Hanyu Pharmaceutical Co., Ltd. will obtain the production approval this year

Hanyu pharmaceutical said at the 2013 performance presentation that the company's heavyweight new drug enkephalin will be approved this year 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 Previously, Hanyu pharmaceutical executives had said that enkephalin is a PCI (coronary intervention) surgical drug, with a large market After being listed, it is expected to catch up with the bidding work of each province next year Combined with the company's Hospital advantages in peptide field, the market scale of enkephalin may reach 1 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.