- 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).

The designation follows a positive opinion from the EMA's Committee for Orphan Medicinal Products (COMP), recognizing both the seriousness of neuroendocrine carcinomas and the need for new treatment options. Small cell lung cancer (SCLC) is the most significant pulmonary NEC, accounting for around 15% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year (an estimated 375,000 new cases annually), and is one of the most aggressive and lethal solid tumors. 1,2

In granting the designation, the COMP noted that preliminary clinical data in patients with relapsed or refractory extensive-stage SCLC suggest zoci may offer a more favorable effect than currently authorized therapies, including durable responses, a finding the Committee characterized as a clinically relevant advantage.

The U.S. FDA previously granted Fast Track designation (FTD) and ODD to zoci for SCLC. The FDA also recently granted FTD to zoci for extrapulmonary NECs (epNECs).