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.
|Selected Chinese anti-PD-(L)1 projects in the US|
|Project||Company||Targeted indication||Supporting study||US regulatory outcome|
|Sintilimab||Lilly/Innovent||1st-line non-squam NSCLC (Alimta combo)||CRL on 24 Mar 2022, data not generalisable to US population|
|Toripalimab||Coherus/Shanghai Junshi||1st-line chemo combo & 3rd-line monoRx nasopharyngeal carcinoma||Polaris-02 (China only)
Jupiter-02 (Asia only)
|CRL on 2 May 2022, quality process change required|
|Penpulimab||Akeso/Sino||3rd-line nasopharyngeal carcinoma||NCT03866967 (China only)||Pdufa date expected H1 2022|
|Tislelizumab||Novartis/Beigene||2nd-line oesophageal squamous cell carcinoma||Rationale-302 (global)||Pdufa date 12 Jul 2022|
|Sugemalimab||Cstone/EQRX||1st-line NSCLC||Gemstone-302 (China only)||EQRX "continuing to engage in discussions with the FDA" while initially targeting ex-US filings|
|Source: Evaluate Vantage.|
Evaluate Vantage’s latest PD(L)anner, available on free download, focuses on China.