Immunology company argenx SE (Euronext Brussels:ARGX) (Nasdaq:ARGX) and biopharmaceutical company Zai Lab Limited (Nasdaq:ZLAB) (HKEX:9688) announced on Monday that the Chinese National Medical Products Administration (NMPA) has approved VYVGART Hytrulo for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
VYVGART Hytrulo is the first and only NMPA-approved treatment for CIDP in China. The approval was based on positive results from the ADHERE clinical trial, which demonstrated the drug's efficacy and safety in Chinese patients.
Zai Lab holds exclusive rights to develop and commercialise efgartigimod in mainland China, Hong Kong, Macau and Taiwan.
VYVGART Hytrulo is now approved in China for both generalised myasthenia gravis (gMG) and CIDP.
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