Welcome to our dedicated page for Zai Lab news (Ticker: $ZLAB), a resource for investors and traders seeking the latest updates and insights on Zai Lab stock.
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Zai Lab announced the acceptance of a supplemental Biologics License Application (sBLA) for efgartigimod alfa injection (subcutaneous) for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in China. The application received priority review from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) on May 11, 2024. The decision is based on positive results from the ADHERE trial, showing a 69% reduction in relapse rates and 78% clinical improvement in Chinese participants. CIDP affects about 50,000 patients in China, with treatment options. The milestone reflects Zai Lab's expertise in developing and commercializing innovative treatments in China, with ongoing collaboration with argenx.
Zai Lab announced that China’s NMPA has approved AUGTYRO™ (repotrectinib) for treating ROS1-positive NSCLC based on the TRIDENT-1 trial, showing high response rates and durable responses. The drug addresses an unmet need for patients with treatment options due to resistance. The study demonstrated promising results, positioning repotrectinib as a potential new standard of care.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) reported a strong first quarter of 2024 with net product revenue of $87.1 million, a 39% year-over-year growth. The company highlighted VYVGART® sales of $13.2 million, regulatory reviews ongoing for several products, and a robust balance sheet with $750.8 million in cash. With plans for new launches in 2024 and a focus on profitability by 2025, Zai Lab is poised for significant growth.
