HanchorBio Doses First Patient in Taiwan in Phase 1 Trial of HCB301
Marks the first clinical milestone in Taiwan for what the Company believes is the world’s first tri-specific SIRPα-Fc fusion protein in clinical evaluation
[Taipei, Shanghai, San Francisco | April 8, 2026] — HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and immune-related diseases, today announced that the first patient in Taiwan has been dosed in HCB301-101, the Company’s ongoing first-in-human Phase 1 clinical study of HCB301.
HCB301-101 is an open-label, multiregional, multicenter, dose-escalation study evaluating HCB301 in adults with advanced solid tumors or relapsed/refractory classical Hodgkin lymphoma. The study is designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity, while supporting dose finding for future development.
To HanchorBio’s knowledge, HCB301 is the first tri-specific SIRPα-Fc fusion protein to enter global clinical evaluation, and this milestone marks the first such program to reach the clinic in Taiwan.
HCB301 was designed to coordinate blockade of three interdependent immune suppressive pathways—CD47/SIRPα, PD-L1/PD-1, and TGF-β/TGFβ-R—within a single engineered Fc fusion molecule. As previously disclosed by the Company, HCB301 integrates an AI-guided (AlphaFold), structurally engineered SIRPα-Fc backbone, an anti-PD-L1 VHH, and an engineered TGF-β receptor. The program reflects HanchorBio’s broader view that, in many tumors, durable anti-tumor activity may require multi-pronged, synergistic modulation of innate immune suppression, adaptive checkpoint signaling, and suppression in the tumor micro-environment (by a dominant cytokine), rather than the blockade of a single immunosuppressive pathway.
“This first-patient-dosed milestone in Taiwan is important not only for HCB301, but also for what it represents scientifically and technologically,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “To our knowledge, HCB301 is the first tri-specific SIRPα-Fc fusion protein to enter clinical evaluation globally, and this milestone marks the first such program to reach the clinic in Taiwan. HCB301 was designed from the outset around a clear translational hypothesis: in tumors shaped by prolonged immune resistance, targeting a single checkpoint may not be enough. We believe coordinated modulations of three signaling pathways, namely CD47/SIRPα, PD-L1/PD-1, and TGF-β/TGFβ-R may offer a more clinically powerful and potentially more efficacious approach to addressing innate, adaptive, and stromal immune suppression simultaneously by a single biological molecule. Equally important, a molecular of this complexity must be developed in a way that supports manufacturability, quality control, and reliable clinical supply.”
The Taiwan milestone is also significant because it moves HCB301 beyond regulatory readiness and into active clinical execution in Taiwan. For the physicians and patients this program is intended to serve, this milestone marks an important transition from molecular design and study activation to real-world clinical development.
“We have seen strong interest in HCB301 from oncologists and immuno-oncology specialists in Taiwan, particularly because it was designed to simultaneously modulate three important immunosuppressive pathways in a single molecule,” added Alvin Luk, Ph.D., M.B.A., C.C.R.A., President & Chief Medical Officer (Group) and CEO (USA) of HanchorBio. “Reaching this first clinical milestone in Taiwan is important not only scientifically and clinically, but also because it demonstrates real execution behind the program. The challenge in multi-functional immunotherapy is not simply adding more targeting arms, but doing so in a way that remains clinically usable. This milestone marks the beginning of real clinical development for HCB301.”
HCB301 is part of HanchorBio’s proprietary FBDB™ (Fc-Based Designer Biologics) platform, which focuses on engineering multifunctional biologics designed to modulate complex immune pathways and support rational therapeutic development across oncology and immune-related diseases.
The Company will continue to advance HCB301-101 in accordance with the clinical protocol and applicable regulatory requirements.
About HCB301-101
HCB301-101 (NCT06487624) is an ongoing first-in-human, open-label, multiregional, multicenter Phase 1 study evaluating HCB301 in adults with advanced solid tumors or relapsed/refractory classical Hodgkin lymphoma. The study is assessing safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity (RECIST/iRECIST) and is intended to support dose-finding for future development.
About HCB301
HCB301 is an investigational tri-specific fusion protein designed to simultaneously modulate the CD47/SIRPα, PD-L1/PD-1, and TGF-β/TGFβ-R pathways. The molecule is intended to simultaneously trigger innate immune activation, adaptive checkpoint inhibition, and stromal modulation in a single construct.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TPEx) is a global clinical-stage biotechnology company focused on immuno-oncology and immune-mediated diseases. The company is led by an experienced team with a proven track record in biologics discovery and global development, aiming to reshape the landscape of cancer therapies. HanchorBio’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics with diverse targeting modalities, designed to activate both innate and adaptive immune pathways and overcome the current challenges of anti-PD1/L1 immunotherapies. The FBDB™ platform has delivered proof-of-concept data in several in vivo tumor animal models. HanchorBio is advancing a portfolio of innovative biologics designed to address significant unmet medical needs through differentiated molecular configurations in R&D and scalable CMC strategies.
漢康生技 HCB301 於台灣完成第一期臨床試驗首位患者給藥
此里程碑象徵全球首創的三功能 SIRPα-Fc 融合蛋白，正式在台灣展開臨床評估。
【台北、上海、舊金山｜2026年4月8日】──致力於開發新一代免疫療法的全球臨床階段生技公司漢康生技，今日宣布，公司開發中的 HCB301 首次於人體執行之藥物臨床試驗（First-in-Human）第一期臨床研究HCB301-101，已於台灣順利完成首位患者給藥。
HCB301-101是一項開放標籤（Open-label）、多國多中心、劑量遞增的第一期臨床研究 ，旨在評估 HCB301 用於治療晚期實體腫瘤或復發/難治型何杰金氏症成年患者(relapsed/refractory classical Hodgkin lymphoma)的療效。本研究除評估安全性、耐受性、藥物動力學（PK）、藥效動力學（PD）及免疫抗原性(immunogenicity)外，亦將觀察初步抗腫瘤活性，並為下一階段臨床試驗提供劑量探索之關鍵數據。
據漢康生技所知，HCB301 是全球首款進入臨床評估階段的三功能 SIRPα-Fc 融合蛋白；此次進展亦象徵台灣首個三功能融合蛋白的研發項目正式進入臨床階段。HCB301 的設計核心，在於透過單一工程化 Fc 融合蛋白分子，協同阻斷 CD47/SIRPα、PD-L1/PD-1 與 TGF-β/TGFβ-R 三條相互依賴的免疫抑制通路。如公司先前揭露，HCB301 整合了由 AI 導引（AlphaFold）設計的結構工程化SIRPα-Fc骨架、抗PD-L1 VHH，以及經工程化的TGF-β受體 。此研發計畫充分體現了漢康生技的前瞻理念：針對多種腫瘤，持久的抗癌療效需仰賴多管齊下的協同調控——同時針對先天免疫抑制、適應性免疫檢查點信號，以及腫瘤微環境中的關鍵細胞因子抑制進行干預，而非僅僅阻斷單一的免疫抑制路徑。
漢康生技創始人、董事長兼執行長劉世高博士表示：
「此次在台灣完成首位患者給藥，不僅是 HCB301 計畫的重要里程碑，更具備深遠的科學與技術意義」。據我們所知，HCB301 是全球首款進入臨床評估階段的三功能SIRPα-Fc融合蛋白，而這項里程碑也象徵著台灣首個此類開發計畫正式進入臨床階段。HCB301自設計之初便基於一個明確的轉譯醫學假說：針對受長期免疫抗性影響的腫瘤，單一檢查點的阻斷可能不足以達成理想療效。我們相信，透過單一生物分子同時協同調控 CD47/SIRPα、PD-L1/PD-1 與 TGF-β/TGFβ-R 三條信號通路，能更強大且有效地同時解決先天免疫、適應性免疫及基質（Stromal）免疫抑制問題 。同樣重要的是，開發如此高複雜性的分子，必須確保其具備優異的可批量生產性（Manufacturability）、品質管理以及穩定的臨床供應能力 。」
此次台灣臨床里程碑的達成深具意義，因為它象徵著 HCB301 在台灣已超越法規核准階段，正式進入實質的臨床執行層面。對於本計畫旨在服務的醫療團隊與患者而言，這項進展標誌著一個關鍵轉折：從分子設計與試驗啟動階段，正式邁入真實世界的臨床開發路徑。
漢康生技總裁暨集團醫療長陸英明博士表示 :
「我們觀察到台灣的腫瘤科醫生與免疫治療專家對 HCB301 展現出濃厚興趣 ，特別是因為它能在單一抗癌生物藥中同時調控三條關鍵的免疫抑制路徑。在台灣達成首個臨床里程碑，不僅具備科學與臨床意義，更展現了計畫背後強大的執行力。多功能免疫療法的挑戰，並不在於單純增加標靶數（Targeting arms），而是在於如何確保藥物在臨床應用上的可行性（Clinically usable）。這項里程碑的達成，象徵著HCB301正式邁向實質性的臨床開發階段 。」
核心技術平台：FBDB™
HCB301 源自漢康生技自主研發的 FBDB™ (Fc-Based Designer Biologics) 專有平台 。該平台專注於工程化設計多功能生物藥，旨在調控複雜的免疫路徑，並為癌症及免疫相關疾病提供具備基於機理的藥物研發（rational therapeutic development）的治療方案 。漢康生技將持續嚴格遵循臨床試驗計畫書及各項適用之法規要求，穩健推進HCB301-101臨床研究案。
關於 HCB301-101 臨床研究
HCB301-101（臨床試驗編號：NCT06487624）是一項正在進行中的首次人類首用（First-in-human）、開放試驗之多國多中心第一期臨床研究，旨在評估 HCB301 用於治療患晚期實體腫瘤或復發/難治型何杰金氏症成年患者(relapsed/refractory classical Hodgkin lymphoma)的療效 。本研究除了系統性地評估藥物的安全性、耐受性、藥物動力學（PK）、藥效動力學（PD）及免疫抗原性(immunogenicity)，亦將透過 RECIST/iRECIST 標準觀察其初步抗腫瘤活性，並為後續臨床試驗階段的劑量篩選（Dose-finding）提供關鍵的科學數據支持 。
關於 HCB301
HCB301 是一款開發中的三特異性融合蛋白 ，其設計旨在單一分子架構中，同時精準調控 CD47/SIRPα、PD-L1/PD-1 以及 TGF-β/TGFβ-R 三大關鍵信號通路 。該分子具備獨特的協同作用機制 ，意在單一構建體（Single construct）中，同時啟動先天免疫活化 、抑制適應性免疫檢查點 ，並達成對腫瘤基質微環境的調控 。
關於漢康生技
漢康生技（股票代碼：7827.TPEx）是一家全球臨床階段的生物技術公司，專注於腫瘤免疫學及自體免疫疾病領域，研發總部設於台北，並在上海及美國舊金山灣區設有運營辦公室。公司由一支在生物藥發現與全球開發方面擁有豐富成功經驗的資深團隊領導，致力於重塑癌症治療格局。漢康生技專有的Fc基礎設計生物藥平台能夠開發具有多種靶向模式的多功能生物藥，旨在激活先天性與適應性免疫通路，以突破當前抗PD-1/L1免疫療法的局限。該平台已在多個體內腫瘤動物模型中成功獲得概念驗證數據。通過差異化的分子研發策略與可規模化的CMC工藝開發，漢康生技正推進一系列創新生物藥管線，致力於解決尚未被滿足的重大醫療需求。