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
Drug | INN | Company | Status |
---|---|---|---|
Hetronifly | Serplulimab | Shanghai Henlius (Fosun)/ Intas | Positive CHMP opinion for chemo combo in 1st-line SCLC, 21 Sep 20024 |
Cejemly | Sugemalimab | CStone | Chemo combo approved for 1st-line NSCLC |
Loqtorzi | Toripalimab | Shanghai Junshi Bioscience | Positive CHMP opinion for chemo combos in 1st-line oesophageal squamous cell & nasopharyngeal carcinomas, 26 Jul 2024 |
Tevimbra | Tislelizumab | BeiGene | 4 approved uses |
Jemperli | Dostarlimab | GSK/ AnaptysBio | 2 approved uses |
Libtayo | Cemiplimab | Regeneron | 5 approved uses |
Imfinzi | Durvalumab | AstraZeneca | 7 approved uses |
Bavencio | Avelumab | Merck KGaA | 3 approved uses |
Tecentriq | Atezolizumab | Roche | 10 approved uses |
Opdivo | Nivolumab | Bristol-Myers Squibb/ Ono | 22 approved uses |
Keytruda | Pembrolizumab | Merck & Co | 29 approved uses |
Source: OncologyPipeline.
161