Chinese registrational clinical trial for derazantinib to begin in 2H
2019
BURLINGTON, Mass.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/search?q=%24ARQL&src=ctag” target=”_blank”gt;$ARQLlt;/agt; lt;a href=”https://twitter.com/hashtag/arql?src=hash” target=”_blank”gt;#arqllt;/agt;–ArQule, Inc.’s (Nasdaq: ARQL) partner, Sinovant Sciences, announced that
its Clinical Trial Application (CTA) for derazantinib has been accepted
by the Center for Drug Evaluation at the China National Medical Products
Administration (NMPA), enabling the initiation of a registrational
clinical trial in patients with second-line intrahepatic
cholangiocarcinoma (iCCA) in the second half of 2019.
“This is an important step forward for derazantinib in China, where the
unmet need in iCCA is particularly acute,” said Peter Lawrence,
President and COO of ArQule. “We are very pleased with the operational
and regulatory progress our partner has made in this region and look
forward to further clinical updates.”
To read the full Sinovant Sciences press release announcing the
approval, click
here.
In 2018, ArQule and Sinovant Sciences, entered into a licensing
agreement for derazantinib in China. Under the terms of the agreement,
ArQule granted Sinovant Sciences, a subsidiary of Roivant Sciences, an
exclusive license to develop and commercialize derazantinib in the
People’s Republic of China, Hong Kong, Macau and Taiwan (greater China).
In addition to the $3 million upfront payment and $2.5 million
developmental milestone it has already received, ArQule is eligible for
regulatory and commercial milestones and royalties on future sales of
derazantinib in Greater China.