regulatory
confidence high
sentiment positive
materiality 0.75
China NMPA approves Zai Lab's VYVGART for generalized myasthenia gravis
Zai Lab Ltd
- NMPA approved VYVGART (efgartigimod alfa) as add-on for anti-AChR+ gMG adults.
- Phase 3 ADAPT: 68% responders on MG-ADL vs 30% placebo (p<0.0001) in first cycle.
- Zai Lab to seek National Reimbursement Drug List inclusion for broader patient access.
- Zai Lab holds exclusive license from argenx to develop/commercialize in mainland China, HK, Macau, Taiwan.
- VYVGART is the first approved FcRn antagonist for gMG in China; ~200,000 MG patients in country.