China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced the receipt of supplementary Biologic License Application (sBLA) approval from the National Medical Products Administration (NMPA) for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows Vygart Hytrulo to be used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating immune-mediated peripheral nervous system disorder.
Vygart Hytrulo: First CIDP Therapy in China
Vygart Hytrulo is the first and currently the only CIDP therapy available in China. It combines efgartigimod alfa, a human IgG1 antibody fragment marketed as Vygart, with recombinant human hyaluronidase PH20 (rHuPH20), utilizing Halozyme’s Enhanze drug delivery technology to facilitate subcutaneous injection delivery of biologics. Zai Lab acquired rights to the drug through a licensing deal with argenx in 2021, which was followed by marketing approval for use in generalized myasthenia gravis (gMG) in July of this year.
Regulatory Approval Based on ADHERE Study
The NMPA’s regulatory decision is based on positive results from the ADHERE study, a multi-center, randomized, double-blinded, placebo-controlled trial assessing Vygart Hytrulo in CIDP. The study included an open-label phase, where patients who responded to the treatment entered a randomized, placebo-controlled phase. Subgroup analysis of Chinese subjects demonstrated that Vygart Hytrulo reduced the risk of recurrence by 69% compared to placebo. The safety and tolerability of weekly efgartigimod alfa subcutaneous injections in the Chinese patient cohort were consistent with those observed in the global study participants.-Fineline Info & Tech
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