in October 2005, and was approved to carry out clinical trials in July 2006; it declared production in March 2010, and has been required to submit technical supplementary data twice so far, and the approval time of the products has been correspondingly delayed At the beginning of the year, company executives said on various occasions that the blockbuster new drug would be approved within this year Previously, the company's executives have said that enkephalin is a PCI (coronary intervention) surgical drug, with a large market, and it is expected to catch up with the bidding work in various provinces after listing Combined with the company's Hospital advantages in the peptide field, the market size of enkephalin may reach one billion yuan The existing peptide drugs of Hanyu pharmaceutical industry include thymopentin for injection, somatostatin for injection, deammopressin acetate injection and terlipressin for injection In addition to enkephalin injection, the new heavyweight polypeptide products under research also include new drugs such as carbetoxine, atroxaban acetate injection, cetrix for injection, etc., and are also applying for production approval According to the public information, by 2012, the overall sales scale of China's chemical synthetic peptide drug market has exceeded 10 billion yuan.