- NECs are aggressive malignancies with poor prognoses and limited treatment options, representing significant unmet patient need

- U.S. FDA Orphan Drug Designation (ODD) follows receipt of ODD for zoci in pulmonary NECs from the European Medicines Agency, reinforcing zoci’s first-in-class potential in a range of NECs

Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))) today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company’s potential first-in-class Delta-like ligand 3 (DLL3) antibody-drug conjugate (ADC), for the treatment of neuroendocrine carcinomas (NECs). NECs are aggressive malignancies that frequently express DLL3. There are no available targeted therapies and no approved standard of care for NECs in previously treated patients.

The U.S. FDA previously granted Fast Track designation (FTD) to zoci for extrapulmonary NECs (epNECs), as well as FTD and ODD to zoci for small cell lung cancer (SCLC), the most significant pulmonary NEC and one of the most aggressive and lethal solid tumors.1,2 The European Medicines Agency (EMA) has also granted ODD to zoci for pulmonary NECs.

Benefits of the ODD include eligibility for certain development incentives, including a waiver of the Prescription Drug User Fee Act registration application fee; tax credits for certain clinical trials; and the potential to receive a seven-year U.S. market exclusivity period granted upon product approval.