On August 3, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported 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.
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"Zoci has now received important regulatory designations around the world, signifying its potential to become an important new therapeutic option for patients with multiple types of cancer with DLL3 expressions." said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Given the need among the NEC patient community, we are focused on efficiently advancing our clinical programs for this investigational DLL3-targeting ADC."
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.
About Zocilurtatug Pelitecan (Zoci, ZL-1310)
Zoci targets Delta-like ligand 3 (DLL3), a validated therapeutic target that is overexpressed in many neuroendocrine carcinomas, such as small cell lung cancer (SCLC) and extrapulmonary neuroendocrine carcinomas (epNEC), and is generally associated with poor clinical outcomes. Zoci is on track to potentially become Zai Lab’s first global oncology launch, with plans for three registration-enabling studies across second- and third-line SCLC, first-line SCLC, and epNECs by the end of 2026. Its potential best-in-class safety profile, coupled with compelling systemic and intracranial efficacy, support its potential role as a new standard of care in previously treated extensive-stage SCLC as well as epNEC, and a backbone DLL3-targeting antibody-drug conjugate (ADC) in first-line combination regimens, including those that reduce the burdens of chemotherapy, such as checkpoint inhibitors and T-cell engagers.
(Press release, Zai Laboratory, AUG 3, 2026, View Source [SID1234669626])