Zai Lab and argenx have announced that China’s National Medical Products Administration (NMPA) has approved the supplemental biologics license application (sBLA) for Vyvgart Hytrulo (1,000mg/5.6ml vial) [Efgartigimod Alfa Injection].
This approval is for treating adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). It is administered as a once-weekly, 30- to 90-second subcutaneous injection.
The drug is approved in the US for the treatment of generalised myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). In July, it secured NMPA approval for gMG treatment.
In the European Union (EU), it is marketed as Vyvgart SC for gMG, while in Japan, it is sold as Vyvdura for gMG. In China, efgartigimod is approved for both gMG and CIDP.
Zai Lab holds an exclusive licensing agreement with argenx to develop and commercialise efgartigimod in Greater China.
In May 2024, Zai Lab announced that China’s Centre for Drug Evaluation (CDE) accepted the sBLA for Vyvgart Hytrulo for CIDP with a priority review designation.
Argenx CEO Tim Van Hauwermeiren said: “Vyvgart Hytrulo is a precision therapy for patients living with CIDP, many of whom have been waiting for a new treatment innovation.
“We are grateful to our partners at Zai Lab for collaborating with argenx to reach CIDP patients in China, and to the NMPA for approving Vyvgart Hytrulo for CIDP.”
The NMPA’s approval of Vyvgart Hytrulo is based on positive results from the ADHERE study, a multicentre, randomised, double-blind, placebo-controlled trial.
This study assessed the drug for treating CIDP and included an open-label phase to identify responders, who then entered a randomised-withdrawal, double-blind phase.
Zai Lab enrolled patients in Greater China, and the treatment response was consistent with the global trial results.
In a subgroup analysis of Chinese participants, Vyvgart Hytrulo reduced the risk of relapse by 69% compared to placebo.
Additionally, 78% of Chinese participants in the open-label phase showed clinical improvement.
Efgartigimod’s safety and tolerability profile in the Chinese cohort was consistent with that seen in the global participants.
Zai Lab president and global research and development head Rafael Amado said: “We are pleased to receive NMPA approval for Vyvgart Hytrulo, marking a groundbreaking milestone for CIDP patients in China.
“This approval brings a much-needed treatment option to patients who have been suffering from CIDP for far too long.”
In August 2022, Argenx received the European Commission (EC) marketing authorisation for Vyvgart to treat gMG in adults.
