China-backed US approvals continue to hang in the balance

If there is good news in yesterday’s US regulatory rejection of Coherus/Shanghai Junshi’s anti-PD-1 MAb toripalimab it is that absence of clinical data relevant to a US population was not the reason behind it. Rather, the complete response letter cited a manufacturing issue that the companies claim is readily addressable; the filing is to be resubmitted by mid-summer. No such luck for Hutchmed, whose filing for surufatinib has received a CRL that specifically cites the lack of an ex-China study. Surufatinib, a kinase inhibitor targeting FGFR1, CSF1R and VEGFR, is marketed in China as Sulanda, but US approval would have made it the company's first novel oncology drug sold outside Hutchmed’s home market. Its US data package included two pivotal trials conducted in China plus a bridging study, and the FDA's rejection echoes last month’s CRL for Lilly/Innovent’s sintilimab. What is worse, surufatinib targets neuroendocrine tumours, the sort of relatively niche cancer type thought to have been safe from concerns over lack of generalisability of Chinese data to the US population. Akeso/Sino await their verdict nervously.

Evaluate Vantage’s latest PD(L)anner, available on free download, focuses on China.