现在看，可能真的有政治因素，因为之前FDA与和黄达成了协议，说可以根据中国临床数据+美国桥接数据来批准的，这次看来FDA是反悔了，必须要求国际多中心临床。如果搞国际多中心临床，那成本要高很多很多：In a May 2020 pre-NDA meeting, HUTCHMED reached an agreement with the FDA that the two positive Phase III studies of surufatinib in patients with pNETs and epNETs in China, along with the bridging trial in the U.S. could form the basis to support a U.S. NDA submission. The FDA accepted the filing of the NDA on June 30, 2021.