Zai Lab is rapidly advancing its internally developed oncology pipeline, with zocilurtatug pelitecan, or zoci, progressing from an Investigational New Drug application to global Phase 3 development in under two years.
Zoci is a DLL3-targeting antibody-drug conjugate that Zai Lab is developing across small cell lung cancer and extrapulmonary neuroendocrine carcinomas. Management described the candidate as potentially best-in-class and said its development speed reflects the maturation of Zai Lab’s global R&D capabilities.
The global Phase 3 DLLEVATE study is evaluating zoci in second-line and later extensive-stage small cell lung cancer. Enrollment is expected to be completed during the first half of 2027, followed by an interim analysis that could support a U.S. BLA submission for accelerated approval.
Zai Lab also expects to present initial Phase 1 data from zoci in combination with atezolizumab, with or without chemotherapy, in first-line small cell lung cancer at ESMO 2026. Subject to the emerging data and regulatory discussions, the company plans to initiate a registrational Phase 3 study in the second half of 2026.
The candidate has accumulated several regulatory designations. The FDA granted zoci Orphan Drug Designation for neuroendocrine carcinomas in July and Fast Track Designation for extrapulmonary neuroendocrine carcinomas in May, its second FDA Fast Track designation. The European Medicines Agency also granted Orphan Drug Designation for pulmonary neuroendocrine carcinomas.
Zai Lab expects three registrational studies across its global pipeline to be underway by the end of 2026, with the potential for the company’s first U.S. regulatory submission in 2027.
Beyond zoci, Zai Lab is advancing ZL-1503, a potential first-in-class long-acting IL-13/IL-31Rα bispecific antibody for atopic dermatitis. Initial first-in-human data are expected in the second half of 2026.
KEY QUOTES:
“Today, our innovation pipeline is rapidly maturing. We advanced zocilurtatug pelitecan (zoci), our potential best-in-class DLL3 antibody-drug conjugate (ADC), from Investigational New Drug (IND) to global Phase 3 in under two years.”
Dr. Samantha Du, Founder, Chairperson and CEO of Zai Lab
“We are excited about the progress across our growing global pipeline, with three registrational studies expected to be underway by year end and the potential for our first U.S. regulatory submission next year.”
Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab
