漢康生技 2025 年度里程碑總回顧
漢康為癌症及自體免疫疾病病患，打造具臨床突破力的創新抗癌生物藥。
漢康生技透過自主開發的 FBDB™ (Fc-Based Designer Biologics) 技術平台，持續推進具備 同類首創 (First-in-Class) 與 同類最優 (Best-in-Class) 潛力的融合蛋白藥物，並於 2025 年在臨床、國際學術與市場面向皆取得關鍵驗證成果。
FBDB™ 技術平台價值
- 可理性設計並靈活串聯多重靶點，解決腫瘤免疫治療反應不足及安全性不足的雙重核心瓶頸
- 支撐多項臨床與臨床前產品線同步推進
- 2025 年透過臨床數據、國際會議發表、專利取得與授權合作，全面驗證平台可行性與延展性
2020 漢康成立 → 2021 FBDBTM技術平台創立 → 2023 HCB101 進入臨床一期 → 2024 HCB301 進入臨床一期 → 2025年的漢康?
2025 年度關鍵里程碑
臨床與研發突破
- HCB101 啟動 1b/2 期臨床試驗 (多國多中心多癌種)，其中，二線胃癌治療聯合療法展現 80% 客觀緩解率 (ORR)，顯著優於歷史標準療法 (26.5%)
- HCB101 聯合療法獲 TFDA 核准適應症擴展（頭頸癌、結直腸癌）
- HCB301於一期臨床試驗，完成兩個劑量組安全性觀察，顯示耐受性佳
- HCB303 啟動新藥臨床試驗申請 (IND) 準備階段
- HCB206 啟動新領域: 自體免疫疾病治療
國際學術與能見度
- ASCO 2025：發表 HCB101 初步臨床數據
- ASH 2025：發表 HCB101 單藥治療人體試驗結果
- ESMO 免疫腫瘤學大會：獲選口頭報告
- Journal of Hematology & Oncology (JHO)：研究成果刊登國際頂尖 (IF: 40.4) 期刊
- 受邀出席 CBA 年會，為唯一代表台灣之創新藥物公司
- SITC 2025：發表HCB301臨床前研究成果
獎項與肯定
- IMAPAC 2025 臺灣生物製藥卓越獎
- 2025 傑出生技產業獎－傑出新創獎
市場與公司發展
- HCB101 完成國際授權交易
- 簽約金 1,000 萬美元
- 總里程碑金最高達1.92億美元，以上合計最高達2.02億美元
- 公司登錄台灣興櫃市場（股票代碼：7827），並完成創新板上市申請送件
- HCB101 取得美國專利
關鍵團隊布局
- 陸英明 博士出任集團總裁兼醫療長 (CMO)，全面強化臨床策略、國際藥物開發與平台價值轉譯
2025年總結
2025 年是漢康從「平台建構」正式邁向「臨床與市場雙重驗證」的關鍵一年。
FBDB™ 已被證實不僅是一項技術平台，而是一個能持續產出具臨床影響力創新藥物的研發引擎。
漢康生技不僅是家擁有潛力藥物的公司，更代表免疫腫瘤療法的下一篇章 – 一個始於台灣，即將改寫全球癌症治療格局的重大機遇!
HanchorBio 2025 Milestones
Patient First, Data Driven.
HanchorBio is a clinical-stage biotechnology company advancing differentiated immuno-oncology biologics through its proprietary FBDB™ (Fc-Based Designer Biologics) platform. In 2025, the platform achieved meaningful validation across clinical development, global scientific recognition, intellectual property, and capital markets, marking its transition from platform build-out to clinical execution.
FBDB™ Platform Overview
The FBDB™ platform enables the rational design of multi-functional fusion proteins intended to address key limitations of existing immuno-oncology therapies. Platform strengths demonstrated in 2025:
- Rational multi-target engagement to improve therapeutic index in solid tumors
- A diversified pipeline spanning clinical and preclinical stages
- Platform scalability validated through clinical data, global conferences, peer-reviewed publication, IP grants, and a completed licensing transaction
Key Milestones in 2025
Clinical & R&D Progress
- HCB101 advanced into a Phase 1b/2 clinical trial
2L GC combo therapy demonstrated an 80% objective response rate (ORR), significantly outperforming historical standard-of-care (26.5%) - TFDA approvals obtained for HCB101 combination therapy (HNSCC, CRC)
- HCB301 entered Phase I clinical trial and completed safety evaluations for two dose cohorts with favorable tolerability
- HCB303 entered IND-enabling preparation stage
- HCB206: Program expansion into auto-immune disease, broadening platform applicability beyond oncology
Global Scientific Presence
- ASCO 2025: Presentation of preliminary clinical data for HCB101
- ASH 2025: First-in-human monotherapy results of HCB101
- ESMO Immuno-Oncology Congress: Selected for mini-oral presentation
- Journal of Hematology & Oncology (JHO): Peer-reviewed publication (IF: 40.4)
- SITC 2025: Preclinical data presentation for HCB301
- CBA Annual Meeting: Invited participant; sole innovative drug company from Taiwan
Awards & Recognition
- IMAPAC 2025 Taiwan Biopharma Excellence Award
- Taiwan BIO Awards 2025 “Startup of the Year
Business & Corporate Progress
- HCB101 licensing agreement executed
- USD 10 million upfront payment
- Up to USD192 million in development and commercial milestones
- Company listed on the Taiwan Emerging Stock Market (7827.TPEx)
- Application submitted for listing on the Taiwan Innovation Board (TIB), pending approval
- U.S. patent granted for HCB101
Key Leadership Appointment
- Alvin Luk, PhD, MBA, CCRA, was appointed as Group President & Chief Medical Officer (CMO), strengthening clinical strategy, global development execution, and platform-to-patient translation
Summary
2025 marks HanchorBio’s evolution from platform establishment to clinical and commercial validation.
The FBDB™ platform has progressed beyond concept, demonstrating its ability to generate clinically relevant therapeutics supported by human data, regulatory momentum, and external partnerships.
HanchorBio enters 2026 as a company with:
- Multiple clinical-stage assets
- A validated biologics platform
- Growing global visibility
- Clear pathways toward value inflection