Zai Lab Announces Zocilurtatug Pelitecan (Zoci) Receives Orphan Drug Designation from the European Medicines Agency for the Treatment of Pulmonary Neuroendocrine Carcinoma

• The European Medicines Agency’s Committee for Orphan Medicinal Products considers that preliminary clinical data for zoci show a potentially clinically relevant advantage over currently approved therapies in relapsed or refractory extensive-stage small cell lung cancer.
• Small cell lung cancer is the most prevalent neuroendocrine carcinoma originating from the lung, with approximately 375,000 new cases globally each year, and current treatment options are limited.
• The European Medicines Agency has granted orphan drug designation to zoci for the treatment of neuroendocrine carcinomas originating from the lung; shortly prior to this, zoci had received Fast Track designation from the U.S. Food and Drug Administration for extrapulmonary neuroendocrine carcinoma, and encouraging data were presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2026.

Shanghai, China and Cambridge, Massachusetts, USAJune 16, 2026 /PRNewswire/ — Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the European Medicines Agency has granted orphan drug designation to zocilurtatug pelitecan (zoci, formerly ZL-1310), a potential first-in-class antibody-drug conjugate (ADC) targeting Delta-like ligand 3 (DLL3), for the treatment of neuroendocrine carcinomas originating from the lung.

This designation is based on a positive opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP). The committee recognized the severity of neuroendocrine carcinomas and the urgent need for new treatment options. Small cell lung cancer is the most prevalent neuroendocrine carcinoma originating from the lung. Globally, there are approximately 2.5 million newly diagnosed lung cancer patients each year, of which small cell lung cancer accounts for about 15% (estimated at approximately 375,000 new cases annually), making it one of the fastest-progressing and most lethal solid tumors.^[1],[2]

In granting this designation, COMP noted that preliminary clinical data in patients with relapsed or refractory extensive-stage small cell lung cancer suggest that zoci may offer superior efficacy compared to currently approved therapies, including durable responses, which the committee considered a clinically relevant advantage.

Previously, the U.S. FDA had granted zoci Fast Track designation (FTD) and orphan drug designation for the treatment of small cell lung cancer. The FDA recently also granted zoci FTD for the treatment of extrapulmonary neuroendocrine carcinoma.

Dr. Rafael G. Amado, President and Head of Global Research and Development at Zai Lab, stated: “This important designation from the European Medicines Agency further supports the potential of zoci to become a first-in-class therapy for the treatment of neuroendocrine carcinomas originating from the lung. This milestone once again underscores Zai Lab’s commitment to addressing significant unmet medical needs for patients with limited treatment options.”

Orphan drug designation from the European Medicines Agency provides several important regulatory and development incentives, including potential market exclusivity upon approval, reduced development fees, and enhanced development efficiency, thereby helping to accelerate clinical development.

About Zocilurtatug Pelitecan (Zoci, ZL-1310)

Zoci is a novel ADC targeting DLL3. DLL3 is a validated therapeutic target that is overexpressed in various neuroendocrine tumors, including small cell lung cancer (SCLC) and extrapulmonary neuroendocrine carcinomas (epNECs), and is typically associated with poor clinical outcomes. Zoci has the potential to be Zai Lab’s first globally marketed oncology product, with plans to initiate three registrational studies by the end of 2026, covering second-line and beyond SCLC, first-line SCLC, and extrapulmonary neuroendocrine carcinoma. Zoci has a potential best-in-class safety profile and demonstrated systemic and intracranial efficacy, supporting its potential to become a new standard of care for previously treated extensive-stage small cell lung cancer (ES-SCLC) and serve as a foundational DLL3-targeting ADC for first-line combination regimens, including those aimed at reducing chemotherapy toxicity burden, such as combinations with immune checkpoint inhibitors and T-cell engagers.

About Zai Lab

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is a research-based, commercial-stage innovative biopharmaceutical company headquartered in China and the United States. We are dedicated to addressing significant unmet medical needs in oncology, immunology, neuroscience, and infectious diseases through the discovery, development, and commercialization of innovative products. Our goal is to leverage our capabilities and resources to make a positive impact on human health.

For more information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global.

Zai Lab Forward-Looking Statements

This press release contains forward-looking statements regarding Zai Lab’s future expectations, plans, and prospects, including but not limited to statements related to our prospects and plans for the development and commercialization of zoci, the potential benefits of zoci, and potential therapies for small cell lung cancer, neuroendocrine carcinomas, and solid tumors. All statements in this press release other than statements of historical fact are forward-looking statements, which can be identified by terms such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. These statements constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of future performance or assurances. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those anticipated in the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results may differ materially from those indicated in the forward-looking statements due to various important factors, including but not limited to: (1) our ability to successfully commercialize our approved products and generate revenue from them; (2) our ability to secure funding for our operations and business activities; (3) the results of clinical development and preclinical development of our product candidates; (4) the content and timing of regulatory decisions regarding our product candidates; (5) risks related to doing business in China; and (6) other factors identified in our most recent annual and quarterly reports and other filings submitted to the U.S. Securities and Exchange Commission (SEC). We expect subsequent events and developments will cause our expectations and assumptions to change, but we are under no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.

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