Akeso (9926.HK): HARMONi-GI1 Positive but OS Upside Capped by Strong Control Arm; SSGJ-707 Supports PD-1/VEGF Class Read-Across

Akeso's HARMONi-GI1 Ph3 data in 1L BTC (biliary tract cancer) were clinically positive, with ivonescimab-chemo delivering a statistically significant OS benefit vs. durvalumab-chemo. While the OS HR came in below our prior bull-case scenario, the absolute mOS delta of 2.8 months compares favorably with TOPAZ-1's 1.3-month mOS improvement, which was sufficient to support approval and establish durvalumab-chemo as SoC. We also note that Summit and ECOG-ACRIN have initiated the global registrational Ph2/3 EA2251 study of ivonescimab plus chemotherapy versus pembrolizumab- or durvalumab-chemo in 1L advanced BTC, which should help validate global applicability of the China HARMONi-GI1 data. Separately, SSGJ-707/PF'4404's 1L NSCLC Ph2 ESMO data provide supportive PD-1/VEGF class read-across, but given the dataset remains open-label and relatively immature, we would still wait for Ph3 validation before drawing firm conclusions on the competitiveness of PF'4404 versus ivonescimab.