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Zai Lab's Application for Priority Review of Efgartigimod Alfa Injection Accepted for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in China

Wednesday, May 15, 2024

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for efgartigimod alfa injection (efgartigimod SC) aimed at treating chronic inflammatory demyelinating polyneuropathy (CIDP). This marks a significant advancement in potentially offering a treatment option for CIDP patients in China, where the disease affects around 50,000 diagnosed individuals. Currently, only a small proportion of patients find relief through corticosteroids and intravenous immunoglobulin (IVIg) treatment, the current standard of care.

Dr. Harald Reinhart, President and Head of Global Development, Neuroscience, Autoimmune & Infectious Diseases at Zai Lab, highlighted their commitment to developing meaningful therapies for patients in China alongside their partner argenx. He emphasized, “Achieving this milestone helps demonstrate our capabilities and commitment to develop and deliver meaningful and differentiated therapies to patients in China with our partner argenx.”

The sBLA application draws support from the ADHERE study (NCT04281472), a multicenter, randomized, double-blind, placebo-controlled trial assessing efgartigimod SC for CIDP treatment. Patients from Greater China were enrolled in the study, and their treatment response aligned with global study outcomes. Notably, Chinese participants showed a 69% reduction in relapse rates with efgartigimod SC compared to placebo, with 78% demonstrating evidence of clinical improvement during the open-label portion of the study.

In addition to CIDP, Zai Lab previously launched VYVGART® (efgartigimod alfa injection) for generalized myasthenia gravis (gMG) in mainland China, making it the first and only approved FcRn antagonist for these gMG patients.

CIDP treatment options in China are currently limited, primarily relying on corticosteroids and IVIg, with plasma exchange (PLEX) used for refractory cases. Given the need for effective, well-tolerated, and convenient treatments, there is a significant unmet need for alternative therapies in this patient population.

The ADHERE trial, sponsored by argenx, enrolled 322 adult patients with CIDP across different regions, including Greater China. The trial consisted of an open-label Stage A followed by a randomized, placebo-controlled Stage B, with patients having the option to roll over to an open-label extension study after Stage B.

VYVGART Hytrulo, a subcutaneous combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), facilitates subcutaneous injection delivery of biologics. It is the first and only approved FcRn blocker administered by subcutaneous injection.

Zai Lab holds an exclusive license agreement with argenx to develop and commercialize efgartigimod in Greater China for various autoimmune indications with significant unmet patient needs.



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