The third application and production of "Tribulus terrestris for injection", a new 5-class traditional Chinese medicine drug in Aodong, Jilin Province, failed

The reexamination conclusion of "refined Tribulus terrestris" API and "Tribulus terrestris for injection" preparation that Taonan Pharmaceutical Co., Ltd., a subsidiary of Aodong holding company of Jilin Province, has applied for the production of five kinds of traditional Chinese medicine for the second time is "it is suggested to maintain the original approval conclusion", which means that after the second breakthrough, the application and production of this billion level heavy new medicine may fail again If the production approval of the product fails again, a high probability event will occur Tribulus terrestris for injection is a new drug developed by Aodong in Jilin Province for more than ten years Its main component is refined Tribulus terrestris, which is used for the treatment of severe chest pain, ischemic stroke and hyperviscosity syndrome At present, there is no production approval document for this product in China, and only one enterprise in Aodong Jilin Province is applying for the production of this product According to Jilin Aodong securities affairs department, the main ingredients of Tribulus terrestris for injection and Xinnaoshutong Capsule, the exclusive product of the company, are all Tribulus terrestris, which belongs to the company's modified dosage form product The market expects that the future sales space of the freeze-dried powder injection will reach 1 billion yuan However, the approval process of the product is rather bumpy Jilin Aodong has applied for the clinical approval of the product since February 2002, obtained the clinical approval in 2003, and applied for production for the first time in 2008 In January 2013, CFDA's review opinion was not passed Two months later (March 2013), Aodong, Jilin Province, broke through the customs again and applied for the production of the product for a second time The result is still not optimistic Tribulus terrestris for injection is mainly used for the treatment of severe chest pain, ischemic stroke and hyperviscosity syndrome At present, there is no production approval document for this product in domestic pharmaceutical enterprises, and only Jilin Aodong company is applying for the production of this product.