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.
Zai Lab Limited (ZLAB) is a research-based, commercial-stage biopharmaceutical company based in China and the United States, with a focus on oncology, immunology, neuroscience, and infectious disease. The Zai Lab news feed on Stock Titan aggregates company announcements, clinical updates, regulatory milestones, and financial disclosures that the company releases through channels such as Business Wire and SEC filings.
Investors and followers of ZLAB stock can use this page to review news on Zai Lab’s global pipeline, including progress of assets like zocilurtatug pelitecan (zoci), a DLL3-targeted antibody-drug conjugate for extensive-stage small cell lung cancer and other neuroendocrine carcinomas, and ZL-1503, an IL-13/IL-31R bispecific antibody for atopic dermatitis. Updates on other oncology and immunology programs, such as ZL-6201, ZL-1222, and ZL-1311, also appear in company press releases.
The news stream highlights regulatory developments in Greater China, including National Medical Products Administration (NMPA) approvals and National Reimbursement Drug List (NRDL) decisions for products in Zai Lab’s commercial portfolio. Recent examples include announcements about COBENFY for schizophrenia and AUGTYRO for ROS1-positive non-small cell lung cancer and NTRK-positive solid tumors, as well as renewals and coverage decisions for VYVGART, NUZYRA, and ZEJULA.
In addition, this page surfaces Zai Lab’s financial result releases, conference call notices, and participation in healthcare and investor conferences. These items provide context on revenue trends, R&D spending, and the company’s dual-engine strategy combining a China commercial business with a global innovation platform. Bookmark this page to quickly access ZLAB-related news, organized in one place for efficient review of the company’s ongoing clinical, regulatory, and corporate developments.
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.
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.