$和黄医药(00013)$ 的索凡替尼，申请在美国上市，也黄了。FDA给了跟拒绝信达的PD-1差不多的理由，FDA还是要求补国际多中心临床。和黄比信达多做了美国的桥接临床试验，但也没有用。

Surufatinib：FDA determined that the current data package, based on two positive Phase III trials in China and one bridging study in the United States (U.S.), does not support an approval in the U.S. at this time. The CRL indicated that a multi-regional clinical trial ("MRCT") is required for U.S. approval. 网页链接