Zai Lab Ltd
For the period ended Dec 31, 2024. Filed Feb 27, 2025.
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FY2024 · Filed Feb 27, 2025
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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, 2025 | By: | /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:
| Signature | Title | Date |
|---|---|---|
| /s/ Samantha (Ying) Du | Chief Executive Officer and Chairperson of the Board of Directors | February 27, 2025 |
| Samantha (Ying) Du | (Principal Executive Officer) | |
| /s/ Yajing Chen | Chief Financial Officer | February 27, 2025 |
| Yajing Chen | (Principal Financial and Accounting Officer) | |
| /s/ John Diekman | Director | February 27, 2025 |
| John Diekman | ||
| /s/ Richard Gaynor | Director | February 27, 2025 |
| Richard Gaynor | ||
| /s/ Nisa Leung | Director | February 27, 2025 |
| Nisa Leung | ||
| /s/ William Lis | Director | February 27, 2025 |
| William Lis | ||
| /s/ Leon O. Moulder, Jr. | Director | February 27, 2025 |
| Leon O. Moulder, Jr. | ||
| /s/ Scott Morrison | Director | February 27, 2025 |
| Scott Morrison | ||
| /s/ Michel Vounatsos | Director | February 27, 2025 |
| Michel Vounatsos | ||
| /s/ Peter Wirth | Director | February 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 2023 | F-5 |
| Consolidated Statements of Operations for the Years Ended December 31, 2024, 2023, and 2022 | F-6 |
| Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2024, 2023, and 2022 | F-7 |
| Consolidated Statements of Shareholders’ Equity for the Years Ended December 31, 2024, 2023, and 2022 | F-8 |
| Consolidated Statements of Cash Flows for the Years Ended December 31, 2024, 2023, and 2022 | F-9 |
| Notes to Consolidated Financial Statements | F-10 |
| Schedule I — Condensed Financial Information of Registrant | F-39 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.