Biopharmaceutical company Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported on Monday that it has received Fast Track designation from the U.S. Food and Drug Administration for ZL-1310, a Delta-like ligand 3 (DLL3)-targeted antibody-drug conjugate, for the treatment of extensive-stage small cell lung cancer (ES-SCLC).

Currently under evaluation in a global Phase 1a/1b trial (NCT06179069), ZL-1310 is being developed using Zai Lab's proprietary TMALIN® platform, designed to enhance efficacy through targeted delivery in the tumor microenvironment. The compound previously secured Orphan Drug designation for SCLC.

Fast Track status enables Zai Lab to accelerate ZL-1310's development and regulatory review, offering benefits such as frequent FDA interactions and potential eligibility for Accelerated Approval and Priority Review. A pivotal study in SCLC is scheduled to begin in 2025.

Zai Lab will present updated clinical data at the 2025 American Society of Clinical Oncology Annual Meeting and hold an investor call to discuss results and development plans.

SCLC represents roughly 5% of the 2.5 million annual lung cancer cases globally, with two-thirds diagnosed at the extensive stage. DLL3 is highly expressed in these aggressive tumors and is associated with poor prognosis. ZL-1310 combines a humanised anti-DLL3 monoclonal antibody with a novel camptothecin payload, aiming to improve outcomes in a high-unmet-need population.