Zai Lab accelerates global launch plans for Zoci with landmark European ODD

UK — Zai Lab has secured orphan drug designation from the European Medicines Agency for its investigational DLL3-targeting antibody-drug conjugate zocilurtatug pelitecan (Zoci), designed to treat pulmonary neuroendocrine carcinomas.

The EMA Committee for Orphan Medicinal Products supported the designation after recognising a strong unmet need in neuroendocrine carcinomas.

According to the committee, early clinical results in relapsed or refractory extensive-stage small cell lung cancer suggest that Zoci may show improved outcomes compared with currently authorised therapies.

It also highlighted durable responses and described the findings as a clinically relevant advantage.

Regulatory momentum across the US and Europe

The US Food and Drug Administration has already granted Zoci fast track and orphan drug designations for small cell lung cancer and later expanded fast track status to include extrapulmonary neuroendocrine carcinomas.

Zai Lab president and global R&D head Rafael Amado said the EMA designation reinforces Zoci’s potential as a first-in-class therapy for pulmonary neuroendocrine carcinomas and reflects the company’s commitment to patients with limited treatment options.

The EMA orphan designation provides regulatory advantages, including potential market exclusivity after approval, reduced fees, and support for more efficient clinical development of rare disease therapies.

Orphan drug designation in Europe typically applies to conditions affecting fewer than five in 10,000 people and is intended to encourage development of treatments for rare and aggressive cancers such as neuroendocrine carcinomas.

Targeting DLL3 in aggressive tumours

Zoci targets DLL3, a protein widely expressed in small cell lung cancer and extrapulmonary neuroendocrine carcinomas, and is generally associated with poor patient outcomes.

DLL3 has emerged as an important therapeutic target in neuroendocrine tumors because its expression is largely restricted to malignant cells, making it an attractive candidate for targeted drug delivery approaches such as antibody-drug conjugates.

Zai Lab plans three registration-enabling studies for Zoci across second-line and third-line small cell lung cancer, first-line small cell lung cancer, and extrapulmonary neuroendocrine carcinomas, with completion targeted for the end of 2026.

Pipeline expansion and collaboration strategy

In April 2026, Boehringer Ingelheim and Zai Lab entered a clinical collaboration to evaluate a dual DLL3-targeting approach for extensive-stage small cell lung cancer and other neuroendocrine carcinomas.

The collaboration with Boehringer Ingelheim reflects a broader industry effort to combine targeted therapies and deepen research into combination strategies that may improve outcomes for patients with extensive-stage disease.

These combined regulatory pathways in Europe and the United States may help accelerate clinical development by enabling earlier engagement with regulators, streamlined trial design discussions, and potential access to expedited review mechanisms once pivotal data become available.

Ongoing oncology development efforts

Zai Lab has continued to advance its oncology pipeline and strengthen partnerships to expand its precision oncology portfolio across Asia, Europe, and the United States.

These developments reflect ongoing efforts to expand precision oncology options for rare and aggressive neuroendocrine cancers.