obrixtamig with zocilurtatug pelitecan (zoci, formerly ZL-1310)

August 3, 2026: Zai Lab (NASDAQ: ZLAB; HKEX: 9688) said the FDA granted Orphan Drug Designation to zocilurtatug pelitecan (zoci, formerly ZL-1310), a DLL3-targeting antibody-drug conjugate, for neuroendocrine carcinomas (NECs). The company said NECs are aggressive cancers with no approved standard of care for previously treated patients and no available targeted therapies.

The release also notes prior regulatory milestones for zoci: FDA Fast Track designation for extrapulmonary NECs, and FDA Fast Track plus Orphan Drug Designation for small cell lung cancer (SCLC). Zai Lab added that the EMA has granted Orphan Drug Designation for pulmonary NECs.

No new clinical data were reported. The company said ODD may provide development incentives including fee waivers, certain tax credits, and potential seven-year U.S. market exclusivity upon approval.

Upcoming catalyst: Zai Lab said zoci is on track for three registration-enabling studies by the end of 2026 across second-/third-line SCLC, first-line SCLC, and extrapulmonary NECs.