HanchorBio Outlines Global Growth Strategy and Multi-Asset Pipeline at Second Annual R&D Day
Lead asset HCB101 advances toward global registrational Phase 2/3 trial in second-line gastric cancer, supported by robust clinical activity data.
[TAIPEI, SHANGHAI, SAN FRANCISCO | September 23, 2026] — HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today hosted its second R&D Day. The Company presented its evolution from a single-asset clinical validation model into a multi-asset, macrophage-directed immunotherapy platform with global commercial potential.
At the center of HanchorBio’s strategy is its proprietary FBDB™ platform, designed to engage both innate and adaptive immunity. Lead candidate, HCB101 (SIRPα-IgG4-Fc fusion protein) serves as the clinical foundation, complemented by an expanding pipeline targeting distinct mechanism of immune resistance in oncology and immune-mediated diseases.
HCB101: Defined Registrational Path in Gastric Cancer and Portfolio Expansion
HanchorBio highlighted second-line gastric and gastroesophageal junction (GC/GEJ) cancer as the lead registrational path for HCB101, supported by a benchmarkable standard-of-care regimen, encouraging clinical activity and a defined global development strategy.
Key clinical milestones and updates include:
- High Responses Rates in GC/GEJ – in response-evaluable patients receiving mid-dose HCB101 (5.12–8 mg/kg QW) alongside with ramucirumab and paclitaxel, the combination demonstrated an 80% confirmed objective response rate (ORR) and a 100% disease control rate (n=10 participants).
- Global Registrational Trials Strategy – Following a recent face-to-face meeting with the U.S. FDA, HanchorBio is advancing a Q2W dose and schedule exploration protocol through the ongoing Phase 1b/2a HCB101-201 trial, followed by an international randomized Phase 2 lead-in to select the final regimen for a planned global confirmatory Phase 3 study evaluating overall survival (OS) rates.
- Expanding Franchise into CRC and HNSCC: As of July 2026, 6 of 12 efficacy-evaluable patients with microsatellite stable colorectal cancer (MSS CRC) achieved partial responses (50% overall ORR and 100% DCR) in 2L CRC cohorts. Development also continues in head and neck squamous cell carcinoma (HNSCC) in combination with an anti-PD-1 monoclonal antibody.
“HCB101 has moved beyond proof of biology,” said Alvin Luk, PhD, MBA, CCRA, President and Chief Medical Officer (Group) & CEO (USA) of HanchorBio. “We now have a clear registrational path in second-line GC/GEJ cancer, while strong preliminary antitumor activity signals in CRC and HNSCC demonstrate how broadly this biology can apply. Our focus is turning those clinical signals into disciplined global trials and strategic partnerships.”
Multi-Asset Pipeline: Moving Beyond HCB101.
HanchorBio’s research engine is advancing three additional differentiated assets through preclinical and clinical development:
- HCB301: Target TGFβ-associated immune exclusion to reactive cold tumors.
- HCB303:Combines SIRPα, PD-L1, and TIGIT/PVR biology to overcome adaptive immune resistance.
- HCB206: Extends the FBDB™ immune-engineering platform into autoimmune diseases through deep B-cell depletion initially targeting systemic lupus erythematosus (SLE).
“Our strategy centers on building differentiated biology, validating it in patients, and scaling through internal research projects and external partnerships,” said Scott Liu, PhD, Founder and Chairman of HanchorBio. “HCB101 is our clinical anchor, but our FBDB™ platform gives us an enabling engine to generate novel therapeutics across oncology and immunity.”
Strategic Collaborations to Accelerate Platform Research
HanchorBio continues to build external partnerships to maximize platform potential:
InxMed Collaboration – Combining HCB101 with small-molecule FAK inhibitor IN10018/ifebemtinib to tackle stroma-rich solid tumors.
AI-Driven Clinical Development – Partnering with InSilicoTrials to integrate AI modeling and simulation into clinical trial design, aiming to optimize dose selection and reduce patient burden during global execution.
External Innovation – Actively evaluating combination trials involving cancer mRNA/DNA vaccines, ADCs, and bispecific antibodies with global biopharmaceutical partners.
Build the platform. Generate the pipeline. Validate it in patients. Expand it globally.
Immunity was never one-dimensional. Neither are we.
One Clinical Anchor. A Broader Platform. Multiple Paths to Value.
About HanchorBio
HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company dedicated to developing transformative immunotherapies for cancer and immune-mediated diseases. Driven by its proprietary FBDB™ platform, HanchorBio designs multi-functional biologics engineered to overcome immune-resistance mechanisms. With operations in Taipei, Shanghai, and San Francisco, HanchorBio is advancing multi-asset pipeline through global clinical trials and strategic partnerships. For more information, please visit http://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.
HanchorBio Business Development Contact:
Email: [email protected]
Investor & Media Contact:
Email: [email protected]
漢康-KY第二屆技術研發日揭示全球成長策略與多元產品線布局
HCB101以二線胃癌為主要註冊開發路徑，朝全球第二／三期臨床試驗推進，並由具潛力的臨床活性數據支持後續開發
【台北、上海、舊金山｜2026年9月23日】－全球臨床階段生技公司漢康-KY（TWSE：7827）今日舉辦第二屆技術研發日，分享公司從單一資產臨床驗證，逐步發展為具多元產品線及全球商業潛力的巨噬細胞導向免疫治療平台。
漢康生技策略的核心為自主研發的 FBDB™ 多功能生物藥平台，旨在同時調控先天免疫與適應性免疫。核心候選藥物HCB101（SIRPα-IgG4-Fc 融合蛋白）作為公司的臨床開發基礎，並透過持續擴展的產品線，針對腫瘤及免疫介導疾病中不同的免疫抗性機制進行開發。
HCB101：確立胃癌註冊開發路徑，並持續拓展產品價值
漢康生技於會中指出，二線胃癌及胃食道交界部癌（GC/GEJ）為 HCB101 目前主要的註冊開發路徑。此策略奠基於具明確比較基準的標準治療、令人鼓舞的初步臨床活性，以及已逐步確立的全球臨床開發策略。
主要臨床里程碑及最新進展包括：
- GC/GEJ展現具潛力的臨床反應：在可評估腫瘤反應、接受中劑量 HCB101（5.12–8 mg/kg，每週一次）聯合雷莫蘆單抗（ramucirumab）及紫杉醇（paclitaxel）治療的病人中，經確認的客觀緩解率（ORR）達 80%，疾病控制率（DCR）達 100%（n=10）。
- 全球註冊臨床試驗策略：在近期與美國 FDA 進行面對面會議後，漢康生技正透過進行中的第一期 b／第二期 a HCB101-201 臨床試驗，推進每兩週一次（Q2W）的劑量及給藥時程探索；後續規劃進行國際隨機第二期導入研究，以選定最終治療方案，並進一步銜接規劃中的全球驗證性第三期臨床試驗，以整體存活期（OS）作為評估指標。
- 拓展至結直腸癌及頭頸癌：截至 2026 年 7 月，在二線微衛星穩定型結直腸癌（MSS CRC）研究組別中，12 名可評估療效病人有 6 名達腫瘤顯著縮小（PR），整體 ORR 為 50%，DCR 為 100%。此外，HCB101 聯合抗 PD-1 單株抗體於頭頸部鱗狀細胞癌（HNSCC）的臨床開發亦持續推進。
漢康生技集團總裁、醫療長暨美國子公司執行長陸英明博士表示：「HCB101 已不再只是生物學機制的概念驗證。我們目前在二線 GC/GEJ 已建立清晰的註冊開發路徑，同時 CRC 與 HNSCC 所觀察到的初步抗腫瘤活性訊號，也進一步展現這項生物學機制在不同腫瘤中的應用潛力。接下來，我們的重點是將這些臨床訊號轉化為嚴謹的全球臨床試驗與策略合作機會。」
多元產品線布局：從 HCB101 延伸至更多差異化資產
除 HCB101 外，漢康生技亦持續推進三項具差異化潛力的候選藥物進入臨床前及臨床開發階段：
- HCB301：鎖定與 TGFβ 相關的免疫排斥機制，旨在重新活化免疫反應較低的「冷腫瘤」。
- HCB303：整合 SIRPα、PD-L1 及 TIGIT/PVR 三項生物學機制，以克服適應性免疫抗性。
- HCB206：透過深度 B 細胞清除策略，將 FBDB™ 免疫工程平台延伸至自體免疫疾病領域，初期鎖定全身性紅斑性狼瘡（SLE）。
漢康生技創辦人暨董事長劉世高博士表示：「我們的策略核心，是建立具差異化的生物學機制，在病人中進行臨床驗證，並透過內部研發計畫與外部合作持續擴大其價值。HCB101 是我們的臨床支點，而 FBDB™ 平台則提供一個可持續產生創新療法的研發引擎，讓我們得以進一步拓展腫瘤與免疫相關疾病領域。」
策略合作加速平台研發與全球開發
漢康生技亦持續拓展外部策略合作，以進一步發揮 FBDB™ 平台及產品線的開發潛力：
- 與應世生物合作：探索 HCB101 與小分子 FAK 抑制劑 IN10018／ifebemtinib 的聯合治療，以因應富含基質的實體腫瘤。
- AI 驅動臨床開發：與 InSilicoTrials 合作，將 AI 建模與模擬技術導入臨床試驗設計，協助優化劑量選擇，並降低全球臨床執行過程中的病人負擔。
- 外部創新合作：積極評估與全球生技製藥夥伴進行癌症 mRNA／DNA 疫苗、抗體藥物複合體（ADC）及雙特異性抗體等聯合治療研究的可能性。
建立平台、拓展產品線、於病人中完成驗證，並走向全球。
免疫系統從來不是單一路徑，漢康的研發策略亦然。
一個臨床支點，更廣泛的平台，多元價值成長路徑。
關於漢康生技
漢康生技（TWSE：7827）為全球臨床階段生技公司，致力於開發癌症及免疫介導疾病的創新免疫療法。以自主研發的 FBDB™ 多功能生物藥平台為核心，漢康生技設計多功能生物製劑，以克服不同的免疫抗性機制。
漢康生技於台北、上海及舊金山設有營運據點，並透過全球臨床試驗及策略合作持續推進多元產品線開發。
前瞻性聲明
本新聞稿包含前瞻性聲明，包括有關 HCB101 與 HCB301 的臨床開發、初步臨床結果之解讀及潛在意義、未來臨床研究與開發策略、漢康生技候選藥物的潛在治療特性，以及 FBDB™ 平台能力與潛力等相關陳述。
上述聲明係基於目前的預期與假設，並涉及可能導致實際結果與本新聞稿所述內容產生重大差異的風險與不確定性。臨床結果，包括初步數據，可能隨著更多病人納入、數據逐步成熟及分析完成而有所變化。除適用法律另有要求外，漢康生技不負有更新前瞻性聲明之義務。