SHANGHAI & CAMBRIDGE, Mass., June 16, 2026
Zai Lab announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to zocilurtatug pelitecan (zoci, formerly ZL-1310) for the treatment of pulmonary neuroendocrine carcinomas (NECs). The designation follows a positive opinion from the EMA’s Committee for Orphan Medicinal Products (COMP), which recognized both the severity of pulmonary NECs and the significant unmet need for new therapeutic options. The decision was supported by preliminary clinical evidence suggesting that zoci may provide clinically meaningful advantages over currently available treatments, including durable responses in patients with relapsed or refractory extensive-stage small cell lung cancer (SCLC), the most common and aggressive form of pulmonary neuroendocrine carcinoma.
EMA Recognizes Potential Clinical Benefit in Aggressive Lung Cancer
Small cell lung cancer (SCLC) accounts for approximately 15% of all lung cancer diagnoses worldwide and represents one of the most aggressive and difficult-to-treat solid tumors. With an estimated 375,000 new cases annually worldwide, patients often face limited treatment options and poor long-term outcomes, particularly following disease relapse. In granting Orphan Drug Designation, the EMA highlighted preliminary data indicating that zoci may offer a favorable therapeutic effect compared with currently authorized therapies. The recognition underscores the urgent need for innovative treatments capable of improving outcomes for patients with advanced neuroendocrine malignancies and reinforces the growing clinical interest in DLL3-targeted therapies.
DLL3-Targeting ADC Positioned as a Potential First-in-Class Therapy
Zocilurtatug pelitecan is an investigational DLL3-targeting antibody-drug conjugate (ADC) designed to selectively target tumor cells that overexpress Delta-like ligand 3 (DLL3), a protein commonly found in neuroendocrine cancers and associated with poor clinical prognosis. DLL3 has emerged as one of the most promising therapeutic targets in SCLC and other neuroendocrine tumors. According to Zai Lab, zoci has demonstrated encouraging systemic and intracranial activity alongside a potentially favorable safety profile, supporting its development as both a standalone treatment and a foundational component of future combination regimens. The company believes the therapy has the potential to establish a new standard of care for previously treated extensive-stage SCLC and other DLL3-positive malignancies.
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Regulatory Momentum Accelerates Global Development Strategy
The EMA designation adds to a growing list of regulatory milestones for zoci. The therapy has already received Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) for SCLC, while also recently securing FDA Fast Track Designation for extrapulmonary neuroendocrine carcinomas (epNECs). Orphan Drug Designation in Europe provides important incentives, including potential market exclusivity following approval, reduced regulatory fees, and enhanced support throughout the development process. Zai Lab plans to initiate three registration-enabling studies by the end of 2026, covering second- and third-line SCLC, first-line SCLC, and epNECs. These efforts position zoci as a key component of the company’s oncology pipeline and a potential global launch candidate targeting some of the most challenging neuroendocrine cancers with limited treatment options.
Source: Zai La press release
