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Zai Lab Ltd

For the period ended Dec 31, 2024. Filed Feb 27, 2025.

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About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Feb 27, 2025

ZLAB$26.86+5.4%Stored close · as of Nov 9, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

See the whole filing, with its images and exhibits
Contents

Glossary

This Glossary includes acronyms and defined terms that are used throughout this report.

ABC: Acinetobacter baumannii-calcoaceticus complex

ABSSSI: Acute bacterial skin and skin structure infections

AChR: Anti-acetylcholine receptor

AD: Atopic dermatitis

ADC: Antibody-drug conjugate

ADP: Psychosis associated with Alzheimer’s Disease

ADS: American Depositary Share, each representing ten of the Company’s ordinary shares

Amgen: Amgen Inc.

Archives Rules: Provisions on Strengthening Confidentiality and Archives Administration of Overseas Securities Offering and Listing by Domestic Companies

argenx: argenx BV

ASC: Accounting Standard Codification

Asia Pacific: Refers to Greater China, Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, the Philippines, Singapore, Australia, New Zealand, and Japan, collectively

Audit Committee: The Audit Committee of the Board of Directors

AUGTYRO (Repotrectinib): A next-generation TKI of ROS proto-oncogene 1 (ROS1) tyrosine-protein kinase and of the tropomyosin receptor tyrosine kinases (TRKs) TRKA, TRKB, and TRKC

Bemarituzumab: A humanized anti-FGFR2b IgG1 monoclonal antibody

Bemarituzumab FPA144-004 Study: A global Phase III registrational trial of bemarituzumab (FPA144) in combination with FOLFOX in front-line gastric and gastroesophageal cancer

BLA: Biologics License Application

BMS: Bristol-Myers Squibb Company

Board of Directors (or Board): The Board of Directors of Zai Lab Limited

BOC HK: Bank of China (Hong Kong) Limited

BOCOM: Bank of Communications Co., Ltd. Shanghai Zhangjiang Sub-Branch

BOC Pudong Branch: Bank of China Pudong Development Zone Sub-Branch

BTD: Breakthrough Therapy Designation

CABP: Community-acquired bacterial pneumonia

CAC: Cyberspace Administration of China

CC: Cervical cancer

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CCR8: Human chemokine (C-C motif) receptor 8

cGMPs: Current Good Manufacturing Practices

CI: Confidence interval

CIDP: Chronic inflammatory demyelinating polyneuropathy

CFIUS: U.S. Committee on Foreign Investment

CMB: China Merchants Bank Co., Ltd. Shanghai Branch

CMO: Contract Manufacturing Organization

Code: The Company’s Code of Business Conduct and Ethics

Commercial Committee: The Commercial Committee of the Board of Directors

Company: Zai Lab Limited and its subsidiaries, collectively

Compensation Committee: The Compensation Committee of the Board of Directors

CPP: Chronic plaque psoriasis

CRAB: Carbapenem-resistant Acinetobacter strains

CRO: Contract Research Organization

CSRC: China Securities Regulatory Commission

CTA: Clinical trial application

Current Articles: The Sixth Amended and Restated Memorandum and Articles of Association of Zai Lab Limited

D&O: Director and officer

Deciphera: Deciphera Pharmaceuticals, LLC, a subsidiary of Deciphera Pharmaceuticals, Inc.

DLL3: An inhibitor of the Notch ligand that is overexpressed in SCLC and other neuroendocrine neoplasmas

Efgartigimod (efgartigimod alfa fcab or efgartigimod alfa injection): A human IgG1 antibody fragment that binds to FcRn

Efgartigimod SC: The subcutaneous formulation of efgartigimod

EIT: Enterprise income tax

EIT Law: The Enterprise Income Tax Law of the People’s Republic of China

EMA: European Medicines Agency

Entasis: Entasis Therapeutics Holdings Inc.

EU: European Union

Exchange Act: U.S. Securities Exchange Act of 1934, as amended

FASB: Financial Accounting Standards Board

FCPA: U.S. Foreign Corrupt Practices Act, as amended

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FcRn: The neonatal fragment crystallizable receptor

FDA: U.S. Food and Drug Administration

FGFR2b: Human fibroblast growth factor receptor 2 isoform IIb

Five Prime: Five Prime Therapeutics, Inc.

GBM: Glioblastoma multiforme, an aggressive form of brain tumor

GC: Gastric cancer

GCPs: Good Clinical Practices

GEJ: Gastroesophageal junction

GIST: Gastrointestinal stromal tumors

gMG: Generalized myasthenia gravis

GMPs: Good Manufacturing Practices

Greater China: Mainland China, Hong Kong, Macau, and Taiwan, collectively

GSK: GlaxoSmithKline plc

HABP: Hospital-acquired bacterial pneumonia

Hanhui: Hanhui Pharmaceutical Co., Ltd.

HFCAA: U.S. Holding Foreign Companies Accountable Act, as amended

HGRAC: Human Genetic Resources Administration Office of China

HK Listing Rules: The Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited, as amended

HKMA: Hong Kong Monetary Authority

HNTE: High and new technology enterprises

Hong Kong (or HK): Hong Kong Special Administrative Region

Hong Kong Stock Exchange (or HKEx): The Stock Exchange of Hong Kong Limited

Huizheng: Huizheng (Shanghai) Pharmaceutical Technology Co., Ltd.

ICI: Immune checkpoint inhibitor

IL: Interleukin

IMCCTs: International multi-center clinical trials

IND: Investigational New Drug

Innoviva: Innoviva, Inc.

IPO: Initial public offering

IV: Intravenous

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IVIg: Intravenous immunoglobin

Karuna: Karuna Therapeutics, Inc.

KarXT: Xanomeline and trospium chloride, a combination of an oral M1/M4-preferring muscarinic acetylcholine receptor agonist and an antimuscarinic agent

KPMG LLP: KPMG LLP, an auditor located in the United States that is inspected by the PCAOB

LN: Lupus nephritis

LRRC15: Leucine-rich repeat-containing protein 15, a type 1 transmembrane protein involved in cell-cell and cell-extracellular matrix interactions that is overexpressed in various mesenchymal tumors where it promotes tumor metastases

MAA: Marketing Authorization Application

Macau: Macau Special Administrative Region

MacroGenics: MacroGenics, Inc.

MediLink: MediLink Therapeutics (Suzhou) Co., Ltd.

MG: Myasthenia gravis

MMAE: Microtubule-disrupting agent monomethyl auristatin E

MOFCOM: China’s Ministry of Commerce

mOS: Median overall survival

mPFS: Median progression-free survival

Nasdaq: Nasdaq Global Market

NDA: New Drug Application

NHSA: China’s National Healthcare Security Administration

Ningbo Bank: Bank of Ningbo Co., Ltd. Suzhou Sub-Branch

Ningbo Bank Agreements: Maximum Credit Contract, Electronic Commercial Draft Discounting Master Agreement and Online Working Capital Loan Master Agreement between Zai Lab Suzhou and Ningbo Bank, collectively

NIST: National Institute of Standards and Technology

NMPA: China’s National Medical Products Administration

Nominating and Corporate Governance Committee: The Nominating and Corporate Governance Committee of the Board of Directors

NovoCure: NovoCure Ltd.

Novo Holdings: Novo Holdings A/S

NRDL: China’s National Reimbursement Drug List

NSCLC: Non-small cell lung cancer

NTRK: Neurotrophic tropomyosin-receptor kinase

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NUZYRA (Omadacycline): A novel tetracycline-class antibacterial with both oral and IV formulations that is a broad-spectrum antibiotic

OPTUNE: Tumor Treating Fields (or TTFields) devices marketed under various brand names, including OPTUNE GIO® for GBM

ORR: Overall response rate

OS: Overall survival

Our commercial products / programs: ZEJULA, VYVGART / VYVGART Hytrulo, NUZYRA, OPTUNE, QINLOCK, XACDURO, and AUGTYRO, collectively

Our securities: Our ADSs and/or ordinary shares, individually or collectively

Ovarian cancer: Epithelial ovarian, fallopian tube, and primary peritoneal cancer, collectively

Paratek: Paratek Bermuda Ltd., a subsidiary of Paratek Pharmaceuticals, Inc.

PANSS: Positive and Negative Syndrome Scale

PARP / PARP Inhibitor: PARP (poly (ADP-ribose) polymerase) is a protein that helps repair DNA damage in cells; PARP inhibitors block PARP from repairing DNA damage, such as may be caused by radiation and/or certain chemotherapies, which may lead to cancer cell death and slow the return or progression of cancer

PBOC: People’s Bank of China

PCAOB: U.S. Public Company Accounting Oversight Board

PDGFRα: Platelet-derived growth factor receptor alpha

PDUFA: U.S. Prescription Drug User Fee Act

PFIC: Passive foreign investment company

Pfizer: Pfizer Inc.

PMA: Premarket Approval

POC: Proof of Concept

QINLOCK (Ripretinib): An orally administered switch-control TKI that broadly inhibits KIT and PDGFRα tyrosine kinases, including wild-type and forms with multiple primary mutations or secondary mutations

R&D Committee: The Research and Development Committee of the Board of Directors

RMB: Chinese Renminbi

r/m: Recurrent or metastatic

SAFE: State Administration of Foreign Exchange of China

SAMR: China’s State Administration for Market Regulation

sBLA: Supplemental Biologics License Application

SC: Subcutaneous

SCLC: Small cell lung cancer

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Seagen: Seagen Inc.

SEC: U.S. Securities and Exchange Commission

Securities Act: U.S. Securities Act of 1933, as amended

Security Assessment Measures: The Measures on Security Assessment of Cross-Border Data Transfer

sNDA: Supplemental new drug application

sn-gMG: Seronegative gMG

SOC: Standard of care

SPD Bank: Shanghai Pudong Development Bank Co., Ltd. Zhangjiang Hi-Tech Park Sub-Branch

TEAE: Treatment emergent adverse events

TED: Thyroid eye disease

Tesaro: Tesaro, Inc.

TIVDAK (Tisotumab Vedotin): An ADC composed of Genmab’s human monoclonal antibody directed against cell surface tissue factor and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches MMAE to the antibody

TKI: Tyrosine kinase inhibitor

TMZ: Temozolomide, a chemotherapy drug

TREA: Treatment-related adverse event

Trial Measures: Trial Measures for the Administration of Overseas Issuance and Listing of Securities by Domestic Enterprises

Trust for Life: Our sustainability strategy, which includes three pillars: improve human health, create better outcomes, and act right now with ethical business practices and strong governance

Turning Point: Turning Point Therapeutics, Inc.

U.S.: United States

U.S. GAAP: Generally Accepted Accounting Principles in the United States

VABP: Ventilator-associated bacterial pneumonia

Vertex: Vertex Pharmaceuticals Inc.

VIEs: Variable interest entities

VYVGART: The brand name for the IV formulation of efgartigimod

VYVGART Hytrulo: The brand name for the SC formulation of efgartigimod

XACDURO (SUL-DUR): A combination of a beta-lactam antibiotic (sulbactam) and beta-lactamase inhibitor (durlobactam)

Zai Lab: Zai Lab Limited, holding company, and its subsidiarieson a consolidated basis

Zai Lab Limited: Zai Lab Limited, a holding company

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Zai Lab Shanghai: Zai Lab (Shanghai) Co., Ltd., a wholly-owned subsidiary of the Company

Zai Lab Suzhou: Zai Lab (Suzhou) Co., Ltd., a wholly-owned subsidiary of the Company

ZEJULA (Niraparib): An orally administered PARP 1/2 inhibitor

ZL-1102: An early clinical stage human VH antibody fragment that binds to IL-17

ZL-1218: An early clinical stage humanized anti-CCR8 IgG1 monoclonal antibody

ZL-1310: An early-stage next generation DLL3 ADC

ZL-1503: A pre-clinical IL-13 / IL-31 bi-specific antibody

1L: First line

2L: Second line

4L: Fourth Line

2015 Plan: Zai Lab Limited 2015 Omnibus Equity Incentive Plan, as amended

2017 Plan: Zai Lab Limited 2017 Equity Incentive Plan

2022 Plan: Zai Lab Limited 2022 Equity Incentive Plan

2024 Annual Report: Annual Report on Form 10-K for the year ended December 31, 2024

2024 Plan: Zai Lab Limited 2024 Equity Incentive Plan

2025 Proxy Statement: Our definitive proxy statement pursuant to Regulation 14A to be filed with the SEC not later than 120 days after the close of our fiscal year ended December 31, 2024

$: U.S. Dollar

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

ZAI LAB LIMITED
Date: February 27, 2025By:/s/ Samantha (Ying) Du
Name:Samantha (Ying) Du
Title:Chief Executive Officer

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Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated below:

SignatureTitleDate
/s/ Samantha (Ying) DuChief Executive Officer and Chairperson of the Board of DirectorsFebruary 27, 2025
Samantha (Ying) Du(Principal Executive Officer)
/s/ Yajing ChenChief Financial OfficerFebruary 27, 2025
Yajing Chen(Principal Financial and Accounting Officer)
/s/ John DiekmanDirectorFebruary 27, 2025
John Diekman
/s/ Richard GaynorDirectorFebruary 27, 2025
Richard Gaynor
/s/ Nisa LeungDirectorFebruary 27, 2025
Nisa Leung
/s/ William LisDirectorFebruary 27, 2025
William Lis
/s/ Leon O. Moulder, Jr.DirectorFebruary 27, 2025
Leon O. Moulder, Jr.
/s/ Scott MorrisonDirectorFebruary 27, 2025
Scott Morrison
/s/ Michel VounatsosDirectorFebruary 27, 2025
Michel Vounatsos
/s/ Peter WirthDirectorFebruary 27, 2025
Peter Wirth

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Index to Consolidated Financial Statements

Page
Reports of Independent Registered Public Accounting Firms (KPMG LLP, Short Hills, NJ, Auditor Firm ID: 185)F-2
Consolidated Balance Sheets as of December 31, 2024 and 2023F-5
Consolidated Statements of Operations for the Years Ended December 31, 2024, 2023, and 2022F-6
Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2024, 2023, and 2022F-7
Consolidated Statements of Shareholders’ Equity for the Years Ended December 31, 2024, 2023, and 2022F-8
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024, 2023, and 2022F-9
Notes to Consolidated Financial StatementsF-10
Schedule I — Condensed Financial Information of RegistrantF-39
ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.