Shuangcheng pharmaceutical focuses on clinical re declaration after withdrawal of etibatide for injection

Hainan Shuangcheng Pharmaceutical Co., Ltd focuses on the research of etibatide, which has attracted market attention since the withdrawal of registration application last year The company said in a public information that it will take about one year for etibatide for injection (formerly known as yifeibat) to re apply for clinical application after withdrawal Etibatin, also known as enkephalin, is mainly used in the treatment of acute coronary syndrome, such as unstable angina, acute myocardial infarction, sudden cardiac death and so on Schering plough was first listed in the United States under the trade name of itrifiban in July 1998 Jiangsu Haosen Pharmaceutical Co., Ltd obtained the first copy of the drug in China in October 2012 Because of its good efficacy and potential huge market, it was rated as "China's top ten heavyweight prescription drugs in 2012" by many pharmaceutical authorities In addition, Hanyu Pharmaceutical (300199 SZ) is applying for the production approval of enkephalin In December 2013, Shuangcheng pharmaceutical suddenly withdrew the production application of this variety The relevant person in charge of the company said that because the usage and dosage of the original investigational drug had changed, it was decided to withdraw the registration and application for production of etibatide and etibatide for injection, and said that it would continue to complete the new clinical trial before applying for production However, an insider of Howson pharmaceutical and the relevant head of Hanyu pharmaceutical have questioned this statement Howson pharmaceutical insiders said the company's etibatide has been listed and no serious adverse reactions have been detected Recently, hausen has not been informed of the change of the usage and dosage of etibatide If the original research drug had changed, it would have done something a few years ago The person pointed out that "it is relatively rare to withdraw the production registration application when the clinical trial is completed and the production is ready for declaration in the declaration process It should be that there are some problems in some links." The head of Hanyu pharmaceutical also said that at present, he has not heard about the changes in the original research drug "The most recent revision of the original specification of etibatide was in March this year, without mentioning the change of usage and dosage." He stressed that hanyu pharmaceutical's enkephalin declaration will not be affected It is understood that hanyu pharmaceutical's enkephalin API and injection were applied for production in March 2010, and it has twice been required to submit supplementary information, and the market expects that it is likely to be approved this year About Hainan Shuangcheng Pharmaceutical Co., Ltd.: Hainan Shuangcheng Pharmaceutical Co., Ltd is a young high-tech enterprise established in 2000 with the characteristics of chemical synthetic peptide drugs, specializing in drug research and development, production and sales The company has rich experience in research and development, registration and application, production and marketing of chemical synthetic polypeptide drugs In China, it has successfully developed three chemical synthetic polypeptide drugs: Jitai (thymus injection method new), somatostatin for injection and thymopentin for injection Several chemical synthetic polypeptide drugs are in registration and application The company has a GMP production workshop with an annual capacity of 10kg for chemical synthetic peptide API, rich production management experience in the injection type of freeze-dried powder for injection, two freeze-dried preparation workshops meeting the requirements of GMP in China, with an annual capacity of nearly 30 million pieces, and another solid preparation production workshop meeting the requirements of GMP in China.