Akeso cracks the US at last

After a review period lasting nearly four years the FDA has approved Akeso's penpulimab, marking the third China-originated anti-PD-(L)1 MAb, after Coherus's Loqtorzi and BeiGene's Tevimbra, to get a US green light. Remarkably, not only had penpulimab first been filed all the way back on 24 May 2021 – making it the first Chinese anti-PD-1 to go before the FDA – it was subsequently deprioritised. Though Akeso made no public statement about it, the filing was assumed to have been held up by Covid-related travel restrictions and possible CRLs; a year ago Akeso told ApexOnco that the filing was still "in progress", but that it was not its primary focus, the company having switched to more technologically advanced bispecific MAbs including cadonilimab and ivonescimab. Now the FDA has approved penpulimab, an Fc-enhanced anti-PD-1, for its originally sought indication of third-line nasopharyngeal carcinoma, in addition to greenlighting first-line chemo combo use, an indication Akeso must subsequently have requested. That said, the prospects of penpulimab actually being launched always depended on Akeso finding a US partner, and with the company having no US sales infrastructure this still remains the case. Akeso's approved immuno-oncology drugsDrugMechanismIndicationChina statusUS statusAnniko (penpulimab)PD-1 MAb3rd-line Hodgkin’s lymphomaApproved Aug 2021NA1st-line squam NSCLC (chemo combo)Approved Jan 2023NA3rd-line nasopharyngeal carcinomaApproved Apr 2024Approved Apr 20251st-line nasopharyngeal carcinoma (chemo combo)Approved Mar 2025Approved Apr 20251st-line liver cancerFiledNAKettany (cadonilimab)PD-1 x CTLA-4 MAb2nd-line cervical cancerApproved Jun 2022NA2st-line gastric cancer (chemo combo)Approved Sep 2024NA1st-line cervical cancer (chemo +/-Avastin combo)FiledNAIvonescimabPD-1 x VEGF MAbPost-EGFRi non-squam NSCLCApproved May 2024Ph3 (licensed to Summit)1st-line PD-L1+ve (≥1%) NSCLCApproved Apr 2025NAThis table has been updated to reflect ivonescimab's second approval. Source: OncologyPipeline.