HanchorBio Outlines Global Strategy for Gastric Cancer Immunotherapy as HCB101 Advances Beyond Phase 1
At the Early Clinical Trials Forum, HanchorBio highlights how clinical translation, translational biology, and multi-layered immunotherapies are shaping the future of oncology
TAIPEI, SHANGHAI, and SAN FRANCISCO — August 24, 2026 — HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced that Alvin Luk, PhD, MBA, CCRA, President and Chief Medical Officer (Group) and CEO (USA) of HanchorBio, presented the Company’s vision for the next phase of gastric cancer immunotherapy at the Early Phase Clinical Trials: Innovation and Precision Medicine Forum in Taichung, Taiwan.
Beyond Phase 1: Redefining Early Clinical Development in Oncology
Historically, Phase 1 studies aimed primarily to establish safety, identify dose-limiting toxicities, and define maximum tolerated doses. With the rise of targeted therapies, immune checkpoint inhibitors, and bispecific antibodies, early clinical development must answer broader strategic questions:
- Regimen Optimization: Identifying optimal dosing, schedule, and combination regimens.
- Patient Selection: Pinpointing patient populations most likely to benefit through biomarker strategies.
- Global Translation: Generating robust early translational evidence to support global pivotal development decisions.
HanchorBio’s HCB101 development exemplifies this evolution — leveraging early signals to guide registration-enabling global strategies.
HCB101: Clinical Validation in Gastric Cancer
HCB101 is an AI-guided, engineered SIRPα-IgG4 Fc fusion protein developed using HanchorBio’s proprietary FBDB™ (Fc-Based Designer Biologics) platform. Designed to block the CD47-SIRPα innate immune checkpoint and enhance macrophage-mediated anti-tumor activity, HCB101 promotes tumor-cell clearance, antigen processing, and downstream immune activation.
In the ongoing HCB101-201 multi-cohort combination study across selected solid tumors, middle-dose cohort data in second-line gastric cancer/gastroesophageal junction cancer demonstrated encouraging early clinical activity:
80% Overall Response Rate (ORR): 8 of 10 evaluable patients achieving partial responses.
100% Disease Control Rate (DCR): Observed at initial post-baseline imaging assessments.
These results directly inform HanchorBio’s advancement of HCB101 toward a globally aligned gastric cancer program.
Beyond PD-1: A Three-Layer Immunotherapy Paradigm
Recent clinical milestones — such as an individualized neoantigen mRNA cancer vaccine combined with PD-1 blockade — highlight a shift toward coordinated immune system engineering. HanchorBio views the future of oncology through an integrated, three-layer framework:
- Immune Education (Neoantigen Vaccines): Teaching the immune system to recognize tumor-specific immune responses.
- Immune Reinvigoration (PD-1 Blockade): Restoring and sustaining adaptive T-cell responses.
- Immune Execution (HCB101/Innate Activation): Triggering macrophage-mediated tumor clearance, enhancing tumor antigen presentation, and broadening the immune response by inducing de novo tumor-reactive T-cell clones.
Designing Today for the Decisions of Tomorrow
“Early clinical development is no longer just about establishing tolerance — it is building the biological, clinical, and translational evidence needed to make decisive development moves,” said Dr. Luk. “For HCB101, our goal is to translate macrophage-directed biology into a meaningful global strategy for patients with gastric cancer and beyond.”
“Scientific breakthroughs are only meaningful when translated into therapies that reach patients worldwide,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “ HCB101 represents our commitment to advancing macrophage-directed immunotherapy from a biological concept into a disciplined, global clinical execution strategy.”
About HCB101
HCB101 is an investigational engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s proprietary FBDB™ platform. HCB101 blocks CD47–SIRPα signaling and is designed to enhance macrophage-mediated antitumor immunity. It is being evaluated as monotherapy (NCT05892718) and in combinations (NCT06771622) across solid and hematologic malignancies. HCB101 has received U.S. FDA Orphan Drug Designation for gastric cancer.
About HanchorBio
HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company dedicated to reinventing immunotherapies through its proprietary FBDB™ platform. By targeting innate and adaptive immune pathways, HanchorBio develops breakthrough biologics designed to overcome treatment resistance in oncology and immune-mediated diseases.
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受邀於臨床試驗論壇分享胃癌免疫治療全球開發策略 HCB101邁向第一期臨床後新階段
漢康-KY於早期臨床試驗論壇分享臨床轉譯、轉譯生物學及多層次免疫治療如何共同形塑腫瘤治療未來
【台北、上海、舊金山，2026 年 8 月 24 日】－全球臨床階段生技公司漢康生技（TWSE：7827）宣布，漢康生技集團總裁暨醫療長、美國子公司執行長陸英明博士受邀參與由中國醫藥大學附設醫院血液腫瘤科主辦的「早期臨床試驗：創新與精準醫療論壇（Early Phase Clinical Trials: Innovation and Precision Medicine Forum）」發表演講，分享公司對下一階段胃癌免疫治療發展的布局與願景。論壇已於8 月 22 日在台中福華飯店舉行。
本次研討會聚焦早期臨床試驗最新進展、創新療法及精準醫療應用，邀集來自台灣、新加坡及日本等地的早期臨床試驗與腫瘤新藥開發專家，包括 National University Cancer Institute, Singapore 相關資深專家，以及日本 National Cancer Center Hospital East Department of Experimental Therapeutics Chief Yasutoshi KUBOKI 等，與臨床試驗主持人、研究人員、醫療專業人員、藥廠及 CRO 產業人士共同交流。
漢康生技表示，早期臨床開發不僅涉及創新藥物本身，更涵蓋法規策略、試驗設計、患者選擇與臨床執行等多個環節。透過此次與亞洲臨床試驗及新藥開發專家交流，公司將持續深化早期臨床開發經驗與區域專業連結，並以 HCB101 累積的臨床與法規經驗為基礎，推進後續創新免疫療法的全球臨床開發。
超越第一期臨床：重新定義腫瘤早期臨床開發
過去，第一期臨床試驗主要著重於確認藥物安全性、辨識劑量限制毒性（DLTs），以及確定最大耐受劑量（MTD）。隨著標靶治療、免疫檢查點抑制劑及雙特異性抗體等療法快速發展，現今的早期臨床開發已需要回答更廣泛且具策略性的問題，包括：
- 治療方案最佳化： 確認最佳劑量、給藥時程及聯合治療方案。
- 病人選擇： 透過生物標記策略，辨識最可能從治療中獲益的病人族群。
- 全球轉譯： 建立具充分支持力的早期轉譯證據，作為全球關鍵性臨床開發決策的依據。
漢康生技 HCB101 的開發正體現此一早期臨床發展趨勢，透過早期臨床訊號，進一步引導以全球註冊為目標的開發策略。
HCB101：於胃癌建立臨床驗證
HCB101為透過人工智慧輔助設計的工程化 SIRPα-IgG4 Fc 融合蛋白，採用漢康生技自主開發的 FBDB™多功能生物藥平台所開發。HCB101旨在阻斷 CD47-SIRPα 先天免疫檢查點，增強巨噬細胞介導的抗腫瘤活性，促進腫瘤細胞清除、抗原處理及後續免疫活化。
於目前進行中的 HCB101-201 多組別聯合治療臨床試驗中，針對特定實體腫瘤進行評估。其中，二線胃癌／胃食道交界癌中劑量組數據展現令人鼓舞的早期臨床活性：
- 客觀緩解率（ORR）80%： 10 名可評估病人中，8 名達到部分緩解（PR）。
- 疾病控制率（DCR）100%： 於治療後首次影像評估時觀察到。
上述結果正進一步支持漢康生技推進 HCB101，朝向全球一致的胃癌臨床開發計畫發展。
超越 PD-1：三層次免疫治療新架構
近期臨床發展的重要里程碑，例如個人化新抗原 mRNA 癌症疫苗結合 PD-1 阻斷療法，突顯癌症免疫治療正逐步朝向協同調控多重免疫機制的方向發展。漢康生技認為，未來腫瘤治療可透過整合性的三層次架構進一步推進：
- 免疫教育（新抗原疫苗）： 教導免疫系統辨識腫瘤特異性免疫反應。
- 免疫再活化（PD-1 阻斷）： 恢復並維持適應性 T 細胞免疫反應。
- 免疫執行（HCB101／先天免疫活化）： 啟動巨噬細胞介導的腫瘤清除、增強腫瘤抗原呈現，並透過誘導新生（de novo）腫瘤反應性 T 細胞克隆，進一步擴大整體免疫反應。
為未來的開發決策，建立今日的臨床基礎
陸英明博士表示：「早期臨床開發的目的已不再只是確認治療耐受性，而是建立足以支持關鍵開發決策所需的生物學、臨床及轉譯證據。對 HCB101 而言，我們的目標是將巨噬細胞導向的生物學機制，轉化為具實際意義的全球開發策略，為胃癌及其他癌症病人創造更多治療機會。」
漢康生技創辦人、董事長暨執行長劉世高博士表示：「科學上的突破，唯有真正轉化為能夠惠及全球病人的治療方式，才具有實質意義。HCB101代表我們致力於將巨噬細胞導向免疫治療，從生物學概念進一步轉化為具系統性及全球布局的臨床開發策略。」
關於 HCB101
HCB101為一項研究中的工程化 SIRPα-IgG4 Fc 融合蛋白，採用漢康生技自主開發的 FBDB™ 平台所開發。HCB101可阻斷 CD47-SIRPα 訊號傳導，並旨在增強巨噬細胞介導的抗腫瘤免疫。目前 HCB101 正於實體腫瘤及血液腫瘤中進行單藥治療（NCT05892718）及聯合治療（NCT06771622）臨床評估，並已獲美國食品藥物管理局（FDA）授予胃癌孤兒藥資格（ODD）。
關於漢康生技
漢康生技（HanchorBio，TWSE：7827）是一家全球臨床階段生技公司，致力於透過自主開發的 FBDB™ 多功能生物藥平台，重新定義免疫治療。透過同時布局先天性與適應性免疫路徑，漢康生技持續開發突破性生物製劑，以克服腫瘤及免疫介導疾病中的治療抗藥性。
前瞻性聲明
本新聞稿包含有關漢康生技臨床開發計畫、候選產品、法規策略及未來計畫之前瞻性陳述。由於臨床開發結果、法規審查決策、市場環境及其他各項風險與不確定因素，實際結果可能與本新聞稿中明示或暗示之前瞻性陳述存在重大差異。除適用法律另有規定外，漢康生技不承擔更新任何前瞻性陳述之義務。