{ "figure_id": "P02", "pilot_version": "ADC-20261007-R1-VISUAL-PILOT2-1.0", "research_parent_version": "ADC-20261007-R1", "parent_figure_id": "F05", "evidence_as_of": "2026-10-07", "timezone": "Asia/Taipei", "parent_master_sha256": "ba5a46bc85a086921ef421928922e515d24c3a51283bd5c4c9dd5e9f0f077f0c", "numeric_inventory": { "records_total": 465, "numeric_records": 185, "numeric_records_by_topic": { "抗藥性": 4, "股權投資": 1, "臨床證據": 131, "交易金額": 33, "交易分工": 1, "製造與供應": 5, "製造設備容量": 8, "台灣臨床狀態": 2 }, "eligible_annual_product_sales_or_revenue_records": 0, "eligible_same_scope_sales_time_series": 0, "near_candidates_excluded": [ { "record_id": "TX03_MAX", "entity": "Merck / Daiichi Sankyo", "period": "2023-10-19", "numeric_value": 22000, "unit": "百萬美元", "source_ids": [ "D01", "D02", "D03", "D04", "D05" ], "reason_excluded": "授權最高條件對價；不是產品銷售收入。" }, { "record_id": "TX05_MAX", "entity": "Gilead / Tubulis", "period": "2024-12-03", "numeric_value": 465, "unit": "百萬美元", "source_ids": [ "D14" ], "reason_excluded": "授權最高條件對價；不是產品銷售收入。" }, { "record_id": "TX06_MAX", "entity": "Gilead / Tubulis", "period": "2026-04-07", "numeric_value": 5000, "unit": "百萬美元", "source_ids": [ "D15", "D16", "D17" ], "reason_excluded": "收購最高條件對價；不是產品銷售收入。" }, { "record_id": "TX03_JAPAN_ROYALTY", "entity": "Merck／Daiichi Sankyo", "period": "2026-06-30", "numeric_value": 5, "unit": "%", "source_ids": [ "D02" ], "reason_excluded": "權利金百分比；沒有可核年度銷售額分母。" }, { "record_id": "TX04_US_COST_ADJUSTMENT", "entity": "BioNTech／DualityBio", "period": "2026年上半年公告之一次性調整；資料日2026-06-30", "numeric_value": 290.7, "unit": "百萬元人民幣", "source_ids": [ "D13" ], "reason_excluded": "2026上半年的歷史開發費一次性收入扣減，單一會計調整；不是ADC產品銷售年序列。" }, { "record_id": "TX03_PAID_UPFRONT", "entity": "Merck／Daiichi Sankyo", "period": "付款年度2023；財報截至2026-06-30", "numeric_value": 4000, "unit": "百萬美元", "source_ids": [ "D02" ], "reason_excluded": "2023年合作簽約金付款；不是產品銷售。" }, { "record_id": "TX03_PAID_CONT_2024", "entity": "Merck／Daiichi Sankyo", "period": "付款月份2024-10；財報截至2026-06-30", "numeric_value": 750, "unit": "百萬美元", "source_ids": [ "D02" ], "reason_excluded": "2024年10月延續付款；不是產品銷售。" }, { "record_id": "TX03_PAID_CONT_2025", "entity": "Merck／Daiichi Sankyo", "period": "付款月份2025-10；財報截至2026-06-30", "numeric_value": 750, "unit": "百萬美元", "source_ids": [ "D02" ], "reason_excluded": "2025年10月延續付款；不是產品銷售。" }, { "record_id": "CMC05_CAP_3_MAX", "entity": "WuXi XDC Singapore", "period": "名義年容量；公司公告資料日2026-09-21", "numeric_value": 8000000, "unit": "vials/year_nominal", "source_ids": [ "D23" ], "reason_excluded": "名義年灌裝容量，單位瓶／年；不是實際銷量或收入。" }, { "record_id": "TW_MYCENAX_CAPACITY_VALUE", "entity": "永昕", "period": null, "numeric_value": 50, "unit": "L", "source_ids": [ "T13" ], "reason_excluded": "公司宣告的偶聯製造尺度；不是實際年產量或銷售。" } ], "precise_missing_fields": [ "同一ADC產品或同一可比企業範圍的至少兩個年度銷售／營收原值", "各年度完整財務期間及地域／權利收入範圍", "銷售／權利金／合作收入等一致會計口徑", "原幣種與年度間口徑或匯率變動說明", "逐年度可回查的正式財報支持位置" ], "decision": "使用F05同試驗對照之三個獨立panel；不繪製銷售增長、市占或市場總額。" }, "panels": [ { "panel_id": "TB02", "trial": "TROPION-Breast02", "phase": 3, "population_zh": "不適合PD-(L)1治療", "common_population_zh": "成人不可切除局部晚期／轉移TNBC，未接受該晚期階段全身治療的試驗族群。", "experimental": "Dato-DXd", "control": "醫師選擇化療", "n_fda_analysis": 644, "n_experimental_stored": 323, "n_control_stored": 321, "pfs": { "endpoint": "BICR-assessed PFS", "summary_statistic": "median", "experimental": 10.8, "control": 5.6, "unit_zh": "月", "unit_en": "months", "hazard_ratio": 0.57, "hr_95_ci_low": 0.47, "hr_95_ci_high": 0.69, "hazard_ratio_unit": "dimensionless" }, "os": { "endpoint": "OS", "summary_statistic": "median", "experimental": 23.7, "control": 18.7, "unit_zh": "月", "unit_en": "months", "hazard_ratio": 0.79, "hr_95_ci_low": 0.64, "hr_95_ci_high": 0.98, "hazard_ratio_unit": "dimensionless" }, "fda_announcement_date": "2026-05-22", "trial_data_cutoff": null, "trial_data_cutoff_status": "R1未存試驗資料截點；不可用FDA公告日或登錄更新日替代。", "registry_last_update": "2026-05-15", "source_ids": [ "C03", "C18" ], "currency": null, "f05_record_ids": [ "TB02_N_ALL", "TB02_N_EXP", "TB02_N_CTRL", "TB02_PFS_EXP", "TB02_PFS_CTRL", "TB02_PFS_HR", "TB02_PFS_HR_CI_LOW", "TB02_PFS_HR_CI_HIGH", "TB02_OS_EXP", "TB02_OS_CTRL", "TB02_OS_HR", "TB02_OS_HR_CI_LOW", "TB02_OS_HR_CI_HIGH", "TB02_LIMITATION", "TB02_PRIOR_ADC" ], "population_en": "Not candidates for PD-(L)1 therapy", "common_population_en": "Adults with unresectable locally advanced or metastatic TNBC; no prior systemic treatment for advanced disease.", "control_en": "Investigator's choice chemotherapy", "numeric_source_id": "C03", "registry_source_id": "C18", "trial_data_cutoff_status_en": "Not stored in R1; FDA notice and registry-update dates are not substituted for a trial data cutoff." }, { "panel_id": "ASCENT03", "trial": "ASCENT-03", "phase": 3, "population_zh": "不適合PD-(L)1治療", "common_population_zh": "成人不可切除局部晚期／轉移TNBC，未接受該晚期階段全身治療的試驗族群。", "experimental": "SG", "control": "nab-paclitaxel、paclitaxel或gemcitabine＋carboplatin", "n_fda_analysis": 558, "n_experimental_stored": null, "n_control_stored": null, "pfs": { "endpoint": "BICR-assessed PFS", "summary_statistic": "median", "experimental": 9.7, "control": 6.9, "unit_zh": "月", "unit_en": "months", "hazard_ratio": 0.62, "hr_95_ci_low": 0.5, "hr_95_ci_high": 0.77, "hazard_ratio_unit": "dimensionless" }, "os": { "status_zh": "FDA核准分析時尚未成熟", "status_en": "Immature at the FDA approval analysis", "median_experimental": null, "median_control": null, "hazard_ratio": null, "hr_95_ci_low": null, "hr_95_ci_high": null, "unit_zh": "月", "unit_en": "months", "hazard_ratio_unit": "dimensionless" }, "fda_announcement_date": "2026-06-24", "trial_data_cutoff": null, "trial_data_cutoff_status": "R1未存試驗資料截點；不可用FDA公告日或登錄更新日替代。", "registry_last_update": "2026-04-06", "source_ids": [ "C06", "C19" ], "currency": null, "f05_record_ids": [ "ASCENT03_N_ALL", "ASCENT03_PFS_EXP", "ASCENT03_PFS_CTRL", "ASCENT03_PFS_HR", "ASCENT03_PFS_HR_CI_LOW", "ASCENT03_PFS_HR_CI_HIGH", "ASCENT03_LIMITATION", "ASCENT03_OS_MATURITY", "ASCENT03_PRIOR_ADC" ], "population_en": "Not candidates for PD-(L)1 therapy", "common_population_en": "Adults with unresectable locally advanced or metastatic TNBC; no prior systemic treatment for advanced disease.", "control_en": "Nab-paclitaxel, paclitaxel, or gemcitabine plus carboplatin", "numeric_source_id": "C06", "registry_source_id": "C19", "trial_data_cutoff_status_en": "Not stored in R1; FDA notice and registry-update dates are not substituted for a trial data cutoff." }, { "panel_id": "ASCENT04", "trial": "ASCENT-04 / KEYNOTE-D19", "phase": 3, "population_zh": "PD-L1 CPS≥10", "common_population_zh": "成人不可切除局部晚期／轉移TNBC，未接受該晚期階段全身治療的試驗族群。", "experimental": "SG＋pembrolizumab", "control": "醫師選擇化療＋pembrolizumab", "n_fda_analysis": 443, "n_experimental_stored": null, "n_control_stored": null, "pfs": { "endpoint": "BICR-assessed PFS", "summary_statistic": "median", "experimental": 11.2, "control": 7.8, "unit_zh": "月", "unit_en": "months", "hazard_ratio": 0.65, "hr_95_ci_low": 0.51, "hr_95_ci_high": 0.84, "hazard_ratio_unit": "dimensionless" }, "os": { "status_zh": "FDA核准分析時尚未成熟", "status_en": "Immature at the FDA approval analysis", "median_experimental": null, "median_control": null, "hazard_ratio": null, "hr_95_ci_low": null, "hr_95_ci_high": null, "unit_zh": "月", "unit_en": "months", "hazard_ratio_unit": "dimensionless" }, "fda_announcement_date": "2026-06-24", "trial_data_cutoff": null, "trial_data_cutoff_status": "R1未存試驗資料截點；不可用FDA公告日或登錄更新日替代。", "registry_last_update": "2025-09-18", "source_ids": [ "C06", "C20" ], "currency": null, "f05_record_ids": [ "ASCENT04_N_ALL", "ASCENT04_PFS_EXP", "ASCENT04_PFS_CTRL", "ASCENT04_PFS_HR", "ASCENT04_PFS_HR_CI_LOW", "ASCENT04_PFS_HR_CI_HIGH", "ASCENT04_LIMITATION", "ASCENT04_OS_MATURITY", "ASCENT04_PRIOR_ADC" ], "population_en": "PD-L1 CPS ≥10", "common_population_en": "Adults with unresectable locally advanced or metastatic TNBC; no prior systemic treatment for advanced disease.", "control_en": "Investigator's choice chemotherapy plus pembrolizumab", "numeric_source_id": "C06", "registry_source_id": "C20", "trial_data_cutoff_status_en": "Not stored in R1; FDA notice and registry-update dates are not substituted for a trial data cutoff." } ], "csv_numeric_rows": 25, "csv_rows_displayed": 23, "csv_rows_retained_but_not_displayed": [ "TB02_N_EXP", "TB02_N_CTRL" ], "numeric_data_file": "P02_clinical.csv", "source_index": "../sources.csv", "chart_mapping": { "panel_order": [ "TB02", "ASCENT03", "ASCENT04" ], "order_basis": "R1 F05 order; not a ranking", "axis_endpoint": "BICR-assessed median PFS", "x_axis_min": 0, "x_axis_max": 12, "unit": "months", "ticks": [ 0, 4, 8, 12 ], "bar_origin": 0, "bar_length_fraction_formula": "(median_pfs_months - 0) / (12 - 0)", "logical_plot_width_px": 302, "bar_length_px_formula": "median_pfs_months / 12 * 302", "hr_ci": "Separate text only. HR is dimensionless and its CI is not a median-PFS error bar.", "os": "Separate annotation, never plotted on the PFS axis.", "cross_trial_effect_or_market_calculations": null }, "unknowns": { "trial_data_cutoffs": null, "ascent03_ascent04_arm_counts": null, "ascent03_ascent04_median_os_hr_ci": null, "ascent03_count_difference": { "fda_r1_count": 558, "r1_registry_c19_count": 623, "relationship_verified": false, "figure_count_basis": "FDA numerical extract used by R1; kept at 558." } }, "currency": null, "missing_value_convention": "JSON null and CSV empty fields mean not stored or not applicable, never zero.", "takeaway_zh": "各自同試驗對照支持第一線PFS改善；這些試驗不能回答既往Topo-I ADC失敗後的接續療效。", "takeaway_en": "Each trial supports a PFS benefit against its own first-line comparator; these trials do not establish efficacy after prior topoisomerase-I ADC failure." }