ZLAB News & Events

Zai Lab announced changes to its senior leadership team aimed at strengthening operational performance and efficiency. As part of these changes, the Board has made the decision that Josh Smiley, President and COO, will no longer be with the company, effective Friday, May 22. Zai Lab anticipates multiple clinical data readouts in 2026 for its lead global investigational therapies, including zoci in first-line ES-SCLC and extrapulmonary NECs, and ZL-1503, with a first-in-human data readout from the global Phase 1/1b study. The company is also preparing for the launch of COBENFY in China and for multiple anticipated regional regulatory approvals and expected data readouts.

Zai Lab announced the U.S. Food and Drug Administration has granted Fast Track Designation to zocilurtatug pelitecan, the Company's potential first-in-class Delta-like ligand 3-targeting antibody-drug conjugate, for the treatment of extrapulmonary neuroendocrine carcinomas following progression after standard first-line therapy. epNECs are an aggressive malignancy affecting approximately 100,000 people worldwide, with no targeted therapies and no approved standard of care in previously treated disease. Zai Lab reported promising preliminary data from an ongoing registration-enabling multicenter, Phase 1b/2 clinical trial of zoci in patients with epNEC and other selected solid tumors at the American Association for Cancer Research Annual Meeting 2026 last month. In heavily pretreated patients enrolled in the Phase 1b/2 study, zoci demonstrated encouraging antitumor activity, including an objective response rate of 38.2%. Zoci also demonstrated a manageable safety profile-neutrophil count decrease was the only grade greater than or equal to3 treatment-related adverse event occurring in more than one patient.

Reports Q1 revenue $99.6M, consensus $108.43M. "We continue to accelerate the development of our global pipeline, with numerous clinical trials underway across oncology and immunology," said CEO Samantha Du. "During the quarter, we made strong progress advancing zoci, with AACR data reinforcing its differentiated profile in both SCLC and epNECs, collaborations with Amgen and Boehringer Ingelheim to evaluate zoci as a potential backbone therapy, and rapid enrollment in the registrational DLLEVATE study...We also continue to advance our growing portfolio of global clinical programs, including ZL-1503 for atopic dermatitis...At the same time, our commercially profitable regional business provides a stable foundation, with several near-term opportunities expected to support future growth." "We are deepening our presence in key markets to capitalize on underlying demand for VYVGART and are expanding our regional footprint as we prepare for the launch of KarXT in China in Q2," said COO Josh Smiley. "KarXT's launch positions us to bring the first novel therapy in decades to this critical market, with potential NRDL inclusion next year. In addition, we anticipate a potential regulatory approval for TIVDAK this year, and with positive Phase 3 readouts for povetacicept and elegrobart, we have additional opportunities for future growth."