Immunology company argenx SE (Euronext Brussels:ARGX) (Nasdaq:ARGX) and biopharmaceutical company Zai Lab Limited (Nasdaq:ZLAB) (HKEX:9688) revealed on Tuesday that they have received Chinese regulatory approval for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC) 1,000mg (5.6ml)/vial for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

The approval is based on positive results from the Phase 3 ADAPT-SC study, which demonstrated similar efficacy and safety compared to the intravenous formulation.

Efgartigimod SC is also being evaluated for chronic inflammatory demyelinating polyneuropathy (CIDP) in China and has been approved for CIDP in the United States.