Company: ZLAB
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0001628280-25-008409
Chunk: 80

Company: Zai Lab Ltd
Filing Date: 2025-02-27
Form: 10-K
Item: Item 8
Chunk 80
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P (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