HanchorBio Advances Myeloid-Directed Therapeutics Strategy Beyond Oncology with HCB101 Clinical Progress and FBDB™ Platform Expansion
From clinical anchor to strategic franchise: HCB101 provides human validation of macrophage-directed immunity, enabling expansion across oncology and immune-mediated diseases
[Taipei, Shanghai, San Francisco | August 21, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today shared its latest clinical and research progress in myeloid-directed therapeutics at the 2026 Autumn Industry Trends and Corporate Forum hosted by Hua Nan Securities.
The Company presented its development strategy centered on the proprietary FBDB™ multifunctional biologics platform and myeloid enhancer approach, highlighting clinical progress of HCB101 in solid tumors and the expansion of macrophage-directed biology into HCB206 for immune-mediated diseases.
Expanding Immune Therapeutics Beyond T-Cell Checkpoint Modulation
The next generation of immune therapeutics is increasingly focused on addressing broader immune regulation beyond individual checkpoint pathways, including the role of innate immune cells within the disease microenvironment.
While PD-1/PD-L1 inhibitors primarily modulate existing T-cell responses, HanchorBio’s approach focuses on macrophages as an upstream component of innate immunity, with the potential to regulate cellular clearance, antigen processing, and subsequent immune activation.
HCB101 Establishes the Clinical Anchor for Macrophage-Directed Immunobiology
Scott Liu, Ph.D., Founder and Chairman of HanchorBio, said, “HCB101 represents the first clinical anchor for our myeloid enhancer approach. Our objective is not simply to develop an individual therapeutic candidate, but to establish human clinical evidence that macrophage-directed immune modulation can become a scalable approach across oncology and immune-related diseases. The clinical data generated with HCB101 not only support its continued development but also validate the broader myeloid enhancer approach, which is designed to restore macrophage phagocytosis, enhance antigen processing and presentation, and subsequently engage adaptive antitumor immunity through T-cell responses.”
HCB101 targets the upstream CD47/SIRPα macrophage immune checkpoint and is designed to restore macrophage-mediated tumor-cell phagocytosis, promote tumor antigen processing and presentation, and potentially induce de novo tumor-reactive T-cell clones that were not previously present or activated, generating broader antitumor immune responses. By initiating immune activation through macrophage-mediated tumor-cell clearance and antigen presentation, HCB101 shares an important biological principle with emerging immune-priming approaches, including therapeutic cancer vaccines being developed by Moderna/Merck, which seek to generate new tumor-reactive immune responses through antigen-directed strategies.
Clinical data generated with HCB101 continue to support its development across selected tumor types and provide important translational insights for expansion of the broader FBDB™ platform.
Clinical Validation: HCB101 Data Support Expansion Across Tumor Types
The ongoing HCB101-201 Phase 1b/2a study is evaluating HCB101 in combination with established standards of care across selected solid tumors, including gastric cancer, colorectal cancer, triple-negative breast cancer and head and neck squamous cell carcinoma.
Rather than broadly pursuing all indications, HanchorBio prioritizes development opportunities based on tumor biology, translational findings and combination rationale.
In second-line gastric cancer/gastroesophageal junction cancer, the intermediate-dose cohort demonstrated encouraging early clinical activity, with 8 of 10 evaluable patients achieving partial responses (ORR 80%) and a disease control rate of 100% at initial imaging assessment. Follow-up remains ongoing. Most of these patients had previously experienced disease progression following PD-1/PD-L1 treatment. By comparison, the ORR associated with standard treatment is approximately 26.5-28.0%. Patient follow-up remains ongoing, and median progression-free survival (mPFS) has not yet matured.
In colorectal cancer, HCB101 combination studies have also demonstrated encouraging clinical activity. Among 11 evaluable patients receiving HCB101 in combination with different standard therapies, 6 achieved partial responses, and 5 achieved stable disease, corresponding to a pooled ORR of 54.5% and DCR of 100%. Partial responses were observed across three distinct standard-of-care treatment architectures: bevacizumab plus chemotherapy, cetuximab plus chemotherapy, and ramucirumab plus FOLFIRI. Stable disease was also observed with chemotherapy alone. The activity observed across multiple therapeutic backbones supports further evaluation of macrophage-directed immune activation across additional tumor settings. By comparison, outcomes with established second-line metastatic colorectal cancer therapies vary according to prior treatment, molecular selection, and treatment backbone. Historical objective response rates are generally approximately 10%–20% in broader, non-biomarker-selected populations.
Translating Clinical Validation into a Multi-Disease Pipeline
Building on HCB101 as the clinical anchor, HanchorBio is expanding myeloid-directed biology across additional therapeutic areas.
HCB301 and HCB303 integrate macrophage-directed biology with additional immune pathways to explore broader immune activation strategies and next-generation immunotherapeutic approaches.
HCB206 extends macrophage-mediated cellular clearance beyond oncology into B-cell depletion and immune-mediated diseases through a CD20 × SIRPα dual-targeting design, with the goal of achieving deeper and more durable immune modulation.
Preclinical studies of HCB206 demonstrated B-cell depletion activity through multiple mechanisms, including antibody-dependent cellular phagocytosis (ADCP), antibody-dependent cellular cytotoxicity (ADCC), and complement-dependent cytotoxicity (CDC), supporting further evaluation in immune-mediated diseases.
Building a Strategic Franchise Through the FBDB™ Platform
HanchorBio’s FBDB™ platform integrates disease biology, AI-assisted protein engineering, translational research, and clinical feedback to continuously optimize therapeutic design and application.
Through HCB101 as the clinical anchor, HanchorBio aims to establish human validation of macrophage-directed therapeutics and leverage clinical data to guide expansion into additional disease areas.
The Company will continue advancing HCB101 across selected oncology indications while progressing its broader pipeline, including HCB301, HCB303 and HCB206, to further validate the potential of myeloid-directed therapeutic strategies across cancer, immune-mediated diseases and future applications of cellular clearance biology.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on immuno-oncology and immune-mediated diseases. The Company’s proprietary Fc-based designer biologics (FBDB™) platform enables the engineering of multifunctional biologics with diverse targeting modalities designed to activate innate and adaptive immune pathways and address limitations of current immunotherapies.
HanchorBio is advancing a portfolio of innovative biologics designed to address significant unmet medical needs through differentiated molecular configurations, translational development strategies, and scalable CMC capabilities.
Forward-Looking Statements
This press release contains forward-looking statements regarding HanchorBio’s clinical development programs, product candidates, regulatory strategy, and future plans. Actual results may differ materially from those expressed or implied due to various risks and uncertainties, including clinical development outcomes, regulatory decisions, and market conditions. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.
漢康-KY受邀於產業論壇分享髓系細胞導向治療策略 HCB101臨床進展支持FBDB™平台拓展至腫瘤以外疾病領域
從臨床支點到策略性產品布局：HCB101提供巨噬細胞導向免疫的人體驗證，支持拓展至腫瘤及免疫介導疾病
【台北、上海、舊金山，2026 年 8 月 21 日】－全球臨床階段生技公司漢康-KY（TWSE：7827）今日受邀參加由華南綜合證券舉辦之2026 年秋季產業趨勢暨企業論壇，分享公司在髓系細胞導向治療領域的最新臨床與研究進展。
公司於會中說明以專有 FBDB™ 多功能生物藥平台及髓系免疫增強策略為核心的研發布局，並分享 HCB101 於實體腫瘤的臨床進展，以及將巨噬細胞導向生物學延伸至 HCB206、拓展免疫介導疾病的開發方向。
拓展 T 細胞免疫檢查點調控以外的免疫治療
下一代免疫治療的研發方向，正逐步從單一免疫檢查點路徑，延伸至更廣泛的免疫調控機制，包括疾病微環境中先天免疫細胞所扮演的角色。
相較於 PD-1/PD-L1 抑制劑主要調節既有 T 細胞反應，漢康生技的研發策略聚焦於作為先天免疫上游環節的巨噬細胞，期望透過調控細胞清除、抗原處理及後續免疫活化，拓展免疫治療的應用潛力。
HCB101 建立巨噬細胞導向免疫生物學的臨床支點
漢康生技創辦人暨董事長劉世高博士表示：「HCB101 是我們髓系免疫增強策略的首個臨床支點。我們的目標並不只是開發單一候選藥物，而是建立人體臨床證據，驗證巨噬細胞導向的免疫調控能否成為可延展至腫瘤及免疫相關疾病的治療策略。HCB101 所累積的臨床數據，不僅支持其持續開發，也進一步驗證更廣泛的髓系免疫增強策略；此一策略旨在恢復巨噬細胞吞噬作用、強化抗原處理與呈現，並進一步透過 T 細胞反應啟動後續適應性抗腫瘤免疫。」
HCB101 鎖定較上游的 CD47/SIRPα 巨噬細胞免疫檢查點，其設計目標為恢復巨噬細胞吞噬腫瘤細胞的能力、促進腫瘤抗原處理與呈現，並可能誘導新生成、先前未存在或未被活化的腫瘤反應性 T 細胞株，進而產生更廣泛的抗腫瘤免疫反應。透過巨噬細胞介導的腫瘤細胞清除與抗原呈現啟動免疫反應，HCB101 與包括莫德納/默克（Moderna／Merck）正在開發的治療性癌症疫苗等新興免疫啟動策略，共享一項重要的生物學原則，即透過抗原導向策略產生新的腫瘤反應性免疫反應。
HCB101 所產生的臨床數據持續支持其於選定腫瘤類型中的開發，並為 FBDB™ 平台進一步拓展提供重要的轉譯研究依據。
臨床驗證：HCB101 數據支持跨癌種拓展
目前進行中的 HCB101-201 1b/2a 期臨床研究，正評估 HCB101 與既有標準治療聯合使用於選定實體腫瘤，包括胃癌、結直腸癌、三陰性乳癌及頭頸部鱗狀細胞癌。
漢康生技並非廣泛探索所有癌別，而是依據腫瘤生物學、轉譯研究結果及聯合治療的科學合理性，選擇優先開發機會。
在二線胃癌／胃食道交界癌的 HCB101 聯合治療研究中，中劑量組目前 10 名可評估患者中有 8 名達到部分緩解（PR），客觀緩解率（ORR）為 80%，首次影像評估的疾病控制率（DCR）為 100%。患者追蹤仍持續進行中，其中大多數患者先前均曾接受 PD-1/PD-L1 治療後疾病進展。相較之下，標準治療的 ORR 約為 26.5%–28.0%。目前患者追蹤仍持續進行，中位無惡化存活期（mPFS）尚未成熟。
在結直腸癌方面，HCB101 聯合治療研究亦呈現令人鼓舞的早期臨床活性。11 名接受 HCB101 搭配不同標準療法且可評估的患者中，共有 6 名達到部分緩解、5 名達到疾病穩定，整體 ORR 為 54.5%，DCR 為 100%。部分緩解分別出現在三種不同的標準治療架構，包括貝伐珠單抗加化學治療、西妥昔單抗加化學治療，以及雷莫蘆單抗加 FOLFIRI；化學治療單獨合併組亦觀察到疾病穩定。跨不同治療骨幹所觀察到的臨床活性，支持進一步評估巨噬細胞導向免疫活化於更多腫瘤情境中的應用。相較之下，既有二線轉移性結直腸癌治療的結果會因既往治療、分子篩選及治療骨幹而異，在較廣泛、未依生物標記篩選的患者族群中，歷史客觀緩解率一般約為 10%–20%。
從臨床驗證延伸至多疾病產品線
以 HCB101 作為臨床支點，漢康生技正將髓系細胞導向生物學進一步拓展至其他治療領域。
HCB301 與 HCB303 將巨噬細胞導向生物學與其他免疫路徑整合，以探索更廣泛的免疫活化策略及下一代免疫治療方法。
HCB206 則透過 CD20 × SIRPα 雙靶點設計，將巨噬細胞介導的細胞清除機制由腫瘤領域延伸至 B 細胞清除及免疫介導疾病，目標為實現更深度且更持久的免疫調控。
HCB206 的臨床前研究顯示，其可透過多重機制產生 B 細胞清除活性，包括抗體依賴性細胞吞噬作用（ADCP）、抗體依賴性細胞毒殺作用（ADCC）及補體依賴性細胞毒殺作用（CDC），支持後續於免疫介導疾病中的進一步評估。
透過 FBDB™ 平台建立策略性產品布局
漢康生技的 FBDB™ 平台整合疾病生物學、AI 輔助蛋白質工程、轉譯研究及臨床回饋，持續優化治療分子的設計與應用。
透過 HCB101 作為臨床支點，漢康生技希望建立巨噬細胞導向治療的人體驗證，並運用臨床數據引導後續拓展至更多疾病領域。
未來，公司將持續推進 HCB101 於選定腫瘤適應症中的臨床開發，同時推進包括 HCB301、HCB303 及 HCB206 在內的整體產品線，進一步驗證髓系細胞導向治療策略於癌症、免疫介導疾病，以及未來其他細胞清除生物學應用中的潛力。
關於漢康生技
漢康生技（HanchorBio，TWSE：7827）據點遍及台北、上海及舊金山灣區，是一家專注於腫瘤免疫及免疫相關疾病的全球臨床階段生技公司。公司專有的FBDB™（以Fc為骨架、具特殊構型的多功能腫瘤免疫生物製劑）平台，可透過多樣化靶向模式設計具多重功能的生物製劑，以活化先天性及適應性免疫路徑，並解決現有免疫治療的部分限制。
漢康生技正推進一系列創新生物製劑產品組合，透過差異化的分子設計、轉譯開發策略，以及具規模化能力的 CMC 技術，致力於解決重大的未滿足醫療需求。
前瞻性聲明
本新聞稿包含前瞻性陳述，包括有關 HCB101 的臨床開發；HCB101-201 試驗及其頭頸部鱗狀細胞癌（HNSCC）研究組別的設計、執行、時程與潛在結果；HCB101 潛在的治療特性、作用機制及聯合治療策略；巨噬細胞導向免疫治療於 HNSCC 及其他腫瘤類型中的潛在應用；漢康生技產品管線的開發；以及 FBDB™ 平台的能力與潛力等相關陳述。上述陳述係基於漢康生技目前的預期與假設，並涉及可能導致實際結果與所述內容存在重大差異的風險與不確定性。
早期臨床數據及研究者發起的臨床研究數據，未必能預測較大規模或較後期臨床試驗的結果。公司亦無法保證目前進行中或規劃中的臨床試驗將如預期推進，或 HCB101 最終能證實其安全性與有效性，或取得監管機構核准。除適用法律另有規定外，漢康生技無義務更新任何前瞻性陳述。