ZLAB - China accepts Zai Lab's biologics license application for neuromuscular disorder drug
- Zai Lab ( NASDAQ: ZLAB ) on Wednesday said China's drug regulator had accepted the company's biologics license application (BLA) for efgartigimod alfa injection for the treatment of generalized myasthenia gravis (gMG).
- Myasthenia gravis is a disorder characterized by weakness and rapid fatigue of any of the muscles under a person's voluntary control. gMG is when multiple muscle groups throughout the body are affected.
- Efgartigimod alfa injection was developed by argenx ( ARGX ) and is approved by the U.S. FDA under the brand name Vyvgart. ZLAB has an exclusive licensing agreement with ARGX to develop and commercialize efgartigimod in Greater China.
- U.S.-listed shares of ZLAB were down 4.8% to $35.87 in the first few minutes of trading.
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China accepts Zai Lab's biologics license application for neuromuscular disorder drug