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 13, 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.
漢康生技宣布 HCB101 完成首次 2,000 公升臨床用藥 GMP 批次生產
頭對頭分析結果支持高度可比較性，為後續臨床推進、未來擴產及中長期製造規劃建立重要基礎
【台北、上海、舊金山｜2026年4月13日】──致力於開發新一代免疫療法的全球臨床階段生技公司漢康生技，今日宣布，旗下核心 FBDBTM（Fc-Based Designer Biologics）抗癌藥物管線之一 HCB101，已順利完成由 500 公升放大至 2,000 公升生物反應器（bioreactor） 的首次臨床用藥 GMP 批次生產。本次生產於藥明生物（WuXi Biologics）同一製造基地完成，涵蓋原液（Drug Substance）與製劑（Drug Product）完整製造流程，並已達成既定生產目標。
在生物藥臨床階段的最重要的一個CMC（chemistry, manufacture and control）里程碑之一，就是生產產程及產量在確保品質的前提下，順利放大到商業化生產所需的規模，一般而言也就是每批2,000公升的規模。此次順利完成2,000公升放大規模的生產，代表著漢康又往HCB101的商業化製造邁開了一大步。
根據漢康生技實驗室自主完成之頭對頭平行比較分析結果，HCB101 在純度、分子異質性及功能相關品質屬性等面向，整體結果支持2000升所生產的HCB101的原液品質與500升規模所生產出的原液具高度可比性。此一結果顯示，本次放大後批次於品質表現上與既有 500 公升批次維持一致趨勢，反映 HCB101 在更大生產規模下仍具良好的製程穩定性與品質一致性。
HCB101 為漢康生技重點開發中的蛋白質藥物管線之一，也是公司核心臨床開發資產之一，目前處於臨床開發階段，並以胃癌二線治療為首要開發方向。此次成功放大至 2,000 公升，標誌 HCB101 在製造成熟度上再向前邁進一個重要節點，也進一步彰顯其作為公司關鍵資產的戰略地位。
對蛋白質藥物而言，製程放大不僅是產能提升，更是對製程理解、分析方法、品質控制策略及外部製造整合能力的綜合驗證。尤其對 FBDBTM 這類複雜融合蛋白而言，能在不同規模下維持穩定製造表現，對藥物後續的開發與商業化推進具有關鍵意義。本次放大成果與頭對頭分析結果，顯示公司已在關鍵製造技術與品質管控上建立更扎實的執行基礎。
漢康生技創辦人暨董事長劉世高博士表示，本次HCB101以既有製程的放大生產為核心目標，重點在於驗證 HCB101 自 500 公升提升至 2,000 公升後，是否仍能維持穩定且可預測的產品品質表現。由於 500 公升批次與 2,000 公升批次均於藥明生物的同一製造基地完成，此次成果更清楚反映公司在製程放大執行、外部製造協作與跨規模品質控制上的整合能力，並有助於顯著降低後續製造風險，並確保二期乃至三期臨床試驗所需藥品供應充足。
HCB101 目前正處於1b/2a臨床開發階段，此次完成2,000 公升臨床用藥 GMP 批次生產，除支持現階段臨床開發所需之供應準備外，亦為後續擴產、中長期製造規劃，以及朝關鍵臨床批次所需之製造與供應能力穩步邁進建立更有力的基礎。公司將持續以審慎、務實且數據導向的方式推進 HCB101 的CMC開發，並同步為後續商業化生產做好準備。
漢康生技 CMC 執行總監郭孟薇博士表示，生物藥製程放大的關鍵，不在於單純提升生產體積，而在於能否在更高規模下持續維持穩定且一致的產品品質。本次 HCB101 自 500 公升成功放大至 2,000 公升，除了實際藥品產量從原先的近 8,000 vials 大幅提升至近40,000 vials 之外，並獲得支持其品質具高度可比性的分析結果，代表我們對製程與品質控制已有更進一步的理解，也為後續臨床供應、關鍵臨床批次、及未來商業化擴產推進，奠定了更扎實的基礎。
漢康生技將持續推進 HCB101 與其他核心產品管線之開發，並持續強化公司在蛋白質藥物開發、製造、質控與供應鏈的整體核心能力及國際競爭力，以加速達成造福全球癌症病患的使命。
關於 HCB101
HCB101 為漢康生技以 FBDB™ 平台理性設計開發之 SIRPα–IgG4 Fc 融合蛋白，旨在選擇性阻斷 CD47–SIRPα 先天免疫檢查點，同時降低血液學毒性。不同於早期的抗 CD47，HCB101 在保留巨噬細胞介導抗腫瘤活性的同時，降低對紅血球 CD47 的結合能力，以克服過去限制該療法發展的關鍵挑戰。
透過 AI 輔助結構建模，HCB101 對腫瘤細胞上的 CD47 具差異化結合特性，並維持對紅血球 CD47 的低親和力。其安全性、受體佔有率與藥理特性，皆有利於與既有腫瘤治療方案整合。目前 HCB101 正於胃癌、大腸直腸癌及頭頸癌等適應症持續進行劑量遞增與臨床二期擴展研究。
綜合上述特質，HCB101 已定位為具備差異化的先天免疫檢查點骨幹（Backbone），並具備橫跨實體腫瘤與血液腫瘤的廣泛潛力。
關於漢康生技
漢康生技（股票代碼：7827.TPEx）是一家全球臨床階段的生物技術公司，專注於腫瘤免疫學及自體免疫疾病領域，研發總部設於台北，並在上海及美國舊金山灣區設有運營辦公室。公司由一支在生物藥發現與全球開發方面擁有豐富成功經驗的資深團隊領導，致力於重塑癌症治療格局。漢康生技專有的Fc基礎設計生物藥平台能夠開發具有多種靶向模式的多功能生物藥，旨在激活先天性與適應性免疫通路，以突破當前抗PD-1/L1免疫療法的局限。該平台已在多個體內腫瘤動物模型中成功獲得概念驗證數據。通過差異化的分子研發策略與可規模化的CMC工藝開發，漢康生技正推進一系列創新生物藥管線，致力於解決尚未被滿足的重大醫療需求。
本新聞稿包含若干前瞻性陳述，相關陳述係基於本公司目前對未來事件及發展之看法與預期，實際結果可能因臨床試驗進度、監管審查、製造執行、市場環境及其他風險因素而與目前預期有所差異。本公司不負更新該等前瞻性陳述之義務，除非法令另有要求。