汉康生技宣布HCB101-201
联合研究结直肠癌队列
出现首个确认的
部分缓解(PR)
结直肠癌的早期活性将HCB101的临床信号拓展至胃癌和头颈癌之外,支持其作为髓系丰富实体瘤中联合骨干疗法的潜力
【台北、上海、旧金山|2026年5月19日】——汉康生技,一家致力于开发肿瘤及自身免疫疾病下一代免疫疗法的全球临床阶段生物技术公司,今日宣布在其正在进行的评估HCB101联合标准治疗方案(NCT06771622)的临床研究中,结直肠癌队列出现了首个确认的部分缓解。
HCB101是汉康生技领先的SIRPα–IgG4 Fc融合蛋白,旨在选择性阻断CD47-SIRPα先天免疫检查点,同时降低早期CD47靶向方法常见的血液学风险。新出现的结直肠癌信号提供了额外的临床证据,支持HCB101作为先天免疫调节联合骨干疗法在具有髓系细胞丰富肿瘤微环境的实体瘤中的潜力。
在正在进行的结直肠癌队列中,HCB101联合标准治疗已展现出首个确认的部分缓解。此外,在台湾研究者发起试验的低剂量2.56 mg/kg队列中,观察到持久的疾病控制,3例可评估疗效患者中有2例无进展生存期接近11个月。HCB101联合研究的低至中剂量队列中的其他患者也显示出初步的疾病稳定信号。
结直肠癌队列正在评估HCB101联合既定治疗方案(包括抗VEGF和抗EGFR药物如贝伐珠单抗、西妥昔单抗或雷莫西尤单抗,以及化疗基础治疗)在二线结直肠癌中的疗效。该研究旨在评估通过CD47-SIRPα阻断的先天免疫检查点骨干疗法能否在临床验证的治疗框架内增强抗肿瘤活性。
结直肠癌中观察到的活性建立在汉康生技更广泛的HCB101临床开发策略之上,该策略优先考虑巨噬细胞生物学和髓系细胞信号可能导致治疗抵抗和肿瘤免疫抑制的肿瘤类型,包括二线胃癌、一线HER2阳性或CLDN18.2阳性胃癌、二线结直肠癌以及一线复发或转移性头颈癌。
“HCB101在结直肠癌中首个确认的部分缓解是一个重要的临床里程碑,因为它将该项目的活性信号拓展至另一个主要的实体瘤领域,”汉康生技创始人、董事长兼首席执行官刘世高博士表示。“我们的目标不是将HCB101开发为单一适应症资产,而是作为能够与选定髓系丰富肿瘤的现有标准治疗相整合的潜在先天免疫骨干疗法。我们将继续生成临床数据,以确定HCB101能为患者和未来开发伙伴带来最大价值的领域。”
关于HCB101
HCB101是一款AI引导、结构工程化的SIRPα–IgG4 Fc融合蛋白,利用汉康生技的FBDB™平台开发,旨在选择性阻断CD47–SIRPα先天免疫检查点,同时最大程度降低血液学毒性。与早期抗CD47方法不同,HCB101的设计在保留巨噬细胞介导的抗肿瘤活性的同时,减少了对红细胞的结合——这一限制历史上制约了CD47类药物的开发。HCB101正在多个临床环境中作为单药和联合疗法进行评估。
关于汉康生技
汉康生技(股票代码:7827.TPEx)是一家全球临床阶段的生物技术公司,专注于肿瘤免疫学及免疫介导疾病领域,总部设于台北,并在上海及美国旧金山湾区设有运营机构。公司专有的Fc基础设计生物药平台能够设计具有多种靶向模式的多功能生物药,旨在通过结构化的安全性、暴露及工艺控制,调节先天性与适应性免疫通路。汉康生技正通过创新的分子工程与可规模化的CMC策略,推进一系列差异化生物药管线,致力于解决尚未被满足的重大医疗需求。
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www.HanchorBio.com
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 19, 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.
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https://www.HanchorBio.com.