China's 20th PD-(L)1 drug

Earlier this month Fosun's Hetronifly became the 11th anti-PD-(L)1 drug to be approved in the EU, but China has this beat by a long way. This week's approval of Sinocelltech's finotonlimab by the NMPA means that China now has no fewer than 20 marketed drugs with this mechanism. Sinocelltech's approval is for a chemo combo in first-line head and neck cancer, and follows last year's publication in Nature Medicine of the supporting phase 3 data. Here the combo yielded median OS of 14.1 months, versus 10.5 months for chemo alone, resulting in a 27% reduction in risk of death (p=0.0165). The only other anti-PD-(L)1 approved in China for head and neck cancer is Bristol Myers Squibb's Opdivo, but that's in the second-line setting. This is just as well, otherwise Sincelltech might not have been able to run a phase 3 study against placebo; in the US Merck & Co's Keytruda plus chemo is approved first line, having scored a 13-month median OS result in Keynote-048. As for the EU, Hetronifly's nod came as part of a chemo combo in first-line SCLC, where AstraZeneca's Imfinzi and Roche's Tecentriq are already available.

Anti-PD-(L)1 MAb approvals in China

Source: OncologyPipeline.