08:41 AM EDT, 05/14/2024 (MT Newswires) -- Zai Lab ( ZLAB ) said Tuesday that its supplemental biologics license application for efgartigimod alfa injection to treat an autoimmune disease has been accepted by the China National Medical Products Administration's Center for Drug Evaluation, or CDE.

The CDE granted priority review for the application on May 11, according to the company.

Efgartigimod subcutaneous injection provides a treatment option for patients with chronic inflammatory demyelinating polyneuropathy, Zai Lab ( ZLAB ) said, adding its application is based on a study that showed the favorable safety and tolerability profile of efgartigimod alfa injection weekly dosing in the Chinese patient group was consistent with trial participants globally.

Zai Lab ( ZLAB ) shares were up 1.8% in recent premarket activity.

Price: 21.90, Change: +0.38, Percent Change: +1.77