HanchorBio Advances HCB101 Toward Global Registrational Development Following SAB Review and FDA Alignment
Six months of clinical progress establish 2L gastric cancer as the primary clinical anchor, with expanding proof-of-concept activity across 2L MSS colorectal cancer, HER2+ gastric cancer, and HNSCC, alongside growing value through partnerships and next-generation research
[Taipei, Shanghai, San Francisco | October 19, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced outcomes from its latest Scientific Advisory Board (SAB) meeting. Highlights included significant clinical progress for its lead asset, HCB101; alignment with the U.S. FDA on a registrational pathway in second-line gastric/ gastroesophageal junction (GC/GEJ) cancer; and continued expansion of the company’s research pipeline across oncology and immune-mediated diseases.
The meeting marked a clear strategic transition for HCB101 from early clinical proof of concept toward global development optimization and broad combination strategies. Discussion focused on establishing second-line GC/GEJ cancer as the clinical and registrational anchor, optimizing HCB101 dose and schedule for global development, defining expansion opportunities in MSS colorectal cancer and HNSCC, and extending HCB101’s value through external combinations and partnerships. The HCB101 clinical program was presented by Dr. Alvin Luk, President and Chief Medical Officer of HanchorBio.
“This was a very different SAB meeting from six months ago and reflected remarkable progress at HanchorBio—not only clinically, but across research, translational science and discovery,” said Professor Mingyi Chen, SAB Chairman. “HCB101 has moved from proof of biology toward a clearly defined development strategy. At the same time, the team has generated an extraordinary amount of new research across oncology, autoimmune disease, glioblastoma, and next-generation immune engineering. What impressed me most was how quickly the organization is turning scientific concepts into actionable data and development opportunities. The progress in just six months is genuinely exciting.”
2L Gastric Cancer Emerges as Clinical Anchor with FDA Alignment
The SAB reviewed encouraging clinical data evaluating HCB101 in combination with ramucirumab and paclitaxel in second-line GC/GEJ cancer. Highlights of the GC/GEJ trial include: (1) High Response Rate: HCB101 achieved a 63% objective response rate (ORR) (10/16 evaluable patients) and a 100% disease control rate (DCR) across the 5.12 and 8 mg/kg mid-dose cohorts. (2) Durable Benefit: A substantial proportion of patients remained on treatment beyond 18 weeks.
For context, in RAINBOW-Asia (NCT01939899), a Phase 3 bridging study conducted in an Asian, predominantly Chinese population, ramucirumab plus paclitaxel achieved an ORR of 26.5% and a median PFS of 4.14 months (~18 weeks). Direct cross-trial comparisons should be interpreted with caution.
Importantly, following a June 2026 meeting with the U.S. FDA, HanchorBio reached alignment on a stepwise registrational strategy. The path forward includes a randomized Phase 2 lead-in for regimen selection, followed by a confirmatory Phase 3 trial with overall survival (OS) as the primary endpoint.
Expansion Signals in MSS Colorectal and Head & Neck Cancers
HanchorBio presented expanding data for HCB101 in additional solid tumor settings:
Microsatellite-stable (MSS) Colorectal Cancer (CRC): In a second-line MSS CRC cohort evaluating HCB101 plus bevacizumab and chemotherapy, HCB101 achieved a 50% ORR (2/4 patients) and 100% DCR. Across broader sponsor-led CRC combination cohorts, responses were also observed with multiple standard-of-care regimens, supporting the potential portability of HCB101 in CRC treatment backbones. Complementary investigator-initiated trials in Taiwan showed sustained disease control with low-dose HCB101 plus bevacizumab and chemotherapy, including clinical benefit extending beyond 48 and 64 weeks in selected patients. For context, historical second-line bevacizumab-based regimens have produced ORRs of ~5–23% and median PFS of ~5.7-7.3 months (24-31 weeks). Cross-trial comparisons should be interpreted cautiously.
Head and Neck Squamous Cell Carcinoma (HNSCC): HCB101 monotherapy generated a durable partial response lasting more than 80 weeks, with recent FDA-granted single-patient expanded access (compassionate use) allowing continued treatment. Importantly, a Taiwan investigator-initiated study combining low-dose HCB101 with PD-1 blockade has produced early objective responses, including one complete response and one partial response, further supporting development of HCB101-based immunotherapy combinations.
Multiplicative Value Through Combination Partnerships
The SAB viewed HCB101 as a flexible, combination-ready macrophage backbone, rather than a drug tied to a single regimen. HanchorBio is actively evaluating rational combinations pairing HCB101 with next-generation bispecific and multispecific modalities, HER2-directed therapies, cancer vaccines, ADCs, chemotherapy, and stromal/TME-directed agents.
“Six months ago, we were still proving what HCB101 could become. Today, we have a clinical anchor, an FDA-aligned registrational development path, expanding clinical signals in CRC and HNSCC, and growing opportunities to multiply HCB101’s value through partnerships,” said Scott Liu, Ph.D., Founder and Chairman of HanchorBio. “Our ambition is larger than a single drug. We are building a global innovation engine through our FBDB™ platform that can repeatedly turn differentiated science into high-value medicines.”
Discovery Engine Advances Multi-Disciplinary Portfolio
Led by Chief Scientific Officer Dr. Wenwu Zhai, HanchorBio’s research organization presented progress across oncology, autoimmune disease, CNS disorders, and cardiovascular biology.
Glioblastoma (GBM): HanchorBio presented encouraging preclinical data exploring macrophage-directed therapy in combination with standard-of-care treatment, together with next-generation approaches designed to improve delivery across the blood-brain barrier. The SAB encouraged further validation across orthotopic models and direct demonstration of CNS exposure.
Autoimmune & Cardiovascular Biology: The SAB reviewed next-generation approaches designed to achieve deeper and more durable depletion of pathogenic B-cell and antibody-producing cell populations, as well as programs targeting inflammatory pathways implicated in treatment-resistant autoimmune disease. The SAB also reviewed exploratory research extending macrophage biology into atherosclerosis and plaque stabilization, with emphasis on identifying value beyond conventional lipid lowering.
About HanchorBio
HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on developing transformational immunotherapies for cancer and severe immune-related diseases. Powered by its proprietary FBDB™ platform, HanchorBio designs multi-functional biologics engineered to re-engage innate and adaptive immunity. With operations spanning Taipei, Shanghai, and San Francisco, the company is committed to advancing differentiated science into high-impact global therapies.
Forward-Looking Statements
This press release contains forward-looking statements regarding the development of HCB101, HCB301 and HanchorBio’s pipeline; the interpretation and potential significance of preliminary clinical findings; future clinical studies, development strategies, indications, combinations and partnerships; 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. Preliminary clinical findings may change as follow-up continues and data mature. Regulatory discussions do not constitute approval or assurance of future development or product approval.
HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.
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漢康生技召開科學顧問委員會議 HCB101 臨床進展與 FDA 共識支持邁向全球註冊性臨床開發
六個月臨床進展確立二線胃癌為核心開發方向，並於二線微衛星穩定型大腸直腸癌、HER2 陽性胃癌及頭頸癌持續累積概念驗證數據，透過策略合作與新一代研發布局拓展產品價值
【台北、上海、舊金山，2026 年 10 月 19 日】－全球臨床階段生技公司漢康生技（TWSE：7827），致力於開發應用於腫瘤及免疫介導疾病的次世代免疫療法，今日公布最新科學顧問委員會（Scientific Advisory Board, SAB）會議成果，重點包括核心候選藥物 HCB101 的重要臨床進展、與美國食品藥物管理局（FDA）就二線胃癌及胃食道交界處癌（GC/GEJ）註冊性臨床開發路徑達成共識，以及持續拓展腫瘤與免疫介導疾病的研發產品線。
本次會議標誌著 HCB101 從早期臨床概念驗證，逐步邁向全球臨床開發優化與多元聯合治療策略。討論重點包括確立二線胃癌及胃食道交界處癌為核心臨床與註冊開發方向、優化全球開發劑量及給藥時程、評估微衛星穩定型（MSS）大腸直腸癌與頭頸癌的拓展機會，以及透過外部聯合治療與策略合作擴大 HCB101 的產品價值。HCB101 臨床開發計畫由漢康生技總裁暨醫療長陸英明博士進行報告。
科學顧問委員會主席陳明義教授表示：「與六個月前相比，本次會議展現漢康生技在臨床、研究、轉譯科學及新藥探索方面的顯著進展。HCB101 已從生物學機制驗證邁向明確的開發策略，同時，研發團隊也在腫瘤、自體免疫疾病、膠質母細胞瘤及新一代免疫工程等領域取得大量新研究成果。最令我印象深刻的是，團隊能迅速將科學概念轉化為具體數據與開發機會，短短六個月內的進展令人振奮。」
二線胃癌確立為核心臨床開發方向，並與 FDA 達成開發共識
科學顧問委員會審閱 HCB101 聯合雷莫蘆單抗（ramucirumab）及紫杉醇（paclitaxel）治療二線胃癌及胃食道交界處癌的臨床數據。在 5.12 及 8 mg/kg 中劑量組別中，16 名可評估病人有 10 名達到客觀緩解，客觀緩解率（ORR）為 63%，疾病控制率（DCR）達 100%，且相當比例病人持續接受治療超過 18 週。
作為參考，於亞洲、以中國病人為主的第三期橋接試驗 RAINBOW-Asia（NCT01939899）中，雷莫蘆單抗聯合紫杉醇的 ORR 為 26.5%，中位無惡化存活期（PFS）為 4.14 個月（約 18 週）。惟不同臨床試驗間的數據比較仍須審慎解讀。
此外，漢康生技於 2026 年 6 月與美國 FDA 會議後，就分階段註冊性臨床開發策略達成共識。後續規劃將先進行隨機分組第二期臨床試驗，以選定治療方案，再推進至以整體存活期（OS）為主要評估指標的確認性第三期臨床試驗。
HCB101 於大腸直腸癌及頭頸癌持續展現臨床活性訊號
漢康生技亦於會中分享 HCB101 在其他實體腫瘤適應症的最新臨床進展。
微衛星穩定型大腸直腸癌（MSS CRC）：
在二線 MSS 大腸直腸癌研究組別中，HCB101 聯合貝伐珠單抗（bevacizumab）及化學治療，4 名病人中有 2 名達到客觀緩解，ORR 為 50%，DCR 達 100%。
此外，在公司主導的其他大腸直腸癌聯合治療研究組別中，HCB101 搭配不同標準治療方案均觀察到腫瘤反應，支持其與多種治療組合搭配的潛力。台灣研究者發起的臨床試驗亦觀察到，低劑量 HCB101 聯合貝伐珠單抗及化療可帶來持續的疾病控制，部分病人的臨床受益時間超過 48 週及 64 週。
作為參考，歷史二線貝伐珠單抗相關治療方案的 ORR 約為 5% 至 23%，中位 PFS 約為 5.7 至 7.3 個月（24 至 31 週），惟跨試驗比較仍須審慎解讀。
頭頸部鱗狀細胞癌（HNSCC）：
HCB101 單藥治療已觀察到持續超過 80 週的部分緩解（PR），近期並獲美國 FDA 核准單一病人擴大使用（恩慈使用），使該病人得以持續接受治療。
此外，台灣研究者發起的臨床試驗中，低劑量 HCB101 聯合 PD-1 抑制劑已觀察到初步客觀緩解，包括一例完全緩解（CR）及一例部分緩解（PR），進一步支持 HCB101 免疫聯合治療的開發潛力。
透過多元聯合治療與策略合作擴大 HCB101 產品價值
科學顧問委員會認為，HCB101 不僅適用於單一治療方案，更具備作為巨噬細胞導向聯合治療基礎藥物的潛力。
漢康生技正積極評估 HCB101 與新一代雙特異性及多特異性療法、HER2 標靶治療、癌症疫苗、抗體藥物複合體（ADC）、化學治療，以及針對腫瘤基質與腫瘤微環境（TME）的療法進行聯合開發。
漢康生技創辦人暨董事長劉世高博士表示：「六個月前，我們仍在驗證 HCB101 的發展潛力。如今，我們已確立核心臨床開發方向、與 FDA 達成註冊性開發路徑共識，並在大腸直腸癌及頭頸癌持續累積臨床訊號，同時透過策略合作拓展 HCB101 的產品價值。我們的目標不僅是開發單一藥物，更希望透過 FBDB™ 平台建立全球創新研發引擎，持續將差異化科學技術轉化為具高度價值的創新藥物。」
推進跨領域創新研發，拓展多元產品布局
由科學長翟文武博士領導的研發團隊，於會中展示涵蓋腫瘤、自體免疫疾病、中樞神經系統疾病及心血管生物學等領域的研究進展。
膠質母細胞瘤（GBM）：
漢康生技分享巨噬細胞導向療法聯合標準治療的初步臨床前研究數據，以及旨在改善藥物穿越血腦障壁的新一代技術。科學顧問委員會建議進一步透過原位腫瘤模型驗證，並直接確認藥物於中樞神經系統的暴露情形。
自體免疫疾病與心血管生物學：
科學顧問委員會審閱新一代免疫治療策略，包括更深入且持久地清除致病性 B 細胞及抗體生成細胞，以及針對治療抗性自體免疫疾病相關發炎路徑的研發計畫。
此外，會議亦討論將巨噬細胞生物學延伸至動脈粥狀硬化及斑塊穩定性的探索性研究，著重評估超越傳統降血脂治療的潛在價值。
關於漢康生技
漢康生技（TWSE：7827）為全球臨床階段生技公司，專注於開發癌症及嚴重免疫相關疾病的創新免疫療法。公司透過自主研發的 FBDB™ 平台，設計可重新活化先天性與適應性免疫系統的多功能生物藥。漢康生技於台北、上海及舊金山設有營運據點，致力於將差異化科學技術推進為具全球影響力的創新療法。
前瞻性聲明
本新聞稿包含有關 HCB101、HCB301 及漢康生技產品線開發、初步臨床結果的解讀與潛在意義、未來臨床試驗、開發策略、適應症、聯合治療、合作機會，以及 FBDB™ 平台能力與潛力之前瞻性陳述。
相關陳述係基於目前預期與假設，涉及風險及不確定性，實際結果可能存在重大差異。初步臨床結果可能隨後續追蹤及數據成熟而改變。與監管機關的討論不代表已獲核准，亦不保證未來開發或產品上市取得核准。
除適用法律另有規定外，漢康生技不承擔更新前瞻性陳述之義務。