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argenx’s Vygart Hytrulo Approved in Japan for Chronic Inflammatory Demyelinating Polyneuropathy
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Holland-based argenx SE (NASDAQ: ARGX) has announced receiving another indication approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows the drug to be used for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), who can…
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Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy
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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…
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J&J Files NDA for FcRn Blocker Nipocalimab, Targets Myasthenia Gravis Market
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US-based Johnson & Johnson (NYSE: JNJ) has made a global first New Drug Application (NDA) filing with the US FDA for its FcRn blocker nipocalimab. The drug’s initial indication is anticipated to be for the treatment of adults with generalized myasthenia gravis (gMG) who test positive for certain antibodies. This…
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Zai Lab’s Partner Argenx Receives FDA Approval for CIDP Treatment Vygart Hytrulo
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Argenx SE (NASDAQ: ARGX), the U.S. partner of China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), has announced that the U.S. Food and Drug Administration (FDA) has granted approval for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).…
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Zai Lab and argenx Report Positive Preliminary Results from Vyvgart Hytrulo CIDP Study
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China-based Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its Netherlands-based partner argenx SE (NASDAQ: ARGX) have announced preliminary positive results from the ADHERE study. The study assessed the effects of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The ADHERE trial is the…
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Zai Lab’s Vyvgart Receives NMPA Review for Subcutaneous Injection Form in gMG Treatment
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China-based Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced that the National Medical Products Administration (NMPA) has accepted for review a Biologics License Application (BLA) for Vyvgart (efgartigimod alfa) in subcutaneous injection form. The intended indication is for adult patients with generalized myasthenia gravis (gMG). Exclusive Rights and Prior…
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Zai Lab’s Vyvgart Receives NMPA Approval as First-in-Class FcRn Antagonist for Myasthenia Gravis
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has approved its Biologics License Application (BLA) for Vyvgart (efgartigimod alfa injection). Vyvgart, a first-in-class neonatal Fc receptor (FcRn) antagonist, is now approved for use as an add-on to standard…
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Zai Lab’s Efgartigimod NDA Accepted by NMPA for Myasthenia Gravis
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Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for efgartigimod, the world’s first FcRn antagonist, targeting generalized myasthenia gravis (MG). Drug ProfileEfgartigimod, developed by Netherlands-based Argenx and licensed to Zai Lab in January 2024 for up…
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Zai Lab Ltd Makes FcRn Antagonist Efgartigimod Available for Myasthenia Gravis Treatment
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Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced the availability of efgartigimod, the world’s first FcRn antagonist, via the Bo’Ao Lecheng Medical Tourism Pilot Zone for the treatment of myasthenia gravis (MG). Understanding Myasthenia GravisMyasthenia gravis is a rare and chronic autoimmune disease caused by the dysfunction of nerve…
