Application for production of dashatinib, a heavy new drug of Shuanglu pharmaceutical industry, has been accepted

According to the information from the State Food and Drug Administration (CFDA) on April 2, Shuanglu Pharmaceutical Co., Ltd applied for the production of dasatinib tablets and was accepted Liang Shujie, Secretary of the board of directors of Shuanglu pharmaceutical, said that dashatinib has applied to go through the green channel of evaluation, which is faster than the ordinary drug evaluation Dasatinib is a specific drug for chronic myeloid leukemia It is an important new drug in Shuanglu pharmaceutical industry as well as lenalidomide In December last year, Shuanglu pharmaceutical completed the clinical research of dasatinib, and its subsidiary, Xinxiang Shuanglu, applied for the production of API Nanjing Cavendish, another subsidiary of Shuanglu pharmaceutical, is responsible for the R & D and production of dasatinib tablets It has agreed with Shuanglu pharmaceutical that its domestic rights and interests belong to Shuanglu, and Shuanglu can have 40% rights and interests in markets outside China Liang Shujie said that according to the company's plan, Shuanglu in Xinxiang will become the origin of raw materials for dasatinib Because the application and production of raw materials and preparations need to be in step, when waiting for the application materials of preparations in January this year, the review status of APIs applied by Shuanglu in Xinxiang will be "suspended" According to the public data, dasatinib was developed and listed by Bristol Myers Squibb in 2006 and imported to China for the first time in 2011, which is expected to gradually replace imatinib in clinical use Chronic myelogenous leukemia is one of the three major leukemias in China, accounting for about 13% of all leukemias Imatinib, a first-line drug, has an annual sales volume of more than 4 billion US dollars Shuanglu pharmaceutical once pointed out that the patent protection period of dasatinib is about 10 years, during which other enterprises' listing and sales constitute infringement Many foreign new drugs have been approved by many manufacturers during the patent period, but all enterprises dare to go on sale only the next day after the patent expires At present, Shuanglu pharmaceutical industry has built a patent network for two new drugs, dasatinib and lenalidomide, and has completed patent applications in the United States, South Korea, Europe, Australia, Japan, or international cooperation in the future.