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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 has secured exclusive rights to develop and commercialize TIVDAK, an FDA-approved antibody-drug conjugate for recurrent or metastatic cervical cancer, in Mainland China, Hong Kong, Macau, and Taiwan. The agreement includes an upfront payment of $30 million to Seagen, plus milestone payments and royalties shared with Genmab. With approximately 110,000 new cervical cancer cases annually in China and limited treatment options, Zai Lab aims to expand patient access and support ongoing clinical trials such as InnovaTV 301.
Zai Lab has secured exclusive rights to develop and commercialize TIVDAK, an FDA-approved antibody-drug conjugate, in Mainland China, Hong Kong, Macau, and Taiwan. The collaboration with Seagen involves a $30 million upfront payment, milestone payments, and shared royalties. TIVDAK addresses a significant unmet need in treating recurrent or metastatic cervical cancer, with 110,000 new cases annually in China. Ongoing clinical trials underpin the therapeutic potential of TIVDAK in various cancer treatments.
Zai Lab Limited announces new findings from the Phase 3 PRIME study of ZEJULA® (niraparib), showing improved efficacy in treating advanced ovarian cancer when maintenance therapy is initiated within 12 weeks after completing first-line platinum-based chemotherapy. The study demonstrated a significant increase in median progression-free survival (PFS): 29.4 months versus 8.3 months for treatment started within 9 weeks, and 24.7 months versus 10.8 months for treatment started between 9-12 weeks. The findings will be presented at the 2022 ICGS Annual Meeting.
On August 23, 2022, Zai Lab Limited (NASDAQ: ZLAB) announced participation in several investor conferences in September. These include the 5th HKEX Biotech Summit on September 1, Citi’s 17th Annual BioPharma Conference on September 8, and others in New York. The events will feature presentations and panel discussions aimed at advancing their mission to provide transformative medicines. Zai Lab operates in oncology, autoimmune disorders, infectious diseases, and neurological disorders, focusing on improving global human health.
Zai Lab Limited (NASDAQ: ZLAB) reported strong financial results for Q2 2022, with total revenues increasing to $48.2 million, up from $36.9 million year-over-year. The company's product revenue surged significantly for ZEJULA, totaling $34.1 million, while revenues for QINLOCK fell to $0.6 million. Zai Lab's cash position remains robust at $1.26 billion. Notably, the BLA for efgartigimod was accepted by China's NMPA, and positive results were achieved in the Phase 3 EMERGENT-2 trial for KarXT. The company anticipates continued growth and has outlined strategic milestones for the remainder of 2022.
Zai Lab Limited (NASDAQ: ZLAB) will announce its financial results for Q2 2022 on August 9, after U.S. market close. The company will hold a conference call and webcast on August 10 at 8:00 a.m. ET to discuss these results and provide corporate updates. Interested participants must register in advance for the call. Zai Lab focuses on innovative biopharmaceutical solutions for oncology, autoimmune disorders, infectious diseases, and neurological conditions, aiming to improve global health.
Zai Lab announced that its shares are now included in the Shanghai-Hong Kong Stock Connect program, effective today. This inclusion provides mainland Chinese investors greater access to Zai Lab’s shares, complementing its prior inclusion in the Shenzhen-Hong Kong Stock Connect since June 2022. The dual-primary listing on Nasdaq and the Hong Kong Stock Exchange enhances Zai Lab’s market presence. CFO Billy Cho highlighted the potential for expanding the shareholder base and accelerating growth in developing transformative medicines.
Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for efgartigimod alfa injection, the first FcRn antagonist for treating generalized myasthenia gravis (gMG) in adults. This milestone is pivotal for the estimated 200,000 gMG patients in China facing limited treatment options. Efgartigimod has previously received FDA and Japanese MHLW approvals. The drug specifically targets disease-causing autoantibodies, aiming for an effective therapy with minimal side effects.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has successfully transitioned from a secondary to a primary listing on the Hong Kong Stock Exchange, marking a first for any company. This dual-primary listing enhances access for investors and broadens Zai Lab's shareholder base, thereby improving liquidity and visibility in global markets. The move is aligned with Zai Lab's strategy to attract investors and leverage the potential of the China-Hong Kong Stock Connect, which will facilitate trading for Chinese investors. This shift underscores the company's commitment to improving healthcare solutions worldwide.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced that the Center for Drug Evaluation (CDE) in China granted two Breakthrough Therapy Designations for repotrectinib, a treatment for ROS1-positive metastatic non-small cell lung cancer (NSCLC). These designations are for patients who have previously received specific lines of treatment. The recognition underscores repotrectinib's potential as a leading therapy for ROS1-positive NSCLC. The company aims to expedite the drug's availability for patients in need.