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"2026-11-06" } ], "sections": [ "asia" ], "asset_zh": "BGB-45035", "originator_zh": "百濟神州（BeOne）", "asia": true, "deal_zh": "—", "deal_en": "—", "master_record": { "section": "asia", "asset": "BGB-45035", "company": "百濟神州（BeOne）", "country": "中國", "target": "IRAK4", "modality": "降解劑", "route": "口服", "stage": "第二期（已終止）", "indication": "自體免疫", "trials": [ "NCT07100938", "NCT06342713" ], "deal": "—", "latest": "第二期登錄狀態為終止；第一期完成", "date": "2026-05-28", "sources": [ "https://clinicaltrials.gov/study/NCT07100938" ], "asia": true }, "target_zh": "IRAK4", "mechanism_zh": "CDAC" }, { "id": "icp-490", "asset": "ICP-490", "originator": "InnoCare Pharma / Beijing InnoCare Pharma Tech Co., Ltd.", "country": "China", "target": "IKZF1 (Ikaros); IKZF3 (Aiolos)", "mechanism": "CRBN molecular glue", "route": "oral", "highest_phase": 2, "approved": false, "trial_ids": [ "NCT05719701", "NCT06845241" ], "indications_en": "Multiple myeloma; non-Hodgkin lymphoma", "indications_zh": "多發性骨髓瘤、非何杰金氏淋巴瘤", "company_source": "https://www.innocarepharma.com/uploads/2026-03-26/2025-Annual-Report-CN-A.pdf", "company_source_date": "2026-03-26", "latest_event_en": "NHL Phase 1/2 trial NCT06845241 registered; not yet recruiting", "latest_event_zh": "NHL 第 1/2 期 NCT06845241 登錄，尚未招募", "latest_event_date": "2025-02-25", "deal": { "upfront_usd": null, "total_usd": null, "status_en": "Not found in reviewed primary sources", "status_zh": "所查一級來源查無金額" }, "checked_at": "2026-11-06", "trials": [ { "id": "NCT05719701", "phase": [ "PHASE1", "PHASE2" ], "status": "UNKNOWN", "updated": "2024-04-09", "countries": [ "China" ], "url": "https://clinicaltrials.gov/study/NCT05719701", "completion": { "date": "2025-12-30", "type": "ESTIMATED" } }, { "id": "NCT06845241", "phase": [ "PHASE1", "PHASE2" ], "status": "NOT_YET_RECRUITING", "updated": "2025-02-25", "countries": [ "China" ], "url": "https://clinicaltrials.gov/study/NCT06845241", "completion": { "date": "2028-12", "type": "ESTIMATED" } } ], "phase_label_en": "Phase 1/2", "phase_label_zh": "第一／二期", "sources": [ { "url": "https://www.innocarepharma.com/uploads/2026-03-26/2025-Annual-Report-CN-A.pdf", "published": "2026-03-26", "type": "company", "checked": "2026-11-06" }, { "url": "https://clinicaltrials.gov/study/NCT05719701", "published": "2024-04-09", "type": "trial_registry", "checked": "2026-11-06" }, { "url": "https://clinicaltrials.gov/study/NCT06845241", "published": "2025-02-25", "type": "trial_registry", "checked": "2026-11-06" } ], "sections": [ "asia" ], "asset_zh": "ICP-490", "originator_zh": "諾誠健華", "asia": true, "deal_zh": "—", "deal_en": "—", "master_record": { "section": "asia", "asset": "ICP-490", "company": "諾誠健華（InnoCare）", "country": "中國", "target": "IKZF1／IKZF3", "modality": "分子膠", "route": "口服", "stage": "第一／二期", "indication": "多發性骨髓瘤、非何杰金氏淋巴瘤", "trials": [ "NCT05719701", "NCT06845241" ], "deal": "—", "latest": "NHL 第 1/2 期 NCT06845241 登錄，尚未招募", "date": "2025-02-25", "sources": [ "https://clinicaltrials.gov/study/NCT06845241" ], "asia": true }, "target_zh": "IKZF1 (Ikaros); IKZF3 (Aiolos)", "mechanism_zh": "CRBN 分子膠" }, { "id": "icp-538", "asset": "ICP-538", "originator": "InnoCare Pharma / Beijing InnoCare Pharma Tech Co., Ltd.", "country": "China", "target": "VAV1", "mechanism": "CRBN molecular glue", "route": "oral", "highest_phase": 1, "approved": false, "trial_ids": [], "indications_en": "Healthy volunteers; autoimmune disease development", "indications_zh": "自體免疫", "company_source": "https://www.innocarepharma.com/uploads/2026-03-26/2025-Annual-Report-CN-A.pdf", "company_source_date": "2026-03-26", "latest_event_en": "Phase 1 (March 2026).", "latest_event_zh": "第一期（2026-03）", "latest_event_date": "2026-03", "deal": { "upfront_usd": null, "total_usd": null, "status_en": "Not found in reviewed primary sources", "status_zh": "所查一級來源查無金額" }, "checked_at": "2026-11-06", "trials": [], "phase_label_en": "Phase 1", "phase_label_zh": "第一期", "sources": [ { "url": "https://www.innocarepharma.com/uploads/2026-03-26/2025-Annual-Report-CN-A.pdf", "published": "2026-03-26", "type": "company", "checked": "2026-11-06" }, { "url": "https://clinicaltrials.gov/study/NCT07535099", "published": "2026-06-18", "type": "trial_registry", "checked": "2026-11-06" }, { "url": "https://drugnews.com.tw/landscapes/asia-degraders.html", "published": "2026-03", "type": "company", "checked": "2026-11-06" } ], "sections": [ "asia" ], "asset_zh": "ICP-538", "originator_zh": "諾誠健華", "asia": true, "deal_zh": "—", "deal_en": "—", "master_record": { "section": "asia", "asset": "ICP-538", "company": "諾誠健華（InnoCare）", "country": "中國", "target": "VAV1", "modality": "分子膠", "route": "口服", "stage": "第一期", "indication": "自體免疫", "trials": [], "deal": "—", "latest": "第一期（2026-03）", "date": "2026-03", "sources": [ "https://drugnews.com.tw/landscapes/asia-degraders.html" ], "asia": true }, "target_zh": "VAV1", "mechanism_zh": "CRBN 分子膠" }, { "id": "hsk29116", "asset": "HSK29116", "originator": "Haisco Pharmaceutical Group Co., Ltd.", "country": "China", "target": "Bruton tyrosine kinase (BTK)", "mechanism": "PROTAC", "route": "oral", "highest_phase": 1, "approved": false, "trial_ids": [ "NCT04861779" ], "indications_en": "B-cell malignancies", "indications_zh": "復發／難治 B 細胞惡性腫瘤", "company_source": "https://disc.static.szse.cn/disc/disk03/finalpage/2026-08-27/8ef41362-8592-467c-8fba-38d4f313eb45.PDF", "company_source_date": "2026-08-27", "latest_event_en": "Phase 1; registry status has not been updated.", "latest_event_zh": "第一期，登錄狀態未更新", "latest_event_date": "2022-08-03", "deal": { "upfront_usd": null, "total_usd": null, "status_en": "Not found in reviewed primary sources", "status_zh": "所查一級來源查無金額" }, "checked_at": "2026-11-06", "trials": [ { "id": "NCT04861779", "phase": [ "PHASE1" ], "status": "UNKNOWN", "updated": "2022-08-03", "countries": [ "Australia", "China" ], "url": "https://clinicaltrials.gov/study/NCT04861779", "completion": { "date": "2023-10", "type": "ESTIMATED" } } ], "phase_label_en": "Phase 1", "phase_label_zh": "第一期", "sources": [ { "url": "https://disc.static.szse.cn/disc/disk03/finalpage/2026-08-27/8ef41362-8592-467c-8fba-38d4f313eb45.PDF", "published": "2026-08-27", "type": "company", "checked": "2026-11-06" }, { "url": "https://clinicaltrials.gov/study/NCT04861779", "published": "2022-08-03", "type": "trial_registry", "checked": "2026-11-06" }, { "url": "https://disc.static.szse.cn/disc/disk03/finalpage/2023-04-17/5654a016-14a7-434f-a5c8-ff7e3624f99f.PDF", "published": "2023-04-17", "type": "company", "checked": "2026-11-06" } ], "sections": [ "asia" ], "asset_zh": "HSK29116", "originator_zh": "海思科", "asia": true, "deal_zh": "—", "deal_en": "—", "master_record": { "section": "asia", "asset": "HSK29116", "company": "海思科（Haisco）", "country": "中國", "target": "BTK", "modality": "PROTAC", "route": "口服", "stage": "第一期", "indication": "復發／難治 B 細胞惡性腫瘤", "trials": [ "NCT04861779" ], "deal": "—", "latest": "第一期，登錄狀態未更新", "date": "2022-08-03", "sources": [ "https://clinicaltrials.gov/study/NCT04861779" ], "asia": true }, "target_zh": "Bruton tyrosine kinase (BTK)", "mechanism_zh": "PROTAC" }, { "id": "ubx303061", "asset": "UBX-303061", "originator": "Ubix Therapeutics", "country": "South Korea", "target": "BTK", "mechanism": "PROTAC / chimeric degrader", "route": "oral", "highest_phase": 1, "approved": false, "trial_ids": [ "NCT06590961" ], "indications_en": "Relapsed/refractory B-cell malignancies", "indications_zh": "復發／難治 B 細胞惡性腫瘤", "company_source": "https://en.ubixtrx.com/pipeline", "company_source_date": "2026-11-06", "latest_event_en": "Phase 1 recruiting in South Korea, the US and Poland.", "latest_event_zh": "韓國、美國、波蘭第一期收案中", "latest_event_date": "2026-10-21", "deal": { "upfront_usd": null, "total_usd": null, "status_en": "Not found in reviewed primary sources", "status_zh": "所查一級來源查無金額" }, "checked_at": "2026-11-06", "trials": [ { "id": "NCT06590961", "phase": [ "PHASE1" ], "status": "RECRUITING", "updated": "2026-10-21", "countries": [ "Poland", "South Korea", "United States" ], "url": "https://clinicaltrials.gov/study/NCT06590961", "completion": { "date": "2027-08", "type": "ESTIMATED" } } ], "phase_label_en": "Phase 1", "phase_label_zh": "第一期", "sources": [ { "url": "https://en.ubixtrx.com/pipeline", "published": "2026-11-06", "type": "company", "checked": "2026-11-06" }, { "url": "https://clinicaltrials.gov/study/NCT06590961", "published": "2026-10-21", "type": "trial_registry", "checked": "2026-11-06" } ], "sections": [ "asia" ], "asset_zh": "UBX-303061", "originator_zh": "Ubix Therapeutics", "asia": true, "deal_zh": "—", "deal_en": "—", "master_record": { "section": "asia", "asset": "UBX-303061", "company": "Ubix Therapeutics", "country": "韓國", "target": "BTK", "modality": "降解劑", "route": "口服", "stage": "第一期", "indication": "復發／難治 B 細胞惡性腫瘤", "trials": [ "NCT06590961" ], "deal": "—", "latest": "韓國、美國、波蘭第一期收案中", "date": "2026-10-21", "sources": [ "https://clinicaltrials.gov/study/NCT06590961" ], "asia": true }, "target_zh": "BTK", "mechanism_zh": "PROTAC / chimeric degrader" }, { "id": "hsk40118", "asset": "HSK40118", "originator": "Haisco Pharmaceutical Group Co., Ltd.", "country": "China", "target": "Mutant epidermal growth factor receptor (EGFR)", "mechanism": "PROTAC", "route": "oral", "highest_phase": 1, "approved": false, "trial_ids": [ "NCT06050980" ], "indications_en": "EGFR-mutant non-small-cell lung cancer", "indications_zh": "EGFR 突變晚期非小細胞肺癌", "company_source": "https://disc.static.szse.cn/disc/disk03/finalpage/2026-08-27/8ef41362-8592-467c-8fba-38d4f313eb45.PDF", "company_source_date": "2026-08-27", "latest_event_en": "Phase 1; registry has not been updated since September 2023.", "latest_event_zh": "第一期，登錄 2023-09 後未更新", "latest_event_date": "2023-09", "deal": { "upfront_usd": null, "total_usd": null, "status_en": "Not found in reviewed primary sources", "status_zh": "所查一級來源查無金額" }, "checked_at": "2026-11-06", "trials": [ { "id": "NCT06050980", "phase": [ "PHASE1" ], "status": "RECRUITING", "updated": "2023-09-22", "countries": [ "China" ], "url": "https://clinicaltrials.gov/study/NCT06050980", "completion": { "date": "2027-06-07", "type": "ESTIMATED" } } ], "phase_label_en": "Phase 1", "phase_label_zh": "第一期", "sources": [ { "url": "https://disc.static.szse.cn/disc/disk03/finalpage/2026-08-27/8ef41362-8592-467c-8fba-38d4f313eb45.PDF", "published": "2026-08-27", "type": "company", "checked": "2026-11-06" }, { "url": "https://clinicaltrials.gov/study/NCT06050980", "published": "2023-09-22", "type": "trial_registry", "checked": "2026-11-06" }, { "url": "https://disc.static.szse.cn/disc/disk03/finalpage/2023-04-17/5654a016-14a7-434f-a5c8-ff7e3624f99f.PDF", "published": "2023-04-17", "type": "company", "checked": "2026-11-06" } ], "sections": [ "asia" ], "asset_zh": "HSK40118", "originator_zh": "海思科", "asia": true, "deal_zh": "—", "deal_en": "—", "master_record": { "section": "asia", "asset": "HSK40118", "company": "海思科（Haisco）", "country": "中國", "target": "突變型 EGFR", "modality": "PROTAC", "route": "口服", "stage": "第一期", "indication": "EGFR 突變晚期非小細胞肺癌", "trials": [ "NCT06050980" ], "deal": "—", "latest": "第一期，登錄 2023-09 後未更新", "date": "2023-09", "sources": [ "https://clinicaltrials.gov/study/NCT06050980" ], "asia": true }, "target_zh": "突變型 EGFR", "mechanism_zh": "PROTAC" }, { "id": "bg75098", "asset": "BG-75098", "asset_zh": "BG-75098", "originator": "BeOne Medicines", "originator_zh": "百濟神州（BeOne）", "country": "China", "target": "CDK2", "mechanism": "CDAC", "route": "oral", "highest_phase": 1, "approved": false, "trial_ids": [ "NCT07226349" ], "trials": [ { "id": "NCT07226349", "phase": [ "PHASE1" ], "status": "RECRUITING", "updated": "2026-09-28", "start": { "date": "2025-12-11", "type": "ACTUAL" }, "completion": { "date": "2028-11-01", "type": "ESTIMATED" }, "countries": [ "Australia", "China", "Denmark", "United States" ], "url": "https://clinicaltrials.gov/study/NCT07226349" } ], "asia": true, "sections": [ "asia" ], "phase_label_en": "Phase 1", "phase_label_zh": "第一期", "indications_zh": "乳癌與婦癌", "indications_en": "Breast and gynecologic cancers", "latest_event_zh": "第 1 期 NCT07226349 招募中（登錄更新）", "latest_event_en": "Phase 1 trial NCT07226349 recruiting (registry update).", "latest_event_date": "2026-09-28", "deal_zh": "查無已揭露交易", "deal_en": "No disclosed transaction found in the reviewed primary sources.", "sources": [ { "url": "https://beonemedicines.com/science/pipeline/", "published": null, "checked": "2026-11-06", "type": "company" }, { "url": "https://clinicaltrials.gov/study/NCT07226349", "published": "2026-09-28", "checked": "2026-11-06", "type": "trial_registry" } ], "checked_at": "2026-11-06", "target_zh": "CDK2", "mechanism_zh": "CDAC" } ], "scope_zh": "", "scope_en": "", "page_copy": { "zh": "# 蛋白降解（PROTAC／分子膠）賽道\n\n截至 2026 年 11 月 6 日，藥時事追蹤 24 項進入臨床的蛋白降解資產：2 項已在美國上市、6 項在第三期，其中亞洲公司 15 項（中國 12、日本 1、台灣 1、韓國 1）。\n\n## 這個賽道在做什麼\n\n傳統標靶藥是把致病蛋白「卡住」，蛋白降解劑則是把它「拆掉」。PROTAC 一端抓住致病蛋白，另一端拉來細胞內負責回收的 E3 連接酶，讓細胞自己把蛋白分解；分子膠則是用一顆小分子，讓 E3 連接酶直接黏上原本不會碰到的蛋白。\n\n拆掉而不只是卡住，帶來兩個好處：過去找不到下藥口袋的蛋白有機會成為標靶，標靶突變後產生的抗藥性也有機會繞過。\n\n## 2026 年的轉折：降解劑開始上市\n\n2026 年 5 月，美國 FDA 核准 Arvinas 與 Pfizer 的 VEPPANU（vepdegestrant），用於 ESR1 突變的 ER+/HER2- 晚期乳癌，這是第一個上市的 PROTAC。8 月，BMS 的 ZENBEXUS（iberdomide）合併 daratumumab 拿到多發性骨髓瘤加速核准，是第一個上市的 CELMoD 分子膠。同一年兩種降解機轉都有藥上市，賽道從「機轉能不能成藥」進入「誰能把哪個靶點先做到上市」。\n\n第三期集中在兩個戰場：\n\n- 血液腫瘤：BTK 降解劑有百濟神州 tacabrutideg、Nurix bexobrutideg，兩家都已開打對 pirtobrutinib 的頭對頭第三期；BMS 的 mezigdomide、golcadomide 接在 iberdomide 之後，鎖定骨髓瘤與淋巴瘤。\n- 荷爾蒙受體：ER（vepdegestrant）與 AR（BMS-986365 第三期、諾華 luxdegalutamide 第二期）。\n- 過去被認為難以下藥的 KRAS：日本安斯泰來的 setidegrasib（KRAS G12D 降解劑）已在胰臟癌與肺癌啟動第三期。\n\n## 亞洲：中國數量最多，AR 最擁擠\n\n亞洲 15 項臨床資產裡，中國占 12 項。進到第三期的亞洲資產有兩項：百濟神州 tacabrutideg（BTK，三項第三期進行中）與安斯泰來 setidegrasib（KRAS G12D）。\n\n雄性素受體（AR）是亞洲最擁擠的靶點，分成兩條完全不同的路：\n\n- 口服、打前列腺癌：海創 HP518、齊魯 QLH12016、恒瑞 HRS-5041，對手是 BMS 與諾華的後期資產。\n- 外用、打雄性禿與痤瘡：開拓藥業 GT20029 與台灣安宏生醫 AH-001，是目前進入臨床的兩個外用 AR 降解劑。\n\n外用路線要解的是另一個問題：雄性禿是長期用藥，口服抗雄性素藥物會作用到全身。外用降解劑的設計目標，是讓藥物在頭皮局部把 AR 拆掉。\n\n兩家的路徑也不同。開拓先做中國：2024 年 4 月公布中國雄性禿第二期正向結果，2025 年 8 月痤瘡第二期達主要終點，美國第一期已完成。安宏先做美國：AH-001 已完成美國第一期單次與多次劑量遞增試驗，正在準備第二期，並尋求全球授權與共同開發。\n\n## 台灣的位置\n\n台灣目前只有安宏一項蛋白降解資產進入臨床，而且走的是美國臨床路線。安宏同時把輝達 BioNeMo 與自主開發的 AI 平台 AIMCADD 整合進藥物開發流程，用在蛋白降解劑的分子設計上。\n\n## 接下來看什麼\n\n- 百濟神州 tacabrutideg、Nurix bexobrutideg 對 pirtobrutinib 的第三期結果：決定 BTK 降解劑能不能取代現有 BTK 抑制劑。\n- BMS-986365 第三期：決定 AR 降解劑在前列腺癌的地位。\n- 外用 AR 降解劑：開拓 GT20029 的下一步臨床，以及安宏 AH-001 第二期的啟動時間。\n\n本頁為產業資料整理，不構成投資或醫療建議。資料來源：ClinicalTrials.gov、公司公告與美國證管會文件，各列附來源與日期。\n", "en": "# Protein Degraders (PROTACs and Molecular Glues)\n\nAs of November 6, 2026, Drugnews tracks 24 clinical-stage protein degraders: 2 approved in the US, 6 in Phase 3, and 15 from Asian companies (12 China, 1 Japan, 1 Taiwan, 1 South Korea).\n\n## What these drugs do\n\nA conventional targeted drug blocks a disease protein. A degrader removes it. A PROTAC binds the target with one end and recruits an E3 ligase with the other, so the cell's own disposal system breaks the protein down. A molecular glue is a single small molecule that makes an E3 ligase stick to a protein it would not normally touch.\n\nRemoving a protein, rather than blocking it, opens targets that have no druggable pocket and can get around resistance mutations.\n\n## 2026: degraders reach the market\n\nIn May 2026 the US FDA approved Arvinas and Pfizer's VEPPANU (vepdegestrant) for ESR1-mutated, ER+/HER2- advanced breast cancer, the first PROTAC on the market. In August, BMS's ZENBEXUS (iberdomide), combined with daratumumab, received accelerated approval in multiple myeloma as the first CELMoD molecular glue. With both degrader mechanisms approved in the same year, the question has moved from whether degraders can become drugs to who reaches approval first on each target.\n\nPhase 3 activity sits in two areas:\n\n- Blood cancers: BTK degraders from BeOne (tacabrutideg) and Nurix (bexobrutideg), both now in head-to-head Phase 3 trials against pirtobrutinib; and BMS's mezigdomide and golcadomide following iberdomide in myeloma and lymphoma.\n- Hormone receptors: ER (vepdegestrant) and AR (BMS-986365 in Phase 3; Novartis's luxdegalutamide in Phase 2).\n- KRAS, long considered hard to drug: Astellas's setidegrasib, a KRAS G12D degrader, has started Phase 3 trials in pancreatic and lung cancer.\n\n## Asia: China leads on numbers, AR is the most crowded target\n\nChina accounts for 12 of the 15 Asian clinical assets. Two Asian assets are in Phase 3: BeOne's tacabrutideg (BTK, three Phase 3 trials under way) and Astellas's setidegrasib (KRAS G12D).\n\nThe androgen receptor (AR) is the most crowded target in Asia, split into two different businesses:\n\n- Oral AR degraders for prostate cancer: Hinova's HP518, Qilu's QLH12016 and Hengrui's HRS-5041, up against late-stage assets from BMS and Novartis.\n- Topical AR degraders for hair loss and acne: Kintor's GT20029 and Taiwan-based AnHorn Medicines' AH-001, the only two topical AR degraders in the clinic.\n\nThe topical approach targets a different problem. Androgenetic alopecia needs long-term treatment, and oral anti-androgens act throughout the body. A topical degrader is designed to remove AR locally in the scalp.\n\nThe two companies took different routes. Kintor started in China: it reported a positive Phase 2 in androgenetic alopecia in April 2024, met the primary endpoint of a Phase 2 in acne in August 2025, and has completed a US Phase 1. AnHorn started in the US: AH-001 has completed a US Phase 1 single- and multiple-ascending-dose study, is preparing for Phase 2, and is seeking global licensing and co-development partners.\n\n## Taiwan's position\n\nAnHorn's AH-001 is currently Taiwan's only clinical-stage protein degrader, and it is on a US clinical path. AnHorn has also integrated NVIDIA BioNeMo and its in-house AI platform AIMCADD into its drug development process for degrader design.\n\n## What to watch\n\n- Phase 3 results for tacabrutideg and bexobrutideg against pirtobrutinib, which will show whether BTK degraders can replace BTK inhibitors.\n- The BMS-986365 Phase 3, which will set the position of AR degraders in prostate cancer.\n- Topical AR degraders: Kintor's next GT20029 trial and the start of AnHorn's AH-001 Phase 2.\n\nThis page is an industry data summary, not investment or medical advice. Sources: ClinicalTrials.gov, company announcements and SEC filings; each row lists its source and date.\n" }, "coverage_notes": [ { "asset": "HRS-5041", "result": "AR oral degrader confirmed in issuer filing; v2 trial stage retained for independent review.", "source": "https://static.cninfo.com.cn/finalpage/2026-01-06/1224919042.PDF", "date": "2026-01-06" }, { "asset": "QLH12016", "result": "Sponsor registry intervention explicitly says oral androgen receptor PROTAC.", "source": "https://clinicaltrials.gov/api/v2/studies/NCT07198633", "date": "2026-06-02" } ], "counts": { "total": 24, "approved": 2, "phase3": 6, "countries": { "United States": 8, "China": 12, "Japan": 1, "Switzerland": 1, "Taiwan": 1, "South Korea": 1 }, "asia": 15, "asia_countries": { "China": 12, "Japan": 1, "Taiwan": 1, "South Korea": 1 } } }