汉康生技宣布 HCB101
完成首次2,000升
临床用药GMP批次生产
头对头分析结果支持高度可比性，为后续临床推进、未来扩产及中长期生产规划建立重要基础
【台北、上海、旧金山｜2026年4月14日】——致力于开发新一代免疫疗法的全球临床阶段生物技术公司汉康生技，今日宣布，旗下核心 FBDB™（Fc-Based Designer Biologics）抗癌药物管线之一 HCB101，已顺利完成由 500 升放大至 2,000 升生物反应器的首次临床用药 GMP 批次生产。本次生产于药明生物同一生产基地完成，涵盖原液与制剂完整生产流程，并已达成既定生产目标。
在生物药临床阶段最重要的 CMC 里程碑之一，就是生产规模在确保质量的前提下，顺利放大到商业化生产所需的规模，一般而言即每批 2,000 升的规模。此次顺利完成 2,000 升放大规模的生产，标志着汉康在 HCB101 商业化制造方面迈出了一大步。
根据汉康生技实验室自主完成的头对头平行比较分析结果，HCB101 在纯度、分子异质性及功能相关质量属性等方面，整体结果支持 2,000 升所生产的 HCB101 原液质量与 500 升规模所生产的原液具有高度可比性。此结果表明，本次放大后批次在质量表现上与既有 500 升批次保持一致趋势，反映 HCB101 在更大生产规模下仍具有良好的工艺稳定性与质量一致性。
HCB101 为汉康生技重点开发的蛋白质药物管线之一，也是公司核心临床开发资产之一，目前处于临床开发阶段，并以胃癌二线治疗为首要开发方向。此次成功放大至 2,000 升，标志着 HCB101 在制造成熟度上再向前迈进一个重要节点，也进一步彰显其作为公司关键资产的战略地位。
对蛋白质药物而言，工艺放大不仅是产能提升，更是对工艺理解、分析方法、质量控制策略及外部制造整合能力的综合验证。尤其对 FBDB™ 这类复杂融合蛋白而言，能在不同规模下维持稳定制造表现，对药物后续的开发与商业化推进具有关键意义。本次放大成果与头对头分析结果，显示公司已在关键制造技术与质量管控上建立更扎实的执行基础。
汉康生技创始人兼董事长刘世高博士表示，本次 HCB101 以既有工艺的放大生产为核心目标，重点在于验证 HCB101 自 500 升提升至 2,000 升后，是否仍能维持稳定且可预测的产品质量表现。由于 500 升批次与 2,000 升批次均在药明生物的同一生产基地完成，此次成果更清楚反映公司在工艺放大执行、外部制造协作与跨规模质量控制上的整合能力，并有助于显著降低后续制造风险，确保二期乃至三期临床试验所需药品供应充足。
HCB101 目前正处于 1b/2a 临床开发阶段，此次完成 2,000 升临床用药 GMP 批次生产，除支持现阶段临床开发所需的供应准备外，也为后续扩产、中长期生产规划，以及向关键临床批次所需的制造与供应能力稳步迈进建立更有力的基础。公司将持续以审慎、务实且数据驱动的方式推进 HCB101 的 CMC 开发，并同步为后续商业化生产做好准备。
汉康生技 CMC 执行总监郭孟薇博士表示，生物药工艺放大的关键，不在于单纯提升生产体积，而在于能否在更高规模下持续维持稳定且一致的产品质量。本次 HCB101 自 500 升成功放大至 2,000 升，除了实际药品产量从原先的近 8,000 瓶大幅提升至近 40,000 瓶之外，并获得了支持其质量具有高度可比性的分析结果，代表我们对工艺与质量控制已有更深入的理解，也为后续临床供应、关键临床批次及未来商业化扩产推进，奠定了更扎实的基础。
汉康生技将持续推进 HCB101 与其他核心产品管线的开发，并持续强化公司在蛋白质药物开发、制造、质控与供应链的整体核心能力及国际竞争力，以加速实现造福全球癌症患者的使命。
关于 HCB101
HCB101 为汉康生技以 FBDB™ 平台理性设计开发的 SIRPα–IgG4 Fc 融合蛋白，旨在选择性阻断 CD47–SIRPα 先天免疫检查点，同时降低血液学毒性。不同于早期的抗 CD47 方法，HCB101 在保留巨噬细胞介导抗肿瘤活性的同时，降低对红细胞 CD47 的结合能力，以克服过去限制该疗法发展的关键挑战。
通过 AI 辅助结构建模，HCB101 对肿瘤细胞上的 CD47 具有差异化结合特性，并维持对红细胞 CD47 的低亲和力。其安全性、受体占有率与药理特性，均有利于与现有肿瘤治疗方案整合。目前 HCB101 正于胃癌、结直肠癌及头颈癌等适应症持续进行剂量递增与临床二期扩展研究。
综合上述特质，HCB101 已定位为具备差异化的先天免疫检查点骨干疗法，并具备横跨实体瘤与血液肿瘤的广泛潜力。
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，研发总部设于台北，并在上海及美国旧金山湾区设有运营办公室。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。
HanchorBio Announces Successful Completion of First 2,000L GMP Clinical Batch Production of HCB101
Head-to-head comparability results support high similarity, establishing a strong foundation for clinical advancement, future scale-up, and long-term manufacturing strategy
[Taipei, Shanghai, San Francisco | April 14, 2026] — HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and immune-related diseases, today announced that HCB101, one of its core FBDB™ (Fc-Based Designer Biologics) oncology pipeline assets, has successfully completed its first GMP clinical batch production scaled up from a 500L to a 2,000L bioreactor. This production was carried out at WuXi Biologics’ manufacturing facility, covering the full process from Drug Substance (DS) to Drug Product (DP), and achieved all predefined manufacturing objectives.
In biologics development, one of the most critical CMC (Chemistry, Manufacturing, and Control) milestones during the clinical stage is the successful scale-up of both process and production volume—while maintaining product quality—to levels required for commercialization, typically around 2,000L per batch. The successful completion of this 2,000L scale-up marks a significant step forward toward the commercial manufacturing readiness of HCB101.
According to internal head-to-head comparability studies conducted by HanchorBio, HCB101 produced at the 2,000L scale demonstrated high comparability to material produced at the 500L scale across key attributes, including purity, molecular heterogeneity, and functional quality characteristics. These results indicate that the scaled-up batch maintains consistent quality performance, reflecting strong process robustness and product consistency at a larger manufacturing scale.
HCB101 is one of HanchorBio’s key protein therapeutics under development and a core clinical asset of the Company. Currently in clinical development, its primary focus is on second-line treatment for gastric cancer. The successful scale-up to 2,000L represents another important milestone in manufacturing maturity and further underscores its strategic importance within the Company’s pipeline.
For protein therapeutics, process scale-up is not merely about increasing production capacity—it is a comprehensive validation of process understanding, analytical methods, quality control strategies, and external manufacturing integration capabilities. This is especially critical for complex fusion proteins such as FBDB™. Demonstrating consistent manufacturing performance across scales is essential for advancing clinical development and future commercialization. The successful scale-up and supporting comparability data indicate that HanchorBio has further strengthened its execution capabilities in manufacturing technology and quality control.
Dr. Scott Liu, Founder and Chairman of HanchorBio, stated that the primary objective of this scale-up was to verify whether HCB101 could maintain stable and predictable product quality when transitioning from 500L to 2,000L production. As both batches were manufactured at the same WuXi Biologics facility, the results clearly demonstrate the Company’s integrated capabilities in process scale-up execution, external manufacturing collaboration, and cross-scale quality control. This achievement is expected to significantly reduce future manufacturing risks and ensure sufficient drug supply for Phase II and Phase III clinical trials.
HCB101 is currently in Phase 1b/2a clinical development. The successful completion of the 2,000L GMP clinical batch not only supports current clinical supply readiness but also establishes a stronger foundation for future scale-up, long-term manufacturing planning, and progression toward pivotal clinical batch production. The Company will continue to advance HCB101’s CMC development in a prudent, data-driven manner while preparing for future commercial manufacturing.
Dr. Vivian Kuo, Executive Director of CMC at HanchorBio, commented that the key to biologics scale-up lies not simply in increasing production volume, but in maintaining consistent and stable product quality at higher scales. With HCB101 successfully scaled from 500L to 2,000L, the production output has increased significantly from approximately 8,000 vials to nearly 40,000 vials. Together with strong comparability results, this milestone reflects an enhanced understanding of process and quality control, laying a solid foundation for future clinical supply, pivotal batch manufacturing, and eventual commercial-scale production.
HanchorBio will continue advancing the development of HCB101 and its other core pipeline assets, while strengthening its capabilities in protein drug development, manufacturing, quality control, and supply chain management to enhance its global competitiveness and accelerate its mission to benefit cancer patients worldwide.
About HCB101
HCB101 is a rationally 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 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.
Forward-Looking Statements
This press release contains forward-looking statements based on the Company’s current expectations and beliefs regarding future events and developments. Actual results may differ materially due to risks and uncertainties, including clinical trial progress, regulatory review, manufacturing execution, market conditions, and other factors. The Company undertakes no obligation to update these forward-looking statements, except as required by applicable laws.
