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 third China-originated anti-PD-(L)1 to enter the EU market after BeiGene’s Tevimbra and CStone’s Cejemly; a fourth, Shanghai Junshi’s Loqtorzi, is also about to be approved, after receiving positive CHMP recommendations for oesophageal squamous cell carcinoma and nasopharyngeal carcinoma in July. 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 EU

Source: OncologyPipeline.