{
 "as_of": "2026-11-06",
 "title": "IL-12 與急性輻射症候群（ARS）新藥賽道",
 "title_en": "IL-12 and Acute Radiation Syndrome (ARS) Pipeline",
 "slug": "il12-acute-radiation-syndrome",
 "groups": {
  "ars": "急性輻射症候群（骨髓型，H-ARS）",
  "ars_en": "Hematopoietic acute radiation syndrome (H-ARS)",
  "onc": "IL-12 腫瘤免疫",
  "onc_en": "IL-12 in cancer immunotherapy"
 },
 "assets": [
  {
   "group": "ars",
   "section": "approved",
   "asset": "Neupogen（filgrastim）",
   "asset_en": "Neupogen (filgrastim)",
   "company": "安進（Amgen）",
   "company_en": "Amgen",
   "country": "美國",
   "country_en": "US",
   "mechanism": "G-CSF，促進嗜中性白血球恢復",
   "mechanism_en": "G-CSF; restores neutrophils",
   "route": "皮下注射",
   "stage": "已核准（動物法則）",
   "stage_en": "Approved (Animal Rule)",
   "indication": "急性暴露於骨髓抑制劑量輻射",
   "indication_en": "Acute exposure to myelosuppressive doses of radiation",
   "trials": [],
   "deal": "—",
   "latest": "2015-03-30 FDA 核准，第一個以動物法則核准的骨髓型 ARS 藥",
   "latest_en": "FDA-approved on 2015-03-30 under the Animal Rule, the first H-ARS drug",
   "date": "2015-03-30",
   "sources": [
    "https://www.fda.gov/emergency-preparedness-and-response/about-mcms/fda-approves-radiation-medical-countermeasure"
   ],
   "asia": false
  },
  {
   "group": "ars",
   "section": "approved",
   "asset": "Neulasta（pegfilgrastim）",
   "asset_en": "Neulasta (pegfilgrastim)",
   "company": "安進（Amgen）",
   "company_en": "Amgen",
   "country": "美國",
   "country_en": "US",
   "mechanism": "長效 G-CSF",
   "mechanism_en": "Long-acting G-CSF",
   "route": "皮下注射",
   "stage": "已核准（動物法則）",
   "stage_en": "Approved (Animal Rule)",
   "indication": "輻射或核事故後有骨髓抑制風險者",
   "indication_en": "Patients at risk of myelosuppression after a radiological or nuclear incident",
   "trials": [],
   "deal": "—",
   "latest": "2015-11-13 FDA 核准",
   "latest_en": "FDA-approved on 2015-11-13",
   "date": "2015-11-13",
   "sources": [
    "https://www.fda.gov/emergency-preparedness-and-response/about-mcms/fda-approves-radiation-medical-countermeasure"
   ],
   "asia": false
  },
  {
   "group": "ars",
   "section": "approved",
   "asset": "Leukine（sargramostim）",
   "asset_en": "Leukine (sargramostim)",
   "company": "Partner Therapeutics",
   "company_en": "Partner Therapeutics",
   "country": "美國",
   "country_en": "US",
   "mechanism": "GM-CSF，促進白血球恢復",
   "mechanism_en": "GM-CSF; restores white blood cells",
   "route": "皮下注射",
   "stage": "已核准（動物法則）",
   "stage_en": "Approved (Animal Rule)",
   "indication": "急性暴露於骨髓抑制劑量輻射，提高存活",
   "indication_en": "Improving survival after acute exposure to myelosuppressive doses of radiation",
   "trials": [],
   "deal": "—",
   "latest": "2018-03-29 FDA 核准",
   "latest_en": "FDA-approved on 2018-03-29",
   "date": "2018-03-29",
   "sources": [
    "https://www.fda.gov/emergency-preparedness-and-response/about-mcms/fda-approves-radiation-medical-countermeasure"
   ],
   "asia": false
  },
  {
   "group": "ars",
   "section": "approved",
   "asset": "Nplate（romiplostim）",
   "asset_en": "Nplate (romiplostim)",
   "company": "安進（Amgen）",
   "company_en": "Amgen",
   "country": "美國",
   "country_en": "US",
   "mechanism": "TPO 受體促效劑，促進血小板生成",
   "mechanism_en": "TPO-receptor agonist; stimulates platelet production",
   "route": "皮下注射",
   "stage": "已核准（動物法則）",
   "stage_en": "Approved (Animal Rule)",
   "indication": "骨髓型 ARS",
   "indication_en": "H-ARS",
   "trials": [],
   "deal": "2022-10 美國衛生部 BARDA 以 Project BioShield 經費採購 2.9 億美元",
   "deal_en": "Oct 2022: HHS/BARDA bought US$290M under Project BioShield",
   "latest": "2021-01 FDA 核准用於 ARS；由安進以供應商管理庫存方式為政府儲備",
   "latest_en": "FDA-approved for ARS in January 2021; held as vendor-managed inventory for the government",
   "date": "2022-10-04",
   "sources": [
    "https://www.ntd.com/us-buys-290-million-worth-of-drugs-in-preparation-for-nuclear-emergencies_852247.html"
   ],
   "asia": false
  },
  {
   "group": "ars",
   "section": "clinical",
   "asset": "LIB-101（重組人類 IL-12）",
   "asset_en": "LIB-101 (recombinant human IL-12)",
   "company": "麗寶新藥（Libo Pharma，7888）",
   "company_en": "Libo Pharma (TPEx Emerging: 7888)",
   "country": "台灣",
   "country_en": "Taiwan",
   "mechanism": "重組人類介白素-12，調節免疫並促進造血恢復；公司主張單次皮下注射可讓多種血球恢復",
   "mechanism_en": "Recombinant human interleukin-12 that modulates immunity and supports blood-cell recovery; the company says a single subcutaneous dose aids recovery across several blood-cell lineages",
   "route": "皮下注射",
   "stage": "第三期（健康受試者安全性，動物法則）",
   "stage_en": "Phase 3 (healthy-volunteer safety, Animal Rule)",
   "indication": "骨髓型 ARS",
   "indication_en": "H-ARS",
   "trials": [
    "NCT02343133",
    "NCT01742221"
   ],
   "deal": "BARDA 過去累計投入逾 7,000 萬美元（2022 年報導）；2017 年授權引進",
   "deal_en": "BARDA has invested over US$70M (2022 report); in-licensed in 2017",
   "latest": "第三期規劃約 300 名健康受試者，2026-03 報導還需約 81 人完成收案；前身 HemaMax（NM-IL-12，Neumedicines）已完成 200 名健康受試者第二期安全性試驗；與日本福島醫科大學、東京電力合作研究者發起試驗，美國生產、運到福島儲存，供核電廠受曝工人使用；2025-12-23 登錄興櫃",
   "latest_en": "Phase 3 plans about 300 healthy volunteers; as of March 2026 about 81 more were needed to complete enrollment. Its predecessor HemaMax (NM-IL-12, Neumedicines) completed a 200-subject Phase 2 safety study. An investigator-initiated trial with Fukushima Medical University and TEPCO will ship US-made drug to Fukushima for storage and use in exposed plant workers. Listed on Taiwan's emerging board on 2025-12-23",
   "date": "2026-03-14",
   "sources": [
    "https://www.ctee.com.tw/news/20260314700450-430504",
    "https://geneonline.news/libo-pharma-earnings-call-lib-101/",
    "https://geneonline.news/nuclear-medicine-libo-pharma-il12/",
    "https://clinicaltrials.gov/study/NCT02343133"
   ],
   "asia": true,
   "client": true
  },
  {
   "group": "ars",
   "section": "clinical",
   "asset": "Entolimod（CBLB502）",
   "asset_en": "Entolimod (CBLB502)",
   "company": "Tivic Health",
   "company_en": "Tivic Health",
   "country": "美國",
   "country_en": "US",
   "mechanism": "TLR5 促效劑，活化 NF-κB 細胞保護路徑",
   "mechanism_en": "TLR5 agonist that activates NF-κB cell-protective pathways",
   "route": "肌肉注射",
   "stage": "後期開發（動物法則）",
   "stage_en": "Advanced development (Animal Rule)",
   "indication": "ARS（骨髓型與腸胃型）",
   "indication_en": "ARS (hematopoietic and gastrointestinal)",
   "trials": [],
   "deal": "—",
   "latest": "2026-01-26 與 BARDA 首次會談，2026-03-10 續談資金與國家戰略儲備；另與 NIAID 簽非臨床評估協議（腸胃型 ARS）",
   "latest_en": "Met BARDA on 2026-01-26 and again on 2026-03-10 on funding and the Strategic National Stockpile; separate NIAID non-clinical evaluation agreement for GI-ARS",
   "date": "2026-02-18",
   "sources": [
    "https://www.biospace.com/press-releases/tivic-and-barda-continue-discussions-of-entolimod-for-acute-radiation-syndrome-on-march-10",
    "https://www.biospace.com/press-releases/tivic-secures-niaid-non-clinical-evaluation-agreement-for-entolimod-targeting-gastrointestinal-acute-radiation-syndrome"
   ],
   "asia": false
  },
  {
   "group": "ars",
   "section": "clinical",
   "asset": "BIO 300",
   "asset_en": "BIO 300",
   "company": "Humanetics",
   "company_en": "Humanetics",
   "country": "美國",
   "country_en": "US",
   "mechanism": "輻射防護劑，暴露前預防",
   "mechanism_en": "Radioprotective agent given before exposure",
   "route": "口服",
   "stage": "第一期（動物法則）",
   "stage_en": "Phase 1 (Animal Rule)",
   "indication": "ARS 預防（軍人、第一線救援人員）",
   "indication_en": "ARS prophylaxis (military, first responders)",
   "trials": [
    "NCT06741345",
    "NCT04650555"
   ],
   "deal": "—",
   "latest": "口服懸液劑第一期（56 名健康受試者）2025-08 完成；美國目前沒有核准可在暴露前預防 ARS 的藥",
   "latest_en": "Phase 1 of the oral suspension (56 healthy volunteers) completed in August 2025; no FDA-approved drug prevents ARS before exposure",
   "date": "2025-08-15",
   "sources": [
    "https://clinicaltrials.gov/study/NCT06741345",
    "https://www.biospace.com/press-releases/humanetics-advances-development-of-novel-radiation-protection-drug-with-new-study-results"
   ],
   "asia": false
  },
  {
   "group": "ars",
   "section": "clinical",
   "asset": "PLX-R18（胎盤來源細胞）",
   "asset_en": "PLX-R18 (placenta-derived cells)",
   "company": "Pluri",
   "company_en": "Pluri",
   "country": "以色列",
   "country_en": "Israel",
   "mechanism": "胎盤來源細胞，分泌促造血因子",
   "mechanism_en": "Placenta-derived cells that secrete hematopoietic factors",
   "route": "肌肉注射",
   "stage": "第一期",
   "stage_en": "Phase 1",
   "indication": "骨髓型 ARS（暴露後預防或治療）",
   "indication_en": "H-ARS (post-exposure prevention or treatment)",
   "trials": [
    "NCT03797040"
   ],
   "deal": "—",
   "latest": "2024-11 評估量產準備；第一期登錄狀態未更新",
   "latest_en": "Evaluating mass-production readiness as of November 2024; Phase 1 registry status not updated",
   "date": "2024-11-25",
   "sources": [
    "https://clinicaltrials.gov/study/NCT03797040",
    "https://www.quantisnow.com/insight/pluri-evaluates-readiness-for-mass-production-of-plx-r18-for-acute-5789640"
   ],
   "asia": false
  },
  {
   "group": "onc",
   "section": "clinical",
   "asset": "LIB-101（重組人類 IL-12）",
   "asset_en": "LIB-101 (recombinant human IL-12)",
   "company": "麗寶新藥（Libo Pharma，7888）",
   "company_en": "Libo Pharma (TPEx Emerging: 7888)",
   "country": "台灣",
   "country_en": "Taiwan",
   "mechanism": "重組人類 IL-12，搭配放射治療",
   "mechanism_en": "Recombinant human IL-12 combined with radiotherapy",
   "route": "皮下注射",
   "stage": "第二期 a 完成",
   "stage_en": "Phase 2a completed",
   "indication": "皮膚 T 細胞淋巴瘤（CTCL）；瀰漫性大 B 細胞淋巴瘤（DLBCL）第二期",
   "indication_en": "Cutaneous T-cell lymphoma (CTCL); Phase 2 in DLBCL",
   "trials": [
    "NCT02542124",
    "NCT02544724"
   ],
   "deal": "—",
   "latest": "CTCL 第二期 a 合併療法用於早期（IB 期）患者整體反應率 100%（公司法說）；獲美國 FDA 與歐盟 EMA 孤兒藥資格；規劃多國多中心樞紐試驗",
   "latest_en": "In Phase 2a, the combination produced a 100% overall response rate in early-stage (IB) CTCL patients (company briefing); FDA and EMA orphan designations; multinational pivotal trial planned",
   "date": "2025-12-18",
   "sources": [
    "https://geneonline.news/libo-pharma-earnings-call-lib-101/",
    "https://blog.fugle.tw/post/earnings-call-7888-2025-12-18",
    "https://clinicaltrials.gov/study/NCT02542124"
   ],
   "asia": true,
   "client": true
  },
  {
   "group": "onc",
   "section": "clinical",
   "asset": "efarindodekin alfa（XTX301）",
   "asset_en": "efarindodekin alfa (XTX301)",
   "company": "Xilio Therapeutics（授權吉利德 Gilead）",
   "company_en": "Xilio Therapeutics (licensed to Gilead)",
   "country": "美國",
   "country_en": "US",
   "mechanism": "腫瘤活化型 IL-12，只在腫瘤微環境切開活化",
   "mechanism_en": "Tumor-activated IL-12, unmasked in the tumor microenvironment",
   "route": "靜脈注射",
   "stage": "第二期",
   "stage_en": "Phase 2",
   "indication": "晚期實體腫瘤",
   "indication_en": "Advanced solid tumors",
   "trials": [
    "NCT05684965"
   ],
   "deal": "2024-03 吉利德預付 4,350 萬美元（現金 3,000 萬＋股權 1,350 萬），後續最高 6.04 億美元；吉利德接手需付 7,500 萬美元轉移費",
   "deal_en": "Mar 2024: Gilead paid US$43.5M upfront (US$30M cash + US$13.5M equity), up to US$604M contingent; US$75M transition fee if Gilead takes over",
   "latest": "2025-09 啟動第二期，取得吉利德 1,750 萬美元開發里程碑",
   "latest_en": "Phase 2 began in September 2025, triggering a US$17.5M Gilead milestone",
   "date": "2025-09-09",
   "sources": [
    "https://www.gilead.com/news/news-details/2024/gilead-and-xilio-announce-exclusive-license-agreement-for-tumor-activated-il-12-program",
    "https://www.itiger.com/news/2566765691"
   ],
   "asia": false
  },
  {
   "group": "onc",
   "section": "clinical",
   "asset": "WTX-330",
   "asset_en": "WTX-330",
   "company": "Werewolf Therapeutics",
   "company_en": "Werewolf Therapeutics",
   "country": "美國",
   "country_en": "US",
   "mechanism": "條件活化型 IL-12（INDUKINE 前藥）",
   "mechanism_en": "Conditionally activated IL-12 (INDUKINE prodrug)",
   "route": "靜脈注射",
   "stage": "第一期 b／二期",
   "stage_en": "Phase 1b/2",
   "indication": "實體腫瘤",
   "indication_en": "Solid tumors",
   "trials": [],
   "deal": "尋求合作夥伴",
   "deal_en": "Seeking partners",
   "latest": "前 12 名患者中 1 名轉移性膽囊癌確認部分緩解（目標病灶縮小 45%）；後續開發需要額外資金",
   "latest_en": "Among the first 12 patients, one confirmed partial response in metastatic gallbladder cancer (45% target-lesion reduction); further development requires additional funding",
   "date": "2025-12-18",
   "sources": [
    "https://www.biospace.com/press-releases/werewolf-therapeutics-announces-pipeline-and-business-updates"
   ],
   "asia": false
  },
  {
   "group": "onc",
   "section": "clinical",
   "asset": "tolododekin alfa（ANK-101）",
   "asset_en": "tolododekin alfa (ANK-101)",
   "company": "Ankyra Therapeutics",
   "company_en": "Ankyra Therapeutics",
   "country": "美國",
   "country_en": "US",
   "mechanism": "錨定型 IL-12，打進腫瘤後留在局部",
   "mechanism_en": "Anchored IL-12 that stays in the tumor after injection",
   "route": "腫瘤內注射",
   "stage": "第一期",
   "stage_en": "Phase 1",
   "indication": "非小細胞肺癌（併用 PD-1／PD-L1 抗體）、皮膚鱗狀細胞癌、實體腫瘤",
   "indication_en": "NSCLC (with anti-PD-1/PD-L1), cutaneous squamous cell carcinoma, solid tumors",
   "trials": [],
   "deal": "—",
   "latest": "2026 ASCO：多種實體腫瘤未見劑量限制毒性",
   "latest_en": "ASCO 2026: no dose-limiting toxicities across multiple solid tumor types",
   "date": "2026-05-27",
   "sources": [
    "https://www.biospace.com/press-releases/ankyra-therapeutics-announces-presentations-on-novel-il-12-anchored-immunotherapy-at-2026-asco"
   ],
   "asia": false
  },
  {
   "group": "onc",
   "section": "preclinical",
   "asset": "DAX-044（IL-12 抗體細胞激素融合蛋白）",
   "asset_en": "DAX-044 (IL-12 antibody-cytokine fusion)",
   "company": "Audax Biosciences（授權選擇權：安斯泰來 Astellas）",
   "company_en": "Audax Biosciences (option and license: Astellas)",
   "country": "澳洲／日本",
   "country_en": "Australia / Japan",
   "mechanism": "免疫標靶型 IL-12 抗體融合蛋白（AVIKINE 平台），把 IL-12 活性集中在腫瘤微環境",
   "mechanism_en": "Immune-targeted IL-12 antibody-cytokine fusion (AVIKINE platform) that concentrates IL-12 activity in the tumor microenvironment",
   "route": "—",
   "stage": "臨床前（IND／CTN 準備）",
   "stage_en": "Preclinical (IND/CTN-enabling)",
   "indication": "腫瘤免疫",
   "indication_en": "Immuno-oncology",
   "trials": [],
   "deal": "2026-10-27 安斯泰來取得全球授權選擇權：預付加選擇權行使金合計 2.85 億美元、開發與銷售里程碑最高 10.5 億美元，總值最高 13.4 億美元（不含兩位數分級權利金）",
   "deal_en": "On 2026-10-27 Astellas took an exclusive option to a worldwide license: US$285M in upfront and option-exercise payments plus up to US$1.05B in milestones, up to US$1.34B in total (excluding tiered double-digit royalties)",
   "latest": "Audax 繼續開發，第一期預計 2027 年開始",
   "latest_en": "Audax continues development, with Phase 1 expected to start in 2027",
   "date": "2026-10-27",
   "sources": [
    "https://www.placera.se/pressmeddelanden/astellas-and-audax-biosciences-enter-exclusive-option-and-license-agreement-for-dax-044-a-novel-immune-targeted-il-12-antibody-cytokine-fusion-for-immuno-oncology-20261028",
    "https://pharmaphorum.com/news/astellas-pays-285m-audax-cancer-drug-and-other-deals"
   ],
   "asia": true
  },
  {
   "group": "onc",
   "section": "returned",
   "asset": "DF6002（IL-12 Fc 融合蛋白）",
   "asset_en": "DF6002 (IL-12 Fc fusion)",
   "company": "Dragonfly Therapeutics",
   "company_en": "Dragonfly Therapeutics",
   "country": "美國",
   "country_en": "US",
   "mechanism": "單價 IL-12 Fc 融合蛋白",
   "mechanism_en": "Monovalent IL-12 Fc fusion protein",
   "route": "皮下注射",
   "stage": "第一／二期（權利退回）",
   "stage_en": "Phase 1/2 (rights returned)",
   "indication": "轉移性實體腫瘤（單用或併用 nivolumab）",
   "indication_en": "Metastatic solid tumors (alone or with nivolumab)",
   "trials": [],
   "deal": "2020 年必治妥施貴寶（BMS）以 4.75 億美元取得，2023-02 退回",
   "deal_en": "BMS licensed it in 2020 for US$475M and returned the rights in Feb 2023",
   "latest": "2023-02 BMS 退回全部權利，Dragonfly 自行開發",
   "latest_en": "BMS returned all rights in February 2023; Dragonfly continues development",
   "date": "2023-02-07",
   "sources": [
    "https://www.geneonline.com/bms-returns-475-million-cancer-asset-to-dragonfly-therapeutics/"
   ],
   "asia": false
  }
 ],
 "summary_expected": {
  "rows": 14,
  "unique_assets": 13,
  "ars_approved": 4,
  "ars_clinical": 4,
  "onc_clinical": 4,
  "onc_preclinical": 1,
  "onc_returned": 1,
  "taiwan_assets": 1
 }
}