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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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On June 3, 2022, Zai Lab (NASDAQ: ZLAB) and Novocure announced promising results from the EF-31 Phase 2 pilot study for Tumor Treating Fields (TTFields) in treating gastric adenocarcinoma. The study achieved a 50% objective response rate and a one-year survival rate of 72%. Patients experienced a median progression-free survival of 7.8 months and a duration of response lasting 10.3 months. TTFields therapy demonstrated good tolerability with no significant increase in toxicity. This represents a significant step forward in managing a challenging cancer.
Novocure (NASDAQ: NVCR) and Zai Lab (NASDAQ: ZLAB) announced promising results from their EF-31 phase 2 study on Tumor Treating Fields (TTFields) combined with the XELOX chemotherapy regimen for gastric adenocarcinoma. The study achieved a confirmed objective response rate of 50%, with a median progression-free survival of 7.8 months and a duration of response of 10.3 months. The one-year survival rate stood at 72%. TTFields therapy demonstrated good tolerability, with no significant increase in systemic toxicity. These results pave the way for future clinical studies.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced new findings from a subgroup analysis of the Phase 3 PRIME study on niraparib maintenance therapy for advanced ovarian cancer patients in China. The study showed that niraparib significantly extends progression-free survival (PFS) for patients who responded to first-line platinum-based chemotherapy, with a median PFS of 29.4 months versus 8.3 months for placebo in those with complete response. Results were presented at the 2022 ASCO Annual Meeting, emphasizing the importance of niraparib in treating advanced ovarian cancer.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced its participation in two major investor conferences in June 2022, aimed at enhancing investor relations. Management will present at the Jefferies Global Healthcare Conference on June 9 at 9:00 a.m. ET, followed by a Fireside Chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on June 16 at 9:20 a.m. PT. These presentations will be accessible via webcast on the company’s website, with archived replays available for 90 days. Zai Lab focuses on innovative therapies for oncology, autoimmune disorders, and infectious diseases.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced a change in the format of its 2022 Annual General Meeting due to COVID-19 pandemic restrictions in Shanghai. The Annual Meeting will be held virtually on June 22, 2022, at 8:00 a.m. U.S. Eastern Time. Shareholders of record can attend by visiting the dedicated website and using their control number from proxy materials. Zai Lab remains focused on developing therapies for unmet medical needs across oncology, autoimmune disorders, infectious diseases, and neuroscience.
Zai Lab reported Q1 2022 revenues of $46.7 million, up from $20.1 million in Q1 2021, driven by substantial growth in its marketed products. ZEJULA's product revenue was $29.6 million, and Optune reached $12.8 million.
R&D expenses decreased to $53.9 million due to the absence of upfront licensing fees. However, SG&A expenses rose to $57.0 million, reflecting investment in commercial operations. Zai Lab's net loss was $82.4 million, significantly lower than the $232.9 million loss in the same quarter last year. Cash reserves totaled $1.31 billion.
Zai Lab announced positive results from the Phase 3 ADVANCE trial of VYVGART for chronic immune thrombocytopenia (ITP). The trial met its primary endpoint, showing 21.8% of patients on VYVGART achieved a sustained platelet response, compared to 5% on placebo (p=0.0316). Significant benefits were also observed in key secondary endpoints related to platelet counts. VYVGART maintained a consistent safety profile. With 131 patients enrolled, this trial positions VYVGART as a promising treatment option for ITP, with topline data from the subsequent ADVANCE-SC trial expected in Q1 2023.
Zai Lab (NASDAQ: ZLAB) and Turning Point Therapeutics announced encouraging topline results from the Phase 1/2 TRIDENT-1 study of repotrectinib in China. The study demonstrated a 91% confirmed objective response rate (cORR) in the TKI-naïve cohort, with a duration of response (DOR) follow-up of 3.7 months. In three TKI-pretreated cohorts, cORR ranged from 36%-67%. Zai Lab plans to discuss these results with Chinese health authorities in Q4 2022, aiming to advance their regulatory pathway. The TRIDENT-1 study continues to enroll patients globally.
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) has engaged KPMG as its independent registered public accounting firm to facilitate compliance with U.S. audit requirements under the Holding Foreign Companies Accountable Act. This strategic move aims to ensure the company's continued listing on Nasdaq. The engagement of KPMG, based in the United States, will cover annual consolidated financial statements and internal controls over financial reporting for the fiscal year ending December 31, 2022. The transition was amicable, with no unresolved issues with the previous auditor.
Zai Lab Limited (NASDAQ: ZLAB) has announced it will report its financial results for Q1 2022 on May 10, 2022, following market close. The company will host a conference call and webcast on May 11, 2022, at 8:00 a.m. ET. Zai Lab is focused on developing therapies for unmet medical needs in oncology, autoimmune disorders, infectious diseases, and neuroscience. It aims to become a leading global biopharmaceutical company through innovative product development and strategic partnerships.