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 XX, 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.
隨著科學顧問委員會（SAB）就胃癌藥證註冊路徑達成共識，漢康生技釋出 HCB101 具備「治療骨幹療法」潛力的明確訊號
聯合治療數據凸顯CD47項目躋身下一代免疫腫瘤交易資產之列；平台拓展至自體免疫、動脈粥樣硬化及中樞神經系統領域
【台北、上海、舊金山｜2026年4月3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，今日公布近期科學顧問委員會（SAB）會議重點成果，科學顧問委員會由多位國際級生醫專家與權威醫學教授組成，展現公司正由平台驗證階段，邁向以產品組合布局與藥證申請策略為核心的發展轉型。
在最新數據支持下，HCB101 已逐步展現出在 CD47 領域中日益少見的藥物特性：兼具可運用的安全治療窗口，並在聯合治療中呈現具一致性的療效表現。在進行中的 HCB101-201 聯合治療試驗中，二線胃癌（2L GC）於多個劑量組別中觀察到約 60% 的整體反應率（ORR）（9/15）。其中有療效潛力的中劑量區間（5.12 與 8 mg/kg）表現更為突出，ORR 提升至約 80%（8/10）。目前更高劑量組的試驗正持續進行中，後續數據更新值得期待，或有望進一步提升客觀反應率（ORR）。
在上述劑量水平下，腫瘤平均縮小幅度分別為 -33.4% 與 -46.0%，顯示不僅具備較高的反應率，同時亦呈現顯著的反應深度（depth of response）。在一線 HER2 陽性胃癌中，亦觀察到約 83% 的 ORR（5/6）。這些療效訊號已在不同劑量組別與聯合方案中持續出現，逐步呈現出一致性的療效模式（consistent pattern of activity），而非單一或偶發性反應。此外，在 HCB101 單藥試驗中，劑量已提升至 36 mg/kg，仍未達到最大耐受劑量（MTD），支持其具備寬廣的治療窗口（therapeutic window），並有助於其作為多種治療骨幹（treatment backbone）的靈活應用。綜合上述數據，科學顧問委員會形成明確共識：HCB101 正逐步發展為一項「聯合治療骨幹」療法——作為一種先天免疫檢查點機制，設計上可與 HER2、VEGF、PD-1 以及化療等療法整合應用，並定位為具平台特性的關鍵組成，而非僅止於單一競爭型產品。
漢康生技創始人、董事長兼執行長劉世高博士表示：
「HCB101 的差異化優勢，不僅在於單一的安全性或療效，而在於兩者的結合，使其能夠靈活應用於多種治療組合。這也正是決定一項治療機制是否具備臨床可用性的關鍵——在此基礎上，HCB101 有潛力成為聯合治療的核心基石。」而基於整體數據評估，科學顧問委員會亦達成共識，將優先以胃癌（特別是二線治療）作為主要的藥證申請路徑，並進一步聚焦於療效持久性驗證、劑量最佳化，以及跨不同聯合治療組合的一致性表現。
在聯合導向的免疫腫瘤格局中的定位
隨著免疫腫瘤學從單一免疫檢查點阻斷逐步走向多機制聯合策略，產業競爭焦點也隨之轉變：關鍵不再只是單一療法的效果，而是某一機制是否具備成為「聯合賦能骨幹療法」的潛力。在此趨勢下，價值判斷逐漸建立於幾項核心要素，包括：跨不同治療骨幹的相容性、可重現的早期療效訊號，以及能支持長期聯合開發的可預測安全性特徵。近期多特異性抗體與新一代免疫檢查點療法相關的大型授權與併購交易，也反映出此一明確趨勢。在這樣的產業背景下，科學顧問委員會指出，HCB101 目前逐步展現的藥物特性——特別是在胃癌適應症中的表現——已與聯合開發及潛在策略合作所需的關鍵生物藥特徵高度契合，並因近期取得美國 FDA 孤兒藥資格認定而進一步強化其策略價值。整體而言，「跨骨幹療法的相容性」、「可預測的安全性」以及「可重現的療效訊號」，正逐漸成為當前免疫腫瘤領域交易與合作評估的核心指標。
HCB301：將治療架構拓展至單一機制檢查點之外
科學顧問委員會亦審閱了 HCB301 的早期臨床數據。HCB301 為一項三特異性分子，設計上可在單一治療架構中同時協同調控 CD47、PD-L1 及 TGF-β 三大機制。在各劑量組中已觀察到初步療效訊號，疾病控制率約為 35.7%，顯示其具備將先天免疫活化、適應性免疫檢查點調節，以及腫瘤微環境重塑等關鍵生物學機制整合於單一分子的潛力。本次討論反映出該領域的整體趨勢轉變：隨著多機制架構在免疫腫瘤學中逐漸成為核心，關鍵問題已不再是「是否可行」，而是「能否在臨床上實際應用」。在這樣的背景下，HCB301 早期展現的安全性特徵——具備可解釋性、可逆性，且在臨床上可控——被視為界定此類複雜分子開發方向的重要里程碑。科學顧問委員會一致認為，後續開發應聚焦於提升可預測性與操作上的可控性，為劑量最佳化及後續臨床擴展奠定基礎。
超越腫瘤：將 CD47 平台拓展至更廣泛的疾病領域
雖然 HCB101 定義了公司近期的臨床發展重點，科學顧問委員會亦審視了漢康生技在腫瘤以外領域的持續布局。近期研發已將以 CD47 為核心的多特異性技術，延伸至自身免疫疾病、血管生物學（包含動脈粥樣硬化），以及中樞神經系統適應症（如膠質母細胞瘤）等領域。這些領域在藥物遞送與免疫調控上各具挑戰。相關專案展現出公司一貫的策略方向：將先天免疫調控視為可跨疾病應用的核心機制，而非僅限於腫瘤領域。自 2025 年 10 月以來，公司在研專案已擴展至超過 16 項，並導入 AI 輔助工具，以強化靶點篩選、分子設計與整體開發規劃。
從平台走向產品
科學顧問委員會的討論明確指出，漢康生技正邁入新一階段——由平台拓展轉向臨床優先排序與實質執行。專家們一致認可 HCB-101 具備開發為廣譜百搭藥物（Backbone）的巨大潛力，未來可透過多元化的聯合用藥策略（Combination Therapy），為多項實體腫瘤提供具突破性的臨床選擇。隨著胃癌被確立為 HCB101 的主要適應症，且 HCB301 的結構化開發策略逐步成形，公司未來的重點將放在驗證療效持久性、擴展聯合治療策略、推進後期臨床開發，以及積極尋求全球合作機會。
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。