Merrimack company mm-398, an authorized partner of Taiwan smart engine biotechnology, has obtained the FDA's new drug priority review qualification

Pharmaengine, Inc announced on June 25 that Merrimack pharmaceutical company, the authorized partner of the company, was informed by the US Food and Drug Administration (US FDA) to cooperate with Zhiqing Biotechnology Co., Ltd The US FDA will make a decision to give the drug certificate within 6 months after receiving the application of gemcitabine, which is the first-line standard drug for pancreatic cancer patients who have obtained the qualification of new drug priority review Compared with the standard review procedure, the drug certificate can be obtained 4 months earlier Mm-398 (i.e pep02) is a rare disease drug for the treatment of pancreatic cancer In 2011, Zhiqing signed a contract of authorization and cooperation with Merrimack company of the United States, authorizing the rights of development, manufacturing and commercialization of pep02 in Europe and Asia (except Taiwan) to Merrimack company Merrimack granted exclusive authorization to Baxter in September 2014 to mm-398 outside the United States and Taiwan after completing the third phase of napoli-1 clinical trial   Mm-398 obtained the rapid review qualification of new drugs from FDA in November 2014, Merrimack completed the delivery of new drug application from FDA in April this year, and obtained the priority review qualification in June of the same year; Baxter company, an authorized partner of the United States, submitted the new drug listing license application to EMA in may of the same year, which is currently under review; Zhiqing also submitted the new drug listing license to TFDA in Taiwan at the end of May this year Apply Dr Ye Changjing, general manager and executive director of Zhiqing, said that mm-398 can successfully obtain the priority examination qualification of new drugs from the FDA of the United States, and the EU EMA accepts the application for marketing license of new drugs from mm-398 In the future, mm-398 will provide another treatment option for patients in need in the limited treatment of metastatic pancreatic cancer (industrial and commercial real time)