argenx and Zai Lab Announce China Approval of VYVGART Hytrulo for CIDP

In a significant development, argenx SE and Zai Lab Limited 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. This medication, which involves efgartigimod alfa administered via subcutaneous injection, is designed for adult patients suffering from chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is unique as it is the first therapy in China approved specifically for CIDP, a progressive, immune-mediated disorder affecting the peripheral nervous system. The treatment involves a quick subcutaneous injection administered once a week.

Tim Van Hauwermeiren, the Chief Executive Officer of argenx, expressed gratitude towards their partners at Zai Lab for their collaboration in bringing this innovative treatment to CIDP patients in China. He emphasized the shared commitment to patient welfare and highlighted the milestone achieved with the NMPA's approval. Van Hauwermeiren also noted Zai Lab’s history of effective execution and looked forward to continuing their partnership to reach more patients in China, a rapidly growing market.

Dr. Rafael G. Amado, President and Head of Global Research and Development at Zai Lab, described the NMPA's approval as a significant breakthrough for CIDP patients in China. He underscored the importance of providing a new treatment option to patients who have been waiting for an effective solution. Dr. Amado thanked the NMPA for their thorough evaluation and acknowledged the unmet medical needs of CIDP patients in China. He also mentioned the ongoing efforts to explore other autoimmune indications mediated by immunoglobulin G (IgG).

CIDP is a debilitating disease that affects approximately 50,000 people in China. Professor Ting Chang, Deputy Chief Physician and Associate Professor at the Department of Neurology, Tangdu Hospital, noted that current treatment options like corticosteroids and plasma-derived therapies are insufficient for many patients, and existing treatments pose significant challenges. VYVGART Hytrulo aims to offer a new, safe, and effective option that could improve disease symptoms and reduce treatment burdens.

The approval by the NMPA is supported by positive results from the ADHERE study, a multicenter, randomized, double-blind, placebo-controlled trial evaluating VYVGART Hytrulo for CIDP treatment. This study included an initial open-label period to identify responders who then continued into a randomized-withdrawal, double-blinded phase. Zai Lab participated in enrolling patients from Greater China into this trial, with the treatment response mirroring global outcomes. A subgroup analysis showed a 69% reduction in relapse risk among Chinese participants treated with VYVGART Hytrulo compared to those given a placebo. Additionally, 78% of Chinese participants in the study's open-label period exhibited clinical improvements, affirming the role of IgG autoantibodies in CIDP's underlying biology. The safety and tolerability profile observed in Chinese patients was consistent with global trial data.

In May 2024, Zai Lab announced that the Centre for Drug Evaluation (CDE) accepted the sBLA with a priority review designation for VYVGART Hytrulo targeting CIDP in China. The CDE also granted Breakthrough Therapy Designation for this treatment in September 2023.

VYVGART Hytrulo is a subcutaneous product combining efgartigimod alfa, a human IgG1 antibody fragment, with recombinant human hyaluronidase PH20 (rHuPH20), facilitated by Halozyme’s ENHANZE® drug delivery technology. This results in a 1,000 mg dose delivered over 30-to-90 seconds weekly. The treatment can be administered by healthcare professionals or by patients and caregivers at home, following adequate training. The product is marketed under various names in different regions and has approvals in the United States, the European Union, Japan, and China for treating generalized myasthenia gravis (gMG) and CIDP.

Zai Lab holds an exclusive licensing agreement with argenx to develop and commercialize efgartigimod in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. CIDP remains a significant medical challenge in China, with current treatments being limited primarily to corticosteroids and intravenous immunoglobulin (IVIg), and plasma exchange (PLEX) generally reserved for refractory cases. This new treatment is expected to fulfill a critical unmet need for effective, well-tolerated therapies for CIDP patients in China.