Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

Zai Lab Receives EMA Orphan Drug Designation for Zocilurtatug Pelitecan (Zoci) in Pulmonary Neuroendocrine Carcinomas

- European Medicines Agency’s Committee for Orphan Medicinal Products recognized zoci’s preliminary clinical data as suggestive of a clinically relevant advantage over currently authorized therapies in relapsed or refractory extensive-stage small cell lung cancer (SCLC)

- SCLC is the most significant pulmonary neuroendocrine carcinoma (NEC), affecting an estimated 375,000 patients annually worldwide, with limited treatment options

- EMA designation for zoci in pulmonary NECs closely follows receipt of Fast Track designation from the U.S. Food and Drug Administration for zoci in extrapulmonary neuroendocrine carcinomas (epNECs) and promising data presented at the AACR Annual Meeting in April 2026

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the European Medicines Agency (EMA) 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)-targeting antibody-drug conjugate (ADC), for the treatment of pulmonary neuroendocrine carcinomas (NECs).