HCB-101( hC Bioscience)

汉康生技HCB101 获选2025年ESMO 免疫肿瘤学大会口头报告 国际首秀彰显巨噬细胞检查点疗法在胃癌、三阴乳腺癌等难治实体瘤中的新兴潜力 前言 Preface [台北，上海，旧金山 | 2025年12月12日] – 致力于开发下一代肿瘤及自身免疫疾病免疫疗法的全球临床阶段生物技术公司汉康生技（TPEx: 7827）今日宣布，其旗舰巨噬细胞检查点项目HCB101的新临床数据，已被遴选为2025年欧洲肿瘤内科学会免疫肿瘤学大会的微型口头报告。 该会议将于英国伦敦举行。今年仅有26篇摘要获此报告资格，这标志着汉康生技首次在国际顶级肿瘤学术会议上进行临床数据口头报告，是其继2022年在SITC大会上报告HCB101临床前数据后的又一重大里程碑。 ESMO免疫肿瘤学大会是欧洲专注于免疫肿瘤科学的首要会议，有别于涵盖更广的ESMO年度大会。后者涵盖所有肿瘤学科，而ESMO-IO则聚焦于免疫机制、转化创新及涵盖先天与适应性免疫的下一代治疗策略。 01 报告详情 摘要编号：242MO 标题：HCB101，一款差异化的SIRPα融合蛋白，在实体瘤和淋巴瘤中显示出良好的安全性和早期抗肿瘤活性 第一作者：宁方玲博士，滨州医学院附属医院 时间：2025年12月11日，11:45 – 12:45（格林威治标准时间） 地点：伦敦伊丽莎白二世女王中心，惠特尔厅 报告人：陆英明博士 (Alvin Luk) – 集团总裁兼首席医学官、美国汉康首席执行官，2025年《时代》周刊健康领域百大影响力人物 “近十年来，CD47疗法的瓶颈并非生物学机制有误，而在于分子设计本身难以同时平衡安全性与有效性，尤其是在免疫‘冷’肿瘤中，”汉康生技创始人、董事长兼首席执行官刘世高博士表示。“HCB101从根本上就是为了解决这一问题而设计。通过AI引导的结构建模，我们发现了三个能重塑SIRPα与CD47相互作用的核心突变，从而将第一代和第二代方法的优势整合进一个独特的差异化分子中。此次获选ESMO免疫肿瘤学大会仅有的26项微型口头报告之一，进一步印证了领域对此差异化的认可。凭借其纯净的安全性、强大的靶点结合力及在冷肿瘤中的早期活性，HCB101正崛起为一个真正的巨噬细胞检查点基石疗法——正如PD-1/PD-L1曾经改变T细胞肿瘤学一样。” 口头报告关键数据亮点—— 1 单药治疗研究  (HCB101-101; NCT05892718) 安全性卓越：在12个剂量队列中（最高至36 mg/kg，每周一次）均显示出对血细胞影响轻微的特性。 无出血事件或免疫相关毒性：大多数治疗相关不良事件为1-2级。 线性药代动力学：半衰期约3天，在剂量≥8 mg/kg时，受体占有率>90%。 持久的抗肿瘤活性，包括以下确认的部分缓解： 头颈鳞状细胞癌：肿瘤缩小约42%，缓解持续≥32周。 边缘区淋巴瘤：肿瘤缩小约89%，缓解持续≥16周。 疾病稳定长达4-9个月：见于结直肠癌、卵巢癌、非小细胞肺癌和肉瘤患者。 2 联合治疗研究  (HCB101-201; NCT06771622) 耐受性良好：在胃癌、三阴性乳腺癌、结直肠癌和头颈癌中均表现良好。 无新的安全性信号：在所有评估的联合方案中均未出现。 血细胞减少完全归因于化疗，而非HCB101。 二线胃癌： 客观缓解率达58.3%（7/12），疾病控制率达100%。 肿瘤最大缩小幅度达-78.2%。 一线HER2阳性胃癌：客观缓解率为33%（1/3）。 一线三阴性乳腺癌：客观缓解率为33%（2/6），疾病控制率达100%。 汉康生技集团总裁兼首席医学官、美国汉康首席执行官陆英明博士补充道：“HCB101在此研发阶段所显示的早期疗效信号格外引人注目。在标准疗法客观缓解率仅约28%的二线胃癌中，HCB101联合方案的客观缓解率超过58%，疾病控制率达到100%，肿瘤缩小幅度接近-78%。这些结果并非微小的改善，而是显著超越了预期，反映了强有力的巨噬细胞检查点激活。结合其纯净的安全性和持续的受体占有率，这些数据使我们有信心将其开发重点锚定在二线疾病，并拓展至对缓解深度和持久性要求最高的一线及围手术期治疗领域。” 02 关于HCB101： 一款新一代SIRPα Fc融合蛋白 HCB101是一款基于汉康生技FBDB™平台开发的3.5代工程化SIRPα-Fc融合蛋白，具有完整的IgG4 Fc骨架。其设计旨在选择性靶向CD47，同时极大降低与红细胞的结合，从而避免了限制早期抗CD47药物开发的贫血和血小板减少问题，同时保留了强大的巨噬细胞激活及下游T细胞招募功能。关键差异化优势包括： 卓越安全性： 剂量高达30-36 mg/kg仍对血细胞影响轻微 高效的靶点结合： 在临床有效暴露剂量下，受体占有率>90% 强大的免疫激活： 有效激活巨噬细胞及下游T细胞 广泛的抗肿瘤活性： 在超过80个PDX/CDX模型及多种临床肿瘤类型中有效 显著的早期联合疗效： 在对CD47靶向疗法历史上不敏感的肿瘤中显现。 与早期方法不同，HCB101的安全性、靶点选择性和受体占有率特征，支持其作为一种巨噬细胞检查点基石疗法使用——类似于PD-1/PD-L1抑制剂在肿瘤学中作为T细胞基石疗法的角色。HCB101设计用于与现有及新兴的治疗模式广泛联用，包括： 化疗 放疗 抗体偶联药物 抗PD-1/PD-L1检查点抑制剂 抗VEGF抑制剂 抗EGFR疗法 抗HER2方案 这种多功能性使HCB101成为一个模块化的、下一代免疫肿瘤组件，有望增强多种治疗方案在实体瘤和血液恶性肿瘤中的疗效。 03 关于汉康生技 汉康生技（HanchorBio, 股票代码：7827.TPEx）是一家全球性免疫肿瘤生物技术公司，设有台北、上海与旧金山湾区办事处。公司由一支在全球生物药研发与产业化领域拥有成功经验的资深团队领导，致力于重塑癌症治疗格局。公司自研的Fc融合蛋白设计平台FBDB™（Fc-based Designer Biologics）支持多靶点创新分子构型开发，激活先天与适应性免疫系统，突破传统PD-1/PD-L1疗法在耐药性与疗效持续性上的局限。FBDB™平台已在多个体内肿瘤模型中获得概念验证（POC）数据。汉康生技在多功能分子设计与CMC工艺优化方面不断突破，持续开发具有颠覆潜力的创新生物药，以满足尚未满足的重大临床需求。更多信息请访问官方网站：www.HanchorBio.com HanchorBio Announces Oral Presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025 International debut underscores emerging role for macrophage checkpoint therapy in gastric cancer, triple-negative breast cancer, and other hard-to-treat solid tumors Preface [Taipei, Shanghai, and San Francisco | December 12, 2025] –HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that new clinical data from its flagship macrophage-checkpoint program, HCB101, has been selected for a mini oral presentation at the ESMO Immuno-Oncology Congress 2025 in London, United Kingdom.  Only 26 abstracts were chosen for mini-oral presentation this year, marking a major milestone for HanchorBio as it delivers its first-ever oral presentation of clinical data at an international oncology congress, following its prior preclinical oral presentation of HCB101 at SITC 2022. The ESMO Immuno-Oncology Congress is Europe’s premier meeting dedicated exclusively to immuno-oncology science, distinct from the broader ESMO Annual Congress. While the annual ESMO meeting spans all oncology disciplines, ESMO-IO focuses on immune mechanisms, translational innovation, and next-generation therapeutic strategies across innate and adaptive immunity. 01 Presentation Details Abstract ID:  242MO Title: HCB101, a Differentiated SIRPα Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity Across Solid Tumors and Lymphoma First Author: Dr. Fangling Ning, Affiliated Hospital of Binzhou Medical University Date / Time: 11 December 2025 / 11:45 – 12:45 GMT Location: Whittle Room, Queen Elizabeth II Centre, London Presenter: Alvin Luk, PhD, MBA, CCRA - President & CMO (Group) and CEO (U.S.A.), TIME100 Health 2025 Honoree “For nearly a decade, CD47 therapies were held back not by flawed biology but by flawed molecules, which struggled to balance safety and efficacy at the same time, especially in immunologically cold tumors,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio.  “HCB101 was engineered from the ground up to solve that problem. Using AI-guided structural modeling, we identified three core mutations that reshape SIRPα’s interaction with CD47, allowing us to combine the strengths of first- and second-generation approaches into a single, differentiated molecule. Being selected as one of only 26 mini-oral presentations at ESMO Immuno-Oncology reinforces the field’s recognition of this differentiation. With its clean safety profile, strong target engagement, and early activity in cold tumors, HCB101 is emerging as a true macrophage-checkpoint backbone – much like PD-1/PD-L1 transformed T-cell oncology.” Key Findings Highlighted in the Mini-Oral—— 1 Monotherapy  (HCB101-101; NCT05892718) Clean, cytopenia-sparing safety across 12 cohorts up to 36 mg/kg QW No bleeding events or immune-related toxicities, with the majority of treatment-related adverse events being Grade 1-2 Linear PK (T1/2 ~3 days) with receptor occupancy (RO) >90% at ≥8 mg/kg Durable antitumor activity, including confirmed PRs in: HNSCC -Head and neck squamous cell carcinoma (~42% tumor regression, ≥32 weeks) MZL - Marginal zone lymphoma (~89% tumor regression, ≥16 weeks) Stable disease ≥4-9 months across colorectal cancer (CRC), ovarian cancer, non-small cell lung cancer (NSCLC), and sarcoma 2 Combination Therapy  (HCB101-201; NCT06771622) Well-tolerated across gastric cancer (GC), triple-negative breast cancer (TNBC), CRC, and HNSCC No new safety signals across all  evaluated combinations Cytopenias fully attributable to chemotherapy, not HCB101 · 2L GC: 58.3% ORR (7/12) and 100% DCR Tumor shrinkage up to -78.2% 1L HER2+ GC: 33% ORR (1/3) 1L TNBC: 33% ORR (2/6) and 100% DCR Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio, added, “The early efficacy signals from HCB101 are unusually compelling for this stage of development. In second-line GC, where standard therapy achieves an ORR of about 28%, HCB101 combinations exceed 58% ORR, with 100% disease control, and tumor reduction approaching -78%. These results are not incremental; they meaningfully exceed expectations and reflect robust macrophage checkpoint engagement. With clean safety and sustained receptor occupancy, the data give us confidence to anchor development in second-line disease and expand into first-line and perioperative settings where depth and durability of response matter most.” 02 About HCB101:  A Next-Generation SIRPα Fc-Fusion Protein HCB101 is a 3.5th-generation engineered SIRPα-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio’s FBDB™ platform to selectively target CD47 while minimizing low red blood cell binding. This design avoids the anemia and thrombocytopenia that limited early anti-CD47 programs, while preserving potent macrophage activation and downstream T-cell engagement.  Key differentiators include: Cytopenia-sparing safety up to 30-36 mg/kg Receptor occupancy (RO) >90% at clinically active exposures Strong macrophage and downstream T-cell activation Broad antitumor activity across >80 PDX/CDX models and multiple clinical tumor types Robust early combination efficacy in historically CD47-resistant tumors Unlike earlier approaches, HCB101’s safety, target selectivity, and RO profile support its use as a macrophage-checkpoint backbone – analogous to how PD-1/PD-L1 inhibitors function as foundational T-cell backbones in oncology. HCB101 is designed for broad combinability across established and emerging treatment modalities, including: Chemotherapy Radiation therapy Antibody-drug conjugates (ADCs) Anti-PD-1/anti-PD-L1checkpoint inhibitors Anti-VEGF inhibitors Anti-EGFR therapies Anti-HER2 regimens This versatility positions HCB101 as a modular, next-generational immuno-oncology component capable of enhancing the efficacy of multiple therapeutic backbones across solid tumors and hematologic malignancies. 03 About HanchorBio Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TPEx: 7827) is a global biotechnology company specializing in immuno-oncology. It is led by an experienced team of pharmaceutical industry veterans with a proven track record in biologics discovery and international development, aiming to rewrite the landscape of cancer therapies. Committed to reactivating the immune system to fight diseases, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By advancing breakthroughs in multi-functional, innovative molecular configurations in R&D and improving CMC manufacturing processes, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: www.HanchorBio.com