Zai Lab and argenx announce NMPA approval for sBLA for VYVGART Hytrulo [Yahoo! Finance]
Zai Lab Limited - American Depositary Shares (ZLAB)
US:NASDAQ Investor Relations:
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Source: Yahoo! Finance
license application (sBLA) for VYVGART Hytrulo 1,000mg vial for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. This once-weekly 30-90-second subcutaneous (SC) injection reportedly marks the first and only approval in China for a therapy to treat this immune-mediated neuromuscular disorder of the peripheral nervous system. The approval is based on the positive outcome of the randomised, double-blind, placebo-controlled multicentre ADHERE study. The trial comprised an open-label period to detect responders, followed by a randomised-withdrawal, double-blinded period to further evaluate the therapy. Patients from the Greater China region were enrolled in the ADHERE trial by Zai Lab, and the treatment response observed was in line with global study results. A 69% reduction in the risk of relapse with VYVGART Hytrulo compared to placebo was shown in a subgroup analysis of Chinese individuals. Furthermore, 78% of Chinese individuals showed clinical imp
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ZLAB
Earnings
- 11/12/24 - Beat
ZLAB
Sec Filings
- 12/13/24 - Form 4
- 11/15/24 - Form 8-K
- 11/15/24 - Form 424B5
- ZLAB's page on the SEC website