Ramucirumab

汉康生技于KSMO/FACO 2026 双获HCB101和HCB301认可 HCB101胃癌数据获最佳海报奖，中剂量组客观缓解率达80%；HCB301口头报告显示在晚期实体瘤中疾病控制率为38.1% 【台北（台湾地区）、上海、旧金山｜2026年9月7日】——汉康生技（TWSE：7827）是一家致力于开发肿瘤及免疫介导疾病下一代免疫疗法的全球临床阶段生物技术公司，今日宣布在韩国首尔举行的KSMO 2026——韩国肿瘤内科学会第19届年会暨2026国际会议（与第14届亚洲临床肿瘤学会联合会国际会议同期举行）上，公布了HCB101和HCB301的临床结果。 汉康生技在会议上获得了多项科学认可。在约500篇入选的海报摘要中，HCB101胃癌数据被选为仅20篇最佳海报展示奖之一，并成为仅10篇入选现场海报讨论的摘要之一。此外，除受邀讲者和主持人外，HCB301被选为整个科学项目中仅12篇口头报告之一。汉康生技还以电子海报形式展示了HCB101头颈鳞状细胞癌临床数据。 这些报告重点展示了汉康生技专有FBDB™平台的关键里程碑：HCB101作为巨噬细胞导向的临床基础，在胃癌和头颈鳞状细胞癌中展现出日益显现的临床活性；HCB301作为同类首创的三特异性免疫疗法，是迈向以单一分子实现协同多轴免疫调节的下一步。 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分别进行了HCB101胃癌海报讨论和HCB301首次人体口头报告。 “HCB101和HCB301在KSMO/FACO上同时获得认可意义重大，因为这反映了我们通过FBDB™平台实施的同一战略的两个阶段——从通过HCB101建立巨噬细胞导向的临床活性，到通过HCB301将该生物学拓展至多轴免疫调节，”汉康生技创始人、董事长兼首席执行官刘世高博士表示。“HCB101正在锚定我们的临床战略，而HCB301则测试三个不同的免疫抵抗驱动因素能否在单个工程化治疗分子中得到解决。” HCB101强化二线胃癌/胃食管 交界处癌作为临床锚点 HCB101是一款工程化SIRPα–IgG4 Fc融合蛋白，旨在阻断CD47–SIRPα先天免疫检查点并重新调动巨噬细胞介导的抗肿瘤活性。 在正在进行的HCB101-201研究（NCT06771622）中，20例二线胃癌/胃食管交界处癌患者在HCB101剂量水平2.56–12 mg/kg范围内入组，联合雷莫西尤单抗及紫杉醇治疗。在15例可评估疗效的患者中，5.12–8 mg/kg中剂量组客观缓解率达80.0%，患者肿瘤出现广泛且深度缩小。总体疾病控制率为93.3%。 作为历史参考，雷莫西尤单抗联合紫杉醇在RAINBOW和RAINBOW-Asia研究中的客观缓解率约为26–28%。肿瘤缩小的深度和一致性支持HCB101在二线胃癌/胃食管交界处癌中的持续开发。 在一线HER2阳性胃癌中，8例可评估疗效的患者接受HCB101联合曲妥珠单抗、帕妥珠单抗和化疗，客观缓解率达75.0%，疾病控制率为100%。 HCB101拓展至头颈鳞状细胞癌， 展现持久单药和联合活性 汉康生技还公布了HCB101在复发或转移性头颈鳞状细胞癌中的数据，支持其作为胃癌临床锚点之外的合理拓展领域。 在HCB101-101单药治疗中，5.12 mg/kg剂量下观察到确认的部分缓解，肿瘤缩小约42%，截至数据截止时治疗持续超过80周。第二例患者实现约34周的疾病控制，在头颈鳞状细胞癌和鼻咽癌中观察到额外的疾病稳定。 在台湾地区一项研究者发起的联合研究中，4例可评估患者中有2例达到客观缓解（客观缓解率50%），包括一例完全缓解和一例确认的部分缓解，所有4例患者均在首次评估时达到疾病控制。3例患者治疗持续超过16周，其中一例超过48周，随访仍在进行中。 单药的持久性和新兴的联合活性共同支持继续评估HCB101在PD-1和EGFR导向策略中的应用。 HCB301将多轴免疫调节 推进至临床 在KSMO 2026的口头报告中，汉康生技公布了正在进行的HCB301-101一期研究（NCT06487624）的首次人体临床发现。HCB301是KSMO 2026两个入选口头报告专场中的第二个。 HCB301是一款三特异性SIRPα–PD-L1–TGFβ融合蛋白，旨在单一分子中协同应对先天免疫抑制、适应性免疫检查点信号和TGFβ介导的免疫排斥。KSMO上展示的临床前数据显示，该药物在两个体内模型中均具有抗肿瘤活性，包括在头颈鳞状细胞癌模型中的肿瘤控制，以及在乳腺癌模型中联合用药达到98.5%的肿瘤生长抑制率，进一步支持了协同作用于这些相互关联的免疫通路的理论依据。 口头报告包括在0.3、0.6、0.9和1.2 mg/kg剂量队列中入组的29例患者。在21例可评估疗效的患者中，8例达到疾病稳定，疾病控制率为38.1%。疾病稳定在多种实体瘤类型中均有观察到，包括下咽癌、肝细胞癌、结直肠癌、胆管癌、盆腔恶性肿瘤和肉瘤，最长疾病控制超过四个月。 该患者人群既往接受过多线治疗，中位既往系统治疗线数为4线。安全性发现（包括血液学和输注相关事件）为后续开发中的方案优化、加强监测和剂量管理策略提供了依据。 “HCB301提出了一个与传统联合免疫治疗不同的问题：协同免疫调节能否被工程化到分子本身？”陆英明博士表示，他进行了口头报告。“令人鼓舞的是，我们已经在早期剂量递增阶段，在既往多线治疗的患者中观察到多种肿瘤类型的疾病稳定。这些仍是早期一期数据，但它们支持持续的剂量优化，我们正努力确定治疗窗口，并判断协同的SIRPα–PD-L1–TGFβ靶向能否转化为有意义的临床获益。” 可重复的FBDB™临床策略 HCB101奠定了汉康生技在巨噬细胞导向先天免疫领域的临床基础。HCB301将该基础拓展至整合先天免疫、适应性免疫和TGFβ介导免疫生物学的三特异性免疫治疗。 理解生物学 → 设计正确的架构 → 生成临床证据 → 了解生物学的作用位点 → 审慎拓展 关于HCB101 HCB101是一款利用汉康生技FBDB™平台开发的在研工程化SIRPα–IgG4 Fc融合蛋白。HCB101阻断CD47–SIRPα信号，以恢复巨噬细胞介导的抗肿瘤免疫及下游新生T细胞激活。它正在实体瘤和血液恶性肿瘤中作为单药及联合方案进行评估，并已获得美国FDA授予的胃癌孤儿药资格认定。 关于HCB301 HCB301是一款在研的三特异性CD47–PD-L1–TGFβ融合蛋白，旨在单一分子中同时应对先天免疫抑制、适应性检查点信号和TGFβ介导的免疫排斥。它正在正在进行的首次人体一期HCB301-101研究（NCT06487624）中进行评估。 关于汉康生技 汉康生技（TWSE：7827）是一家全球临床阶段的生物技术公司，专注于利用其专有FBDB™平台为癌症及免疫介导疾病发明下一代生物药。汉康生技的管线包括临床阶段项目HCB101和HCB301、下一代三特异性项目HCB303，以及覆盖肿瘤和免疫介导疾病的其他候选药物。更多信息，请访问：www.HanchorBio.com 媒体与投资者联络：汉康生技业务发展部 邮箱：BD@HanchorBio.com 前瞻性声明 本新闻稿包含前瞻性陈述，包括关于HCB101和HCB301的临床开发、初步临床发现的解读和潜在意义、未来临床研究和开发策略、汉康生技候选产品的潜在治疗特征，以及FBDB™平台的能力和潜力的陈述。这些陈述基于当前的预期和假设，涉及风险和不确定性，可能导致实际结果与描述存在重大差异。随着更多患者的入组、数据的成熟和分析的完成，临床发现（包括初步结果）可能发生变化。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 Earns Dual KSMO/FACO 2026 Recognition for HCB101 and HCB301 HCB101 gastric cancer data earned Best Poster recognition with 80% ORR at mid-dose levels; HCB301 oral presentation reported 38.1% disease control across advanced solid tumors TAIPEI, SHANGHAI, and SAN FRANCISCO — September 7, 2026 — HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced clinical results from HCB101 and HCB301 presented at KSMO 2026—the 19th Annual Meeting of the Korean Society of Medical Oncology and 2026 International Conference—held in conjunction with the 14th International Conference of the Federation of Asian Clinical Oncology (FACO), in Seoul, South Korea. HanchorBio received multiple forms of scientific recognition at the meeting. Among approximately 500 accepted poster abstracts, HCB101 gastric cancer data were selected as one of only 20 Best Poster Presentation Award recipients and one of only 10 abstracts chosen for a live Poster Discussion. Separately, excluding invited faculty and speakers, HCB301 was selected as one of only 12 oral presentations across the scientific program. HanchorBio also presented HCB101 HNSCC clinical data as an ePoster. The presentations highlighted key milestones for HanchorBio’s proprietary FBDB™ platform: HCB101 as a macrophage-directed clinical foundation with emerging clinical activity across gastric cancer and HNSCC, and HCB301, a first-in-class trispecific immunotherapy, as the next step toward coordinated multi-axis immune modulation with a single molecule. Alvin Luk, PhD, MBA, CCRA, President and Chief Medical Officer (Group) & CEO (USA) of HanchorBio, presented both the HCB101 gastric cancer Poster Discussion and the first-in-human HCB301 oral presentation. “The recognition of both HCB101 and HCB301 at KSMO/FACO is important because it reflects two stages of the same strategy through our FBDB™ platform—from establishing macrophage-directed clinical activity with HCB101 to extending that biology into multi-axis immune modulation with HCB301,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “HCB101 is anchoring our clinical strategy, while HCB301 tests whether three distinct drivers of immune resistance can be addressed within a single engineered therapeutic molecule.” HCB101 Strengthens 2L GC/GEJ as a Clinical Anchor HCB101 is an engineered SIRPα–IgG4 Fc fusion protein designed to block the CD47–SIRPα innate immune checkpoint and re-engage macrophage-mediated antitumor activity. In the ongoing HCB101-201 study (NCT06771622), 20 patients with second-line GC/GEJ were enrolled across HCB101 dose levels of 2.56–12 mg/kg in combination with ramucirumab plus paclitaxel. Among 15 efficacy-evaluable patients, the 5.12–8 mg/kg mid-dose cohorts achieved an ORR of 80.0%, with broad and deep tumor shrinkage observed across patients. The overall DCR was 93.3%. For historical context, ramucirumab plus paclitaxel produced ORRs of approximately 26–28% in RAINBOW and RAINBOW-Asia. The depth and consistency of tumor shrinkage support continued development of HCB101 in second-line GC/GEJ. In first-line HER2-positive gastric cancer, eight efficacy-evaluable patients treated with HCB101 plus trastuzumab, pertuzumab, and chemotherapy achieved an ORR of 75.0% and DCR of 100%. HCB101 Expands into HNSCC with Durable Monotherapy and Combination Activity HanchorBio also presented HCB101 data in recurrent or metastatic HNSCC, supporting its expansion as a rational setting beyond the gastric cancer clinical anchor. In HCB101-101 monotherapy, a confirmed partial response with ~42% tumor reduction was observed at 5.12 mg/kg, with treatment continuing beyond 80 weeks at the data cutoff. A second patient achieved disease control for approximately 34 weeks, with additional disease stabilization observed in HNSCC and nasopharyngeal carcinoma. In a Taiwan investigator-initiated combination study, 2 of 4 evaluable patients achieved objective responses (ORR 50%), including a complete response and a confirmed partial response, while all four achieved disease control at first assessment. Three remained on treatment beyond 16 weeks, including one beyond 48 weeks, with follow-up ongoing. Together, the monotherapy durability and emerging combination activity support continued evaluation of HCB101 in PD-1- and EGFR-directed strategies. HCB301 Advances Multi-Axis Immune Modulationinto the Clinic In an oral presentation at KSMO 2026, HanchorBio presented first-in-human clinical findings from the ongoing Phase 1 HCB301-101 study (NCT06487624). HCB301 opened the second of two selected oral presentation sessions at KSMO 2026. HCB301 is a trispecific SIRPα–PD-L1–TGFβ fusion protein designed to coordinately address innate immune suppression, adaptive immune checkpoint signaling, and TGFβ-mediated immune exclusion within a single molecule. Preclinical data presented at KSMO showed antitumor activity across two in vivo models, including tumor control in an HNSCC model and 98.5% tumor growth inhibition in combination in a breast cancer model, further supporting the rationale for coordinated engagement of these interconnected immune pathways. The oral presentation included 29 patients enrolled across the 0.3, 0.6, 0.9, and 1.2 mg/kg cohorts. Among 21 efficacy-evaluable patients, 8 achieved stable disease, corresponding to a DCR of 38.1%. Disease stabilization was observed across multiple solid tumor types, including hypopharyngeal carcinoma, hepatocellular carcinoma, colorectal cancer, cholangiocarcinoma, pelvic malignancy, and sarcoma, with the longest disease control exceeding four months. The population was heavily pretreated, with a median of four prior systemic therapy lines. Safety findings, including hematologic and infusion-related events, informed protocol refinements, enhanced monitoring, and dose-management strategies as development continues. “HCB301 asks a different question from conventional combination immunotherapy: can coordinated immune modulation be engineered into the molecule itself?” said Dr. Luk, who delivered the oral presentation. “What is encouraging is that we are already seeing disease stabilization across multiple tumor types during early dose escalation in a heavily pretreated population. These remain early Phase 1 data, but they support continued dose optimization as we work to define the therapeutic window and determine whether coordinated SIRPα–PD-L1–TGFβ targeting can translate into meaningful clinical benefit.” A Repeatable FBDB™ Clinical Strategy HCB101 established HanchorBio’s clinical foundation in macrophage-directed innate immunity. HCB301 extends that foundation into trispecific immunotherapy integrating innate, adaptive, and TGFβ-mediated immune biology. Understand the biology → engineer the right architecture → generate clinical evidence → learn where the biology works → expand deliberately About HCB101 HCB101 is an investigational engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB™ platform. HCB101 blocks CD47–SIRPα signaling to restore macrophage-mediated antitumor immunity and downstream de novo T-cell activation. It is being evaluated as monotherapy (NCT05892718) and in combination (NCT06771622) across solid and hematologic malignancies and holds U.S. FDA Orphan Drug Designation for gastric cancer. About HCB301 HCB301 is an investigational trispecific CD47–PD-L1–TGFβ fusion protein designed to concurrently address innate immune suppression, adaptive checkpoint signaling, and TGFβ-mediated immune exclusion within a single molecule. It is being evaluated in the ongoing first-in-human Phase 1 HCB301-101 study (NCT06487624). About HanchorBio HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on inventing next-generation biologics for cancer and immune-mediated diseases using its proprietary FBDB™ platform. HanchorBio’s pipeline includes clinical-stage programs HCB101 and HCB301, next-generation trispecific program HCB303, and additional candidates across oncology and immune-mediated diseases. Learn more at http://hanchorBio.com Media & Investor Contact: HanchorBio Business Development Email: BD@HanchorBio.com Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the clinical development of HCB101 and HCB301, interpretation and potential significance of preliminary clinical findings, future clinical studies and development strategies, potential therapeutic characteristics of HanchorBio’s product candidates, and the capabilities and potential of the FBDB™ platform. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those described. Clinical findings, including preliminary results, may change as additional patients are enrolled, data mature, and analyses are completed. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.