{ "meta": { "title": "Geneseeq North America Oncology Opportunity Radar", "asOf": "2026-08-08", "language": "zh-CN", "scope": "面向世和基因北美实验室的肿瘤临床试验检测、中心实验室、转化研究与CDx共开发机会清单", "purpose": "商务优先级与项目尽调支持，不是全球全部在研药物数据库，也不是收入预测", "opportunityCount": 32, "immediateChaseCount": 12, "scoreScale": "0-100 ordinal; scores compare opportunities in this file only and are not revenue estimates", "sourceCutoff": "2026-08-08", "registrySnapshot": { "source": "ClinicalTrials.gov API v2", "url": "https://clinicaltrials.gov/data-api/api", "retrievedAt": "2026-08-07T20:03:08.052Z", "activeIndustryOncologyTrials": 5395, "northAmericaTrials": 2820, "estimatedPrimaryCompletions2026to2029": 4095, "limitation": "Registry data omit undisclosed/preclinical programs and do not reveal procurement, assay-vendor or contract status." }, "capabilityGuardrail": "GeneseeqPrime K250003 is a 510(k)-cleared tumor-profiling assay, not an FDA-cleared therapy-selecting CDx. IHC, FISH, HLA, flow cytometry, qPCR/ddPCR and PK/ADA are treated as audit-required or partner-delivered unless separately documented." }, "opportunities": [ { "id": "zovegalisib-rly2608", "rank": 1, "tier": "immediate-chase", "account": "Relay Therapeutics", "company": "Relay Therapeutics", "origin": "United States", "asset": "Zovegalisib", "aliases": ["RLY-2608"], "mechanism": "mutant-selective PI3Kα inhibitor", "indications": ["PIK3CA-mutant HR+/HER2- advanced breast cancer"], "biomarker": "PIK3CA mutation, including kinase- and non-kinase-domain variants", "phase": "Phase 3", "northAmerica": true, "chinaOrigin": false, "services": ["CTA/central lab", "tissue CGP", "plasma CGP", "CDx co-development", "longitudinal ctDNA"], "modalities": ["DNA NGS", "plasma NGS", "ctDNA"], "modalityFit": "owned", "enrollmentMechanism": "central confirmation", "valueScore": 91, "winScore": 72, "ctaScore": 89, "cdxScore": 86, "priorityScore": 91, "cdxStatus": "强制PIK3CA生物标志物；未见公开指定CDx厂商，不得等同于开放RFP", "vendorStatus": "undisclosed; BD/RFI核实后才能判断", "whyNow": "ReDiscover-2已进入全球III期且获BTD；中型精准药企、非热点PIK3CA变异带来真实分析难点。", "bidThesis": "以全PIK3CA变异谱、组织-血浆一致性和低VAF复核切入，再附带CTA至CDx bridging选项。", "assays": ["PIK3CA tissue NGS", "PIK3CA plasma NGS", "variant adjudication", "ctDNA kinetics"], "capabilityBoundary": "核心NGS与液体活检匹配；任何治疗选择用途仍需独立CDx分析/临床验证和监管路径。", "risks": ["现有全球中心实验室可能未公开", "PIK3CA成熟竞争生态", "一线组合开发节奏可能变化"], "decisionTrigger": "确认入组是否必须中央复核、当前CTA/CDx供应商以及ReDiscover-2北美样本范围。", "decisionOwner": "BD牵头；北美实验室平台主管与法规/CDx负责人共同Go/No-Go", "ncts": ["NCT06982521"], "milestones": [ {"quarter": "2026Q3", "label": "ReDiscover-2全球III期持续入组", "confidence": "fact", "detail": "BTD已授予该III期目标人群。"}, {"quarter": "2027Q1", "label": "前线三联III期计划窗口", "confidence": "company-guidance", "detail": "公司曾指引2027年初启动，需在启动前复核。"}, {"quarter": "2028Q2", "label": "ReDiscover-2主要完成估计", "confidence": "registry-estimate", "detail": "注册预计2028-04-30；不等于数据公布。"} ], "sources": [ {"label": "ReDiscover-2", "url": "https://clinicaltrials.gov/study/NCT06982521", "type": "ClinicalTrials.gov"}, {"label": "Relay 2026 zovegalisib update", "url": "https://ir.relaytx.com/news-releases/news-release-details/relay-therapeutics-announces-data-zovegalisib-fulvestrant-phase", "type": "company"} ], "tags": ["precision", "PIK3CA", "breast", "CTA", "CDx", "liquid-biopsy"] }, { "id": "silevertinib-bdtx1535", "rank": 2, "tier": "immediate-chase", "account": "Black Diamond Therapeutics", "company": "Black Diamond Therapeutics", "origin": "United States", "asset": "Silevertinib", "aliases": ["BDTX-1535"], "mechanism": "brain-penetrant EGFR inhibitor covering noncanonical EGFR, C797S and EGFRvIII", "indications": ["noncanonical-EGFR NSCLC", "EGFRvIII-positive newly diagnosed glioblastoma"], "biomarker": "nonclassical EGFR mutation/C797S or EGFRvIII; GBM program also uses MGMT methylation", "phase": "Phase 2", "northAmerica": true, "chinaOrigin": false, "services": ["CTA/central lab", "DNA/RNA profiling", "plasma resistance", "CDx strategy"], "modalities": ["DNA NGS", "RNA NGS", "plasma NGS", "methylation assay"], "modalityFit": "mixed", "enrollmentMechanism": "central confirmation", "valueScore": 84, "winScore": 81, "ctaScore": 78, "cdxScore": 82, "priorityScore": 89, "cdxStatus": "复杂强制标志物，未见公开指定主CDx厂商", "vendorStatus": "undisclosed; smaller sponsor may be more approachable", "whyNow": "2026年NSCLC II期数据阳性且EGFRvIII GBM随机II期已启动；rare-variant assay复杂度高。", "bidThesis": "提供rare-EGFR/EGFRvIII DNA+RNA正交方案、血浆耐药和MGMT合作检测，不以单点热点panel竞争。", "assays": ["rare EGFR DNA NGS", "EGFRvIII RNA assay", "plasma resistance panel", "MGMT methylation"], "capabilityBoundary": "DNA/RNA NGS匹配；MGMT甲基化性能与实验室资质需审计，必要时合作交付。", "risks": ["申办方融资与合作风险", "目前主要为II期", "GBM组织与RNA质量挑战"], "decisionTrigger": "取得中央检测流程、EGFRvIII assay specification和未来注册研究设计。", "decisionOwner": "精准肿瘤BD；北美实验室与生物信息平台主管", "ncts": ["NCT05256290", "NCT07326566"], "milestones": [ {"quarter": "2026Q3", "label": "NSCLC II期数据与GBM试验商务窗口", "confidence": "fact", "detail": "GBM随机II期于2026-05启动。"}, {"quarter": "2028Q4", "label": "GBM主要完成估计", "confidence": "registry-estimate", "detail": "注册预计2028-11主要完成。"}, {"quarter": "2029Q2", "label": "注册/合作路径决策窗口", "confidence": "inference", "detail": "取决于NSCLC成熟PFS和GBM结果。"} ], "sources": [ {"label": "NSCLC study", "url": "https://clinicaltrials.gov/study/NCT05256290", "type": "ClinicalTrials.gov"}, {"label": "GBM study", "url": "https://clinicaltrials.gov/study/NCT07326566", "type": "ClinicalTrials.gov"}, {"label": "2026 Phase 2 results", "url": "https://investors.blackdiamondtherapeutics.com/news-releases/news-release-details/black-diamond-therapeutics-announces-positive-phase-2-results", "type": "company"} ], "tags": ["precision", "EGFR", "RNA", "NSCLC", "GBM", "winnable"] }, { "id": "lirafugratinib-rly4008", "rank": 3, "tier": "immediate-chase", "account": "Elevar Therapeutics", "company": "Elevar Therapeutics; licensed from Relay Therapeutics", "origin": "United States", "asset": "Lirafugratinib", "aliases": ["RLY-4008"], "mechanism": "highly selective FGFR2 inhibitor", "indications": ["FGFR2 fusion/rearrangement cholangiocarcinoma", "FGFR2-altered solid tumors"], "biomarker": "FGFR2 fusion or rearrangement", "phase": "Phase 2; described by licensor as NDA-ready", "northAmerica": true, "chinaOrigin": false, "services": ["CTA/central lab", "RNA/DNA fusion", "plasma resistance", "CDx co-development"], "modalities": ["RNA NGS", "DNA NGS", "plasma NGS"], "modalityFit": "owned", "enrollmentMechanism": "central confirmation", "valueScore": 78, "winScore": 83, "ctaScore": 76, "cdxScore": 84, "priorityScore": 88, "cdxStatus": "FGFR2为强制标志物；新权利方的正式CDx安排未公开", "vendorStatus": "undisclosed after rights transfer; uncertainty, not evidence of open bidding", "whyNow": "Elevar刚接手全球开发权，供应商与注册策略可能处于重整期。", "bidThesis": "向新权利方提交RNA-first fusion、DNA补充及血浆耐药的一体化迁移/bridging方案。", "assays": ["FGFR2 RNA fusion", "FGFR2 DNA rearrangement", "plasma FGFR2 resistance"], "capabilityBoundary": "NGS匹配；必须验证FFPE RNA失败率、跨平台桥接和最终CDx监管要求。", "risks": ["具体NDA时间未核实", "资产交接执行风险", "胆管癌样本量有限"], "decisionTrigger": "Elevar确认开发时间表、历史CTA数据可转移性和CDx供应商状态。", "decisionOwner": "BD与法规/CDx负责人；由北美RNA实验室平台主管签署技术可行性", "ncts": ["NCT07359820"], "milestones": [ {"quarter": "2026Q3", "label": "权利转移后的供应商重整窗口", "confidence": "fact", "detail": "Elevar已取得全球独家权利。"}, {"quarter": "2027Q4", "label": "泛瘤种II期数据成熟窗口", "confidence": "inference", "detail": "需以注册更新确认，不写成确定读出。"}, {"quarter": "2028Q4", "label": "潜在注册/确证设计窗口", "confidence": "inference", "detail": "仅在数据和监管互动支持时成立。"} ], "sources": [ {"label": "FGFR2 solid-tumor study", "url": "https://clinicaltrials.gov/study/NCT07359820", "type": "ClinicalTrials.gov"}, {"label": "Relay-Elevar license", "url": "https://ir.relaytx.com/news-releases/news-release-details/relay-therapeutics-and-elevar-therapeutics-announce-exclusive", "type": "company"} ], "tags": ["precision", "FGFR2", "fusion", "RNA", "CDx", "winnable"] }, { "id": "olverembatinib-hqp1351", "rank": 4, "tier": "immediate-chase", "account": "Ascentage Pharma", "company": "Ascentage Pharma", "origin": "China-origin / global development", "asset": "Olverembatinib", "aliases": ["HQP1351"], "mechanism": "third-generation BCR::ABL1 tyrosine kinase inhibitor including T315I", "indications": ["newly diagnosed Ph+ ALL", "BCR::ABL1-positive leukemia"], "biomarker": "BCR::ABL1 transcript, kinase-domain mutation and MRD", "phase": "Global Phase 3", "northAmerica": true, "chinaOrigin": true, "services": ["CTA/central lab", "serial molecular MRD", "kinase-domain NGS", "sample logistics"], "modalities": ["qPCR", "NGS MRD", "DNA NGS"], "modalityFit": "mixed", "enrollmentMechanism": "local prior", "valueScore": 88, "winScore": 82, "ctaScore": 94, "cdxScore": 70, "priorityScore": 87, "cdxStatus": "Ph+为明确入组条件；核心价值是国际标准化重复MRD而非新建单一CDx", "vendorStatus": "undisclosed; originator-channel access is the thesis", "whyNow": "POLARIS-1全球III期覆盖大量美国中心，主要终点即MRD-negative CR，检测频次高。", "bidThesis": "从Ascentage原研方渠道争取北美qPCR/NGS MRD、T315I/耐药突变和样本物流，不主张替换未公开的全球主供应商。", "assays": ["international-scale BCR::ABL1 qPCR", "BCR::ABL1 kinase-domain NGS", "NGS MRD"], "capabilityBoundary": "qPCR国际标准化、LoD和实验室间可比性必须先审计；未文件化的qPCR能力不得直接承诺。", "risks": ["血液瘤中心实验室incumbent强", "qPCR能力需审计", "全球供应商状态未公开"], "decisionTrigger": "通过能力审计并取得POLARIS-1采样频率、中心化比例与北美站点需求。", "decisionOwner": "中国BD/全球化团队牵头；北美血液检测平台主管批准", "ncts": ["NCT06051409", "NCT06817720"], "milestones": [ {"quarter": "2026Q3", "label": "POLARIS-1北美站点启动与入组窗口", "confidence": "fact", "detail": "注册列出约90个中心并含多个美国中心。"}, {"quarter": "2027Q4", "label": "早期MRD数据成熟窗口", "confidence": "inference", "detail": "由Cycle 1-3 MRD主要终点产生；公开读出时间未确认。"}, {"quarter": "2029Q4", "label": "EFS与长期MRD随访持续", "confidence": "registry-estimate", "detail": "注册随访跨度约3-6年。"} ], "sources": [ {"label": "POLARIS-1", "url": "https://clinicaltrials.gov/study/NCT06051409", "type": "ClinicalTrials.gov"}, {"label": "Additional global Phase 3", "url": "https://clinicaltrials.gov/study/NCT06817720", "type": "ClinicalTrials.gov"}, {"label": "Ascentage olverembatinib update", "url": "https://ir.ascentage.com/static-files/2f624c92-9484-4276-b644-8042346b0de8", "type": "company"} ], "tags": ["China-origin", "hematology", "BCR-ABL1", "MRD", "repeat-testing", "originator-channel"] }, { "id": "zoldonrasib-rmc9805", "rank": 5, "tier": "immediate-chase", "account": "Revolution Medicines", "company": "Revolution Medicines", "origin": "United States", "asset": "Zoldonrasib", "aliases": ["RMC-9805"], "mechanism": "RAS(ON) G12D-selective inhibitor", "indications": ["first-line metastatic RAS G12D pancreatic cancer", "KRAS G12D NSCLC"], "biomarker": "RAS/KRAS G12D", "phase": "Phase 1/1b and Phase 3", "northAmerica": true, "chinaOrigin": false, "services": ["CTA/central lab", "tissue/plasma genotyping", "CDx co-development", "ctDNA response and resistance"], "modalities": ["DNA NGS", "plasma NGS", "ctDNA"], "modalityFit": "owned", "enrollmentMechanism": "central confirmation", "valueScore": 96, "winScore": 70, "ctaScore": 92, "cdxScore": 88, "priorityScore": 86, "cdxStatus": "单一G12D强制标志物，公开主CDx厂商未确认", "vendorStatus": "undisclosed; do not infer open procurement", "whyNow": "RASolute-305于2026年开始全球III期治疗，且G12D NSCLC获BTD。", "bidThesis": "以PDAC低脱落血浆、组织-血浆一致性、低VAF复核和耐药纵向包切入。", "assays": ["RAS G12D tissue NGS", "low-VAF plasma NGS", "ctDNA kinetics", "resistance CGP"], "capabilityBoundary": "NGS/液体活检匹配；最终治疗选择CDx必须另行完成分析和临床验证。", "risks": ["大规模III期供应商可能已选定", "PDAC低ctDNA shedding", "最终intended-use与阈值未公开"], "decisionTrigger": "确认RASolute-305中央筛查流程、北美样本量和正式CDx策略。", "decisionOwner": "美国BD；液体活检平台主管与CDx法规负责人", "ncts": ["NCT06040541", "NCT07621718"], "milestones": [ {"quarter": "2026Q3", "label": "RASolute-305全球III期全面启动", "confidence": "fact", "detail": "2026-06已开始治疗患者。"}, {"quarter": "2026Q4", "label": "I/II期主要完成估计", "confidence": "registry-estimate", "detail": "NCT06040541预计2026-12主要完成。"}, {"quarter": "2028Q4", "label": "RASolute-305主要完成估计", "confidence": "registry-estimate", "detail": "注册预计2028-12；不等于读出。"} ], "sources": [ {"label": "Phase 1/1b study", "url": "https://clinicaltrials.gov/study/NCT06040541", "type": "ClinicalTrials.gov"}, {"label": "RASolute-305", "url": "https://clinicaltrials.gov/study/NCT07621718", "type": "ClinicalTrials.gov"}, {"label": "First patient treated", "url": "https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-begins-treating-patients-rasolute-305-phase/", "type": "company"} ], "tags": ["precision", "RAS", "G12D", "PDAC", "CTA", "CDx"] }, { "id": "navlimetostat-bms986504", "rank": 6, "tier": "immediate-chase", "account": "Bristol Myers Squibb", "company": "Bristol Myers Squibb", "origin": "United States", "asset": "Navlimetostat", "aliases": ["BMS-986504", "MRTX1719"], "mechanism": "MTA-cooperative PRMT5 inhibitor", "indications": ["first-line MTAP-homozygous-deleted NSCLC", "first-line MTAP-homozygous-deleted PDAC"], "biomarker": "homozygous MTAP deletion, with CDKN2A/MTAP CNV and possible IHC orthogonal confirmation", "phase": "Seamless Phase 2/3", "northAmerica": true, "chinaOrigin": false, "services": ["high-volume prescreening", "CTA/central lab", "tissue/plasma CNV", "CDx co-development", "discordance adjudication"], "modalities": ["DNA NGS CNV", "plasma NGS", "IHC", "FISH"], "modalityFit": "mixed", "enrollmentMechanism": "central mandatory", "valueScore": 97, "winScore": 54, "ctaScore": 95, "cdxScore": 90, "priorityScore": 84, "cdxStatus": "MTAP纯合缺失为强制标志物；具体screening modality/cutoff与主供应商未公开", "vendorStatus": "undisclosed; BMS incumbent risk is high", "whyNow": "NSCLC与PDAC两项一线II/III期同时启动，低阳性率可产生大量prescreen样本。", "bidThesis": "有条件追逐：先做MTAP screening-modality audit，再提案北美backup、NGS-IHC discordance和血浆探索。", "assays": ["MTAP/CDKN2A deep-deletion CNV", "tumor-purity correction", "MTAP IHC concordance", "plasma CNV"], "capabilityBoundary": "NGS CNV匹配；MTAP IHC/FISH必须审计或合作交付，不能在能力未证实前承诺全包。", "risks": ["BMS全球主实验室可能已锁定", "低肿瘤纯度导致CNV假阴性", "IHC与NGS阈值尚未公开"], "decisionTrigger": "获得MountainTAP central-assay定义、阈值、样本量和供应商边界；未取得则只做探索/backup提案。", "decisionOwner": "全球大药企BD；北美实验室、病理合作与CDx法规三方审批", "ncts": ["NCT07063745", "NCT07076121", "NCT07492680"], "milestones": [ {"quarter": "2026Q3", "label": "MountainTAP-29/30全球II/III期入组", "confidence": "fact", "detail": "NSCLC和PDAC均要求MTAP纯合缺失。"}, {"quarter": "2027Q4", "label": "II期门控与assay-freeze可能窗口", "confidence": "inference", "detail": "需以申办方方案和注册更新确认。"}, {"quarter": "2029Q2", "label": "MountainTAP-30主要完成估计", "confidence": "registry-estimate", "detail": "注册预计2029-05-03。"} ], "sources": [ {"label": "MountainTAP-29", "url": "https://clinicaltrials.gov/study/NCT07063745", "type": "ClinicalTrials.gov"}, {"label": "MountainTAP-30", "url": "https://clinicaltrials.gov/study/NCT07076121", "type": "ClinicalTrials.gov"}, {"label": "MountainTAP-5", "url": "https://clinicaltrials.gov/study/NCT07492680", "type": "ClinicalTrials.gov"} ], "tags": ["precision", "MTAP", "PRMT5", "high-screen-failure", "conditional", "CDx"] }, { "id": "sacituzumab-tirumotecan-mk2870", "rank": 7, "tier": "immediate-chase", "account": "Kelun-Biotech originator channel", "company": "Merck and Kelun-Biotech", "origin": "China-origin / global Merck development", "asset": "Sacituzumab tirumotecan", "aliases": ["sac-TMT", "MK-2870", "SKB264"], "mechanism": "TROP2-directed antibody-drug conjugate", "indications": ["NSCLC", "breast cancer", "endometrial cancer", "gastric cancer", "ovarian cancer", "cervical cancer", "bladder cancer"], "biomarker": "TROP2 expression is mainly translational/exploratory, not generally mandatory for enrollment", "phase": "17 global Phase 3 programs", "northAmerica": true, "chinaOrigin": true, "services": ["originator-channel CTA", "central lab", "tissue/plasma translational profiling", "PK/ADA coordination"], "modalities": ["DNA NGS", "plasma NGS", "IHC", "PK/ADA"], "modalityFit": "mixed", "enrollmentMechanism": "exploratory", "valueScore": 100, "winScore": 55, "ctaScore": 100, "cdxScore": 35, "priorityScore": 82, "cdxStatus": "TROP2通常不是强制入组标志物；CDx逻辑弱于其巨大central-lab价值", "vendorStatus": "Merck global incumbents likely; pursue through Kelun originator channel, not displacement", "whyNow": "Merck公开17项全球III期、计划总样本超过15,000，形成极大的重复样本与转化研究需求。", "bidThesis": "通过Kelun原研方争取区域bridging、转化队列、组织-血液配对和中国/北美样本接口，不试图替换Merck全球主供应商。", "assays": ["broad tissue CGP", "plasma CGP", "TROP2 exploratory IHC", "resistance profiling"], "capabilityBoundary": "NGS匹配；TROP2 IHC和PK/ADA须审计或由合作方交付。", "risks": ["Merck供应商壁垒", "非强制TROP2限制CDx价值", "大项目采购分工不公开"], "decisionTrigger": "Kelun确认其可影响的区域/转化工作包以及Merck主合同外的样本范围。", "decisionOwner": "中国原研方BD牵头；北美交付和联盟管理共同审批", "ncts": ["NCT06170788", "NCT06312176", "NCT06824467"], "milestones": [ {"quarter": "2026Q3", "label": "17项全球III期持续执行", "confidence": "fact", "detail": "Merck临床项目说明文件列示广泛III期组合。"}, {"quarter": "2027Q4", "label": "首批III期数据波次", "confidence": "inference", "detail": "具体读出顺序以各NCT更新为准。"}, {"quarter": "2029Q4", "label": "多瘤种确证与上市后研究窗口", "confidence": "inference", "detail": "不代表任何适应证必然获批。"} ], "sources": [ {"label": "Merck TroFuse clinical-trial explainer", "url": "https://www.merck.com/wp-content/uploads/sites/124/2026/05/TroFuse_Clinical_Trial_Explainer.pdf", "type": "company"}, {"label": "Representative Phase 3", "url": "https://clinicaltrials.gov/study/NCT06170788", "type": "ClinicalTrials.gov"}, {"label": "Representative Phase 3", "url": "https://clinicaltrials.gov/study/NCT06312176", "type": "ClinicalTrials.gov"}, {"label": "Representative Phase 3", "url": "https://clinicaltrials.gov/study/NCT06824467", "type": "ClinicalTrials.gov"} ], "tags": ["China-origin", "whale", "ADC", "TROP2", "originator-channel", "CTA"] }, { "id": "zl1310-dll3-adc", "rank": 8, "tier": "immediate-chase", "account": "Zai Lab", "company": "Zai Lab", "origin": "China-origin / global development", "asset": "ZL-1310", "aliases": ["ZL1310"], "mechanism": "DLL3-directed antibody-drug conjugate", "indications": ["small-cell lung cancer", "DLL3-expressing neuroendocrine cancers"], "biomarker": "DLL3 expression is biologically relevant but public records do not establish a validated mandatory cutoff", "phase": "Phase 1/2 with global Phase 3 program registered", "northAmerica": true, "chinaOrigin": true, "services": ["cross-border CTA", "central lab", "tissue/plasma profiling", "exploratory DLL3 biomarker"], "modalities": ["DNA NGS", "plasma NGS", "IHC"], "modalityFit": "mixed", "enrollmentMechanism": "exploratory", "valueScore": 88, "winScore": 75, "ctaScore": 85, "cdxScore": 40, "priorityScore": 81, "cdxStatus": "DLL3预测性阈值未验证；不应宣传为确定CDx项目", "vendorStatus": "undisclosed; direct cross-border account is the opportunity", "whyNow": "Zai Lab在北美开展全球开发且新III期已登记，原研方沟通链比外授权巨头更直接。", "bidThesis": "争取北美站点样本、baseline/longitudinal CGP和DLL3探索性相关性；IHC由审计合作者交付。", "assays": ["tissue CGP", "plasma CGP", "DLL3 exploratory IHC", "ctDNA kinetics"], "capabilityBoundary": "NGS匹配；DLL3 IHC能力需审计或合作，尚不能承诺CDx。", "risks": ["DLL3不一定强制入组", "ADC竞争激烈", "III期细节可能调整"], "decisionTrigger": "确认NCT07218146的中央检测、北美样本归属和DLL3是否仅探索性。", "decisionOwner": "跨境BD；北美实验室平台主管与病理合作负责人", "ncts": ["NCT06179069", "NCT07218146"], "milestones": [ {"quarter": "2026Q3", "label": "全球早期与III期项目并行窗口", "confidence": "fact", "detail": "Zai 2026Q1业务更新确认项目推进。"}, {"quarter": "2027Q4", "label": "剂量/队列数据成熟窗口", "confidence": "inference", "detail": "需依据公司更新确认。"}, {"quarter": "2029Q2", "label": "III期中期/主要分析可能窗口", "confidence": "inference", "detail": "未找到可核验的确定读出日期。"} ], "sources": [ {"label": "ZL-1310 early study", "url": "https://clinicaltrials.gov/study/NCT06179069", "type": "ClinicalTrials.gov"}, {"label": "ZL-1310 Phase 3", "url": "https://clinicaltrials.gov/study/NCT07218146", "type": "ClinicalTrials.gov"}, {"label": "Zai Lab Q1 2026 update", "url": "https://ir.zailaboratory.com/news-releases/news-release-details/zai-lab-announces-first-quarter-2026-financial-results-and/", "type": "company"} ], "tags": ["China-origin", "cross-border", "ADC", "DLL3", "SCLC", "CTA"] }, { "id": "saruparib-azd5305", "rank": 9, "tier": "immediate-chase", "account": "AstraZeneca", "company": "AstraZeneca", "origin": "United Kingdom / global", "asset": "Saruparib", "aliases": ["AZD5305"], "mechanism": "selective PARP1 inhibitor", "indications": ["BRCA1/2- or PALB2-mutant HR+/HER2- advanced breast cancer"], "biomarker": "germline or tumor loss-of-function BRCA1, BRCA2 or PALB2", "phase": "Phase 3", "northAmerica": true, "chinaOrigin": false, "services": ["CTA/central lab", "germline/somatic HRR", "plasma translation", "CTA-CDx bridging"], "modalities": ["DNA NGS", "plasma NGS", "germline testing"], "modalityFit": "owned", "enrollmentMechanism": "central confirmation", "valueScore": 94, "winScore": 48, "ctaScore": 92, "cdxScore": 58, "priorityScore": 79, "cdxStatus": "注册明确写明样本用于CDx开发和CTA一致性；但BRCA成熟生态显著降低新主CDx可获得性", "vendorStatus": "undisclosed in public record; mature incumbent ecosystem likely", "whyNow": "预计筛查约2,620人仅随机500人，产生高筛查量；注册明确包含CDx比较。", "bidThesis": "按Claude建议以CTA/translation为主：germline+somatic判读、样本救援、plasma和跨平台bridging；不把明确CDx语言误读为开放竞标。", "assays": ["BRCA1/2/PALB2 tissue NGS", "germline confirmation", "plasma HRR", "variant adjudication"], "capabilityBoundary": "NGS适配；遗传咨询/胚系报告与CDx监管责任必须明确，GeneseeqPrime本身不是该药CDx。", "risks": ["AstraZeneca大药企准入", "BRCA平台成熟", "主CDx伙伴可能未公开"], "decisionTrigger": "确认筛查CTA平台、CDx伙伴、北美样本处理与variant-adjudication工作是否可拆分。", "decisionOwner": "大药企BD与医学事务；法规/CDx和遗传检测负责人共同审批", "ncts": ["NCT06380751"], "milestones": [ {"quarter": "2026Q3", "label": "EvoPAR-BR01持续全球筛查", "confidence": "fact", "detail": "注册明确CDx性能与CTA一致性终点。"}, {"quarter": "2028Q4", "label": "潜在CDx assay-lock/bridging窗口", "confidence": "inference", "detail": "实际时间由申办方和监管互动决定。"}, {"quarter": "2029Q1", "label": "主要完成估计", "confidence": "registry-estimate", "detail": "注册预计2029-03-30。"} ], "sources": [ {"label": "EvoPAR-BR01", "url": "https://clinicaltrials.gov/study/NCT06380751", "type": "ClinicalTrials.gov"}, {"label": "AstraZeneca oncology pipeline", "url": "https://www.astrazeneca.com/our-therapy-areas/oncology.html", "type": "company"} ], "tags": ["precision", "HRR", "BRCA", "PALB2", "CTA-first", "large-pharma"] }, { "id": "ivonescimab-ak112", "rank": 10, "tier": "immediate-chase", "account": "Akeso originator channel", "company": "Summit Therapeutics and Akeso", "origin": "China-origin / global Summit development", "asset": "Ivonescimab", "aliases": ["AK112", "SMT112"], "mechanism": "PD-1 x VEGF bispecific antibody", "indications": ["first-line and EGFR-mutant NSCLC"], "biomarker": "PD-L1, EGFR and ctDNA are stratification/translation signals; no validated proprietary predictive CDx", "phase": "Multiple global Phase 3", "northAmerica": true, "chinaOrigin": true, "services": ["originator-channel CTA", "central lab", "EGFR/PD-L1 coordination", "ctDNA translation"], "modalities": ["DNA NGS", "plasma NGS", "PD-L1 IHC"], "modalityFit": "mixed", "enrollmentMechanism": "local prior", "valueScore": 95, "winScore": 60, "ctaScore": 96, "cdxScore": 30, "priorityScore": 78, "cdxStatus": "预测性CDx逻辑弱；重点是高量central testing和转化研究", "vendorStatus": "Summit global vendors undisclosed; use Akeso originator channel", "whyNow": "多项全球III期在北美执行，EGFR分层和纵向ctDNA可形成大样本服务。", "bidThesis": "从Akeso争取区域bridging/转化工作包和北美样本接口，不假设能替代Summit全球供应商。", "assays": ["EGFR tissue/plasma NGS", "broad CGP", "ctDNA kinetics", "PD-L1 coordination"], "capabilityBoundary": "NGS匹配；PD-L1 IHC需审计/合作，且不可声称存在专属预测性CDx。", "risks": ["Summit主合同壁垒", "PD-L1/ctDNA可能仅探索性", "全球与中国数据可推广性"], "decisionTrigger": "Akeso确认其可控制的样本、区域桥接与转化研究预算。", "decisionOwner": "中国原研方BD与联盟管理；北美交付负责人", "ncts": ["NCT06396065", "NCT05899608", "NCT06767514"], "milestones": [ {"quarter": "2026Q3", "label": "全球III期组合持续入组", "confidence": "fact", "detail": "Summit 2026年度更新列示多项全球推进。"}, {"quarter": "2027Q4", "label": "全球队列数据波次", "confidence": "inference", "detail": "依各研究事件数和公司披露。"}, {"quarter": "2029Q2", "label": "确证与扩展研究窗口", "confidence": "inference", "detail": "不代表必然获批。"} ], "sources": [ {"label": "HARMONi global study", "url": "https://clinicaltrials.gov/study/NCT06396065", "type": "ClinicalTrials.gov"}, {"label": "Representative Phase 3", "url": "https://clinicaltrials.gov/study/NCT05899608", "type": "ClinicalTrials.gov"}, {"label": "Summit FY2025 update", "url": "https://smmttx.com/news/press-releases/news-details/2026/Summit-Therapeutics-Reports-Financial-Results-and-Operational-Progress-for-the-Fourth-Quarter-and-Year-Ended-December-31-2025/", "type": "company"} ], "tags": ["China-origin", "whale", "NSCLC", "ctDNA", "originator-channel", "CTA"] }, { "id": "izalontamab-brengitecan-blb01d1", "rank": 11, "tier": "immediate-chase", "account": "SystImmune originator channel", "company": "Bristol Myers Squibb and SystImmune", "origin": "China-origin / global BMS development", "asset": "Izalontamab brengitecan", "aliases": ["iza-bren", "BL-B01D1", "BMS-986453"], "mechanism": "EGFR x HER3 bispecific ADC", "indications": ["TNBC", "NSCLC", "head and neck cancer", "other solid tumors"], "biomarker": "EGFR/HER3 expression and genomic context are translational; a mandatory cutoff is not publicly established", "phase": "Multiple global pivotal/Phase 3 studies", "northAmerica": true, "chinaOrigin": true, "services": ["originator-channel CTA", "central lab", "tissue/plasma translational profiling", "resistance profiling"], "modalities": ["DNA NGS", "plasma NGS", "IHC"], "modalityFit": "mixed", "enrollmentMechanism": "exploratory", "valueScore": 96, "winScore": 47, "ctaScore": 96, "cdxScore": 38, "priorityScore": 77, "cdxStatus": "未建立公开强制表达阈值；CDx价值低于central/translational价值", "vendorStatus": "BMS incumbents likely; route through SystImmune originator relationship", "whyNow": "2026年TNBC III期中期顶线阳性，且多个全球关键研究并行。", "bidThesis": "通过SystImmune争取北美转化队列、组织-血浆配对和耐药研究；不尝试直接置换BMS全球主实验室。", "assays": ["broad tissue CGP", "plasma CGP", "EGFR/HER3 exploratory IHC", "ctDNA resistance"], "capabilityBoundary": "NGS匹配；EGFR/HER3 IHC需审计/合作，不可将探索表达标为既定CDx。", "risks": ["BMS供应商壁垒", "表达biomarker非强制", "跨公司治理复杂"], "decisionTrigger": "SystImmune确认可拆分的区域/转化样本与BMS合同边界。", "decisionOwner": "原研方BD与联盟管理；北美转化医学负责人", "ncts": ["NCT05983432", "NCT06926868", "NCT07100080", "NCT07106762"], "milestones": [ {"quarter": "2026Q3", "label": "TNBC III期阳性后的扩展窗口", "confidence": "fact", "detail": "BMS/SystImmune已公布积极中期顶线结果。"}, {"quarter": "2027Q4", "label": "多项全球关键研究持续入组", "confidence": "registry-estimate", "detail": "具体主要完成日期以各NCT为准。"}, {"quarter": "2029Q2", "label": "多瘤种数据成熟窗口", "confidence": "inference", "detail": "不保证任何适应证成功。"} ], "sources": [ {"label": "BMS/SystImmune Phase 3 topline", "url": "https://news.bms.com/news/corporate-financial/2026/SystImmune-and-Bristol-Myers-Squibb-Highlight-Positive-Phase-III-Interim-Topline-Results-for-izalontamab-brengitecan-Iza-bren-in-Previously-Treated-Unresectable-Locally-Advanced-or-Metastatic-Triple-Negative-Breast-Cancer/default.aspx", "type": "company"}, {"label": "Representative global study", "url": "https://clinicaltrials.gov/study/NCT06926868", "type": "ClinicalTrials.gov"}, {"label": "Representative global study", "url": "https://clinicaltrials.gov/study/NCT07100080", "type": "ClinicalTrials.gov"} ], "tags": ["China-origin", "ADC", "whale", "originator-channel", "CTA", "translation"] }, { "id": "lisaftoclax-apg2575", "rank": 12, "tier": "immediate-chase", "account": "Ascentage Pharma", "company": "Ascentage Pharma", "origin": "China-origin / global development", "asset": "Lisaftoclax", "aliases": ["APG-2575"], "mechanism": "BCL-2 inhibitor", "indications": ["CLL/SLL", "higher-risk MDS", "AML"], "biomarker": "disease genetics, FISH/cytogenetics and serial blood/bone-marrow MRD; no single predictive CDx", "phase": "Multiple global Phase 3", "northAmerica": true, "chinaOrigin": true, "services": ["hematology central lab", "flow/NGS MRD", "FISH/cytogenetics", "sample logistics"], "modalities": ["NGS MRD", "flow cytometry", "FISH", "cytogenetics"], "modalityFit": "audit-required", "enrollmentMechanism": "local prior", "valueScore": 91, "winScore": 68, "ctaScore": 96, "cdxScore": 60, "priorityScore": 76, "cdxStatus": "无单一预测性CDx；高价值来自重复MRD和多项全球III期", "vendorStatus": "undisclosed; direct originator access but laboratory capability is conditional", "whyNow": "CLL/MDS/AML多项全球III期并行，MRD为明确终点，产生高频重复样本。", "bidThesis": "有条件追逐：先完成flow/FISH/骨髓物流能力审计，再向原研方销售北美MRD central-lab包。", "assays": ["NGS MRD", "next-generation flow MRD", "CLL FISH", "myeloid NGS", "cytogenetics"], "capabilityBoundary": "NGS可匹配；flow、FISH、细胞遗传和骨髓处理必须审计或合作交付。审计不过则只投NGS分包。", "risks": ["关键能力未文件化", "传统血液中心实验室incumbent", "多项目执行复杂"], "decisionTrigger": "flow/FISH/骨髓物流审计通过且Ascentage确认北美工作包可拆分。", "decisionOwner": "中国BD与北美血液实验室平台主管；质量体系负责人有否决权", "ncts": ["NCT06104566", "NCT06319456", "NCT06641414"], "milestones": [ {"quarter": "2026Q3", "label": "多项全球III期持续执行", "confidence": "fact", "detail": "CLL/MDS/AML项目形成重复MRD需求。"}, {"quarter": "2027Q4", "label": "CLL/SLL MRD数据成熟窗口", "confidence": "inference", "detail": "NCT06319456将MRD阴性率列为终点。"}, {"quarter": "2029Q2", "label": "GLORA-4主要完成估计", "confidence": "registry-estimate", "detail": "NCT06641414预计2029-06主要完成。"}, {"quarter": "2029Q4", "label": "GLORA-4研究完成估计", "confidence": "registry-estimate", "detail": "注册预计2029-12。"} ], "sources": [ {"label": "Global CLL/SLL Phase 3", "url": "https://clinicaltrials.gov/study/NCT06319456", "type": "ClinicalTrials.gov"}, {"label": "GLORA-4 MDS Phase 3", "url": "https://clinicaltrials.gov/study/NCT06641414", "type": "ClinicalTrials.gov"}, {"label": "Ascentage lisaftoclax update", "url": "https://ir.ascentage.com/news-releases/news-release-details/ascentage-pharma-releases-latest-clinical-data-multiple-trials", "type": "company"} ], "tags": ["China-origin", "hematology", "MRD", "repeat-testing", "conditional", "cash-flow"] }, { "id": "crb701-sys6002", "rank": 13, "tier": "strategic-whale", "account": "Corbus Pharmaceuticals", "company": "Corbus Pharmaceuticals; licensed from CSPC", "origin": "China-origin / US sponsor", "asset": "CRB-701", "aliases": ["SYS6002"], "mechanism": "Nectin-4-directed antibody-drug conjugate", "indications": ["advanced Nectin-4-expressing solid tumors"], "biomarker": "Nectin-4 expression is exploratory; validated mandatory cutoff not established", "phase": "Phase 1", "northAmerica": true, "chinaOrigin": true, "services": ["US CTA", "tissue/plasma translation", "exploratory biomarker", "sample logistics"], "modalities": ["IHC", "DNA NGS", "plasma NGS"], "modalityFit": "partner-delivered", "enrollmentMechanism": "exploratory", "valueScore": 76, "winScore": 76, "ctaScore": 72, "cdxScore": 30, "priorityScore": 74, "cdxStatus": "Nectin-4阈值未验证，CDx逻辑当前较弱", "vendorStatus": "undisclosed; smaller US sponsor increases outsourcing plausibility", "whyNow": "小型美国申办方、单一全球项目，外包可获得性可能较高；但主要biomarker为IHC。", "bidThesis": "先完成Nectin-4 IHC合作链审计，再销售美国样本处理、探索性组织/血浆与CGP分包。", "assays": ["Nectin-4 exploratory IHC", "tissue CGP", "plasma CGP"], "capabilityBoundary": "IHC主导，需合作交付；若无法证明病理链质量，则仅投NGS/样本物流部分。", "risks": ["Phase 1早期风险", "IHC能力依赖合作方", "biomarker可能不用于筛选"], "decisionTrigger": "IHC合作审计通过且Corbus确认北美样本/转化工作未锁定。", "decisionOwner": "美国biotech BD；病理合作与质量负责人共同审批", "ncts": ["NCT06265727"], "milestones": [ {"quarter": "2026Q3", "label": "美国Phase 1扩展与数据窗口", "confidence": "fact", "detail": "Corbus项目持续推进。"}, {"quarter": "2027Q2", "label": "剂量扩展数据成熟窗口", "confidence": "inference", "detail": "公开确定读出日期未找到。"}, {"quarter": "2028Q4", "label": "注册策略决策窗口", "confidence": "inference", "detail": "仅在扩展数据支持时成立。"} ], "sources": [ {"label": "CRB-701 study", "url": "https://clinicaltrials.gov/study/NCT06265727", "type": "ClinicalTrials.gov"}, {"label": "Corbus CRB-701 pipeline", "url": "https://www.corbuspharma.com/our-pipeline/crb-701-nectin-4-targeted-cancer-treatment", "type": "company"} ], "tags": ["China-origin", "US-sponsor", "ADC", "Nectin-4", "IHC-dependent", "watch"] }, { "id": "daraxonrasib-rmc6236", "rank": 14, "tier": "strategic-whale", "account": "Revolution Medicines", "company": "Revolution Medicines", "origin": "United States", "asset": "Daraxonrasib", "aliases": ["RMC-6236"], "mechanism": "RAS(ON) multi-selective inhibitor", "indications": ["metastatic PDAC", "RAS-mutant NSCLC", "adjuvant PDAC"], "biomarker": "broad RAS genotype; some intended-use populations may not require one specific alteration", "phase": "Phase 3; NDA accepted", "northAmerica": true, "chinaOrigin": false, "services": ["large CTA", "pan-RAS CGP", "plasma response/resistance", "adjuvant MRD"], "modalities": ["DNA NGS", "plasma NGS", "ctDNA MRD"], "modalityFit": "owned", "enrollmentMechanism": "central confirmation", "valueScore": 97, "winScore": 46, "ctaScore": 96, "cdxScore": 42, "priorityScore": 73, "cdxStatus": "CTA/MRD价值极高；最终标签未必需要单一RAS CDx", "vendorStatus": "undisclosed; late-stage incumbent risk high", "whyNow": "二线PDAC III期阳性且2026-07 FDA受理NDA；一线、NSCLC和辅助III期继续扩张。", "bidThesis": "作为Revolution账户bundle销售pan-RAS、低shedding血浆和辅助MRD，不以开放主CDx为卖点。", "assays": ["pan-RAS tissue CGP", "low-VAF plasma CGP", "resistance panel", "tumor-informed MRD"], "capabilityBoundary": "NGS匹配；肿瘤定制MRD需验证当前产品化/监管能力，不能沿用普通CGP声明。", "risks": ["晚期项目供应商大概率已固化", "正式CDx需求可能较低", "MRD为长周期机会"], "decisionTrigger": "确认一线/辅助试验的样本范围和MRD是否有可拆分探索性work package。", "decisionOwner": "Revolution账户负责人；液体活检与MRD产品负责人", "ncts": ["NCT06625320", "NCT07491445", "NCT07252232", "NCT06881784"], "milestones": [ {"quarter": "2026Q3", "label": "NDA审评与一线III期执行", "confidence": "fact", "detail": "FDA于2026-07-22受理NDA。"}, {"quarter": "2027Q4", "label": "RASolve-301主要完成估计", "confidence": "registry-estimate", "detail": "注册预计2027-12。"}, {"quarter": "2029Q2", "label": "辅助PDAC主要完成估计", "confidence": "registry-estimate", "detail": "NCT07252232预计2029-05。"} ], "sources": [ {"label": "FDA NDA acceptance", "url": "https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-new-drug-application-daraxonrasib-accepted/", "type": "company"}, {"label": "RASolute-302", "url": "https://clinicaltrials.gov/study/NCT06625320", "type": "ClinicalTrials.gov"}, {"label": "Adjuvant RASolute-304", "url": "https://clinicaltrials.gov/study/NCT07252232", "type": "ClinicalTrials.gov"} ], "tags": ["RAS", "PDAC", "MRD", "late-stage", "CTA", "strategic"] }, { "id": "pumitamig-bnt327", "rank": 15, "tier": "strategic-whale", "account": "BioNTech/Bristol Myers Squibb via Biotheus originator network", "company": "BioNTech and Bristol Myers Squibb", "origin": "China-origin / global BioNTech-BMS development", "asset": "Pumitamig", "aliases": ["BNT327", "BMS-986545", "PM8002"], "mechanism": "PD-L1 x VEGF-A bispecific immunomodulator", "indications": ["NSCLC", "SCLC", "TNBC", "CRC", "gastric cancer"], "biomarker": "mostly all-comer; PD-L1 and molecular markers are stratification/translation rather than proprietary mandatory CDx", "phase": "Seven global Phase 3 programs", "northAmerica": true, "chinaOrigin": true, "services": ["global central lab", "tissue/plasma translation", "PD-L1 coordination", "originator-channel bridging"], "modalities": ["DNA NGS", "plasma NGS", "PD-L1 IHC"], "modalityFit": "mixed", "enrollmentMechanism": "exploratory", "valueScore": 99, "winScore": 27, "ctaScore": 100, "cdxScore": 25, "priorityScore": 72, "cdxStatus": "大多为all-comer，专属预测性CDx逻辑弱", "vendorStatus": "BioNTech/BMS incumbents likely; vendor not publicly disclosed", "whyNow": "七项全球III期同时开展，检测体量巨大，但中标概率低。", "bidThesis": "仅通过Biotheus原研网络或区域translational/bridging入口；不直接以替换BMS全球供应商为目标。", "assays": ["broad CGP", "plasma CGP", "PD-L1 coordination", "ctDNA kinetics"], "capabilityBoundary": "NGS匹配；PD-L1 IHC需合作，且不得包装为专属CDx。", "risks": ["全球大药企供应商锁定", "all-comer限制CDx价值", "联盟采购复杂"], "decisionTrigger": "出现明确区域RFI、originator-channel work package或backup需求才投入重资源。", "decisionOwner": "战略大客户负责人；联盟管理与北美交付负责人", "ncts": ["NCT06712316", "NCT06712355", "NCT07361497", "NCT07173751", "NCT07221357"], "milestones": [ {"quarter": "2026Q3", "label": "七项全球III期持续推进", "confidence": "fact", "detail": "BMS/BioNTech于2026-05公开项目清单。"}, {"quarter": "2028Q4", "label": "ROSETTA Lung-01主要完成估计", "confidence": "registry-estimate", "detail": "NCT06712355预计2028-12。"}, {"quarter": "2029Q1", "label": "ROSETTA Lung-01研究完成估计", "confidence": "registry-estimate", "detail": "注册预计2029-03。"} ], "sources": [ {"label": "BMS/BioNTech global program update", "url": "https://investors.bms.com/iframes/press-releases/press-release-details/2026/Global-Data-for-BioNTech-and-Bristol-Myers-Squibbs-PD-L1xVEGF-A-Bispecific-Pumitamig-Shows-Encouraging-Efficacy-in-Patients-with-Non-Small-Cell-Lung-Cancer-in-ROSETTA-Lung-02-Trial/default.aspx", "type": "company"}, {"label": "ROSETTA Lung-02", "url": "https://clinicaltrials.gov/study/NCT06712316", "type": "ClinicalTrials.gov"}, {"label": "ROSETTA Lung-01", "url": "https://clinicaltrials.gov/study/NCT06712355", "type": "ClinicalTrials.gov"}, {"label": "ROSETTA Lung-201", "url": "https://clinicaltrials.gov/study/NCT07361497", "type": "ClinicalTrials.gov"} ], "tags": ["China-origin", "whale", "all-comer", "originator-channel", "CTA", "low-win"] }, { "id": "ide892-ide397", "rank": 16, "tier": "strategic-whale", "account": "IDEAYA Biosciences", "company": "IDEAYA Biosciences", "origin": "United States", "asset": "IDE892 plus IDE397", "aliases": ["IDE892", "IDE397"], "mechanism": "PRMT5 inhibitor plus MAT2A inhibitor synthetic-lethality strategy", "indications": ["MTAP-deleted PDAC", "MTAP-deleted NSCLC", "MTAP-deleted solid tumors"], "biomarker": "MTAP deletion", "phase": "Phase 1; combination expansion planned", "northAmerica": true, "chinaOrigin": false, "services": ["early CTA", "MTAP tissue/plasma", "assay co-development", "future CDx"], "modalities": ["DNA NGS CNV", "plasma NGS", "IHC"], "modalityFit": "mixed", "enrollmentMechanism": "central confirmation", "valueScore": 77, "winScore": 67, "ctaScore": 75, "cdxScore": 85, "priorityScore": 71, "cdxStatus": "早期强制MTAP项目，CDx尚有塑形空间；供应商未公开", "vendorStatus": "undisclosed; early-stage opportunity", "whyNow": "IDE892已进I期，公司计划2026年中加入IDE397并扩展MTAP缺失PDAC/NSCLC。", "bidThesis": "在assay尚未锁定前销售MTAP CNV/IHC concordance和plasma探索，而非等待III期。", "assays": ["MTAP/CDKN2A CNV", "tumor-purity correction", "MTAP IHC concordance", "plasma CNV"], "capabilityBoundary": "NGS CNV匹配；IHC需审计/合作。", "risks": ["Phase 1早期淘汰风险", "portfolio reprioritization", "组合毒性/剂量不确定"], "decisionTrigger": "组合扩展确认且MTAP入组assay尚未最终锁定。", "decisionOwner": "biotech BD；转化医学与CDx负责人", "ncts": ["NCT07277413"], "milestones": [ {"quarter": "2026Q3", "label": "IDE892+IDE397组合启动窗口", "confidence": "company-guidance", "detail": "公司2026Q1指引年中启动。"}, {"quarter": "2026Q4", "label": "MTAP缺失扩展队列窗口", "confidence": "company-guidance", "detail": "公司指引2026下半年扩展。"}, {"quarter": "2028Q2", "label": "概念验证数据成熟窗口", "confidence": "inference", "detail": "取决于剂量和入组。"} ], "sources": [ {"label": "IDE892 Phase 1", "url": "https://clinicaltrials.gov/study/NCT07277413", "type": "ClinicalTrials.gov"}, {"label": "IDEAYA Q1 2026 update", "url": "https://ir.ideayabio.com/2026-05-05-IDEAYA-Biosciences-Reports-First-Quarter-2026-Financial-Results-and-Provides-Business-Update?asPDF=1", "type": "company"} ], "tags": ["precision", "MTAP", "PRMT5", "early-stage", "CDx", "synthetic-lethality"] }, { "id": "mezigdomide-bms986348", "rank": 17, "tier": "platform-cash-flow", "account": "Bristol Myers Squibb", "company": "Bristol Myers Squibb", "origin": "United States", "asset": "Mezigdomide", "aliases": ["BMS-986348", "CC-92480"], "mechanism": "CELMoD cereblon E3 ligase modulator", "indications": ["relapsed/refractory multiple myeloma"], "biomarker": "bone-marrow and blood MRD; no predictive CDx", "phase": "Phase 3; SUCCESSOR-2 positive", "northAmerica": true, "chinaOrigin": false, "services": ["hematology central lab", "NGS/flow MRD", "FISH/cytogenetics", "sample logistics"], "modalities": ["NGS MRD", "flow cytometry", "FISH", "clinical chemistry"], "modalityFit": "audit-required", "enrollmentMechanism": "local prior", "valueScore": 85, "winScore": 40, "ctaScore": 90, "cdxScore": 20, "priorityScore": 69, "cdxStatus": "无预测性CDx；价值是稳定重复MRD和常规中心实验室", "vendorStatus": "large established hematology incumbents likely", "whyNow": "SUCCESSOR-2于2026年阳性，SUCCESSOR-1仍含MRD终点并持续执行。", "bidThesis": "通过高灵敏NGS MRD分包或北美backup切入，flow/FISH能力审计后再扩大。", "assays": ["myeloma NGS MRD", "next-generation flow", "myeloma FISH", "M-protein/free light chain"], "capabilityBoundary": "flow、FISH和常规实验室需审计/合作；不把MRD服务误称CDx。", "risks": ["传统中心实验室锁定", "非CDx项目", "骨髓物流复杂"], "decisionTrigger": "出现MRD分包、backup或区域桥接RFI且能力审计通过。", "decisionOwner": "血液瘤BD与北美实验室质量负责人", "ncts": ["NCT05552976", "NCT05519085"], "milestones": [ {"quarter": "2026Q3", "label": "SUCCESSOR-2阳性后的申报准备", "confidence": "fact", "detail": "BMS已公布阳性III期结果。"}, {"quarter": "2027Q2", "label": "多地区申报可能窗口", "confidence": "inference", "detail": "公司未在引用来源中给出确定日期。"}, {"quarter": "2029Q4", "label": "早线组合与长期MRD随访", "confidence": "inference", "detail": "适合持续central-lab服务。"} ], "sources": [ {"label": "SUCCESSOR-2", "url": "https://clinicaltrials.gov/study/NCT05552976", "type": "ClinicalTrials.gov"}, {"label": "SUCCESSOR-1", "url": "https://clinicaltrials.gov/study/NCT05519085", "type": "ClinicalTrials.gov"}, {"label": "BMS positive Phase 3", "url": "https://news.bms.com/news/details/2026/Bristol-Myers-Squibb-Announces-Positive-Phase-3-Results-from-the-SUCCESSOR-2-Study-of-Oral-Mezigdomide-in-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx", "type": "company"} ], "tags": ["hematology", "MRD", "repeat-testing", "cash-flow", "myeloma"] }, { "id": "epcoritamab-epkinly", "rank": 18, "tier": "platform-cash-flow", "account": "Genmab/AbbVie", "company": "Genmab and AbbVie", "origin": "Denmark / United States", "asset": "Epcoritamab", "aliases": ["Epkinly", "ABBV-GMAB-3013"], "mechanism": "CD3 x CD20 bispecific antibody", "indications": ["first-line and relapsed/refractory DLBCL"], "biomarker": "lymphoma classification and ctDNA MRD; no mandatory predictive CDx", "phase": "Multiple Phase 3", "northAmerica": true, "chinaOrigin": false, "services": ["lymphoma central lab", "ctDNA MRD", "FISH", "NGS classification"], "modalities": ["DNA NGS", "ctDNA MRD", "FISH", "pathology"], "modalityFit": "mixed", "enrollmentMechanism": "local prior", "valueScore": 84, "winScore": 38, "ctaScore": 88, "cdxScore": 15, "priorityScore": 68, "cdxStatus": "无强制预测性CDx；MRD和病理central-lab为主", "vendorStatus": "incumbent global central labs likely", "whyNow": "一线III期约900例，预计2027年主要分析；R/R项目明确含MRD终点。", "bidThesis": "以ctDNA MRD分包、NGS/FISH整合和北美backup进入。", "assays": ["lymphoma ctDNA MRD", "MYC/BCL2/BCL6 FISH", "cell-of-origin/NGS"], "capabilityBoundary": "FISH与中央病理需审计/合作；NGS MRD需项目级验证。", "risks": ["主实验室锁定", "CDx价值低", "跨平台MRD标准化"], "decisionTrigger": "确认MRD endpoint是否外包以及FISH/病理工作可拆分。", "decisionOwner": "血液瘤BD；MRD产品和病理合作负责人", "ncts": ["NCT04628494", "NCT05578976"], "milestones": [ {"quarter": "2026Q3", "label": "EPCORE全球III期持续执行", "confidence": "fact", "detail": "一线和R/R研究均在随访。"}, {"quarter": "2027Q2", "label": "EPCORE DLBCL-2主要完成估计", "confidence": "registry-estimate", "detail": "注册预计2027-06。"}, {"quarter": "2029Q4", "label": "长期MRD/OS随访", "confidence": "registry-estimate", "detail": "持续产生中心实验室需求。"} ], "sources": [ {"label": "EPCORE DLBCL-1", "url": "https://clinicaltrials.gov/study/NCT04628494", "type": "ClinicalTrials.gov"}, {"label": "EPCORE DLBCL-2", "url": "https://clinicaltrials.gov/study/NCT05578976", "type": "ClinicalTrials.gov"} ], "tags": ["hematology", "DLBCL", "MRD", "repeat-testing", "cash-flow"] }, { "id": "calderasib-mk1084", "rank": 19, "tier": "strategic-whale", "account": "Merck", "company": "Merck", "origin": "United States", "asset": "Calderasib", "aliases": ["MK-1084"], "mechanism": "KRAS G12C inhibitor", "indications": ["first-line KRAS G12C NSCLC", "first-line KRAS G12C CRC", "G12C solid tumors"], "biomarker": "KRAS G12C; PD-L1 stratification in NSCLC", "phase": "Multiple Phase 3; Breakthrough Therapy Designation", "northAmerica": true, "chinaOrigin": false, "services": ["central genotyping", "tissue/plasma CGP", "PD-L1 coordination", "resistance profiling"], "modalities": ["DNA NGS", "plasma NGS", "PD-L1 IHC"], "modalityFit": "mixed", "enrollmentMechanism": "central confirmation", "valueScore": 90, "winScore": 35, "ctaScore": 90, "cdxScore": 45, "priorityScore": 67, "cdxStatus": "G12C强制但成熟CDx生态；新主CDx可获得性有限", "vendorStatus": "Merck incumbents likely; public vendor detail not found", "whyNow": "2026年获BTD且NSCLC/CRC III期同步推进。", "bidThesis": "争取区域central/backup和plasma耐药，不以单点G12C assay竞争。", "assays": ["KRAS G12C tissue/plasma", "broad resistance CGP", "PD-L1 coordination"], "capabilityBoundary": "PD-L1 IHC需合作；CDx用途需独立验证。", "risks": ["Merck供应商壁垒", "G12C竞争拥挤", "成熟CDx平台"], "decisionTrigger": "出现区域RFI、plasma探索或backup需求。", "decisionOwner": "Merck战略大客户负责人", "ncts": ["NCT07190248", "NCT06997497", "NCT07209111"], "milestones": [ {"quarter": "2026Q3", "label": "KANDLELIT-007全球III期与BTD窗口", "confidence": "fact", "detail": "BTD于2026-05公布。"}, {"quarter": "2028Q4", "label": "首批III期数据可能窗口", "confidence": "inference", "detail": "确定日期未公开。"}, {"quarter": "2029Q4", "label": "NSCLC/CRC注册路径窗口", "confidence": "inference", "detail": "依试验结果。"} ], "sources": [ {"label": "KANDLELIT-007", "url": "https://clinicaltrials.gov/study/NCT07190248", "type": "ClinicalTrials.gov"}, {"label": "CRC Phase 3", "url": "https://clinicaltrials.gov/study/NCT06997497", "type": "ClinicalTrials.gov"}, {"label": "FDA BTD announcement", "url": "https://www.merck.com/news/fda-grants-breakthrough-therapy-designation-for-calderasib-mk-1084-an-investigational-kras-g12c-inhibitor-for-certain-patients-with-newly-diagnosed-metastatic-kras-g12c-mutant-non-small-cell-lung/", "type": "company"} ], "tags": ["KRAS", "G12C", "large-pharma", "CTA", "resistance"] }, { "id": "olomorasib-ly3537982", "rank": 20, "tier": "strategic-whale", "account": "Eli Lilly", "company": "Eli Lilly", "origin": "United States", "asset": "Olomorasib", "aliases": ["LY3537982"], "mechanism": "KRAS G12C inhibitor", "indications": ["first-line advanced NSCLC", "perioperative/unresectable NSCLC"], "biomarker": "KRAS G12C; PD-L1 and perioperative ctDNA", "phase": "Multiple Phase 3", "northAmerica": true, "chinaOrigin": false, "services": ["central genotyping", "plasma resistance", "perioperative MRD", "PD-L1 coordination"], "modalities": ["DNA NGS", "plasma NGS", "ctDNA MRD", "PD-L1 IHC"], "modalityFit": "mixed", "enrollmentMechanism": "central confirmation", "valueScore": 88, "winScore": 36, "ctaScore": 91, "cdxScore": 40, "priorityScore": 66, "cdxStatus": "成熟G12C CDx生态；围术期MRD比新主CDx更有差异化", "vendorStatus": "undisclosed; large-pharma incumbent risk", "whyNow": "SUNRAY-01临近主要分析，SUNRAY-02约700例并持续至2029。", "bidThesis": "以围术期MRD、耐药纵向和北美backup切入。", "assays": ["KRAS G12C tissue/plasma", "tumor-informed MRD", "resistance CGP"], "capabilityBoundary": "MRD需要项目级验证；PD-L1由合作方交付。", "risks": ["供应商锁定", "G12C赛道拥挤", "MRD监管与临床效用要求"], "decisionTrigger": "SUNRAY-02是否开放MRD/探索性分包或区域backup。", "decisionOwner": "Lilly账户负责人；MRD平台主管", "ncts": ["NCT06119581", "NCT06890598"], "milestones": [ {"quarter": "2026Q4", "label": "SUNRAY-01主要完成估计", "confidence": "registry-estimate", "detail": "注册约2026-10。"}, {"quarter": "2027Q2", "label": "顶线/申报可能窗口", "confidence": "inference", "detail": "未有确定公司日期。"}, {"quarter": "2029Q2", "label": "SUNRAY-02主要完成估计", "confidence": "registry-estimate", "detail": "注册预计2029-05。"} ], "sources": [ {"label": "SUNRAY-01", "url": "https://clinicaltrials.gov/study/NCT06119581", "type": "ClinicalTrials.gov"}, {"label": "SUNRAY-02", "url": "https://clinicaltrials.gov/study/NCT06890598", "type": "ClinicalTrials.gov"} ], "tags": ["KRAS", "G12C", "NSCLC", "MRD", "large-pharma"] }, { "id": "raludotatug-deruxtecan", "rank": 21, "tier": "strategic-whale", "account": "Daiichi Sankyo/Merck", "company": "Daiichi Sankyo and Merck", "origin": "Japan / United States", "asset": "Raludotatug deruxtecan", "aliases": ["R-DXd", "MK-5909", "DS-6000"], "mechanism": "CDH6-directed DXd antibody-drug conjugate", "indications": ["platinum-resistant ovarian, peritoneal and fallopian-tube cancer"], "biomarker": "CDH6 IHC correlation endpoint; Phase 3 is not clearly restricted by a validated CDH6 cutoff", "phase": "Phase 2/3", "northAmerica": true, "chinaOrigin": false, "services": ["central lab", "CDH6 translational IHC", "CGP", "PK/ADA coordination"], "modalities": ["IHC", "DNA NGS", "plasma NGS", "PK/ADA"], "modalityFit": "partner-delivered", "enrollmentMechanism": "exploratory", "valueScore": 89, "winScore": 29, "ctaScore": 94, "cdxScore": 25, "priorityScore": 65, "cdxStatus": "CDH6为相关性biomarker，可能不形成强制CDx", "vendorStatus": "Daiichi/Merck incumbents likely", "whyNow": "约860例全球II/III期、BTD且含CDH6 IHC相关性终点。", "bidThesis": "仅争取北美样本、探索性IHC/CGP或backup；IHC能力依赖合作。", "assays": ["CDH6 IHC", "tissue/plasma CGP", "ADA/PK coordination"], "capabilityBoundary": "IHC及PK/ADA为合作交付；不把相关性终点标成既定CDx。", "risks": ["大药企供应商锁定", "CDH6不一定强制", "IHC能力边界"], "decisionTrigger": "出现明确区域/探索性RFI且病理合作链通过审计。", "decisionOwner": "ADC战略账户；病理合作负责人", "ncts": ["NCT06161025"], "milestones": [ {"quarter": "2026Q3", "label": "REJOICE-Ovarian01 Phase 3入组", "confidence": "fact", "detail": "约860例，CDH6为预设相关性终点。"}, {"quarter": "2028Q1", "label": "主要完成估计", "confidence": "registry-estimate", "detail": "注册预计2028-02-29。"}, {"quarter": "2029Q1", "label": "潜在申报窗口", "confidence": "inference", "detail": "取决于III期结果。"} ], "sources": [ {"label": "REJOICE-Ovarian01", "url": "https://clinicaltrials.gov/study/NCT06161025", "type": "ClinicalTrials.gov"}, {"label": "Merck/Daiichi Phase 2 results", "url": "https://www.merck.com/news/raludotatug-deruxtecan-demonstrated-clinically-meaningful-response-rates-in-patients-with-recurrent-platinum-resistant-ovarian-primary-peritoneal-or-fallopian-tube-cancer-in-phase-2-part-of-rejoice-o/", "type": "company"} ], "tags": ["ADC", "CDH6", "IHC-dependent", "whale", "CTA"] }, { "id": "risvutatug-rezetecan-hs20093", "rank": 22, "tier": "strategic-whale", "account": "Hansoh originator channel", "company": "GSK and Hansoh Pharma", "origin": "China-origin / global GSK development", "asset": "Risvutatug rezetecan", "aliases": ["Ris-Rez", "HS-20093", "GSK5764227"], "mechanism": "B7-H3-directed antibody-drug conjugate", "indications": ["small-cell lung cancer", "other solid tumors"], "biomarker": "B7-H3 expression is mainly exploratory; mandatory cutoff not established", "phase": "Global Phase 3 program", "northAmerica": true, "chinaOrigin": true, "services": ["originator-channel CTA", "central lab", "tissue/plasma translation"], "modalities": ["IHC", "DNA NGS", "plasma NGS"], "modalityFit": "partner-delivered", "enrollmentMechanism": "exploratory", "valueScore": 91, "winScore": 38, "ctaScore": 90, "cdxScore": 20, "priorityScore": 64, "cdxStatus": "B7-H3预测阈值未建立，CDx价值低", "vendorStatus": "GSK global vendors likely; originator-channel only", "whyNow": "Hansoh中国III期阳性且GSK推进全球研究，样本量与跨境bridging潜力大。", "bidThesis": "通过Hansoh争取区域转化/bridging与NGS分包；IHC由审计合作方承担。", "assays": ["B7-H3 exploratory IHC", "tissue CGP", "plasma CGP"], "capabilityBoundary": "IHC主导，必须partner-delivered；不得承诺主CDx。", "risks": ["GSK供应商锁定", "IHC能力边界", "biomarker非强制"], "decisionTrigger": "Hansoh确认可控制的区域研究包和GSK合同边界。", "decisionOwner": "原研方BD；病理合作与联盟管理", "ncts": ["NCT06551142", "NCT07099898"], "milestones": [ {"quarter": "2026Q3", "label": "中国III期阳性后的全球扩展窗口", "confidence": "fact", "detail": "GSK/Hansoh已公布阳性结果。"}, {"quarter": "2027Q4", "label": "全球III期持续入组", "confidence": "registry-estimate", "detail": "以NCT更新为准。"}, {"quarter": "2029Q2", "label": "全球数据成熟可能窗口", "confidence": "inference", "detail": "无确定读出日期。"} ], "sources": [ {"label": "GSK/Hansoh positive Phase 3", "url": "https://www.gsk.com/en-gb/media/press-releases/gsk-s-licensor-hansoh-pharma-announces-positive-phase-iii-results-for-ris-rez-in-china-patient-population/", "type": "company"}, {"label": "Global study", "url": "https://clinicaltrials.gov/study/NCT06551142", "type": "ClinicalTrials.gov"}, {"label": "Global study", "url": "https://clinicaltrials.gov/study/NCT07099898", "type": "ClinicalTrials.gov"} ], "tags": ["China-origin", "ADC", "B7-H3", "IHC-dependent", "originator-channel"] }, { "id": "mocertatug-rezetecan-hs20089", "rank": 23, "tier": "strategic-whale", "account": "Hansoh originator channel", "company": "GSK and Hansoh Pharma", "origin": "China-origin / global GSK development", "asset": "Mocertatug rezetecan", "aliases": ["Mo-Rez", "HS-20089", "GSK5733584"], "mechanism": "B7-H4-directed antibody-drug conjugate", "indications": ["ovarian cancer", "endometrial cancer", "other gynecologic tumors"], "biomarker": "B7-H4 expression is exploratory; mandatory threshold not established", "phase": "Global Phase 3 program", "northAmerica": true, "chinaOrigin": true, "services": ["originator-channel CTA", "central lab", "tissue/plasma translation"], "modalities": ["IHC", "DNA NGS", "plasma NGS"], "modalityFit": "partner-delivered", "enrollmentMechanism": "exploratory", "valueScore": 88, "winScore": 40, "ctaScore": 87, "cdxScore": 20, "priorityScore": 63, "cdxStatus": "B7-H4 expression 尚非验证强制CDx", "vendorStatus": "GSK global vendors likely; originator-channel only", "whyNow": "GSK公布积极妇瘤数据并推进多项III期。", "bidThesis": "通过Hansoh争取区域bridging/转化NGS；IHC合作交付。", "assays": ["B7-H4 exploratory IHC", "tissue CGP", "plasma CGP"], "capabilityBoundary": "IHC为核心依赖，必须审计合作方；不把表达相关性误写成CDx。", "risks": ["供应商锁定", "biomarker非强制", "IHC能力依赖"], "decisionTrigger": "存在原研方可控制工作包且合作病理链通过审计。", "decisionOwner": "原研方BD；病理合作与北美交付负责人", "ncts": ["NCT06431594", "NCT07286331", "NCT07286266"], "milestones": [ {"quarter": "2026Q3", "label": "积极妇瘤数据后的III期扩展", "confidence": "fact", "detail": "GSK已公开积极数据。"}, {"quarter": "2027Q4", "label": "全球III期入组窗口", "confidence": "registry-estimate", "detail": "以各NCT状态为准。"}, {"quarter": "2029Q4", "label": "数据成熟可能窗口", "confidence": "inference", "detail": "未核实确定读出日期。"} ], "sources": [ {"label": "GSK B7-H4 update", "url": "https://www.gsk.com/en-gb/media/press-releases/gsk-presents-positive-data-for-b7-h4-targeted-adc-in-gynaecological-cancers/", "type": "company"}, {"label": "Global study", "url": "https://clinicaltrials.gov/study/NCT07286331", "type": "ClinicalTrials.gov"}, {"label": "Global study", "url": "https://clinicaltrials.gov/study/NCT07286266", "type": "ClinicalTrials.gov"} ], "tags": ["China-origin", "ADC", "B7-H4", "IHC-dependent", "originator-channel"] }, { "id": "trastuzumab-pamirtecan-bnt323", "rank": 24, "tier": "strategic-whale", "account": "DualityBio originator channel", "company": "BioNTech and DualityBio", "origin": "China-origin / global BioNTech development", "asset": "Trastuzumab pamirtecan", "aliases": ["BNT323", "DB-1303"], "mechanism": "HER2-directed antibody-drug conjugate", "indications": ["HER2-expressing breast cancer", "endometrial cancer", "other solid tumors"], "biomarker": "HER2 IHC/ISH in an established pathology ecosystem", "phase": "Multiple Phase 3", "northAmerica": true, "chinaOrigin": true, "services": ["originator-channel CTA", "HER2 central testing coordination", "CGP", "bridging"], "modalities": ["HER2 IHC", "ISH", "DNA NGS", "plasma NGS"], "modalityFit": "partner-delivered", "enrollmentMechanism": "central confirmation", "valueScore": 90, "winScore": 34, "ctaScore": 88, "cdxScore": 25, "priorityScore": 62, "cdxStatus": "成熟HER2病理生态；新主CDx空间有限", "vendorStatus": "BioNTech global vendor likely; originator-channel work only", "whyNow": "多项全球III期推动HER2中央复核和bridging需求。", "bidThesis": "通过DualityBio争取区域样本、NGS/ctDNA转化和HER2复核合作，不置换成熟主病理平台。", "assays": ["HER2 IHC/ISH coordination", "tissue CGP", "plasma resistance"], "capabilityBoundary": "HER2 IHC/ISH必须合作交付；NGS不能替代标签规定的病理CDx。", "risks": ["成熟HER2供应商", "IHC/ISH能力边界", "BioNTech采购壁垒"], "decisionTrigger": "DualityBio确认区域bridging或translational work package。", "decisionOwner": "原研方BD；病理合作与联盟管理", "ncts": ["NCT05150691", "NCT06340568", "NCT06018337"], "milestones": [ {"quarter": "2026Q3", "label": "全球III期持续推进", "confidence": "fact", "detail": "BioNTech/DualityBio公开推进项目。"}, {"quarter": "2028Q2", "label": "首批III期数据可能窗口", "confidence": "inference", "detail": "以NCT和公司更新确认。"}, {"quarter": "2029Q4", "label": "适应证扩展/桥接窗口", "confidence": "inference", "detail": "不代表获批。"} ], "sources": [ {"label": "BioNTech/DualityBio update", "url": "https://investors.biontech.de/news-releases/news-release-details/biontech-and-dualitybios-antibody-drug-conjugate-trastuzumab/", "type": "company"}, {"label": "Representative study", "url": "https://clinicaltrials.gov/study/NCT06340568", "type": "ClinicalTrials.gov"}, {"label": "Representative study", "url": "https://clinicaltrials.gov/study/NCT06018337", "type": "ClinicalTrials.gov"} ], "tags": ["China-origin", "ADC", "HER2", "IHC-dependent", "originator-channel"] }, { "id": "sonesitatug-vedotin-azd0901", "rank": 25, "tier": "watch-bridging", "account": "AstraZeneca via Keymed originator context", "company": "AstraZeneca; originated by Keymed/CMG", "origin": "China-origin / global AstraZeneca development", "asset": "Sonesitatug vedotin", "aliases": ["AZD0901", "CMG901"], "mechanism": "CLDN18.2-directed antibody-drug conjugate", "indications": ["CLDN18.2-positive gastric/GEJ cancer", "CLDN18.2-positive solid tumors"], "biomarker": "CLDN18.2 IHC expression", "phase": "Phase 3 and multi-tumor Phase 2", "northAmerica": true, "chinaOrigin": true, "services": ["regional CTA", "sample logistics", "exploratory CGP", "assay bridging"], "modalities": ["CLDN18.2 IHC", "digital pathology", "DNA NGS", "plasma NGS"], "modalityFit": "partner-delivered", "enrollmentMechanism": "central mandatory", "valueScore": 92, "winScore": 25, "ctaScore": 89, "cdxScore": 30, "priorityScore": 60, "cdxStatus": "Ventana investigational IVD已占主CDx路径", "vendorStatus": "primary IVD path publicly linked to Ventana; pursue only adjacent work", "whyNow": "全球III期大样本且CLDN18.2强制筛选，但主IHC路径和大药企供应商显著锁定。", "bidThesis": "只做Keymed渠道的区域bridging、北美样本处理、NGS探索或IHC复核合作，不竞逐主CDx。", "assays": ["CLDN18.2 IHC coordination", "digital pathology", "HER2/PD-L1/MSI coordination", "plasma CGP"], "capabilityBoundary": "IHC/digital pathology必须合作；Ventana主路径不可被NGS替代。", "risks": ["Ventana锁定", "AstraZeneca主供应商", "截至截止日未找到正式III期顶线公告"], "decisionTrigger": "出现Keymed可控制的区域/桥接项目或AstraZeneca明确backup需求。", "decisionOwner": "原研方渠道负责人；病理合作与AZ大客户负责人", "ncts": ["NCT06346392", "NCT06219941", "NCT07431281"], "milestones": [ {"quarter": "2026Q3", "label": "III期顶线/申报路径待公告", "confidence": "inference", "detail": "此前预计2026H1数据；截止日未找到正式顶线公告。"}, {"quarter": "2027Q4", "label": "泛瘤种扩展数据窗口", "confidence": "inference", "detail": "取决于NCT06219941和新研究。"}, {"quarter": "2029Q4", "label": "确证/上市后桥接可能窗口", "confidence": "inference", "detail": "不代表获批。"} ], "sources": [ {"label": "CLARITY-Gastric01", "url": "https://clinicaltrials.gov/study/NCT06346392", "type": "ClinicalTrials.gov"}, {"label": "Multi-tumor Phase 2", "url": "https://clinicaltrials.gov/study/NCT06219941", "type": "ClinicalTrials.gov"}, {"label": "Keymed program update", "url": "https://www.keymedbio.com/cn/newsd.html?id=118&type=2", "type": "company"} ], "tags": ["China-origin", "ADC", "CLDN18.2", "locked-CDx", "bridging", "IHC-dependent"] }, { "id": "zongertinib-her2", "rank": 26, "tier": "watch-bridging", "account": "Boehringer Ingelheim", "company": "Boehringer Ingelheim", "origin": "Germany", "asset": "Zongertinib", "aliases": ["Hernexeos", "BI 1810631"], "mechanism": "HER2-selective tyrosine kinase inhibitor", "indications": ["ERBB2/HER2 TKD-mutant NSCLC", "adjuvant HER2-mutant NSCLC"], "biomarker": "ERBB2/HER2 tyrosine-kinase-domain mutation", "phase": "Accelerated approval plus confirmatory/adjuvant Phase 3", "northAmerica": true, "chinaOrigin": false, "services": ["bridging", "central NGS", "plasma resistance", "adjuvant MRD"], "modalities": ["DNA NGS", "plasma NGS", "ctDNA MRD"], "modalityFit": "owned", "enrollmentMechanism": "central confirmation", "valueScore": 80, "winScore": 30, "ctaScore": 75, "cdxScore": 15, "priorityScore": 58, "cdxStatus": "Guardant360 ERBB2 CDx已获批，主CDx锁定", "vendorStatus": "Guardant primary CDx; other central vendors undisclosed", "whyNow": "2026年一线加速批准；确证和辅助III期仍产生NGS/MRD需求。", "bidThesis": "只争取桥接、复杂ERBB2 indel复核、耐药和辅助MRD。", "assays": ["ERBB2 indel NGS", "plasma resistance", "ctDNA MRD"], "capabilityBoundary": "不得替代已批准Guardant CDx；MRD需独立验证。", "risks": ["主CDx锁定", "稀有人群", "辅助MRD周期长"], "decisionTrigger": "出现区域bridging、post-market或MRD工作包。", "decisionOwner": "BI账户负责人；MRD平台主管", "ncts": ["NCT06151574", "NCT07195695"], "milestones": [ {"quarter": "2026Q3", "label": "Beamion LUNG-2主要完成估计", "confidence": "registry-estimate", "detail": "约2026-09。"}, {"quarter": "2027Q2", "label": "确证数据/监管更新可能窗口", "confidence": "inference", "detail": "未有确定日期。"}, {"quarter": "2029Q4", "label": "FDA确证PMR目标窗口", "confidence": "fact", "detail": "FDA ongoing accelerated-approval list显示2029-11目标。"} ], "sources": [ {"label": "FDA first-line accelerated approval", "url": "https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell", "type": "FDA"}, {"label": "Beamion LUNG-2", "url": "https://clinicaltrials.gov/study/NCT06151574", "type": "ClinicalTrials.gov"}, {"label": "Beamion LUNG-3", "url": "https://clinicaltrials.gov/study/NCT07195695", "type": "ClinicalTrials.gov"} ], "tags": ["HER2", "locked-CDx", "bridging", "MRD", "NSCLC"] }, { "id": "sevabertinib-bay2927088", "rank": 27, "tier": "watch-bridging", "account": "Bayer", "company": "Bayer", "origin": "Germany", "asset": "Sevabertinib", "aliases": ["Hyrnuo", "BAY 2927088"], "mechanism": "HER2-mutant selective tyrosine kinase inhibitor", "indications": ["first-line HER2-mutant NSCLC"], "biomarker": "ERBB2/HER2 TKD mutation", "phase": "Accelerated approval plus confirmatory Phase 3", "northAmerica": true, "chinaOrigin": false, "services": ["bridging", "central NGS", "plasma resistance"], "modalities": ["DNA NGS", "plasma NGS"], "modalityFit": "owned", "enrollmentMechanism": "central confirmation", "valueScore": 78, "winScore": 32, "ctaScore": 72, "cdxScore": 15, "priorityScore": 57, "cdxStatus": "已有FDA-authorized HER2 tests，主CDx空间有限", "vendorStatus": "mature approved-test ecosystem", "whyNow": "SOHO-02约444例，预计2027年主要完成。", "bidThesis": "与zongertinib共用ERBB2 indel/耐药验证框架，销售regional central/bridging。", "assays": ["ERBB2 indel tissue NGS", "plasma resistance"], "capabilityBoundary": "不能把通用CGP宣传成该药获批CDx。", "risks": ["成熟CDx生态", "与zongertinib直接竞争", "稀有人群"], "decisionTrigger": "区域RFI或post-approval bridging出现。", "decisionOwner": "Bayer账户负责人", "ncts": ["NCT06452277"], "milestones": [ {"quarter": "2026Q3", "label": "SOHO-02持续入组", "confidence": "fact", "detail": "一线确证III期。"}, {"quarter": "2027Q4", "label": "SOHO-02主要完成估计", "confidence": "registry-estimate", "detail": "注册预计2027-10。"}, {"quarter": "2028Q2", "label": "full-approval决策可能窗口", "confidence": "inference", "detail": "取决于确证结果。"} ], "sources": [ {"label": "SOHO-02", "url": "https://clinicaltrials.gov/study/NCT06452277", "type": "ClinicalTrials.gov"}, {"label": "Bayer BTD update", "url": "https://www.bayer.com/media/en-us/bayer-receives-breakthrough-therapy-designation-in-the-us-and-china-for-sevabertinib-as-a-first-line-treatment-for-patients-with-her2-mutant-non-small-cell-lung-cancer/", "type": "company"} ], "tags": ["HER2", "bridging", "mature-CDx", "NSCLC"] }, { "id": "telisotuzumab-vedotin-emrelis", "rank": 28, "tier": "watch-bridging", "account": "AbbVie", "company": "AbbVie", "origin": "United States", "asset": "Telisotuzumab vedotin", "aliases": ["Emrelis", "Teliso-V"], "mechanism": "c-MET-directed antibody-drug conjugate", "indications": ["high c-MET protein-overexpressing nonsquamous NSCLC"], "biomarker": "MET IHC: at least 50% tumor cells with strong 3+ staining", "phase": "Accelerated approval plus confirmatory Phase 3", "northAmerica": true, "chinaOrigin": false, "services": ["post-market bridging", "central pathology support", "driver-exclusion CGP"], "modalities": ["MET IHC", "DNA NGS", "FISH"], "modalityFit": "partner-delivered", "enrollmentMechanism": "central mandatory", "valueScore": 81, "winScore": 24, "ctaScore": 76, "cdxScore": 10, "priorityScore": 55, "cdxStatus": "VENTANA MET SP44 RxDx已获批并锁定主CDx", "vendorStatus": "Roche/Ventana primary CDx locked", "whyNow": "确证III期与FDA post-market assay study仍需筛查和复核。", "bidThesis": "仅做北美样本前处理、driver排除CGP、post-market/bridging或二读。", "assays": ["MET SP44 coordination", "EGFR/driver CGP", "MET amplification/exon14 context"], "capabilityBoundary": "MET IHC必须由合格病理合作方执行；不得竞逐已锁定主CDx。", "risks": ["Ventana锁定", "AbbVie主实验室", "post-market范围有限"], "decisionTrigger": "明确post-market/bridging RFI或北美样本处理缺口。", "decisionOwner": "AbbVie账户负责人；病理合作负责人", "ncts": ["NCT04928846"], "milestones": [ {"quarter": "2026Q3", "label": "确证III期与post-market研究持续", "confidence": "fact", "detail": "FDA批准后研究仍在进行。"}, {"quarter": "2027Q2", "label": "post-market预筛样本窗口", "confidence": "fact", "detail": "FDA PAS资料包含至2027-04的预筛。"}, {"quarter": "2028Q4", "label": "确证数据可能窗口", "confidence": "inference", "detail": "以注册和AbbVie更新为准。"} ], "sources": [ {"label": "FDA accelerated approval and CDx", "url": "https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-telisotuzumab-vedotin-tllv-nsclc-high-c-met-protein-overexpression", "type": "FDA"}, {"label": "Confirmatory Phase 3", "url": "https://clinicaltrials.gov/study/NCT04928846", "type": "ClinicalTrials.gov"}, {"label": "FDA post-approval study", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm?c_id=8321&t_id=836256", "type": "FDA"} ], "tags": ["MET", "ADC", "locked-CDx", "bridging", "IHC-dependent"] }, { "id": "ziftomenib-komzifti", "rank": 29, "tier": "watch-bridging", "account": "Kura Oncology", "company": "Kura Oncology", "origin": "United States", "asset": "Ziftomenib", "aliases": ["Komzifti", "KO-539"], "mechanism": "menin inhibitor", "indications": ["NPM1-mutant AML", "KMT2A-rearranged AML"], "biomarker": "NPM1 mutation or KMT2A rearrangement; serial AML MRD", "phase": "Approved in NPM1-mutant R/R AML; global Phase 3 expansion", "northAmerica": true, "chinaOrigin": false, "services": ["AML central NGS", "MRD", "orthogonal/backup assay", "bridging"], "modalities": ["DNA NGS", "RNA NGS", "qPCR", "FISH"], "modalityFit": "mixed", "enrollmentMechanism": "central confirmation", "valueScore": 77, "winScore": 35, "ctaScore": 82, "cdxScore": 20, "priorityScore": 54, "cdxStatus": "FDA文件明确QIAGEN为NPM1 CDx合作方；主CDx不开放", "vendorStatus": "QIAGEN primary CDx relationship disclosed", "whyNow": "III期KOMET-017约1,300例，且FDA CDx/variant postmarketing工作延续至2027。", "bidThesis": "只销售orthogonal NGS、MRD、backup和桥接，不竞逐QIAGEN主CDx。", "assays": ["NPM1 DNA/RNA", "KMT2A fusion/rearrangement", "AML MRD"], "capabilityBoundary": "FISH/qPCR需审计；不得取代QIAGEN主CDx。", "risks": ["主CDx锁定", "AML MRD标准化", "大规模III期主实验室可能已选定"], "decisionTrigger": "出现orthogonal/backup或MRD分包需求。", "decisionOwner": "血液瘤BD；MRD平台主管", "ncts": ["NCT07007312"], "milestones": [ {"quarter": "2026Q3", "label": "KOMET-017全球III期持续入组", "confidence": "fact", "detail": "新诊断NPM1/KMT2A人群。"}, {"quarter": "2027Q1", "label": "FDA NPM1 CDx研究报告窗口", "confidence": "fact", "detail": "批准函列出2027-03最终报告节点。"}, {"quarter": "2027Q2", "label": "NPM1 variant activity study完成窗口", "confidence": "fact", "detail": "FDA要求的研究完成节点约2027-06。"} ], "sources": [ {"label": "FDA approval", "url": "https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ziftomenib-relapsed-or-refractory-acute-myeloid-leukemia-npm1-mutation", "type": "FDA"}, {"label": "KOMET-017", "url": "https://clinicaltrials.gov/study/NCT07007312", "type": "ClinicalTrials.gov"}, {"label": "FDA administrative correspondence naming QIAGEN", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/220305Orig1s000AdminCorres.pdf", "type": "FDA"} ], "tags": ["AML", "NPM1", "KMT2A", "MRD", "locked-CDx", "bridging"] }, { "id": "camizestrant-azd9833", "rank": 30, "tier": "watch-bridging", "account": "AstraZeneca", "company": "AstraZeneca", "origin": "United Kingdom / global", "asset": "Camizestrant", "aliases": ["AZD9833"], "mechanism": "oral selective estrogen receptor degrader", "indications": ["ER+/HER2- breast cancer with emergent ESR1 mutation", "early breast cancer"], "biomarker": "serial plasma ESR1 mutation before radiographic progression", "phase": "Phase 3; regulatory review uncertain", "northAmerica": true, "chinaOrigin": false, "services": ["serial plasma CTA", "low-VAF ESR1", "ctDNA kinetics", "MRD research"], "modalities": ["plasma NGS", "ctDNA", "DNA NGS"], "modalityFit": "owned", "enrollmentMechanism": "central mandatory", "valueScore": 86, "winScore": 25, "ctaScore": 88, "cdxScore": 45, "priorityScore": 53, "cdxStatus": "ESR1序贯检测模式创新，但FDA benefit-risk存在显著不确定性", "vendorStatus": "current serial-testing vendor not publicly confirmed", "whyNow": "SERENA-6证明高频ctDNA触发策略的商业模式，但ODAC以3:6未支持当前benefit-risk。", "bidThesis": "仅阶段性追踪并用里程碑合同；不把监管不确定项目作为确定收入。", "assays": ["ultra-low-VAF ESR1 plasma NGS", "serial ctDNA", "clone tracking"], "capabilityBoundary": "低VAF重复确认和临床触发用途需专项验证；普通plasma CGP不足以直接承担。", "risks": ["监管否定风险", "成熟ESR1液体活检竞争", "CAMBRIA主要终点超出窗口"], "decisionTrigger": "FDA最终结论明确且后续方案仍需要序贯ESR1检测。", "decisionOwner": "AstraZeneca账户负责人；法规与液体活检平台主管", "ncts": ["NCT04964934", "NCT05952557"], "milestones": [ {"quarter": "2026Q3", "label": "FDA最终审评结论待核实", "confidence": "fact", "detail": "截至2026-08-08未找到最终批准或CRL；PDUFA此前延长。"}, {"quarter": "2027Q2", "label": "补充分析/监管去风险窗口", "confidence": "inference", "detail": "取决于FDA决定。"}, {"quarter": "2029Q4", "label": "CAMBRIA-2持续入组和随访", "confidence": "registry-estimate", "detail": "主要终点在三年窗口之外。"} ], "sources": [ {"label": "SERENA-6", "url": "https://clinicaltrials.gov/study/NCT04964934", "type": "ClinicalTrials.gov"}, {"label": "CAMBRIA-2", "url": "https://clinicaltrials.gov/study/NCT05952557", "type": "ClinicalTrials.gov"}, {"label": "FDA ODAC briefing", "url": "https://www.fda.gov/media/192156/download", "type": "FDA"} ], "tags": ["ESR1", "liquid-biopsy", "serial-testing", "regulatory-risk", "watch"] }, { "id": "divarasib-gdc6036", "rank": 31, "tier": "watch-bridging", "account": "Roche", "company": "Roche/Genentech", "origin": "Switzerland / United States", "asset": "Divarasib", "aliases": ["GDC-6036"], "mechanism": "KRAS G12C inhibitor", "indications": ["KRAS G12C NSCLC", "adjuvant KRAS G12C NSCLC"], "biomarker": "KRAS G12C and longitudinal resistance/MRD", "phase": "Phase 3 positive; submissions planned", "northAmerica": true, "chinaOrigin": false, "services": ["bridging", "plasma resistance", "adjuvant MRD", "backup central testing"], "modalities": ["DNA NGS", "plasma NGS", "ctDNA MRD"], "modalityFit": "owned", "enrollmentMechanism": "central confirmation", "valueScore": 87, "winScore": 18, "ctaScore": 86, "cdxScore": 20, "priorityScore": 51, "cdxStatus": "Roche/Foundation内部生态强，主CDx可获得性极低", "vendorStatus": "internal/mature Roche-Foundation ecosystem", "whyNow": "2026-07 III期PFS与OS阳性并计划申报；辅助III期将产生长期MRD样本。", "bidThesis": "仅机会主义争取外溢、区域backup、耐药或辅助MRD。", "assays": ["KRAS G12C tissue/plasma", "resistance CGP", "adjuvant MRD"], "capabilityBoundary": "不得声称可替代Roche/Foundation主平台；MRD需单独验证。", "risks": ["内部生态锁定", "G12C成熟", "辅助读出远期"], "decisionTrigger": "Roche明确外部backup/区域MRD RFI。", "decisionOwner": "Roche战略账户；MRD平台主管", "ncts": ["NCT06497556", "NCT07541170", "NCT05789082"], "milestones": [ {"quarter": "2026Q3", "label": "III期阳性后全球申报准备", "confidence": "fact", "detail": "Roche于2026-07-02宣布PFS和OS阳性。"}, {"quarter": "2027Q2", "label": "首批监管决定可能窗口", "confidence": "inference", "detail": "未公布确定日期。"}, {"quarter": "2029Q4", "label": "辅助III期持续入组", "confidence": "registry-estimate", "detail": "主要完成在2032，三年内以样本服务为主。"} ], "sources": [ {"label": "Roche positive Phase 3 update", "url": "https://www.roche.com/investors/updates/inv-update-2026-07-02", "type": "company"}, {"label": "KRAScendo-1", "url": "https://clinicaltrials.gov/study/NCT06497556", "type": "ClinicalTrials.gov"}, {"label": "Adjuvant KRAScendo-3", "url": "https://clinicaltrials.gov/study/NCT07541170", "type": "ClinicalTrials.gov"} ], "tags": ["KRAS", "G12C", "internal-ecosystem", "bridging", "MRD"] }, { "id": "revumenib-revuforj", "rank": 32, "tier": "watch-bridging", "account": "Syndax Pharmaceuticals", "company": "Syndax Pharmaceuticals", "origin": "United States", "asset": "Revumenib", "aliases": ["Revuforj", "SNDX-5613"], "mechanism": "menin inhibitor", "indications": ["NPM1-mutant AML", "KMT2A-rearranged acute leukemia"], "biomarker": "NPM1 mutation, KMT2A rearrangement and serial MRD", "phase": "Approved plus multiple Phase 3 expansions", "northAmerica": true, "chinaOrigin": false, "services": ["AML central NGS", "MRD", "RNA fusion", "bridging"], "modalities": ["DNA NGS", "RNA NGS", "FISH", "qPCR"], "modalityFit": "mixed", "enrollmentMechanism": "central confirmation", "valueScore": 76, "winScore": 26, "ctaScore": 82, "cdxScore": 25, "priorityScore": 50, "cdxStatus": "KMT2A CDx已有Cytocell FISH；NPM1 CDx有FDA承诺节点", "vendorStatus": "KMT2A primary ecosystem partly locked; NPM1 vendor details incomplete", "whyNow": "两项新诊断III期在招募，NPM1 CDx最终报告节点在2027。", "bidThesis": "争取NPM1/KMT2A正交NGS、RNA、MRD和区域桥接，不替代已授权FISH。", "assays": ["NPM1 DNA/RNA", "KMT2A fusion NGS", "AML MRD", "FISH coordination"], "capabilityBoundary": "FISH/qPCR能力需审计；不能取代Cytocell已授权KMT2A CDx。", "risks": ["部分CDx锁定", "AML MRD标准化", "III期主实验室可能固化"], "decisionTrigger": "NPM1 CDx/central vendor状态澄清或出现MRD/backup RFI。", "decisionOwner": "血液瘤BD；MRD和法规负责人", "ncts": ["NCT07211958", "NCT06652438"], "milestones": [ {"quarter": "2026Q3", "label": "NPM1/KMT2A新诊断III期持续入组", "confidence": "fact", "detail": "两项全球研究执行中。"}, {"quarter": "2027Q2", "label": "NPM1 CDx最终报告节点", "confidence": "fact", "detail": "FDA批准函列出2027-06节点。"}, {"quarter": "2029Q2", "label": "REVEAL-ND主要完成估计", "confidence": "registry-estimate", "detail": "NCT07211958预计2029-06。"} ], "sources": [ {"label": "REVEAL-ND", "url": "https://clinicaltrials.gov/study/NCT07211958", "type": "ClinicalTrials.gov"}, {"label": "Additional Phase 3", "url": "https://clinicaltrials.gov/study/NCT06652438", "type": "ClinicalTrials.gov"}, {"label": "FDA approval letter with NPM1 CDx commitment", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218944Orig1s003ltr.pdf", "type": "FDA"} ], "tags": ["AML", "NPM1", "KMT2A", "MRD", "bridging", "partly-locked"] } ], "exclusions": [ { "id": "exclude-amg193", "asset": "AMG 193", "company": "Amgen", "reason": "Amgen在2026Q1明确终止全部进一步开发；注册状态可能滞后，不能作为活跃target。", "sources": [ {"label": "Amgen Q1 2026 results", "url": "https://investors.amgen.com/news-releases/news-release-details/amgen-reports-first-quarter-2026-financial-results", "type": "company"} ] }, { "id": "exclude-tscan-tplex", "asset": "TScan solid-tumor T-Plex", "company": "TScan Therapeutics", "reason": "实体瘤入组已暂停，且公开资料已有其他检测合作方；不作为当前高优先机会。", "sources": [ {"label": "TScan program prioritization", "url": "https://ir.tscan.com/news-releases/news-release-details/tscan-therapeutics-reaches-agreement-fda-pivotal-study-design", "type": "company"}, {"label": "TSCAN-002", "url": "https://clinicaltrials.gov/study/NCT05973487", "type": "ClinicalTrials.gov"} ] }, { "id": "exclude-v940", "asset": "Intismeran autogene / V940", "company": "Merck and Moderna", "reason": "肿瘤-正常WES、RNA、HLA科学价值很高，但个体化疫苗算法、制造和样本链很可能是封闭专有工作流；Claude建议不列为主动追逐，仅监测外部合作信号。", "sources": [ {"label": "INTerpath-001", "url": "https://clinicaltrials.gov/study/NCT05933577", "type": "ClinicalTrials.gov"}, {"label": "Merck/Moderna five-year update", "url": "https://www.merck.com/news/moderna-and-merck-present-5-year-data-for-intismeran-autogene-in-combination-with-keytruda-pembrolizumab-in-patients-with-high-risk-stage-iii-iv-melanoma-following-complete-resection-at-the-20/", "type": "company"} ] } ], "servicePacks": [ { "id": "ras-precision-pack", "name": "RAS精准药CTA包", "description": "pan-RAS/G12D/G12C组织与血浆一致性、低VAF复核、耐药和围术期MRD。", "coreAssays": ["tissue DNA NGS", "plasma NGS", "ctDNA kinetics", "resistance CGP"], "bestFit": ["Zoldonrasib", "Daraxonrasib", "Calderasib", "Olomorasib", "Divarasib"], "capabilityBoundary": "普通CGP不是药物专属CDx；MRD和低VAF触发用途需项目级验证。" }, { "id": "mtap-synthetic-lethality-pack", "name": "MTAP合成致死筛查包", "description": "MTAP/CDKN2A深缺失CNV、纯度校正、NGS-IHC不一致裁决和血浆探索。", "coreAssays": ["DNA NGS CNV", "plasma CNV", "MTAP IHC coordination", "discordance adjudication"], "bestFit": ["Navlimetostat", "IDE892 plus IDE397"], "capabilityBoundary": "IHC/FISH必须审计或合作；先确认入组screening modality和cutoff。" }, { "id": "breast-precision-pack", "name": "乳癌HRR/PIK3CA/ESR1包", "description": "组织、胚系和血浆的PIK3CA、BRCA1/2、PALB2、ESR1检测及跨平台bridging。", "coreAssays": ["tissue NGS", "germline confirmation", "plasma NGS", "variant adjudication"], "bestFit": ["Zovegalisib", "Saruparib", "Camizestrant"], "capabilityBoundary": "胚系责任、低VAF用途和CDx监管边界须写入SOW。" }, { "id": "hematology-repeat-mrd-pack", "name": "血液瘤重复MRD中心实验室包", "description": "BCR::ABL1、CLL/MDS/AML、MM和DLBCL的重复MRD、耐药与样本物流。", "coreAssays": ["NGS MRD", "qPCR", "flow MRD", "FISH/cytogenetics"], "bestFit": ["Olverembatinib", "Lisaftoclax", "Mezigdomide", "Epcoritamab", "Ziftomenib", "Revumenib"], "capabilityBoundary": "flow、FISH、细胞遗传、qPCR和骨髓物流必须先审计；未通过则只做NGS分包。" }, { "id": "china-originator-channel-pack", "name": "中国原研方全球化渠道包", "description": "从原研方争取区域bridging、转化队列和北美样本接口，而不是替换全球被许可方主供应商。", "coreAssays": ["tissue/plasma CGP", "regional bridging", "sample logistics", "translational biomarkers"], "bestFit": ["Sac-TMT", "Ivonescimab", "Iza-bren", "Pumitamig", "Ris-Rez", "Mo-Rez", "Trastuzumab pamirtecan"], "capabilityBoundary": "必须先确认原研方对工作包和采购的实际决策权。" }, { "id": "adc-biomarker-pack", "name": "ADC转化biomarker包", "description": "ADC项目的组织/血浆CGP、表达相关性、耐药和样本链。", "coreAssays": ["tissue CGP", "plasma CGP", "IHC coordination", "digital pathology coordination"], "bestFit": ["ZL-1310", "CRB-701", "R-DXd", "AZD0901", "Ris-Rez", "Mo-Rez"], "capabilityBoundary": "IHC/数字病理和PK/ADA多为partner-delivered；探索性表达不能标为CDx。" }, { "id": "locked-cdx-bridge-pack", "name": "已锁定CDx桥接与耐药包", "description": "针对主CDx已绑定的平台，仅销售区域bridging、正交复核、耐药、post-market与MRD。", "coreAssays": ["orthogonal NGS", "plasma resistance", "bridging", "post-market study support"], "bestFit": ["Zongertinib", "Sevabertinib", "Telisotuzumab vedotin", "Ziftomenib", "Revumenib", "Divarasib"], "capabilityBoundary": "不得声称能替代Guardant、Ventana、QIAGEN、Cytocell或Roche/Foundation的既有主路径。" } ], "methodology": { "scope": "从公开注册、FDA和公司一手来源中筛选北美肿瘤CTA/central-lab/CDx相关机会；这是可操作样本，不是穷尽性全球数据库。", "definitions": { "CTA": "clinical trial assay；为临床试验入组、分层或探索终点提供检测，不等同于最终获批CDx。", "CDx": "对特定药物安全有效使用必需的受监管伴随诊断，需要独立分析、临床验证和监管申报。", "vendorUndisclosed": "公开来源未披露供应商，只代表不确定性，绝不代表开放RFP。" }, "scoring": { "valueScore": "biomarker依赖、样本量、三年时点、北美覆盖、科学/战略价值的序数评分", "winScore": "申办方可接近性、供应商锁定、能力匹配和原研方渠道的序数评分", "ctaScore": "未来三年可立即形成CTA/central-lab工作量的序数评分", "cdxScore": "形成受监管CDx的长期上行空间，已锁定或非强制biomarker显著降分", "priorityScore": "综合价值、可获得性、CTA-now和CDx-upside的人工校准排序；不是数学收入模型" }, "confidenceLabels": { "fact": "FDA、公司或注册明确确认", "company-guidance": "公司前瞻指引，可改变", "registry-estimate": "ClinicalTrials.gov申办方估计日期，不等同于读出", "inference": "基于开发常规的推断，不应作为确定事件" }, "inclusionCriteria": [ "2026Q3至2029Q4存在入组、主要完成、申报、桥接或持续重复检测窗口", "北美有站点、全球开发或明确的北美业务切入逻辑", "与NGS、液体活检、MRD、RNA fusion或可审计合作检测相关", "高价值但供应商锁定的项目仅作为bridging/watch列入" ], "limitations": [ "未公开RFP、合同、检测单价、实际样本量、中心实验室和大多数CDx供应商状态", "未对所有CTIS、CDE或未披露项目进行穷尽抓取", "价值和胜率为0-100序数判断，不是收入或成功率", "站点国家和注册日期会变化，需定期刷新", "GeneseeqPrime K250003不能因510(k)自动宣传为任何药物的CDx" ], "updateCadence": "ClinicalTrials.gov weekly; FDA/company pipeline monthly; immediate-chase account status monthly; full rescoring quarterly", "primaryReferences": [ {"label": "ClinicalTrials.gov API", "url": "https://clinicaltrials.gov/data-api/api"}, {"label": "FDA companion diagnostics", "url": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/companion-diagnostics"}, {"label": "FDA K250003", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250003"} ] }, "claudeReview": { "status": "completed", "reviewedAt": "2026-08-08", "model": "claude-opus-5", "effort": "high", "requestedTimeLimitSeconds": 650, "completedInSeconds": 252.5, "summary": "Claude将可立即销售的CTA与多年CDx上行拆开，优先中型精准药企和原研方渠道，显著降级IHC主导、供应商锁定及专有闭环项目。", "agreements": [ "Zovegalisib、Silevertinib、Lirafugratinib、Zoldonrasib和Navlimetostat是高价值精准项目", "Olverembatinib与Lisaftoclax的重复MRD可形成比单次CDx更稳定的中心实验室需求", "未公开vendor绝不能当成开放竞标", "中国来源全球大项目应走原研方区域/bridging/translation渠道", "IHC/FISH/HLA/flow/qPCR/PK-ADA必须审计或合作交付" ], "disagreements": [ "Claude认为Saruparib虽然明确写CDx开发，但BRCA成熟生态使主CDx胜率低于初始Codex排序", "Claude将CRB-701、CLDN18.2、HER2、B7-H3和B7-H4等IHC主导项目下调", "Claude建议V940因专有封闭工作流从主动机会移至排除/监测" ], "changes": [ "新增ctaScore与cdxScore", "新增enrollmentMechanism、modalities、modalityFit、decisionTrigger和decisionOwner", "Top 12重排为zovegalisib、silevertinib、lirafugratinib、olverembatinib、zoldonrasib、navlimetostat、sac-TMT、ZL-1310、saruparib、ivonescimab、iza-bren、lisaftoclax", "Navlimetostat与Lisaftoclax改为能力审计通过后的条件性追逐", "Saruparib改为CTA/translation优先，不假设开放主CDx", "V940移出active pursuits" ] } }