Zai Lab to Present Data from Phase 1 Trial of ZL-1310, Its Investigational Antibody-Drug Conjugate (ADC) for DLL3+ Solid Tumors, at EORTC-NCI-AACR Symposium (ENA) 2024

Oral presentation during plenary session will discuss potential of ZL-1310 as an innovative ADC targeting Delta-like ligand 3 (DLL3), a validated therapeutic target in small cell lung cancer (SCLC)

ZL-1310 is part of Zai Lab’s growing, internally developed global oncology pipeline

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) today announced that data from a Phase 1 study of ZL-1310, the Company’s investigational antibody-drug conjugate (ADC), will be presented during a plenary session at the EORTC-NCI-AACR Symposium (ENA) 2024 taking place October 23-25, in Barcelona, Spain. The preliminary results from the ongoing, open-label, multicenter clinical trial (NCT06179069) will address the potential of ZL-1310 as a novel treatment for small cell lung cancer (SCLC).

DLL3 is overexpressed in many neuroendocrine tumors, including SCLC, and is typically associated with poor clinical outcomes. ZL-1310 comprises a humanized anti-DLL3 antibody and a novel camptothecin derivative as its payload. The compound was designed with a novel linker-payload platform called TMALIN®, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

“New therapies that reduce off-target toxicity and increase anti-tumor effectiveness are critically needed to improve treatment options for many cancer patients, including SCLC and other tumors of neuroendocrine origin,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “ZL-1310 is an example of our company’s commitment to progressing a differentiated global oncology pipeline that will help fill these types of treatment gaps and provide meaningful benefit to patients. We look forward to sharing preliminary results from the Phase 1 study of this exciting next-generation ADC at ENA 2024.”

Details regarding the ZL-1310 oral presentation at ENA 2024 are as follows:

Title: Preliminary Results from a Phase 1a/1b, Open-Label, Multicenter Study of ZL-1310, a DLL3-targeted ADC, to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer

Abstract Number: ENA24-0345

Presenter: Alex Spira, MD, PhD, FACP, FASCO, Virginia Cancer Specialists, Fairfax, VA

Presentation Date and Time: Thursday, October 24, 2024, 11:12 a.m. – 11:24 a.m. CET (presentation), 11:24 a.m. – 11:30 a.m. CET (Q&A)

Location: Centre de Convencions Internacional de Barcelona (CCIB), Room 111 and 112

About Zai Lab

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) 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 in China and worldwide. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.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 ZL-1310, the potential benefits of ZL-1310, 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.

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