Zai Lab and argenx: NMPA Approval for VYVGART Hytrulo sBLA

Zai Lab and Argenx have received approval from the National Medical Products Administration (NMPA) of China for the supplemental biologics license application (sBLA) for VYVGART Hytrulo, a 1,000mg vial designed to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. VYVGART Hytrulo is administered as a once-weekly subcutaneous injection, taking only 30 to 90 seconds to complete. This approval is historic, as it is the first therapy sanctioned in China specifically for this immune-mediated neuromuscular disorder affecting the peripheral nervous system.

The approval was granted based on the positive outcomes from the ADHERE study, a randomized, double-blind, placebo-controlled, multicenter trial. The study included an open-label phase to identify responders, followed by a randomised-withdrawal, double-blind period to further assess the therapy's efficacy. Zai Lab enrolled patients from the Greater China region into the ADHERE trial, and the responses observed in these patients were consistent with the results seen in global studies.

A subgroup analysis of Chinese participants revealed a 69% reduction in the risk of relapse when treated with VYVGART Hytrulo compared to a placebo. Additionally, 78% of the Chinese participants demonstrated clinical improvement during the open-label phase of the study. The safety and tolerability profile of VYVGART Hytrulo in Chinese patients matched the favorable outcomes seen in the global participant group.

Zai Lab holds the exclusive license to develop and commercialize VYVGART Hytrulo in Greater China under an agreement with Argenx. Rafael G Amado, the head of Zai Lab Global Research and Development, expressed their satisfaction with the NMPA approval, calling it a groundbreaking milestone for CIDP patients in China. He emphasized that this approval provides a much-needed treatment option for those suffering from CIDP and reiterated Zai Lab's commitment to working with Argenx to explore the therapy's potential in other immunoglobulin G (IgG)-mediated autoimmune conditions.

Tim Van Hauwermeiren, CEO of Argenx, highlighted that VYVGART Hytrulo is a precision therapy designed for patients with CIDP, many of whom have been awaiting new treatment innovations. He expressed gratitude to Zai Lab for their collaboration in reaching CIDP patients in China and to the NMPA for approving the therapy.

In May of this year, China’s Centre for Drug Evaluation (CDE) accepted the sBLA for VYVGART Hytrulo with a priority review designation for CIDP. The following month, the CDE granted breakthrough status for the therapy. Additionally, in July, the NMPA approved efgartigimod for treating generalized myasthenia gravis, indicating continued progress in addressing autoimmune disorders in China.

This approval of VYVGART Hytrulo marks a significant advancement in the treatment of CIDP, offering new hope and a pioneering solution for patients in China who have long been in need of effective therapy options.