HCB-301

汉康生技HCB101展现 “骨干疗法”潜力 科学顾问委员会就 胃癌注册路径达成共识 联合治疗数据凸显CD47项目跻身下一代免疫肿瘤交易资产之列；平台拓展至自身免疫、动脉粥样硬化及中枢神经系统递送领域 【台北、上海、旧金山｜2026年4月3日】——致力于开发下一代免疫疗法的全球临床阶段生物技术公司汉康生技，今日公布了近期科学顾问委员会会议的成果，重点展示了公司从平台验证向资产层面定位及注册策略的转变。 在最新数据集的支持下，HCB101正逐步形成CD47领域中日益罕见的药物特征：可用的安全窗口与联合治疗中可重复的疗效相结合。 在正在进行的HCB101-201联合研究中，二线胃癌在多个剂量队列中的总体客观缓解率约为60%（9/15），在中剂量水平（5.12 mg/kg和8 mg/kg）观察到更高的活性，客观缓解率达到约80%（8/10）。在这些剂量水平下，平均肿瘤缩小幅度分别为-33.4%和-46.0%，不仅显示出缓解频率，也体现了缓解深度。一线HER2阳性胃癌的客观缓解率约为83%（5/6）。 这些信号——现已跨越不同队列和联合方案得到观察——正开始形成一致的活动模式，而非孤立的反应。与此同时，HCB101单药研究已爬坡至36 mg/kg仍未达到最大耐受剂量，支持宽泛的治疗窗口，并使其能够灵活部署于多种治疗骨干之上。 综合这些数据，科学顾问委员会得出明确结论：HCB101正逐步成为一种联合骨干疗法——一种旨在与HER2、VEGF、PD-1及化疗方案整合的先天免疫检查点，定位为赋能层而非竞争性疗法。 —左右滑动，查看更多— 汉康生技创始人、董事长兼首席执行官刘世高博士表示： “HCB101的差异化优势不仅在于单独的安全性或有活性，而在于两者的结合使其能够跨多种骨干方案进行部署。这最终决定了某一机制是否具有临床可用性——在这种情况下，可能成为联合治疗的基础。” 基于全部数据，科学顾问委员会达成共识，优先将胃癌（尤其是二线治疗）作为主要的注册路径，进一步拓展将集中于确认持久性、剂量优化及跨联合方案的一致性。 在联合驱动的免疫肿瘤格局中的定位 随着免疫肿瘤学超越单一检查点阻断，竞争轴心日益转向某一机制能否作为联合赋能骨干而非单一疗法。在此背景下，价值由跨骨干兼容性、可重复的早期疗效信号以及支持持续联合开发的可预测安全性特征驱动。 近期在多特异性及下一代检查点资产领域的大规模交易反映了这一转变。在此背景下，科学顾问委员会的讨论强调，HCB101逐步显现的药物特征——尤其是在胃癌中的表现——与为联合开发和潜在合作策略设计的资产特征相符，并因其近期获得美国FDA孤儿药认定而进一步强化。跨骨干兼容性、可预测的安全性以及可重复疗效的早期证据正日益成为该领域交易的重心。 HCB301：将架构延伸 至单一机制检查点之外 科学顾问委员会还审阅了HCB301的早期临床数据，这是一种旨在单个治疗架构内协调CD47、PD-L1及TGF-β的三特异性分子。各剂量组观察到早期活性信号，疾病控制率约为35.7%，支持将先天免疫激活、适应性检查点调控及肿瘤微环境重塑整合于一个分子内的生物学前提。 讨论反映出该领域更广泛的转变：随着多机制架构在免疫肿瘤学中日益成为核心，关键问题已不再是可行性，而是临床可用性。在此背景下，HCB301的早期安全性特征——表现为可解释、可逆且临床可控的信号——被视为定义这类复杂分子如何开发的重要一步。科学顾问委员会一致认为，持续开发应集中于建立可预测性和操作控制，为剂量优化及进一步临床拓展铺平道路。 超越肿瘤：将CD47平台 拓展至更广泛的疾病生物学 虽然HCB101定义了公司近期的临床重点，但科学顾问委员会还审阅了汉康生技平台在肿瘤之外领域的持续拓展。近期的努力已将基于CD47及多特异性方法延伸至自身免疫疾病、血管生物学（包括动脉粥样硬化）以及中枢神经系统适应症（如胶质母细胞瘤），这些领域在递送和免疫调控方面面临独特挑战。这些项目反映了一贯的战略：将先天免疫调控作为一种跨疾病的机制，而非肿瘤特异性方法。自2025年10月以来，公司已拓展至超过16个在研项目，整合AI辅助工具以支持靶点选择、分子设计及开发规划。 从平台到产品 科学顾问委员会的讨论明确表明，汉康生技正进入一个新阶段——从平台扩展转向临床优先排序与执行。随着胃癌被确定为HCB101的主要适应症，且HCB301的结构化开发框架已建立，公司的重点转向确认持久性、规模化联合策略、推进后期开发以及寻求潜在的全球合作。 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自身免疫疾病领域，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 END HanchorBio Signals “Backbone” Potential for HCB101 as SAB Aligns on Gastric Cancer Registrational Path Emerging combination profile positions CD47 program alongside next-generation IO deal assets; platform expands beyond oncology into autoimmune, atherosclerosis, and CNS delivery [Taipei, Shanghai, San Francisco | April 3, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies, reported outcomes from its recent Scientific Advisory Board (SAB) meeting, highlighting a shift from platform validation to asset-level positioning and registrational strategy. Across updated datasets, HCB101 is converging on a profile that is increasingly rare in the CD47 field: a usable safety window combined with reproducible efficacy in combination settings. In the ongoing HCB101-201 combination study, second-line gastric cancer demonstrated an overall objective response rate (ORR) of ~60% (9/15) across multiple dose cohorts, with higher activity observed at mid-dose levels (5.12 and 8 mg/kg), where ORR reached ~80% (8/10). At these dose levels, mean tumor shrinkage was -33.4% and -46.0%, respectively, indicating not only response frequency but also depth of response. First-line HER2-positive gastric cancer achieved an ORR of ~83% (5/6). These signals—now observed across cohorts and combinations—are beginning to define a consistent pattern of activity rather than isolated responses. In parallel, the HCB101 monotherapy study has escalated to 36 mg/kg without reaching maximum tolerated dose, supporting a broad therapeutic window and enabling flexible deployment across treatment backbones. Taken together, these data led the SAB to a clear conclusion: HCB101 is emerging as a combination backbone therapy—an innate immune checkpoint designed to integrate across HER2, VEGF, PD-1, and chemotherapy regimens, positioning it as an enabling layer rather than a competing modality. “What differentiates HCB101 is not just safety or activity in isolation, but the combination of both in a way that allows it to be deployed across multiple backbones,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “This is ultimately what determines whether a mechanism becomes clinically usable—and, in this case, potentially foundational to combination therapy.” Based on the totality of data, the SAB reached alignment on prioritizing gastric cancer, particularly in the second-line setting, as the lead registrational path, with further expansion focused on confirming durability, dose optimization, and consistency across combinations. Positioning Within a Combination-Driven IO Landscape As immuno-oncology shifts beyond single-agent checkpoint blockade, the competitive axis increasingly centers on whether a mechanism can serve as a combination-enabling backbone rather than a standalone therapy. In this environment, value is driven by cross-backbone compatibility, reproducible early efficacy signals, and predictable safety profiles that support continued combination development. Recent large-scale transactions in multi-specific and next-generation checkpoint assets reflect this shift. Within this context, the SAB discussion highlighted that HCB101’s emerging profile, particularly in gastric cancer, aligns with these characteristics of assets designed for combination-based development and potential partnership strategies, further reinforced by its recent Orphan Drug Designation from the U.S. FDA. Cross-backbone compatibility, predictable safety, and early evidence of reproducible efficacy are increasingly defining the center of gravity for deal-making in the sector. HCB301: Extending the Architecture Beyond Single-Mechanism Checkpoints The SAB also reviewed early clinical data from HCB301, a tri-specific molecule designed to coordinate CD47, PD-L1, and TGFb within a single therapeutic architecture. Early signals of activity were observed, with a disease control rate (DCR) of ~35.7% across dose levels, supporting the biological premise of integrating innate immune activation, adaptive checkpoint modulation, and tumor microenvironment remodeling within one molecule. The discussion reflected a broader shift in the field: as multi-mechanism architectures become increasingly central to immuno-oncology, the key question is no longer feasibility, but clinical usability. In that context, the early safety profile of HCB301—characterized by signals that appear interpretable, reversible, and clinically manageable—was viewed as an important step toward defining how such complex molecules can be developed. The SAB aligned that continued development should focus on establishing predictability and operational control, enabling a path forward for dose optimization and further clinical expansion. Beyond Oncology: Expanding the CD47 Platform Across Disease Biology While HCB101 defines the company’s near-term clinical focus, the SAB also reviewed continued expansion of HanchorBio’s platform beyond oncology. Recent efforts have extended CD47-based and multispecific approaches into autoimmune disease, vascular biology (including atherosclerosis), and central nervous system indications such as glioblastoma, where delivery and immune modulation present distinct challenges. These programs reflect a consistent strategy: leveraging innate immune modulation as a cross-disease mechanism, rather than a cancer-specific approach. Since October 2025, the company has expanded to more than 16 active programs, integrating AI-enabled tools to support target selection, molecular design, and development planning. From Platform to Product The SAB discussion made clear that HanchorBio is entering a new phase—from platform expansion to clinical prioritization and execution. With gastric cancer now defined as the lead indication for HCB101, and a structured development framework established for HCB301, the company’s focus shifts to confirming durability, scaling combination strategies, advancing into late-stage development, and pursuing potential global partnerships. 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 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. END