{
 "as_of": "2026-11-06",
 "title": "PRMT5 抑制劑（MTAP 缺失）新藥賽道",
 "title_en": "PRMT5 Inhibitors for MTAP-Deleted Cancers",
 "slug": "prmt5-mtap",
 "assets": [
  {
   "section": "clinical",
   "asset": "navlimetostat（BMS-986504／MRTX1719）",
   "asset_en": "navlimetostat (BMS-986504 / MRTX1719)",
   "company": "必治妥施貴寶（BMS，原 Mirati）",
   "company_en": "Bristol Myers Squibb (originally Mirati)",
   "country": "美國",
   "country_en": "US",
   "mechanism": "MTA 協同型 PRMT5 抑制劑",
   "mechanism_en": "MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第二／三期",
   "stage_en": "Phase 2/3",
   "indication": "MTAP 缺失非小細胞肺癌、胰臟癌、膠質母細胞瘤等實體腫瘤",
   "indication_en": "MTAP-deleted NSCLC, pancreatic cancer, glioblastoma and other solid tumors",
   "trials": [
    "NCT07063745",
    "NCT07076121",
    "NCT07492680",
    "NCT06855771"
   ],
   "deal": "2023-10 宣布、2024-01 完成收購 Mirati：前金約 48 億美元，另加最高約 10 億美元 CVR",
   "deal_en": "Announced Oct 2023, closed Jan 2024: BMS acquired Mirati for about US$4.8B upfront plus a CVR worth up to about US$1B",
   "latest": "肺癌一線第二／三期 MountainTAP-29（590 人，2026-01 開始，收案中）；胰臟癌一線第二／三期 MountainTAP-30（470 人，2025-10 開始，2026-06 起停止收案）；另有併用 daraxonrasib 等的第二期 MountainTAP-5（254 人，2026-07 開始），以及經治療肺癌併用 iza-bren 的第二期 MountainTAP-9（182 人）",
   "latest_en": "First-line NSCLC Phase 2/3 MountainTAP-29 (590, from Jan 2026, enrolling); first-line pancreatic cancer Phase 2/3 MountainTAP-30 (470, from Oct 2025, closed to enrollment since Jun 2026); plus the Phase 2 MountainTAP-5 including daraxonrasib combinations (254, from Jul 2026) and the Phase 2 MountainTAP-9 with iza-bren in previously treated NSCLC (182)",
   "date": "2026-07-27",
   "sources": [
    "https://clinicaltrials.gov/study/NCT07063745",
    "https://clinicaltrials.gov/study/NCT07076121",
    "https://clinicaltrials.gov/study/NCT07492680",
    "https://clinicaltrials.gov/study/NCT06855771",
    "https://www.biospace.com/bms-buys-mirati-for-4-8b-to-boost-cancer-business",
    "https://www.dcatvci.org/top-industry-news/bms-completes-5-8-bn-acquisition-of-mirati-therapeutics/"
   ],
   "asia": false
  },
  {
   "section": "discontinued",
   "asset": "anvumetostat（AMG 193）",
   "asset_en": "anvumetostat (AMG 193)",
   "company": "安進（Amgen）",
   "company_en": "Amgen",
   "country": "美國",
   "country_en": "US",
   "mechanism": "MTA 協同型 PRMT5 抑制劑",
   "mechanism_en": "MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一／二期（已停止開發）",
   "stage_en": "Phase 1/2 (discontinued)",
   "indication": "MTAP 缺失實體腫瘤；胰臟癌併用化療",
   "indication_en": "MTAP-deleted solid tumors; pancreatic cancer with chemotherapy",
   "trials": [
    "NCT05094336",
    "NCT06360354",
    "NCT06333951",
    "NCT06593522"
   ],
   "deal": "—",
   "deal_en": "—",
   "latest": "Amgen 2026-04-30 第一季財報宣布停止開發，四個試驗一併停止；CT.gov 上均已停止收案",
   "latest_en": "Amgen said in its first-quarter results on Apr 30, 2026 that it will discontinue development and stop four studies; all are closed to enrollment on CT.gov",
   "date": "2026-04-30",
   "sources": [
    "https://www.sec.gov/Archives/edgar/data/0000318154/000031815426000054/amgn-20260331earningsrelea.htm",
    "https://www.fiercebiotech.com/biotech/amgen-abandons-candidates-cancer-and-sjogrens-syndrome-after-ph-2-data-not-par",
    "https://clinicaltrials.gov/study/NCT05094336",
    "https://clinicaltrials.gov/study/NCT06593522"
   ],
   "asia": false
  },
  {
   "section": "clinical",
   "asset": "vopimetostat（TNG462）",
   "asset_en": "vopimetostat (TNG462)",
   "company": "Tango Therapeutics",
   "company_en": "Tango Therapeutics",
   "country": "美國",
   "country_en": "US",
   "mechanism": "MTA 協同型 PRMT5 抑制劑",
   "mechanism_en": "MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一／二期",
   "stage_en": "Phase 1/2",
   "indication": "MTAP 缺失實體腫瘤；併用 RAS(ON) 抑制劑治療胰臟癌與肺癌",
   "indication_en": "MTAP-deleted solid tumors; with RAS(ON) inhibitors in pancreatic and lung cancer",
   "trials": [
    "NCT05732831",
    "NCT06922591",
    "NCT07897734"
   ],
   "deal": "—",
   "deal_en": "—",
   "latest": "併用 daraxonrasib（Rasonque）：2026-06 胰臟癌可評估 12 人反應率 92%（含 2 例未確認反應）；2026-10 ESMO 二、三線 MTAP 缺失胰臟癌 22 人反應率 82%（截止日含 7 例未確認反應，公司稱其後皆已確認）、9 個月 88% 未惡化；一線第三期目標 2027 上半年啟動；併用 Erasca ERAS-0015 的第一／二期（NCT07897734）尚未收案",
   "latest_en": "With daraxonrasib (Rasonque): 92% ORR in 12 evaluable pancreatic patients, including 2 unconfirmed responses (Jun 2026); at ESMO 2026, 82% ORR in 22 second/third-line MTAP-deleted pancreatic patients, including 7 responses unconfirmed at data cutoff (the company says all were later confirmed), with 88% progression-free at 9 months; first-line Phase 3 targeted to start in 1H 2027; a Phase 1/2 with Erasca's ERAS-0015 (NCT07897734) is not yet recruiting",
   "date": "2026-10-23",
   "sources": [
    "https://finviz.com/news/407142/tango-presents-promising-results-from-phase-12-study-of-vopimetostat-and-daraxonrasib-in-pancreatic-cancer-and-provides-updates-to-development-strategy",
    "https://pharmaphorum.com/news/esmo26-tango-sees-82-orr-combo-pancreatic-cancer",
    "https://www.onclive.com/view/vopimetostat-plus-daraxonrasib-yields-92-orr-in-mtap-deleted-ras-mutant-pancreatic-cancer",
    "https://clinicaltrials.gov/study/NCT06922591",
    "https://clinicaltrials.gov/study/NCT07897734"
   ],
   "asia": false
  },
  {
   "section": "clinical",
   "asset": "TNG456",
   "asset_en": "TNG456",
   "company": "Tango Therapeutics",
   "company_en": "Tango Therapeutics",
   "country": "美國",
   "country_en": "US",
   "mechanism": "MTA 協同型 PRMT5 抑制劑（可穿透血腦屏障）",
   "mechanism_en": "Brain-penetrant MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一／二期",
   "stage_en": "Phase 1/2",
   "indication": "MTAP 缺失實體腫瘤（可入腦）；併用 abemaciclib",
   "indication_en": "MTAP-deleted solid tumors (brain-penetrant); with abemaciclib",
   "trials": [
    "NCT06810544"
   ],
   "deal": "—",
   "deal_en": "—",
   "latest": "第一／二期 191 人收案中",
   "latest_en": "Phase 1/2 (191) enrolling",
   "date": "2025-03-24",
   "sources": [
    "https://clinicaltrials.gov/study/NCT06810544"
   ],
   "asia": false
  },
  {
   "section": "clinical",
   "asset": "AZD3470",
   "asset_en": "AZD3470",
   "company": "阿斯特捷利康（AstraZeneca）",
   "company_en": "AstraZeneca",
   "country": "英國",
   "country_en": "UK",
   "mechanism": "MTA 協同型 PRMT5 抑制劑",
   "mechanism_en": "MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一／二期",
   "stage_en": "Phase 1/2",
   "indication": "MTAP 缺失實體腫瘤（單用或併用 Dato-DXd）；淋巴瘤（單用或併用 pembrolizumab）",
   "indication_en": "MTAP-deleted solid tumors (alone or with Dato-DXd); lymphoma (alone or with pembrolizumab)",
   "trials": [
    "NCT06130553",
    "NCT06137144"
   ],
   "deal": "—",
   "deal_en": "—",
   "latest": "兩個第一／二期收案中：實體腫瘤 PRIMROSE（334 人）、淋巴瘤 PRIMAVERA（161 人）",
   "latest_en": "Two Phase 1/2 trials enrolling: PRIMROSE in solid tumors (334) and PRIMAVERA in lymphoma (161)",
   "date": "2024-01-18",
   "sources": [
    "https://clinicaltrials.gov/study/NCT06130553",
    "https://clinicaltrials.gov/study/NCT06137144"
   ],
   "asia": false
  },
  {
   "section": "clinical",
   "asset": "BGB-58067",
   "asset_en": "BGB-58067",
   "company": "百濟神州（BeOne Medicines）",
   "company_en": "BeOne Medicines",
   "country": "瑞士（源自中國）",
   "country_en": "Switzerland (China origin)",
   "mechanism": "MTA 協同型 PRMT5 抑制劑",
   "mechanism_en": "MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一期",
   "stage_en": "Phase 1",
   "indication": "MTAP 缺失實體腫瘤；併用 RAS(ON) 抑制劑；新診斷膠質母細胞瘤",
   "indication_en": "MTAP-deleted solid tumors; with RAS(ON) inhibitors; newly diagnosed glioblastoma",
   "trials": [
    "NCT06589596",
    "NCT07485049"
   ],
   "deal": "2026-08-10 取得 Revolution Medicines 四款 RAS(ON) 抑制劑在部分亞洲市場的權利（不含日本、韓國），並計畫做 BGB-58067 併用 daraxonrasib 或 zoldonrasib 的試驗",
   "deal_en": "Aug 10, 2026: BeOne took rights in select Asian markets (excluding Japan and South Korea) to four Revolution Medicines RAS(ON) inhibitors and plans trials of BGB-58067 with daraxonrasib or zoldonrasib",
   "latest": "第一期 695 人收案中，含併用 RAS(ON) 抑制劑的組別；另有研究者發起的新診斷膠質母細胞瘤早期第一期（78 人）",
   "latest_en": "Phase 1 (695) enrolling, including RAS(ON) combination arms; plus an investigator-initiated early Phase 1 in newly diagnosed glioblastoma (78)",
   "date": "2026-08-10",
   "sources": [
    "https://clinicaltrials.gov/study/NCT06589596",
    "https://clinicaltrials.gov/study/NCT07485049",
    "https://ir.revmed.com/news-releases/news-release-details/revolution-medicines-and-beone-medicines-announce-clinical",
    "https://www.businesswire.com/news/home/20250526273239/en/beone-medicines-launches-following-redomiciliation-to-switzerland-marking-a-new-chapter-in-global-oncology"
   ],
   "asia": true
  },
  {
   "section": "clinical",
   "asset": "IDE892",
   "asset_en": "IDE892",
   "company": "IDEAYA Biosciences",
   "company_en": "IDEAYA Biosciences",
   "country": "美國",
   "country_en": "US",
   "mechanism": "MTA 協同型 PRMT5 抑制劑",
   "mechanism_en": "MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一期",
   "stage_en": "Phase 1",
   "indication": "MTAP 缺失實體腫瘤；併用 MAT2A 抑制劑 IDE397",
   "indication_en": "MTAP-deleted solid tumors; with the MAT2A inhibitor IDE397",
   "trials": [
    "NCT07277413"
   ],
   "deal": "—",
   "deal_en": "—",
   "latest": "第一期 260 人，2026-03 開始收案",
   "latest_en": "Phase 1 (260) began enrolling in Mar 2026",
   "date": "2026-03-04",
   "sources": [
    "https://clinicaltrials.gov/study/NCT07277413"
   ],
   "asia": false
  },
  {
   "section": "clinical",
   "asset": "BAY 3713372",
   "asset_en": "BAY 3713372",
   "company": "拜耳（Bayer，授權自中國普和）",
   "company_en": "Bayer (licensed from Puhe BioPharma)",
   "country": "德國／中國",
   "country_en": "Germany / China",
   "mechanism": "MTA 協同型 PRMT5 抑制劑",
   "mechanism_en": "MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一／二期",
   "stage_en": "Phase 1/2",
   "indication": "MTAP 缺失實體腫瘤",
   "indication_en": "MTAP-deleted solid tumors",
   "trials": [
    "NCT06914128"
   ],
   "deal": "2025 年拜耳取得普和 PRMT5 計畫全球授權（金額未公開）",
   "deal_en": "Bayer licensed Puhe's PRMT5 program globally in 2025 (terms undisclosed)",
   "latest": "第一／二期 450 人收案中",
   "latest_en": "Phase 1/2 (450) enrolling",
   "date": "2025-03-21",
   "sources": [
    "https://clinicaltrials.gov/study/NCT06914128",
    "https://www.bayer.com/media/en-us/bayer-and-puhe-biopharma-enter-into-global-license-agreement-for-clinical-phase-i-prmt5-inhibitor/"
   ],
   "asia": true
  },
  {
   "section": "clinical",
   "asset": "ABSK131",
   "asset_en": "ABSK131",
   "company": "和譽醫藥（Abbisko Therapeutics）",
   "company_en": "Abbisko Therapeutics",
   "country": "中國",
   "country_en": "China",
   "mechanism": "MTA 協同型 PRMT5 抑制劑",
   "mechanism_en": "MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一期",
   "stage_en": "Phase 1",
   "indication": "晚期或轉移性實體腫瘤",
   "indication_en": "Advanced or metastatic solid tumors",
   "trials": [
    "NCT07288957"
   ],
   "deal": "—",
   "deal_en": "—",
   "latest": "中國第一期 266 人，2025-07 開始收案",
   "latest_en": "China Phase 1 (266) enrolling since Jul 2025",
   "date": "2025-07-22",
   "sources": [
    "https://clinicaltrials.gov/study/NCT07288957"
   ],
   "asia": true
  },
  {
   "section": "clinical",
   "asset": "CTS3497",
   "asset_en": "CTS3497",
   "company": "CytosinLab Therapeutics",
   "company_en": "CytosinLab Therapeutics",
   "country": "中國",
   "country_en": "China",
   "mechanism": "MTA 協同型 PRMT5 抑制劑",
   "mechanism_en": "MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一／二期",
   "stage_en": "Phase 1/2",
   "indication": "MTAP 缺失實體腫瘤",
   "indication_en": "MTAP-deficient solid tumors",
   "trials": [
    "NCT06971523"
   ],
   "deal": "—",
   "deal_en": "—",
   "latest": "中國第一／二期 224 人，2024-12 開始收案",
   "latest_en": "China Phase 1/2 (224) enrolling since Dec 2024",
   "date": "2024-12-25",
   "sources": [
    "https://clinicaltrials.gov/study/NCT06971523"
   ],
   "asia": true
  },
  {
   "section": "clinical",
   "asset": "PEP08",
   "asset_en": "PEP08",
   "company": "智擎生技（PharmaEngine，4162）",
   "company_en": "PharmaEngine (TPEx: 4162)",
   "country": "台灣",
   "country_en": "Taiwan",
   "mechanism": "MTA 協同型 PRMT5 抑制劑",
   "mechanism_en": "MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一期",
   "stage_en": "Phase 1",
   "indication": "MTAP 缺失晚期或轉移性實體腫瘤",
   "indication_en": "MTAP-deleted advanced or metastatic solid tumors",
   "trials": [
    "NCT06973863"
   ],
   "deal": "—",
   "deal_en": "—",
   "latest": "與晶泰科技（XtalPi）AI 平台合作發現；全球權利屬智擎，晶泰已收里程碑款，條件未揭露。2025-07 獲澳洲 HREC 同意（TGA 備查）、2025-08 獲台灣 TFDA 核准第一期；2025-10-20 澳洲第一位病人給藥。第一期劑量遞增在澳洲、台灣、韓國進行，公司預計 2027 上半年完成第一部分並揭露初步數據（2026-11-05 法說會）；臨床前（動物模型）與 CHK1 抑制劑 PEP07 有協同",
   "latest_en": "Discovered with XtalPi's AI platform; PharmaEngine holds global rights, and XtalPi has received a milestone payment (terms undisclosed). Australian HREC approval (TGA notified) in Jul 2025 and Taiwan TFDA approval in Aug 2025; first patient dosed in Australia on Oct 20, 2025. Phase 1 dose escalation is running in Australia, Taiwan and South Korea; the company expects to complete Part 1 and report initial data in 1H 2027 (Nov 5, 2026 investor conference); preclinical (animal model) synergy with the CHK1 inhibitor PEP07",
   "date": "2026-11-05",
   "sources": [
    "https://clinicaltrials.gov/study/NCT06973863",
    "https://mops.twse.com.tw/mops/#/web/t05st01",
    "https://mopsov.twse.com.tw/nas/STR/416220261105M001.pdf",
    "https://mopsov.twse.com.tw/nas/STR/416220260806E001.pdf",
    "https://www.prnewswire.com/apac/zh/news-releases/ai--302548612.html"
   ],
   "asia": true
  },
  {
   "section": "clinical",
   "asset": "GH56",
   "asset_en": "GH56",
   "company": "勤浩醫藥（Genhouse Bio）",
   "company_en": "Genhouse Bio",
   "country": "中國",
   "country_en": "China",
   "mechanism": "MTA 協同型 PRMT5 抑制劑",
   "mechanism_en": "MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一期",
   "stage_en": "Phase 1",
   "indication": "MTAP 缺失晚期實體腫瘤",
   "indication_en": "MTAP-deleted advanced solid tumors",
   "trials": [
    "NCT06796699"
   ],
   "deal": "—",
   "deal_en": "—",
   "latest": "中國第一 a／b 期 G-MAP 101（200 人），2025-03 開始收案",
   "latest_en": "China Phase 1a/1b G-MAP 101 (200) enrolling since Mar 2025",
   "date": "2025-03-07",
   "sources": [
    "https://clinicaltrials.gov/study/NCT06796699",
    "https://www.pharnexcloud.com/zixun/shiye/lcyj_72647"
   ],
   "asia": true
  },
  {
   "section": "clinical",
   "asset": "CS08399",
   "asset_en": "CS08399",
   "company": "微芯生物（Chipscreen Biosciences）",
   "company_en": "Chipscreen Biosciences",
   "country": "中國",
   "country_en": "China",
   "mechanism": "MTA 協同型 PRMT5 抑制劑（可穿透血腦屏障）",
   "mechanism_en": "Brain-penetrant MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一期",
   "stage_en": "Phase 1",
   "indication": "MTAP 缺失實體腫瘤與淋巴瘤",
   "indication_en": "MTAP-deleted solid tumors and lymphoma",
   "trials": [
    "NCT07583771"
   ],
   "deal": "—",
   "deal_en": "—",
   "latest": "2026-03 獲中國 NMPA 核准臨床；第一期（186 人）已登錄、尚未收案",
   "latest_en": "Cleared for clinical testing by China's NMPA in Mar 2026; Phase 1 (186) registered, not yet recruiting",
   "date": "2026-03-16",
   "sources": [
    "https://clinicaltrials.gov/study/NCT07583771",
    "https://www.pharnexcloud.com/zixun/bg_287394",
    "https://flcube.com/?p=59613"
   ],
   "asia": true
  },
  {
   "section": "discontinued",
   "asset": "TNG908",
   "asset_en": "TNG908",
   "company": "Tango Therapeutics",
   "company_en": "Tango Therapeutics",
   "country": "美國",
   "country_en": "US",
   "mechanism": "MTA 協同型 PRMT5 抑制劑",
   "mechanism_en": "MTA-cooperative PRMT5 inhibitor",
   "route": "口服",
   "stage": "第一／二期（已終止）",
   "stage_en": "Phase 1/2 (terminated)",
   "indication": "MTAP 缺失實體腫瘤",
   "indication_en": "MTAP-deleted solid tumors",
   "trials": [
    "NCT05275478"
   ],
   "deal": "—",
   "deal_en": "—",
   "latest": "2024-11-06 停止收案、資源轉向 vopimetostat 與 TNG456：23 位可評估的膠質母細胞瘤病人無部分反應，3 位病人腦脊髓液暴露約為血漿的 30%",
   "latest_en": "Enrollment stopped on Nov 6, 2024 to fully resource vopimetostat and TNG456: no partial responses in 23 evaluable glioblastoma patients, and cerebrospinal fluid exposure in three patients was about 30% of plasma",
   "date": "2024-11-06",
   "sources": [
    "https://clinicaltrials.gov/study/NCT05275478",
    "https://www.businesswire.com/news/home/20241106825271/en"
   ],
   "asia": false
  }
 ],
 "summary_expected": {
  "total": 14,
  "approved": 0,
  "clinical": 12,
  "phase2_3": 1,
  "discontinued": 2,
  "asia": 7,
  "taiwan": 1
 },
 "scope": "收錄範圍：只收 MTA 協同型 PRMT5 抑制劑；MAT2A 抑制劑（如 IDE397）與第一代非協同型不列入。",
 "scope_en": "Scope: only MTA-cooperative PRMT5 inhibitors are included; MAT2A inhibitors (such as IDE397) and first-generation non-cooperative inhibitors are excluded.",
 "not_listed_unconfirmed": [
  {
   "asset": "HSK41959",
   "company": "海思科（Haisco）",
   "trials": [
    "NCT06968572",
    "NCT07699757"
   ]
  },
  {
   "asset": "HRS-6719",
   "company": "恒瑞（Hengrui，山東盛迪亞）",
   "trials": [
    "NCT06922357"
   ]
  },
  {
   "asset": "GTA182",
   "company": "湃隆生物",
   "trials": []
  },
  {
   "asset": "GS-5319",
   "company": "Gilead",
   "trials": [
    "NCT07128303"
   ]
  },
  {
   "asset": "GS-2426",
   "company": "Gilead",
   "trials": [
    "NCT07601243"
   ]
  }
 ],
 "not_listed_note": "以上資產也鎖定 MTAP 缺失腫瘤，但尚無公開來源確認是 MTA 協同型 PRMT5 抑制劑，暫不列入。",
 "not_listed_note_en": "These assets also target MTAP-deleted tumors, but no public source yet confirms that they are MTA-cooperative PRMT5 inhibitors, so they are not listed."
}