08 — ADC Bilingual Glossary (English ↔ Chinese)

ADC中英文术语对照表
按主题分类,附简要定义。标准缩写以括号标注。


A. ADC结构与组分 | ADC Structure & Components

English Term中文术语AbbreviationBrief Definition / 简要释义
Antibody-Drug Conjugate抗体偶联药物 / 抗体药物偶联物ADCBiologic consisting of mAb + linker + cytotoxic payload
Monoclonal Antibody单克隆抗体mAbTargeting vehicle; IgG1 most common scaffold
Payload / Warhead有效载荷 / 弹头Cytotoxic agent conjugated to the antibody
Linker连接子 / 接头Chemical tether between mAb and payload; governs payload release
Cleavable Linker可裂解连接子CLLinker designed to release free payload upon intracellular trigger
Non-Cleavable Linker不可裂解连接子NCLLinker stable to enzymatic cleavage; payload released as catabolite after full Ab degradation
Drug-to-Antibody Ratio药抗比DARAverage number of payload molecules per antibody molecule
Self-Immolative Spacer自解体间隔基Spacer (e.g., PABC) that spontaneously fragments after linker cleavage to release free payload
Para-Aminobenzyl Carbamate对氨基苄基氨基甲酸酯PABCSelf-immolative spacer undergoing 1,6-elimination post-linker cleavage
Conjugation Site偶联位点Amino acid residue on mAb where payload is attached (Lys, Cys, or engineered site)
Site-Specific Conjugation定点偶联Conjugation to defined mAb position → homogeneous DAR product
Stochastic Conjugation随机偶联Conjugation to heterogeneous amino acid positions → DAR mixture
Fc RegionFc区FcAntibody constant region; mediates FcRn recycling, FcγR interactions
Fab RegionFab区FabAntigen-binding fragment; contains CDR loops
CDR (Complementarity-Determining Region)互补决定区CDRHypervariable loops on Fab that determine antigen specificity
Bispecific ADC双特异性抗体偶联药物bsADCADC with mAb binding two different antigens or two epitopes

B. 连接子化学 | Linker Chemistry

English Term中文术语AbbreviationBrief Definition / 简要释义
Hydrazone Linker腙连接子Acid-labile linker cleaved at endosomal/lysosomal pH (4.5–5.5)
Dipeptide Linker二肽连接子Val-Cit or Val-Ala; cleaved by lysosomal cathepsin B
Valine-Citrulline缬氨酸-瓜氨酸Val-CitMost common dipeptide for cathepsin-cleavable linkers
Valine-Alanine缬氨酸-丙氨酸Val-AlaAlternative dipeptide; faster cathepsin cleavage, more hydrophilic
Disulfide Linker二硫键连接子Cleaved by intracellular glutathione (GSH)
Beta-Glucuronide Linkerβ-葡萄糖醛酸连接子Cleaved by beta-glucuronidase; highly hydrophilic
Tetrapeptide Linker四肽连接子GGFG sequence; used in T-DXd; cleaved by lysosomal cathepsins
Thioether Bond硫醚键Non-cleavable C–S bond formed from maleimide + thiol reaction; used in SMCC linker
Maleimide马来酰亚胺Reactive group that conjugates to cysteine thiols via Michael addition
Succinimide Ring琥珀酰亚胺环Product of maleimide-thiol reaction; can undergo retro-Michael if not ring-hydrolyzed
Retro-Michael Addition逆麦克尔加成Reverse reaction releasing maleimide-payload from succinimide adduct; driven by albumin thiol exchange
SMCCSMCCSMCCSuccinimidyl-4-(N-maleimidomethyl)cyclohexane-1-carboxylate; NCL crosslinker for DM1 conjugation
Sulfo-SPDB磺基-SPDBSulfonated disulfide crosslinker for DM4; more hydrophilic than SPDB
CL2ACL2ACL2ACarbonate-containing acid-sensitive linker used for SN-38 in sacituzumab govitecan
Hydrophilic Spacer (PEG)亲水性间隔基(PEG)PEGPolyethylene glycol spacer added to reduce ADC hydrophobicity at high DAR
Linker Stability连接子稳定性Resistance to premature payload release in systemic circulation

C. 有效载荷类型 | Payload Types

English Term中文术语AbbreviationBrief Definition / 简要释义
Auristatin奥利斯他汀Synthetic dolastatin analogue; microtubule inhibitor
Monomethyl Auristatin E单甲基奥利斯他汀EMMAEMembrane-permeable auristatin; strong bystander effect
Monomethyl Auristatin F单甲基奥利斯他汀FMMAFCharged auristatin; minimal bystander effect; used in Blenrep
Maytansinoid美登素衍生物Semi-synthetic class of tubulin inhibitors; DM1 and DM4
DM1DM1DM1Maytansinoid; used in T-DM1 (Kadcyla); non-cleavable SMCC conjugation
DM4DM4DM4Maytansinoid; used with disulfide linker (sulfo-SPDB); cleavable; in mirvetuximab soravtansine
Calicheamicin卡奇霉素Natural enediyne; cleaves DNA via radical mechanism (DSB); used in Mylotarg/Besylomab
Pyrrolobenzodiazepine Dimer吡咯并苯并二氮䓬二聚体PBDDNA interstrand crosslinker; sub-pM potency; used in Zynlonta
SN-38SN-38SN-38Active metabolite of irinotecan; Topoisomerase I inhibitor; used in Trodelvy
DXd (Deruxtecan)DXd(德鲁替康)DXdExatecan derivative; Topoisomerase I inhibitor; used in Enhertu; DAR ~8
Duocarmycin倍卡霉素DNA alkylator (N3 adenine); picomolar potency; used in trastuzumab duocarmazine
Alpha-Amanitinα-鹅膏毒素RNA Polymerase II inhibitor; not MDR-sensitive; used in emerging ADCs (HDP-101)
Microtubule Inhibitor微管抑制剂Payload class disrupting tubulin polymerization → mitotic arrest
Topoisomerase I Inhibitor拓扑异构酶I抑制剂Topo I inh.Payload class stabilizing Topo I-DNA complex → replication fork collapse
DNA Double-Strand BreakDNA双链断裂DSBMechanism of calicheamicin and PBD-type payloads
Bystander Effect旁观者效应Membrane-permeable payload kills neighboring antigen-negative cells after release
MDR (Multi-Drug Resistance)多药耐药MDRP-glycoprotein (P-gp/ABCB1)-mediated efflux; affects MMAE/DM1 payloads

D. 生物分析 | Bioanalysis

English Term中文术语AbbreviationBrief Definition / 简要释义
Bioanalysis生物分析BAMeasurement of drugs, metabolites, and biomarkers in biological matrices
Total Antibody总抗体TAbAll antibody molecules regardless of conjugation status; measured by anti-Fc capture + anti-Fab detection ELISA
Conjugated Antibody偶联抗体cAbAntibody molecules bearing ≥1 payload; measured by anti-Fc capture + anti-drug detection ELISA
Free Payload游离有效载荷 / 游离药物Unconjugated cytotoxic drug in plasma; measured by LC-MS/MS
Conjugated Payload偶联有效载荷Payload molecules still attached to antibody; measured by hybrid LBA-LC/MS/MS
Catabolite分解代谢产物Intracellular degradation product of ADC (e.g., Lys-SMCC-DM1 from T-DM1)
Ligand-Binding Assay配体结合试验LBABinding-based assay (ELISA, MSD/ECL) for large molecule quantification
Enzyme-Linked Immunosorbent Assay酶联免疫吸附试验ELISAAntibody-based colorimetric/chemiluminescent binding assay
Electrochemiluminescence电化学发光ECLDetection technology used in MSD platform; lower matrix interference vs. colorimetric
Meso Scale Discovery美索量级检测平台MSDECL-based multi-array LBA platform widely used for ADA and PK assays
Liquid Chromatography–Tandem Mass Spectrometry液相色谱串联质谱LC-MS/MSGold standard for free payload and small molecule quantification
High-Resolution Mass Spectrometry高分辨质谱HRMSUsed for catabolite identification and intact ADC mass analysis
Hybrid LBA-LC/MS/MS混合配体结合-液质联用法Hybrid assayAffinity capture of ADC + MS quantitation of released payload
Multiple Reaction Monitoring多反应监测MRMLC-MS/MS acquisition mode for quantitative small molecule/payload assays
Lower Limit of Quantitation定量下限LLOQLowest concentration accurately and precisely measured (≤20% CV, ±20% bias)
Upper Limit of Quantitation定量上限ULOQHighest concentration on the calibration curve
Minimum Required Dilution最低稀释倍数MRDMinimum matrix dilution needed to reduce non-specific effects in LBA
Parallelism平行性Comparison of dilution linearity between incurred samples and calibrators; confirms matrix/concentration consistency
Hook Effect钩状效应Signal suppression at very high analyte concentrations in sandwich LBA; controlled by ULOQ and minimum dilution
Critical Reagents关键试剂CRBiological reagents (anti-drug Ab, antigens, reference standards) that define assay performance; lot-controlled
Reference Standard参考标准品RSCharacterized drug material used to prepare calibrators; must match study drug DAR
Selectivity选择性Assay ability to measure analyte in presence of matrix components and related species
Incurred Sample Reanalysis回溯样品重分析ISRRepeat analysis of ≥10% of study samples to confirm reproducibility; required for GCP validation

E. 免疫原性 | Immunogenicity

English Term中文术语AbbreviationBrief Definition / 简要释义
Anti-Drug Antibody抗药抗体ADAImmune response against the ADC or its components
Immunogenicity免疫原性Propensity of a biologic to induce an immune response
Neutralizing Antibody中和抗体NAbADA that blocks drug binding to target or FcRn → reduces efficacy
Non-Neutralizing Antibody非中和抗体ADA that binds drug but does not block function; may accelerate clearance
Bridging Assay桥接试验ECL-based ADA assay using drug-biotin + drug-ruthenium to detect ADA bridging two drug molecules
Tiered Testing Algorithm分级检测策略Screen → Confirm → Titer → Characterize; standard ADA testing cascade
Drug Tolerance药物耐受性DTAssay ability to detect ADA in presence of circulating drug; key challenge for ADC ADA assays
Acid Dissociation酸解离Pre-treatment of serum at pH 3.5 to dissociate ADA-drug complexes; improves drug tolerance
Anti-Idiotype Antibody抗独特型抗体anti-IDAntibody against the unique antigen-binding idiotype of the therapeutic mAb; used as assay reagent
Neoepitope新表位Novel epitope created by linker-payload conjugation; can drive unique anti-linker or anti-drug-linker ADA
Immune Complex免疫复合物ICADA-ADC complex in plasma; may accelerate ADC clearance and deposit in tissues
HAHA / HACA人抗人源抗体 / 人抗嵌合体抗体HAHA / HACAHuman Anti-Human Antibody / Human Anti-Chimeric Antibody; older immunogenicity terms for humanized/chimeric mAbs

F. 药代动力学 | Pharmacokinetics (PK)

English Term中文术语AbbreviationBrief Definition / 简要释义
Pharmacokinetics药代动力学PKStudy of drug absorption, distribution, metabolism, and excretion (ADME) in the body
Area Under the Curve曲线下面积AUCIntegral of concentration-time curve; measure of total systemic exposure
Maximum Concentration峰浓度 / 最大浓度CmaxPeak plasma concentration after dosing
Time to Maximum Concentration达峰时间TmaxTime at which Cmax occurs
Trough Concentration谷浓度CtroughPlasma concentration just before next dose; often used in E-R analysis
Half-Life半衰期Time for plasma concentration to decrease by 50%; terminal phase
Volume of Distribution分布容积VdApparent volume into which drug distributes; Vss = volume at steady state
Clearance清除率CLVolume of plasma cleared of drug per unit time
Bioavailability生物利用度FFraction of dose reaching systemic circulation (IV = 100%)
Target-Mediated Drug Disposition靶标介导的药物处置TMDDNon-linear PK driven by saturable binding to pharmacological target
FcRn (Neonatal Fc Receptor)新生儿Fc受体FcRnReceptor mediating antibody recycling from endosomes → extends IgG half-life
Receptor-Mediated Endocytosis受体介导的内吞RMECellular uptake mechanism for ADC-antigen complex
Deconjugation脱偶联Loss of payload from the antibody in circulation; measured as TAb-cAb divergence
Blood-to-Plasma Ratio血液/血浆比B/PRatio of drug concentration in whole blood vs. plasma; affects dose calculation
Non-Compartmental Analysis非房室分析NCAPK analysis without mechanistic model; derives AUC, Cmax, t½ directly from data
Population PK群体药代动力学popPKMixed-effects modeling of PK across patients; characterizes variability and covariates
Toxicokinetics毒代动力学TKPK measured alongside toxicology studies; characterizes systemic exposure at tox doses

G. 药效动力学与建模 | Pharmacodynamics & Modeling

English Term中文术语AbbreviationBrief Definition / 简要释义
Pharmacodynamics药效动力学PDStudy of drug effects on the body; dose/concentration-effect relationships
Exposure–Response暴露量-效应关系E-RRelationship between PK exposure metric (AUC, Cmax) and clinical outcome (efficacy or toxicity)
Tumor Growth Inhibition肿瘤生长抑制TGIPK/PD metric; % reduction in tumor volume vs. control
Minimum Anticipated Biological Effect Level最低预期生物效应水平MABELStarting dose concept based on minimum biologically effective dose
NOAEL (No Observed Adverse Effect Level)未观察到不良反应的剂量NOAELHighest dose in non-clinical study without adverse effects
Human Equivalent Dose人体等效剂量HEDNOAEL converted to human dose using body weight/BSA scaling
Population PK/PD Model群体药代/药效模型popPK/PDModel integrating PK and biomarker/efficacy data across patients
Transit Compartment Model转运房室模型PK/PD model for delayed drug effects (e.g., Friberg model for neutropenia)
Indirect Response Model间接效应模型IDRPD model where drug affects production or elimination rate of response variable
Maximum Effect最大效应EmaxMaximum pharmacological effect achievable
Half-Maximal Effective Concentration半数有效浓度EC₅₀Concentration producing 50% of Emax
Half-Maximal Inhibitory Concentration半数抑制浓度IC₅₀Concentration inhibiting 50% of baseline response (used for cytotoxicity assays)
Allometric Scaling异速放大 / 异速缩放Scaling PK parameters across species using body weight exponents (CL ∝ BW^0.75)
NONMEMNONMEMNONMEMIndustry-standard software for nonlinear mixed-effects PK/PD modeling
Visual Predictive Check可视化预测核查VPCModel diagnostic: observed data vs. simulated percentiles
Shrinkage收缩度Measure of how much individual PK estimates are pulled toward population mean; affects EBE reliability

H. 基质与分析前变量 | Matrix & Pre-Analytical Variables

English Term中文术语AbbreviationBrief Definition / 简要释义
Plasma血浆Liquid portion of anticoagulated blood (cells removed); preferred matrix for ADC PK
Serum血清Plasma after coagulation; contains activated proteases; generally avoided for ADC PK
Whole Blood全血Unfractionated blood; used for B/P ratio, blood cell target occupancy, ex vivo stability
EDTA (Ethylenediaminetetraacetic Acid)EDTA(乙二胺四乙酸)EDTAAnticoagulant and metal chelator; inhibits MMPs and coagulation; K₂EDTA tube preferred
Sodium Fluoride氟化钠NaFEsterase inhibitor; added to tubes for ester/carbonate linker stability
Hemolysis溶血RBC lysis releasing hemoglobin and GSH; causes assay interference and disulfide linker cleavage
Matrix Effect基质效应MESignal enhancement or suppression caused by matrix components co-eluting with analyte (LC-MS/MS)
Protein Precipitation蛋白沉淀PPTSample extraction method using organic solvent (ACN/MeOH) to remove proteins
Solid Phase Extraction固相萃取SPESample cleanup using sorbent cartridge; selective adsorption + elution
Supported Liquid Extraction支撑液液萃取SLEHybrid technique using diatomaceous earth support for liquid-liquid partition
Glutathione谷胱甘肽GSHIntracellular thiol reductant; cleaves disulfide linkers; released on hemolysis
Carboxylesterase羧酸酯酶CESEnzyme hydrolyzing ester bonds; high in rat plasma → critical for ester-linker ADC stability in rat studies
Cathepsin B组织蛋白酶BCatBLysosomal cysteine protease; cleaves Val-Cit/Val-Ala linkers; key intracellular ADC activator
Matrix Metalloproteinase基质金属蛋白酶MMPZinc-dependent protease in tumor stroma and neutrophils; inhibited by EDTA
Beta-Glucuronidaseβ-葡萄糖醛酸酶β-GUSLysosomal/tumor enzyme cleaving glucuronide linkers; elevated in tumor necrosis
Myeloperoxidase髓过氧化物酶MPONeutrophil enzyme; can oxidize maleimide or payload; released on neutrophil activation
Platelet-Poor Plasma乏血小板血浆PPPDouble-centrifuged plasma with minimal platelet contamination; reduces cathepsin B contamination
Freeze-Thaw Cycle冻融循环F-TRepeated freezing and thawing; must be validated (≥3 cycles per ICH M10)
Bench-Top Stability台面稳定性Stability of analyte in matrix at room temperature; must cover sample processing time

I. 监管法规 | Regulatory

English Term中文术语AbbreviationBrief Definition / 简要释义
Bioanalytical Method Validation生物分析方法验证BMVFormal process establishing assay performance (per ICH M10/FDA guidance)
Good Laboratory Practice良好实验室规范GLPQuality system for non-clinical safety studies; required for pivotal toxicology studies
Good Clinical Practice良好临床规范GCPQuality standard for clinical trials; required for all clinical bioanalytical assays
Fit-for-Purpose适配目的FFPQualification approach for exploratory/early-stage assays not yet fully validated
Investigational New Drug Application新药临床试验申请INDUS regulatory filing to begin human clinical trials
Clinical Trial Application临床试验申请CTAEU equivalent of IND
New Drug Application新药申请NDAUS regulatory filing for small molecule drug approval
Biologics License Application生物制品许可申请BLAUS regulatory filing for biologic (including ADC) approval
Marketing Authorization Application上市许可申请MAAEU regulatory filing for drug approval (EMA)
Summary of Clinical Pharmacology临床药理学概述NDA/BLA Module 2.7.2; includes PK methods and E-R analyses
Common Technical Document通用技术文件CTDStandardized ICH format for regulatory submissions globally
ICH M10ICH M10M10ICH Bioanalytical Method Validation guideline (2022); global harmonized standard
ICH S9ICH S9S9Nonclinical safety guidance for anticancer drugs; allows abbreviated tox package
ICH M3(R2)ICH M3(R2)M3(R2)Nonclinical study timing relative to clinical development
ICH E8(R1)ICH E8(R1)E8(R1)General considerations for design of clinical studies
MABEL最低预期生物效应水平MABELEMA/CHMP approach for FIH dose determination in high-risk biologics
Safety Margin安全余量Ratio of NOAEL exposure (in most sensitive species) to projected human efficacious exposure
Tissue Cross-Reactivity组织交叉反应性TCRIHC study on human normal tissue panel to assess off-target antigen binding
Pharmacovigilance药物警戒PVPost-marketing safety monitoring system
Risk Management Plan风险管理计划RMPEU document outlining identified risks and mitigation strategies

J. 临床终点与疗效生物标志物 | Clinical Endpoints & Efficacy Biomarkers

English Term中文术语AbbreviationBrief Definition / 简要释义
Objective Response Rate客观缓解率ORR% of patients achieving PR + CR per RECIST criteria
Complete Response完全缓解CRNo detectable tumor by imaging
Partial Response部分缓解PR≥30% reduction in tumor size (RECIST)
Stable Disease疾病稳定SDNeither sufficient shrinkage (PR) nor growth (PD)
Progressive Disease疾病进展PD≥20% increase in tumor size or new lesion
Disease Control Rate疾病控制率DCRORR + SD rate
Progression-Free Survival无进展生存期PFSTime from treatment start to disease progression or death
Overall Survival总生存期OSTime from treatment start to death from any cause
Pathologic Complete Response病理完全缓解pCRNo residual invasive tumor in surgical specimen; key endpoint for neoadjuvant ADC trials
Soluble Target Antigen可溶性靶抗原sTAAShed extracellular domain circulating in plasma; decoy for ADC; measured as PD biomarker
Tumor Antigen Expression肿瘤抗原表达IHC/ISH quantitation of target on tumor tissue; determines patient eligibility
Circulating Tumor DNA循环肿瘤DNActDNACell-free tumor-derived DNA in plasma; used for minimal residual disease and resistance monitoring
Pharmacodynamic Biomarker药效动力学生物标志物PD biomarkerMeasurable change in patient reflecting drug’s biological effect (e.g., γH2AX for DNA DSB)
Predictive Biomarker预测性生物标志物Biomarker that predicts differential response to a specific treatment
Prognostic Biomarker预后性生物标志物Biomarker that predicts patient outcome regardless of treatment

K. 常用ADC药物名称对照 | Approved ADC Drug Names

Brand Name中文名 / 音译名INNTarget
Mylotarg麦罗塔 / 吉妥珠单抗奥唑米星Gemtuzumab ozogamicinCD33
Kadcyla赫赛莱 / 恩美曲妥珠单抗Ado-trastuzumab emtansine (T-DM1)HER2
Adcetris安适利 / 维布妥昔单抗Brentuximab vedotinCD30
Polivy普利维 / 维泊妥珠单抗Polatuzumab vedotinCD79b
Padcev帕德赛 / 恩诺单抗Enfortumab vedotinNectin-4
Trodelvy拓达维 / 戈沙妥珠单抗Sacituzumab govitecanTROP-2
Enhertu优赫得 / 德曲妥珠单抗Trastuzumab deruxtecan (T-DXd)HER2
Zynlonta赞洛塔 / 朗卡妥昔单抗替西林Loncastuximab tesirineCD19
Blenrep贝伦雷普 / 贝兰他单抗马法多汀Belantamab mafodotinBCMA
Elahere艾拉赫 / 米维妥珠单抗索拉坦辛Mirvetuximab soravtansineFRα
Besylomab贝司洛单抗 / 奥加伊妥珠单抗Inotuzumab ozogamicinCD22
Tivdak替弗达克 / 替沙妥昔单抗Tisotumab vedotinTF (Tissue Factor)