汉康生技于FOCIS 2026大会
发布突破性数据，
支持先天免疫产品引擎在肿瘤
及自身免疫疾病领域的应用
HCB101临床验证为平台向多检查点肿瘤免疫及B细胞驱动的自身免疫疾病扩展奠定基础
【台北、上海、旧金山｜2026年6月9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2026年6月9日至12日于旧金山举行的美国临床免疫学会联合会年会上，发布了突破性的临床与转化数据。
本次报告重点展示了汉康生技基于SIRPα的免疫工程平台在三款产品中的应用：靶向CD47/SIRPα通路的HCB101、靶向CD47/SIRPα、PD-L1/PD-1及TGF-β/TGFβ-R通路的HCB301，以及靶向CD20同时结合CD47/SIRPα生物学机制的HCB206。这些数据支持汉康生技构建先天免疫产品引擎的战略，该引擎能够在肿瘤及自身免疫疾病领域持续产生差异化的治疗候选药物。
“FOCIS是一个重要的学术平台，因为它让我们能够展示平台背后的免疫学原理，”汉康生技创始人、董事长兼首席执行官刘世高博士表示。“我们的战略以HCB101为起点：单药数据已验证了分子的可行性，联合治疗数据则正在定义临床开发路径。在此基础上，我们将同样的SIRPα工程化逻辑延伸至HCB301（用于协调多检查点免疫重编程）和HCB206（用于B细胞驱动的自身免疫疾病）。”
HCB101是汉康生技领先的临床阶段SIRPα-IgG4 Fc融合蛋白，靶向CD47-SIRPα先天免疫检查点。在正在进行的HCB101-101一期单药研究中，剂量爬坡已达到36 mg/kg，安全性可控，未确定最大耐受剂量。在67例接受治疗的患者中，治疗相关不良事件主要为1-2级，仅出现1例3级贫血。持久的单药活性包括：头颈鳞状细胞癌确认部分缓解（肿瘤缩小约42%，缓解持续超过69周）和边缘区淋巴瘤确认部分缓解（第16周肿瘤缩小约89%），另有11例持久的疾病稳定。
在联合开发方面，HCB101正作为二线胃癌的核心临床验证项目推进。在正在进行的HCB101-201多队列联合研究中，HCB101联合雷莫西尤单抗及紫杉醇的总客观缓解率为57.1%，其中成熟的中剂量组（5.12和8 mg/kg）客观缓解率达80%，深度肿瘤退缩达78.2%。其他临床信号，包括结直肠癌中HCB101联合贝伐珠单抗及FOLFIRI出现的确认部分缓解，以及头颈鳞癌中HCB101联合帕博利珠单抗出现的确认完全缓解，支持其在选定的髓系优势肿瘤类型中的扩展潜力。
在FOCIS 2026上，汉康生技还展示了转化数据，显示HCB101在体内重塑了肿瘤免疫微环境：增加肿瘤浸润白细胞和巨噬细胞，促使巨噬细胞向M1优势表型极化，并增强CD4+及CD8+ T细胞的浸润和活化。
“HCB101是我们平台的临床验证点，”汉康生技集团总裁兼首席医学官、美国子公司首席执行官陆英明博士表示。“单药数据确立了安全性、药理学、受体占有率及早期抗肿瘤活性。联合治疗数据现在将二线胃癌定位为主要验证路径，结直肠癌支持更广泛的胃肠道肿瘤适用性，头颈癌支持向其他髓系优势肿瘤类型的扩展。这就是HCB101如何从单纯的CD47抑制分子演变为具有临床可用性的先天免疫骨干疗法。”
FOCIS报告还重点展示了汉康生技如何将HCB101的研究成果延伸至下一代候选产品。HCB301是一款三特异性SIRPα-PD-L1-TGF-β融合蛋白，旨在通过单个分子协调先天、适应性及肿瘤基质的免疫调节。
来自正在进行的HCB301-101一期研究的最新早期临床数据显示，在既往多线治疗失败的患者中，初始剂量水平下实现了疾病稳定，主要表现为低级别、机制相关的血细胞减少，以及在主动监测和缓解措施下可逆的血液学事件。
HCB206是一款SIRPα-CD20融合蛋白，将平台拓展至B细胞驱动的自身免疫疾病。在FOCIS发布的临床前研究中，HCB206在皮摩尔浓度下即表现出B细胞毒性，并在系统性红斑狼疮患者的原代B细胞中活性增强。在狼疮患者来源的PBMC移植人源化小鼠模型中，HCB206诱导了超过90%的脾脏CD19+ B细胞清除，并在7天内快速抑制血清抗dsDNA IgG，同时表现出可忽略的红细胞吞噬作用和极低的血小板摄取。
综上所述，这些数据支持汉康生技的观点：基于选择性SIRPα工程化的方法可作为可编程的先天免疫骨干和产品引擎，从肿瘤领域的HCB101开始，扩展至多检查点肿瘤免疫及自身免疫疾病。
FOCIS 2026报告信息
标题：CD47-SIRPα工程化的临床与转化验证，实现肿瘤与自身免疫疾病中背景依赖的免疫回路重编程
ID：2384363
专场：肿瘤免疫专场
报告日期/时间：2026年6月9日 17:15 – 18:30（太平洋时间）
关于汉康生技
汉康生技（股票代码：7827.TWSE）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。公司由一支在生物药发现与全球开发方面拥有丰富成功经验的资深团队领导，致力于重塑癌症治疗格局。汉康生技专有的Fc基础设计生物药平台能够开发具有多种靶向模式的多功能生物药，旨在激活先天性与适应性免疫通路，以突破当前抗PD-1/L1免疫疗法的局限。该平台已在多个体内肿瘤动物模型中成功获得概念验证数据。通过差异化的分子研发策略与可规模化的CMC工艺开发，汉康生技正推进一系列创新生物药管线，致力于解决尚未被满足的重大医疗需求。
更多信息，敬请访问：
www.HanchorBio.com
前瞻性声明
本新闻稿包含关于汉康生技临床开发项目、候选产品、监管策略及未来计划的前瞻性陈述。由于各种风险和不确定性，包括临床开发结果、监管决策及市场状况，实际结果可能与这些明示或暗示的陈述存在重大差异。除适用法律要求外，汉康生技不承担更新前瞻性陈述的义务。
HanchorBio Presents Late-Breaking Data at FOCIS 2026 Supporting Innate-Immune Product Engine Across Oncology and Autoimmune Disease
HCB101 clinical validation anchors platform expansion into multi-checkpoint immuno-oncology and B-cell-driven autoimmune disease
[Taipei, Shanghai, San Francisco | June 9, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the presentation of late-breaking clinical and translational data at the Federation of Clinical Immunology Societies Annual Meeting, FOCIS 2026, being held June 9-12, 2026, in San Francisco.
The presentation highlights HanchorBio’s SIRPα-based immune engineering platform across three programs: HCB101, targeting the CD47/SIRPα axis, HCB301, targeting CD47/SIRPα, PD-L1/PD-1, and TGF-β/TGFβ-R pathways, and HCB206, targeting CD20 while engaging CD47/SIRPα biology. The data support HanchorBio’s strategy to build an innate-immune product engine capable of generating differentiated therapeutic candidates across oncology and autoimmune disease.
“FOCIS is an important venue because it allows us to present the immunology behind our platform,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “Our strategy begins with HCB101, where monotherapy data have validated the molecule, and combination-therapy data are defining the clinical development path. From that foundation, we are extending the same SIRPα-based engineering logic into HCB301 for coordinated multi-checkpoint immune reprogramming and HCB206 for B-cell-driven autoimmune diseases.”
HCB101 is HanchorBio’s lead clinical-stage SIRPα-IgG4 Fc fusion protein targeting the CD47-SIRPα innate immune checkpoint. In the ongoing HCB101-101 Phase 1 monotherapy study (NCT05892718), dose escalation reached 36 mg/kg with manageable safety and no maximum tolerated dose identified. In 67 treated patients, treatment-related adverse events were predominantly Grade 1–2, with only 1 case of Grade 3 anemia. Durable monotherapy activity included confirmed partial responses in head and neck squamous cell carcinoma (with ~42% tumor reduction and durability beyond 69 weeks) and marginal zone lymphoma (with ~89% tumor reduction by Week 16), as well as 11 additional cases of durable stable disease.
In combination development, HCB101 is being advanced as the lead clinical anchor in second-line gastric cancer. In the ongoing HCB101-201 combination multi-cohort study (NCT06771622), HCB101 combined with ramucirumab and paclitaxel achieved an overall objective response rate (ORR) of 57.1%, including an 80% ORR in the mature mid-dose cohorts of 5.12 and 8 mg/kg, with deep tumor regressions up to 78.2%.
Additional clinical signals, including a confirmed partial response in colorectal cancer with HCB101 and bevacizumab plus FOLFIRI and a confirmed complete response in HNSCC with HCB101 and pembrolizumab, support potential expansion across selected myeloid-dominant tumor settings.
At FOCIS 2026, HanchorBio also presented translational data showing that HCB101 remodeled the tumor immune microenvironment in vivo by increasing tumor-infiltrating leukocytes and macrophages, shifting macrophage polarization toward an M1-dominant phenotype, and enhancing CD4+ and CD8+ T-cell infiltration and activation.
“HCB101 is the clinical proof point for our platform,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “The monotherapy data established safety, pharmacology, receptor occupancy, and early antitumor activity. The combination-therapy data now position second-line gastric cancer as the lead validation path, with colorectal cancer supporting broader GI applicability and head and neck cancer supporting expansion into other myeloid-dominant tumor settings. This is how HCB101 evolves from a CD47-inhibiting molecule into a clinically usable innate immune backbone.”
The FOCIS presentation also highlighted how HanchorBio is extending the HCB101 thesis into next-generation product candidates. HCB301, a tri-specific SIRPα-PD-L1-TGF-β fusion protein, is designed to coordinate innate, adaptive, and stromal immune modulation within a single molecule. Updated early clinical data from the ongoing HCB301-101 Phase 1 study (NCT06487624) showed disease stabilization in heavily pretreated patients at initial dose levels, with predominantly low-grade, on-mechanism cytopenias and reversible hematologic events under active monitoring and mitigation.
HCB206, a SIRPα-CD20 fusion protein, extends the platform into B-cell-driven autoimmune disease. In preclinical studies presented at FOCIS, HCB206 demonstrated picomolar-range B-cell cytotoxicity and enhanced activity in primary B cells from SLE patients. In an SLE patient-derived PBMC-engrafted humanized mouse model, HCB206 induced greater than 90% depletion of splenic CD19+ B cells and rapid suppression of serum anti-dsDNA IgG within seven days, while showing negligible erythrocyte phagocytosis and minimal platelet uptake.
Together, the data support HanchorBio’s view that selective SIRPα-based engineering can serve as a programmable innate-immune backbone and product engine, beginning with HCB101 in oncology and expanding into multi-checkpoint immuno-oncology and autoimmune diseases.
FOCIS 2026
Presentation Details
Title: Clinical and translational validation of CD47-SIRPα engineering enables context-dependent immune circuit reprogramming across oncology and autoimmunity
ID: 2384363
Session: Immuno-Oncology Session
Presentation Date / Time: June 9, 2026 / 5:15 PM – 6:30 PM PST
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TWSE) 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.
For more information, please visit:
https://www.HanchorBio.com
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.
