Argenx and zai lab announce approval of efgartigimod alfa injection (subcutaneous injection) for generalized myasthenia gravis in china
First and only nmpa-approved subcutaneous injectable fcrn blocker for gmg patients in china consistent clinical benefit and safety profile of efgartigimod sc compared to iv demonstrated in phase 3 adapt-sc study july 16, 2024 6:30am cet amsterdam, the netherlands— argenx se (euronext & nasdaq: argx) and zai lab limited (nasdaq: zlab; hkex: 9688) today announced that china's national medical products administration (nmpa) approved the biologics license application (bla) on july 16, 2024 for efgartigimod alfa injection (subcutaneous injection) (efgartigimod sc), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gmg) who are anti-acetylcholine receptor (achr) antibody positive. “the nmpa approval for efgartigimod sc is yet another key milestone on our journey to expand into new patient populations around the world with our transformative medicine.
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