Zai Lab Limited (NASDAQ:ZLAB) (HKEX:9688), a research-based, commercial-stage biopharmaceutical company based in China and the United States, announced on Monday that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to zocilurtatug pelitecan (zoci, formerly ZL-1310), the company's potential first-in-class DLL3-targeting antibody-drug conjugate, for the treatment of neuroendocrine carcinomas (NECs).

NECs are aggressive malignancies that frequently express DLL3 and have limited treatment options, with no available targeted therapies or approved standard of care for previously treated patients.

This designation follows prior FDA Fast Track Designation for zoci in extrapulmonary NECs, as well as Fast Track and Orphan Drug Designation for small cell lung cancer (SCLC), the most significant pulmonary NEC and one of the most aggressive and lethal solid tumours. The European Medicines Agency (EMA) has also granted Orphan Drug Designation to zoci for pulmonary NECs.

The FDA's Orphan Drug Designation provides eligibility for development incentives, including potential fee waivers, clinical trial tax credits and a possible seven-year US market exclusivity period upon product approval.

Zai Lab is developing zoci as a potential targeted treatment option across a range of NECs.