The EU door to China-based approvals is open

Fosun’s serplulimab is headed for its first approval outside China after the EU’s CHMP on Friday issued a positive opinion on the anti-PD-1 drug’s submission for first-line SCLC. This followed the EMA’s validation of the filing in March, and will see serplulimab, to be trademarked Hetronifly, become the fourth China-originated anti-PD-(L)1 to enter the EU market after BeiGene’s Tevimbra, CStone’s Cejemly and Shanghai Junshi’s Loqtorzi. The backing for Hetronifly’s approval is Astrum-005, a study run in China and eastern Europe, where a chemo combo beat chemo alone on overall survival (medians 15.4 versus 10.9 months, HR=0.63, p<0.001). The western standard of care for front-line SCLC isn’t chemo alone but rather Imfinzi plus chemo or Tecentriq plus chemo, so it’s highly relevant that the EMA has allowed a filing for a drug that didn’t compare head to head against this. Overall this shows a far more open attitude from EU regulator than the FDA, which apart from niche indications wants supporting studies run in the US with real-world US comparators.Anti-PD-(L)1 MAbs in the EUDrugINNCompanyStatusHetroniflySerplulimabShanghai Henlius (Fosun)/ IntasPositive CHMP opinion for chemo combo in 1st-line SCLC, 21 Sep 20024CejemlySugemalimabCStoneChemo combo approved for 1st-line NSCLCLoqtorziToripalimabShanghai Junshi BioscienceChemo combos approved for 1st-line oesophageal squamous cell & nasopharyngeal carcinomasTevimbraTislelizumabBeiGene4 approved usesJemperliDostarlimabGSK/ AnaptysBio2 approved usesLibtayoCemiplimabRegeneron5 approved usesImfinziDurvalumabAstraZeneca7 approved usesBavencioAvelumabMerck KGaA3 approved usesTecentriqAtezolizumabRoche10 approved usesOpdivoNivolumabBristol-Myers Squibb/ Ono22 approved usesKeytrudaPembrolizumabMerck & Co29 approved usesSource: OncologyPipeline.This story was updated to add the approval of Loqtorzi, received on 24 September after a July CHMP positive vote.