Zai Lab Announces Acceptance of Supplemental Biologics License Application with Priority Review for Efgartigimod Alfa Injection (Subcutaneous Injection) in Chronic Inflammatory Demyelinati...
Zai Lab Limited - American Depositary Shares (ZLAB)
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Source: Business Wire
sBLA submission based on positive results from the ADHERE trial, the first positive global neonatal FC receptor (FcRn) pivotal study for CIDPThere are currently no approved therapies available in China for this serious autoimmune diseaseMilestone underscores Zai Lab’s operational capabilities and deep expertise developing and commercializing innovative treatments in China across a broad range of diseases SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today 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 (subcutaneous injection) (efgartigimod SC) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The CDE granted priority review on May 11, 2024 and Breakthrough Therapy Designation for efgartigimod SC for the treatment of patients with CIDP on September 1
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ZLAB
News
- Zai Lab doses first subject in Phase II plaque psoriasis treatment trial [Yahoo! Finance]Yahoo! Finance
- Zai Lab Initiates Global Phase 2 Clinical Trial Evaluating ZL-1102 As a Topical Treatment for Chronic Plaque Psoriasis [Yahoo! Finance]Yahoo! Finance
- Zai Lab Initiates Global Phase 2 Clinical Trial Evaluating ZL-1102 As a Topical Treatment for Chronic Plaque PsoriasisBusiness Wire
- China's NMPA approves Zai Lab's XACDURO NDA for pneumonia [Yahoo! Finance]Yahoo! Finance
- Zai Lab and Innoviva Specialty Therapeutics Announce NMPA Approval for XACDURO® (Sulbactam-Durlobactam or SUL-DUR) for Hospital-Acquired and Ventilator-Associated Pneumonia Caused by Acinetobacter Baumannii-Calcoaceticus Complex in China [Yahoo! Finance]Yahoo! Finance
ZLAB
Earnings
- 11/7/23 - Beat
ZLAB
Sec Filings
- 5/16/24 - Form 4
- 5/15/24 - Form 4
- 5/14/24 - Form 144
- ZLAB's page on the SEC website