VYVGART Hytrulo Approved for CIDP in China, Announce Zai Lab and argenx

Zai Lab Limited and argenx announced that China’s National Medical Products Administration (NMPA) has approved the supplemental Biologics License Application (sBLA) for VYVGART Hytrulo for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). This approval marks the first and only therapy available in China for this debilitating, progressive immune-mediated neuromuscular disorder.

Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab, expressed his satisfaction with the NMPA's approval, emphasizing the significant impact this treatment will have on CIDP patients in China. He mentioned the thorough assessment and recognition by the NMPA of the therapy's unique profile and the unmet medical need in the country. Amado also highlighted the ongoing collaboration with argenx to explore the potential of this therapy in other autoimmune conditions mediated by Immunoglobulin G (IgG).

Tim Van Hauwermeiren, CEO of argenx, reiterated the importance of VYVGART Hytrulo as a precision therapy for CIDP patients. He thanked Zai Lab for their collaboration in making this therapy accessible to Chinese patients and praised the NMPA for their approval. Van Hauwermeiren also noted Zai Lab’s strong track record and commitment to patient care, looking forward to continuing their partnership to benefit more patients in China.

CIDP is a serious condition affecting roughly 50,000 individuals in China. Current treatment methods, including corticosteroids and plasma-derived therapies, often fail to achieve remission for many patients. Prof. Ting Chang from Tangdu Hospital pointed out the limitations and challenges of existing treatments and described VYVGART Hytrulo as a new, safe, and effective option that can improve and stabilize symptoms, reducing the treatment burden for patients.

The approval by the NMPA is based on positive results from the ADHERE study, a multicenter, randomized, double-blind, placebo-controlled trial. The study demonstrated a 69% reduction in the risk of relapse among Chinese participants treated with VYVGART Hytrulo compared to placebo. Additionally, 78% of these participants showed clinical improvement, confirming the role of IgG autoantibodies in CIDP. The safety and tolerability profile in Chinese patients was consistent with global data.

In May 2024, Zai Lab announced that the Centre for Drug Evaluation (CDE) accepted the sBLA with priority review designation for VYVGART Hytrulo for CIDP in China. This designation was granted as a Breakthrough Therapy for CIDP in September 2023.

VYVGART Hytrulo is a subcutaneous injection consisting of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20 (rHuPH20). The product is administered weekly, with a 1,000 mg fixed dose delivered over 30-to-90 seconds. It can be given by a healthcare professional or self-administered at home after proper training. The therapy is also approved in the U.S., EU, Japan, and China for other indications, including generalized myasthenia gravis (gMG).

Zai Lab, based in China and the United States, focuses on developing and commercializing innovative biopharmaceutical products for conditions with significant unmet needs. argenx, a global immunology company, aims to improve the lives of people suffering from severe autoimmune diseases through novel antibody-based medicines. The ongoing partnership between Zai Lab and argenx continues to expand the reach of VYVGART Hytrulo to patients in need.