Qizheng Tibetan medicine re declared the phase II clinical application of class 1 new anticancer drug ethane Selene dispersible tablet

According to the website of the State Food and Drug Administration (CFDA) on April 15, the processing status of phase II clinical application of the class 1 anti-cancer new drug ethane Selene dispersible tablet applied by Qizheng Tibetan medicine in December 2014 was changed to "certificate preparation completed - issued approval document" The company responded that it was not convenient to disclose the specific situation of the certificate obtained Insiders speculate that the enterprise may voluntarily withdraw the declaration of this product At the same time, it is worth noting that according to the CFDA website, the company made a supplementary application on February 3 to obtain a new acceptance number, the registration classification changed from chemical 1.1 to chemical, the application type is supplementary application, and the status remains "under review" The company's personnel affirmed this, saying that the company did make a supplementary application in February, and the application is still phase II clinical, and the company is waiting for further results According to the public data, ethane Selene is intended to be used for cancer treatment, and the first indication is gastrointestinal cancer and lung cancer, with emphasis on adenocarcinoma, which has inhibitory effect on colon cancer, gastric cancer, liver cancer and other tumors In 2006, the product was applied for clinical application for the first time, phase I clinical application was approved in 2007, and phase II clinical application was accepted in December 2014 Qizheng Tibetan medicine pointed out that ethane Selene is a kind of chemical medicine with independent intellectual property rights with brand-new target and brand-new structure At present, there are no similar listed drugs at home and abroad The categories submitted for approval by the company include ethane Selene bulk drug and ethane Selene dispersible tablets Qizheng Tibetan medicine is the largest Tibetan medicine production enterprise in China, the main product is Xiaotong Plaster, and there are few varieties of non main chemical medicine products.