HanchorBio Announces First Confirmed Partial Response in Colorectal Cancer Cohort of Ongoing HCB101-201 Combination Study
Early colorectal cancer activity expands HCB101’s clinical signal beyond gastric and head and neck cancers, supporting its potential as a combination backbone in myeloid-rich solid tumors.
[Taipei, Shanghai, San Francisco | May 18, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the first confirmed partial response (PR) in the colorectal cancer (CRC) cohort of its ongoing clinical study evaluating HCB101 in combination with standard-of-care regimens (NCT06771622).
HCB101 is HanchorBio’s lead SIRPα–IgG4 Fc fusion protein designed to selectively block the CD47-SIRPα innate immune checkpoint while reducing the hematologic liabilities historically associated with earlier CD47-targeting approaches. The emerging colorectal cancer signal provides additional clinical evidence supporting HCB101’s potential as an innate-modulating combination backbone across solid tumors with myeloid-cell-rich tumor microenvironments.
In the ongoing colorectal cancer cohort, HCB101 has now demonstrated a first confirmed partial response in combination with standard-of-care therapy. In addition, durable disease control has been observed in the low-dose 2.56 mg/kg cohort of the Taiwan IIT (NCT07204574), with progression-free survival approaching 11 months in two out of 3 efficacy-evaluable patients. Additional patients in the low- to mid-dose cohorts in the HCB101 combination study have also shown preliminary stable disease (SD) signals.
The colorectal cancer cohort is evaluating HCB101 in second-line CRC in combination with established therapeutic regimens, including anti-VEGF and anti-EGFR agents such as bevacizumab, cetuximab, or ramucirumab, together with chemotherapy-based treatment. The study is designed to assess whether an innate immune checkpoint backbone through CD47-SIRPα blockade can enhance antitumor activity within clinically validated treatment frameworks.
The observation of activity in colorectal cancer builds on HanchorBio’s broader clinical development strategy for HCB101, which prioritizes tumor types where macrophage biology and myeloid-cell signaling may contribute to treatment resistance and tumor immune suppression. These include second-line gastric cancer, first-line HER2-positive or CLDN18.2-positive gastric cancer, second-line colorectal cancer, and first-line recurrent or metastatic head and neck cancer.
“HCB101’s first confirmed partial response in colorectal cancer is an important clinical milestone because it extends the program’s activity signal into another major solid tumor setting,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “Our goal is not to develop HCB101 as a single-indication asset, but as a potential innate immune backbone that can be integrated with established standards of care across selected myeloid-rich tumors. We will continue to generate clinical data to define where HCB101 can deliver the greatest value for patients and future development partners.”
About HCB101
HCB101 is an AI-guided, structurally engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB™ platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing red blood cell binding, a limitation that historically constrained development across the CD47 class. HCB101 is being evaluated across multiple clinical settings as both monotherapy and combination therapy.
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’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics intended to modulate innate and adaptive immune pathways with structural control over safety, exposure, and manufacturability. HanchorBio is advancing a portfolio of differentiated biologics designed to address significant unmet medical needs through innovative molecular engineering and scalable CMC strategies.
漢康生技宣布 HCB101聯合治療研究之結直腸癌臨床研究觀察到首例部分緩解（PR）
HCB101於結直腸癌展現早期臨床活性，將臨床訊號自胃癌及頭頸癌延伸至另一主要實體腫瘤，支持其作為髓系細胞豐富實體腫瘤聯合治療骨幹的潛力
漢康生技（TPEx：7827）為一家致力於開發次世代免疫療法、聚焦腫瘤與自體免疫疾病的全球臨床階段生技公司，今日宣布其創新腫瘤免疫候選藥物 HCB101 聯合標準治療方案臨床研究（NCT06771622）中，於結直腸癌（CRC）隊列觀察到首例部分緩解（Partial Response, PR），顯示 HCB101 聯合標準治療方案具備初步臨床抗腫瘤活性。
HCB101 是漢康生技的領先 SIRPα–IgG4 Fc 融合蛋白，旨在選擇性阻斷 CD47–SIRPα 先天免疫檢查點，同時降低早期 CD47 標靶療法過去常見的血液學風險。此次結直腸癌所觀察到的臨床訊號，進一步支持 HCB101 作為先天免疫調控聯合治療骨幹，應用於髓系細胞豐富腫瘤微環境之實體腫瘤的潛力。
根據目前臨床觀察，HCB101 除於結直腸癌受試者中觀察到首例部分緩解外，在台灣研究者發起的臨床研究（IIT，NCT07204574）低劑量 2.56 mg/kg 組別中亦觀察到持久疾病控制，3 名可評估療效患者中有 2 名無惡化存活期（PFS）接近 11 個月。HCB101 聯合治療研究中其他中低劑量受試者亦呈現初步疾病穩定（Stable Disease, SD）訊號。
本項研究聚焦於二線結直腸癌，評估 HCB101 與現行治療藥物聯合使用的潛力，包括與
本結直腸癌隊列聚焦於二線結直腸癌，評估 HCB101 與既有治療方案聯合使用的潛力，包括與抗 VEGF 及抗 EGFR 藥物，如貝伐珠單抗（bevacizumab）、西妥昔單抗（cetuximab）或雷莫西尤單抗（ramucirumab），以及化療組合之治療方案。本研究旨在評估透過 CD47–SIRPα 阻斷所建立的先天免疫檢查點骨幹，是否能在已獲臨床驗證的治療架構中增強抗腫瘤活性。
此次於結直腸癌觀察到的臨床活性，延續漢康生技對 HCB101 的整體臨床開發策略，即優先聚焦於巨噬細胞生物學與髓系細胞訊號可能參與治療抗性及腫瘤免疫抑制的腫瘤類型。相關適應症包括一線與二線胃癌、二線結直腸癌，以及一線復發或轉移性頭頸癌。
漢康生技創辦人、董事長暨執行長劉世高博士表示：「HCB101 於結直腸癌觀察到首例部分緩解PR，是該項目重要的臨床里程碑，因為這代表 HCB101 的活性訊號已延伸至另一主要實體腫瘤領域。我們的目標並非將 HCB101 開發為單一適應症資產，而是作為一項具潛力的先天免疫治療骨幹，可與既有標準治療整合，應用於特定髓系細胞豐富腫瘤。公司將持續累積臨床數據，以明確界定 HCB101 能為患者及未來開發合作夥伴創造最大價值的臨床定位。」
關於 HCB101
HCB101 是漢康生技運用 FBDB™ 平台開發之 AI 輔助、結構工程設計 SIRPα–IgG4 Fc 融合蛋白，旨在選擇性阻斷 CD47–SIRPα 先天免疫檢查點，同時降低血液學毒性。不同於早期的抗 CD47，HCB101 在保留巨噬細胞介導抗腫瘤活性的同時，降低對紅血球 CD47 的結合能力，以克服過去限制該療法發展的關鍵挑戰。
透過 AI 輔助結構建模，HCB101 對腫瘤細胞上的 CD47 具差異化結合特性，並維持對紅血球 CD47 的低親和力。其安全性、受體佔有率與藥理特性，皆有利於與既有腫瘤治療方案整合。目前 HCB101 正於胃癌、大腸直腸癌及頭頸癌等適應症持續進行劑量遞增與臨床二期擴展研究。
綜合上述特質，HCB101 已定位為具備差異化的先天免疫檢查點骨幹（Backbone），並具備橫跨實體腫瘤與血液腫瘤的廣泛潛力。
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。