Zai Lab Announces Oral Presentation of Updated Data from Global Phase 1 Trial of Zocilurtatug Pelitecan (ZL-1310), a Potential First-in-Class DLL3-Targeted ADC, at 2025 AACR-NCI-EORTC Conference

- Oral presentation to feature new data highlighting the potential of zocilurtatug pelitecan (formerly called ZL-1310) as a promising next-generation, first- and best-in-class, Delta-like ligand (DLL3)-targeted antibody-drug conjugate (ADC) for patients with extensive-stage small cell lung cancer (ES-SCLC)

- Zai Lab to host investor conference call and webcast to discuss data and clinical trial plans on October 24, 2025, at 11 a.m. ET / 11 p.m. HKT

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that a late-breaking abstract (LBA) featuring new data from its global Phase 1 clinical trial (NCT06179069) evaluating zocilurtatug pelitecan (zoci), formerly known as ZL-1310, has been selected for an oral presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22-26, 2025, in Boston, Massachusetts. The presentation will include additional follow-up from patients from the ongoing trial.

Zoci is the Company’s potential first- and best-in-class, Delta-like ligand (DLL3)-targeted antibody-drug conjugate (ADC) being developed for patients with extensive-stage small cell lung cancer (ES-SCLC). The ongoing Phase 1 study is evaluating the safety and antitumor activity of zoci at various doses in patients who have progressed after at least one prior platinum-based chemotherapy regimen. The study is being conducted across multiple global sites.

“The critical need for expanded treatment options for patients with small cell lung cancer propels our strategy to advance zoci as a novel therapeutic option as quickly as possible,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “We remain on track to initiate our Phase 3 registrational study in previously treated SCLC by year-end. We look forward to sharing updated results demonstrating zoci’s continued potential at the AACR-NCI-EORTC International Conference.”

Zai Lab will hold an investor conference call and webcast to highlight updated zoci data at the AACR-NCI-EORTC International Conference and outline next steps in clinical development.

Details regarding the webcast and conference call are as follows:

Date/Time: October 24, 2025, at 11 a.m. ET / 11 p.m. HKT, please register at:
Webcast presentation (preferred): https://edge.media-server.com/mmc/p/92agda72/
Dial-in: https://register-conf.media-server.com/register/BIcb9a4304d71946febe2796d440873654
Presenter: Rafael G. Amado, M.D., President and Head of Global Research and Development, Zai Lab

Details regarding the zoci oral presentation are as follows:

Title: Phase 1 trial of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer
Presenter: Grace K. Dy, M.D., Roswell Park Comprehensive Cancer Center, Buffalo, NY
Session Title: Plenary Session 3: Antibody Drug Conjugates
Date/Time: Friday, October 24, 2025, 9:17 a.m. – 9:27 a.m. ET (presentation), 9:27 a.m. – 9:45 a.m. ET (panel discussion)
Location: Hynes Convention Center, Level 3, Ballroom AB

About Small Cell Lung Cancer and Zocilurtatug Pelitecan (zoci)

Small cell lung cancer (SCLC) is one of the most aggressive and lethal solid tumors, accounting for ~15% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year^1,2. Additionally, two-thirds of all SCLC patients are diagnosed at extensive stage³.

DLL3 is an antigen overexpressed in many neuroendocrine tumors, such as SCLC, and is often associated with poor clinical outcomes. Zocilurtatug pelitecan (zoci), formerly known as ZL-1310, comprises a humanized anti-DLL3 monoclonal antibody connected via a cleavable linker to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN^®, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

Zoci received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in January 2025, recognizing its potential to treat patients with SCLC.

About the Webcast and Conference Call

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company's website.

About Zai Lab

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health.

For additional 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 relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing next generation ADCs, including zocilurtatug pelitecan (formerly known as ZL-1310), the potential benefits of zocilurtatug pelitecan, and the potential treatment of SCLC and neuroendocrine tumors. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. 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 contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of 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 in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.sec.gov.

References:

1 J Thorac Oncol. 2023 Jan;18(1):31-46; Lung Cancer Foundation of America.

2 WHO Globocan 2022.

3 Sabari JK, et al. Nat Rev Clin Oncol. 2017;14:549-561.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251013594159/en/

For more information, please contact:

Investor Relations:

Christine Chiou / Cyan Liu

+1 (917) 886-6929 / +86 195 3130 8895

christine.chiou1@zailaboratory.com / cyan.liu@zailaboratory.com

Media:

Shaun Maccoun/ Xiaoyu Chen

+1 (857) 270-8854 / +86 185 0015 5011

shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com

Source: Zai Lab Limited