Zai Lab and argenx Announce Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in China
Zai Lab Limited - American Depositary Shares (ZLAB)
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Source: Business Wire
First and only NMPA-approved treatment for patients with CIDP in ChinaThird approval for efgartigimod franchise in China demonstrating Zai Lab’s deep expertise developing innovative treatments across a broad range of diseases SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & Nasdaq: ARGX) today announced that China’s National Medical Products Administration (NMPA) approved the supplemental Biologics License Application (sBLA) for VYVGART Hytrulo 1,000mg (5.6ml)/vial [Efgartigimod Alfa Injection (Subcutaneous Injection)] for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only therapy approved in China for the treatment of CIDP, a debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system.“We are pleased to receive NMP
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News
- Zai Lab Announces Proposed Public Offering of American Depositary Shares [Yahoo! Finance]Yahoo! Finance
- Zai Lab Announces Proposed Public Offering of American Depositary SharesBusiness Wire
- Zai Lab Ltd (ZLAB) Q3 2024 Earnings Call Highlights: Strong Revenue Growth and Path to Profitability [Yahoo! Finance]Yahoo! Finance
- Compared to Estimates, Zai Lab Limited (ZLAB) Q3 Earnings: A Look at Key Metrics [Yahoo! Finance]Yahoo! Finance
- Zai Lab and argenx announce NMPA approval for sBLA for VYVGART Hytrulo [Yahoo! Finance]Yahoo! Finance
ZLAB
Earnings
- 11/12/24 - Beat
ZLAB
Sec Filings
- 11/13/24 - Form 8-K
- 11/12/24 - Form 10-Q
- 11/12/24 - Form 8-K
- ZLAB's page on the SEC website