04:38 AM EDT, 07/16/2024 (MT Newswires) -- Argenx SE ( ARGX ) and Zai Lab (ZLAB) said Tuesday that China's National Medical Products Administration approved a biologics license application for efgartigimod alfa injection indicated as an add-on to standard therapy for adult patients with generalized myasthenia gravis.

The 1,000 milligrams subcutaneous injection is for patients with an anti-acetylcholine receptor antibody positive.

The company said the basis of the approval was a "consistent clinical benefit and safety profile" of the efgartigimod alfa injection in a phase 3 study.

"The addition of a flexible 30-to-90second subcutaneous injection opens the door for new patients in China while taking into account personal preference and convenience," Argenx Chief Executive Tim Van Hauwermeiren said.

Efgartigimod SC is also under evaluation to treat additional autoimmune disorders.