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.

Share This Article