Zai Lab (NASDAQ:ZLAB) reported $108.2 million in third-quarter revenue and said it expects to return to year-over-year product revenue growth in 2027, while advancing its lead cancer drug candidate toward potential U.S. regulatory submissions next year.
Founder, CEO and Chairperson Samantha Du said the company expects three registrational studies of zoci to be underway by year-end across small cell lung cancer and neuroendocrine carcinomas. Zai Lab anticipates two registrational results and its first potential U.S. biologics license application in 2027, with a possible U.S. launch as early as 2028.
The timing depends on clinical results and regulatory decisions. Zai Lab also said an approximately $250 million equity financing completed in October strengthened its ability to fund its development plans.
Zoci Studies Target Multiple Cancer Settings
President and Head of Global Research and Development Rafael Amado reviewed first-line small cell lung cancer data presented at the ESMO conference from a global Phase 1 study of zoci, a DLL3-targeting antibody-drug conjugate, combined with atezolizumab.
Among 33 efficacy-evaluable, previously untreated patients receiving the selected zoci dose, the combination produced a confirmed objective response rate of 81.8%. Estimated six-month progression-free survival was 81.9%, Amado said. Among the first 15 patients, with a median follow-up of 10 months, median progression-free survival and duration of response had not been reached; 10 had not progressed at the data cutoff.
Amado said grade 3 or higher zoci-related adverse events occurred in 9.1% of patients receiving the selected-dose combination, and there was one case of grade 1 interstitial lung disease. He compared the results with historical outcomes for chemotherapy plus immunotherapy, although the reported Phase 1 findings were not from a randomized comparison.
Zai Lab plans to advance the zoci-immunotherapy combination into a global randomized Phase 3 study. It is also studying combinations with T-cell engagers through collaborations with Amgen and BI. Amado said the Amgen study began with patients whose disease had progressed on tarlatamab and that the company hopes to evaluate a triplet in previously untreated patients.
In later-line small cell lung cancer, the Phase 3 DLLEVATE trial has overall survival as its primary endpoint. Amado said a formal interim analysis could support an accelerated approval application based on response rate. The analysis is expected to include 200 patients, with follow-up of six months after the first scan to assess response durability. Zai Lab said the potential 2027 filing is contingent on enrolling sufficient patients previously treated with tarlatamab, in addition to second-line patients.
Zai Lab has also completed enrollment in a Phase 1/2 study of zoci in second-line extrapulmonary neuroendocrine carcinomas. Amado said the company plans to present preliminary results and is pursuing a potential accelerated approval based on single-arm data, with final results and a possible submission expected in 2027.
Amado said Zai Lab has discussed a confirmatory first-line study design with the U.S. Food and Drug Administration and plans to start it early next year. He said the study needs to be well underway before the regulatory action date for a potential accelerated approval application.
Commercial Business Stabilizes
Chief Financial Officer Yajing Chen said net product revenue rose 2% sequentially and the China commercial business remained profitable. Research and development and selling, general and administrative expenses were relatively stable compared with the prior-year period, she said.
Chen said ZEJULA maintained its competitive position amid volume-based pricing dynamics and competition, while VYVGART volumes grew sequentially and KarXT gained traction ahead of potential inclusion on China’s National Reimbursement Drug List next year.
Operating Partner Yizhe Wang said anticipated volume expansion for VYVGART SubQ and KarXT, a return to growth for ZEJULA and relief from XACDURO supply constraints could support 2027 growth. Zai Lab ended September with $659.7 million in cash, before the October equity raise.
Immunology Data and U.S. Launch Planning
Zai Lab plans to present its first clinical data for ZL-1503, an internally developed bispecific antibody for atopic dermatitis, at a medical meeting the following week. Amado said the single-ascending-dose portion of the Phase 1 study in healthy volunteers met its prespecified endpoints. The company expects patient efficacy data and initial intravenous-to-subcutaneous bridging data next year and is planning Phase 2b development.
Asked whether Zai Lab would seek a partner for zoci, Du said the current plan is to advance the drug itself and that launch planning is underway. She added that the company would evaluate options that could accelerate patient access or increase shareholder value without changing the pace of development.
About Zai Lab (NASDAQ:ZLAB)
Zai Lab Ltd. (NASDAQ:ZLAB) is a biopharmaceutical company focused on discovering, developing and commercializing medicines for cancer and other serious diseases. Its research and development activities have included oncology, autoimmune and inflammatory disorders, neuroscience, infectious diseases and other areas of significant unmet medical need.
Founded in 2014, Zai Lab has built its business through a combination of internally developed programs and licensing or collaboration agreements with international pharmaceutical and biotechnology companies.
