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Zai Lab Limited (ZLAB) is a global biopharmaceutical innovator developing therapies for oncology, autoimmune disorders, and infectious diseases. This news hub provides verified updates on clinical advancements, regulatory milestones, and strategic partnerships critical to investors and healthcare professionals.
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Zai Lab and Innoviva Specialty Therapeutics have received approval from China's National Medical Products Administration (NMPA) for XACDURO® (sulbactam-durlobactam), a new treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex in adults. This approval is based on positive results from the global Phase 3 ATTACK trial, which demonstrated XACDURO's non-inferiority to colistin in reducing 28-day all-cause mortality and significantly improving clinical cure rates. The drug addresses the urgent need for effective treatments against carbapenem-resistant bacterial strains, which account for approximately 74% of Acinetobacter infections in China. This milestone follows the FDA's approval of XACDURO in the U.S. in May 2023, marking it as the first FDA-approved pathogen-targeted therapy for this condition.
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) announced its senior management team participation in three key investor conferences in May and June 2024. The events include the J.P. Morgan 20th Annual Global China Summit on May 23 in Shanghai, the Jefferies Global Healthcare Conference on June 5 in New York, and the Goldman Sachs 45th Annual Global Healthcare Conference on June 12 in Miami Beach. These conferences offer Zai Lab an opportunity to discuss its strategies, recent developments, and future plans with global investors.
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.
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