HanchorBio Earns Dual KSMO/FACO 2026 Recognition for HCB101 and HCB301
HCB101 gastric cancer data earned Best Poster recognition with 80% ORR at mid-dose levels; HCB301 oral presentation reported 38.1% disease control across advanced solid tumors
TAIPEI, SHANGHAI, and SAN FRANCISCO — September 7, 2026 — HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced clinical results from HCB101 and HCB301 presented at KSMO 2026—the 19th Annual Meeting of the Korean Society of Medical Oncology and 2026 International Conference—held in conjunction with the 14th International Conference of the Federation of Asian Clinical Oncology (FACO), in Seoul, South Korea.
HanchorBio received multiple forms of scientific recognition at the meeting. Among approximately 500 accepted poster abstracts, HCB101 gastric cancer data were selected as one of only 20 Best Poster Presentation Award recipients and one of only 10 abstracts chosen for a live Poster Discussion. Separately, excluding invited faculty and speakers, HCB301 was selected as one of only 12 oral presentations across the scientific program. HanchorBio also presented HCB101 HNSCC clinical data as an ePoster.
The presentations highlighted key milestones for HanchorBio’s proprietary FBDB™ platform: HCB101 as a macrophage-directed clinical foundation with emerging clinical activity across gastric cancer and HNSCC, and HCB301, a first-in-class trispecific immunotherapy, as the next step toward coordinated multi-axis immune modulation with a single molecule.
Alvin Luk, PhD, MBA, CCRA, President and Chief Medical Officer (Group) & CEO (USA) of HanchorBio, presented both the HCB101 gastric cancer Poster Discussion and the first-in-human HCB301 oral presentation.
“The recognition of both HCB101 and HCB301 at KSMO/FACO is important because it reflects two stages of the same strategy through our FBDB™ platform—from establishing macrophage-directed clinical activity with HCB101 to extending that biology into multi-axis immune modulation with HCB301,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “HCB101 is anchoring our clinical strategy, while HCB301 tests whether three distinct drivers of immune resistance can be addressed within a single engineered therapeutic molecule.”
HCB101 Strengthens 2L GC/GEJ as a Clinical Anchor
HCB101 is an engineered SIRPα–IgG4 Fc fusion protein designed to block the CD47–SIRPα innate immune checkpoint and re-engage macrophage-mediated antitumor activity.
In the ongoing HCB101-201 study (NCT06771622), 20 patients with second-line GC/GEJ were enrolled across HCB101 dose levels of 2.56–12 mg/kg in combination with ramucirumab plus paclitaxel. Among 15 efficacy-evaluable patients, the 5.12–8 mg/kg mid-dose cohorts achieved an ORR of 80.0%, with broad and deep tumor shrinkage observed across patients. The overall DCR was 93.3%.
For historical context, ramucirumab plus paclitaxel produced ORRs of approximately 26–28% in RAINBOW and RAINBOW-Asia. The depth and consistency of tumor shrinkage support continued development of HCB101 in second-line GC/GEJ.
In first-line HER2-positive gastric cancer, eight efficacy-evaluable patients treated with HCB101 plus trastuzumab, pertuzumab, and chemotherapy achieved an ORR of 75.0% and DCR of 100%.
HCB101 Expands into HNSCC with Durable Monotherapy and Combination Activity
HanchorBio also presented HCB101 data in recurrent or metastatic HNSCC, supporting its expansion as a rational setting beyond the gastric cancer clinical anchor.
In HCB101-101 monotherapy, a confirmed partial response with ~42% tumor reduction was observed at 5.12 mg/kg, with treatment continuing beyond 80 weeks at the data cutoff. A second patient achieved disease control for approximately 34 weeks, with additional disease stabilization observed in HNSCC and nasopharyngeal carcinoma.
In a Taiwan investigator-initiated combination study, 2 of 4 evaluable patients achieved objective responses (ORR 50%), including a complete response and a confirmed partial response, while all four achieved disease control at first assessment. Three remained on treatment beyond 16 weeks, including one beyond 48 weeks, with follow-up ongoing.
Together, the monotherapy durability and emerging combination activity support continued evaluation of HCB101 in PD-1- and EGFR-directed strategies.
HCB301 Advances Multi-Axis Immune Modulation into the Clinic
In an oral presentation at KSMO 2026, HanchorBio presented first-in-human clinical findings from the ongoing Phase 1 HCB301-101 study (NCT06487624). HCB301 opened the second of two selected oral presentation sessions at KSMO 2026.
HCB301 is a trispecific SIRPα–PD-L1–TGFβ fusion protein designed to coordinately address innate immune suppression, adaptive immune checkpoint signaling, and TGFβ-mediated immune exclusion within a single molecule. Preclinical data presented at KSMO showed antitumor activity across two in vivo models, including tumor control in an HNSCC model and 98.5% tumor growth inhibition in combination in a breast cancer model, further supporting the rationale for coordinated engagement of these interconnected immune pathways.
The oral presentation included 29 patients enrolled across the 0.3, 0.6, 0.9, and 1.2 mg/kg cohorts. Among 21 efficacy-evaluable patients, 8 achieved stable disease, corresponding to a DCR of 38.1%. Disease stabilization was observed across multiple solid tumor types, including hypopharyngeal carcinoma, hepatocellular carcinoma, colorectal cancer, cholangiocarcinoma, pelvic malignancy, and sarcoma, with the longest disease control exceeding four months.
The population was heavily pretreated, with a median of four prior systemic therapy lines. Safety findings, including hematologic and infusion-related events, informed protocol refinements, enhanced monitoring, and dose-management strategies as development continues.
“HCB301 asks a different question from conventional combination immunotherapy: can coordinated immune modulation be engineered into the molecule itself?” said Dr. Luk, who delivered the oral presentation. “What is encouraging is that we are already seeing disease stabilization across multiple tumor types during early dose escalation in a heavily pretreated population. These remain early Phase 1 data, but they support continued dose optimization as we work to define the therapeutic window and determine whether coordinated SIRPα–PD-L1–TGFβ targeting can translate into meaningful clinical benefit.”
A Repeatable FBDB™ Clinical Strategy
HCB101 established HanchorBio’s clinical foundation in macrophage-directed innate immunity. HCB301 extends that foundation into trispecific immunotherapy integrating innate, adaptive, and TGFβ-mediated immune biology.
Understand the biology → engineer the right architecture → generate clinical evidence → learn where the biology works → expand deliberately
About HCB101
HCB101 is an investigational engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB™ platform. HCB101 blocks CD47–SIRPα signaling to restore macrophage-mediated antitumor immunity and downstream de novo T-cell activation. It is being evaluated as monotherapy (NCT05892718) and in combination (NCT06771622) across solid and hematologic malignancies and holds U.S. FDA Orphan Drug Designation for gastric cancer.
About HCB301
HCB301 is an investigational trispecific CD47–PD-L1–TGFβ fusion protein designed to concurrently address innate immune suppression, adaptive checkpoint signaling, and TGFβ-mediated immune exclusion within a single molecule. It is being evaluated in the ongoing first-in-human Phase 1 HCB301-101 study (NCT06487624).
About HanchorBio
HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on inventing next-generation biologics for cancer and immune-mediated diseases using its proprietary FBDB™ platform. HanchorBio’s pipeline includes clinical-stage programs HCB101 and HCB301, next-generation trispecific program HCB303, and additional candidates across oncology and immune-mediated diseases.
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.
漢康生技 HCB101 與 HCB301 雙獲 KSMO/FACO 2026 肯定
HCB101 胃癌臨床數據獲最佳壁報肯定，中劑量組客觀緩解率達 80%；HCB301 口頭報告顯示晚期實體腫瘤疾病控制率達 38.1%
【台北、上海、舊金山，2026 年 9 月 7 日】－全球臨床階段生技公司漢康生技（TWSE：7827）今日宣布，公司於韓國首爾舉行的 KSMO 2026－第 19 屆韓國臨床腫瘤學會年會暨 2026 國際會議，以及同期舉辦的 第 14 屆亞洲臨床腫瘤學聯盟（FACO）國際會議中，發表 HCB101 與 HCB301 最新臨床研究成果。
漢康生技於本次會議獲得多項學術肯定。在約 500 篇獲接受的壁報摘要中，HCB101 胃癌臨床數據獲選為僅 20 篇「最佳壁報發表獎」（Best Poster Presentation Award）得獎研究之一，並成為僅 10 篇獲選進行現場壁報討論的研究之一。此外，在不含受邀講者的情況下，HCB301 獲選為整體科學議程中僅 12 場口頭報告之一。漢康亦以電子壁報形式發表 HCB101 頭頸部鱗狀細胞癌（HNSCC）臨床數據。
本次發表展現漢康專有 FBDB™ 平台的重要臨床進展：HCB101 作為巨噬細胞導向治療的臨床基礎，已於胃癌及 HNSCC 中展現初步臨床活性；首創三特異性免疫療法 HCB301，則進一步朝以單一分子協同調控多重免疫路徑的方向推進。
漢康生技總裁暨集團醫療長、美國公司執行長陸英明博士，於會中進行 HCB101 胃癌壁報討論，並發表 HCB301 首次人體臨床研究口頭報告。
漢康生技創辦人、董事長暨執行長劉世高博士表示：「HCB101 與 HCB301 同時於 KSMO/FACO 獲得肯定，具有重要意義，因為這反映出 FBDB™ 平台同一發展策略的兩個階段——從 HCB101 建立巨噬細胞導向的臨床活性，到 HCB301 進一步將相關生物學拓展至多重免疫路徑調控。HCB101 正作為我們臨床策略的重要支點，而 HCB301 則進一步驗證，是否能透過單一工程化治療分子，同時針對三項不同的免疫抗性機制進行調控。」
HCB101 強化二線胃癌／胃食道交界處癌臨床布局
HCB101 為工程化 SIRPα–IgG4 Fc 融合蛋白，旨在阻斷 CD47–SIRPα 先天免疫檢查點，重新啟動巨噬細胞介導的抗腫瘤活性。
在持續進行中的 HCB101-201 臨床試驗（NCT06771622）中，共有 20 名二線胃癌／胃食道交界處癌（GC/GEJ）患者接受 HCB101 2.56–12 mg/kg 不同劑量，並與雷莫蘆單抗（ramucirumab）及紫杉醇（paclitaxel）聯合治療。在 15 名可評估患者中，5.12–8 mg/kg 中劑量組的客觀緩解率（ORR）達 80.0%，並於多名患者中觀察到廣泛且具深度的腫瘤縮小；整體疾病控制率（DCR）為 93.3%。
作為歷史比較，RAINBOW 與 RAINBOW-Asia 研究中，雷莫蘆單抗聯合紫杉醇的 ORR 約為 26–28%。目前觀察到的腫瘤縮小深度與一致性，支持 HCB101 持續推進二線 GC/GEJ 臨床開發。
在 HER2 陽性一線胃癌中，8 名可評估患者接受 HCB101 聯合曲妥珠單抗（trastuzumab）、帕妥珠單抗（pertuzumab）及化療後，ORR 達 75.0%，DCR 達 100%。
HCB101 拓展至 HNSCC 單藥與聯合治療均觀察到持續臨床活性
漢康亦於本次會議發表 HCB101 於復發性或轉移性 HNSCC 的臨床數據，支持其在胃癌臨床布局之外，進一步拓展至其他具科學依據的適應症。
在 HCB101-101 單藥試驗中，一名接受 5.12 mg/kg 劑量的患者達到經確認的部分緩解（PR），腫瘤縮小約 42%；截至數據截止日，治療已持續超過 80 週。另一名患者疾病控制約 34 週，此外亦於 HNSCC 及鼻咽癌患者中觀察到疾病穩定。
在台灣研究者發起的聯合治療研究中，4 名可評估患者中有 2 名達到客觀緩解，ORR 為 50%，包括 1 名完全緩解（CR）及 1 名經確認的部分緩解；4 名患者於首次評估時均達到疾病控制。3 名患者持續治療超過 16 週，其中 1 名超過 48 週，目前仍持續追蹤。
整體而言，HCB101 單藥治療所觀察到的持續性，以及聯合治療的初步臨床活性，支持持續評估 HCB101 與 PD-1 及 EGFR 導向治療策略的潛力。
HCB301 推進多重免疫路徑協同調控進入臨床
漢康於 KSMO 2026 口頭報告中，發表持續進行中的第一期 HCB301-101 首次人體臨床試驗（NCT06487624）數據。HCB301 為 KSMO 2026 兩場獲選口頭報告場次中，第二場的開場報告。
HCB301 為三特異性 SIRPα–PD-L1–TGFβ 融合蛋白，旨在透過單一分子協同調控先天免疫抑制、適應性免疫檢查點訊號，以及 TGFβ 所介導的免疫排斥。
本次 KSMO 發表的臨床前數據顯示，HCB301 在兩項體內模型中展現抗腫瘤活性，包括於 HNSCC 模型中觀察到腫瘤控制，以及在乳癌模型聯合治療中達到 98.5% 腫瘤生長抑制率，進一步支持同步調控這些相互關聯免疫路徑的科學依據。
此次口頭報告涵蓋 29 名接受 0.3、0.6、0.9 及 1.2 mg/kg 劑量的患者。在 21 名可評估患者中，8 名達到疾病穩定（SD），DCR 為 38.1%。
疾病穩定觀察於多種實體腫瘤，包括下咽癌、肝細胞癌、結直腸癌、膽管癌、骨盆腔惡性腫瘤及肉瘤，其中最長疾病控制時間超過 4 個月。
本研究患者均曾接受多線治療，中位既往全身性治療為 4 線。包括血液學及輸注相關事件在內的安全性觀察結果，已用於後續試驗方案調整、加強監測及劑量管理策略。
陸英明博士表示：「HCB301 所探索的問題與傳統免疫聯合治療不同：能否直接將協同免疫調控設計進單一分子之中？目前令人關注的是，在早期劑量遞增階段，我們已於接受多線治療的患者中觀察到跨多種腫瘤類型的疾病穩定。這些仍屬第一期早期數據，但支持我們持續進行劑量優化，以進一步界定治療窗口，並評估同步針對 SIRPα、PD-L1 與 TGFβ 是否能轉化為具臨床意義的效益。」
可重複拓展的 FBDB™ 臨床策略
HCB101 建立漢康在巨噬細胞導向先天免疫領域的臨床基礎；HCB301 則進一步將此基礎拓展至三特異性免疫療法，整合先天免疫、適應性免疫及 TGFβ 介導的免疫生物學。
理解生物機制 → 設計適切分子架構 → 建立臨床證據 → 找出適用的生物學場景 → 有策略地持續拓展
關於 HCB101
HCB101 是以漢康生技 FBDB™ 平台開發的工程化 SIRPα–IgG4 Fc 融合蛋白候選藥物。HCB101 透過阻斷 CD47–SIRPα 訊號，恢復巨噬細胞介導的抗腫瘤免疫作用，並進一步促進下游新生 T 細胞活化。
HCB101 目前正以單藥（NCT05892718）及聯合治療（NCT06771622）方式，在實體腫瘤及血液腫瘤中進行臨床評估，並已取得美國 FDA 胃癌孤兒藥資格認定。
關於 HCB301
HCB301 為研究中的三特異性 CD47–PD-L1–TGFβ 融合蛋白候選藥物，旨在透過單一分子同步調控先天免疫抑制、適應性免疫檢查點訊號及 TGFβ 介導的免疫排斥。目前正於首次人體第一期 HCB301-101 臨床試驗（NCT06487624）中進行評估。
關於漢康生技
漢康生技（HanchorBio，TWSE：7827）為全球臨床階段生技公司，運用其專有 FBDB™ 平台，致力於開發癌症及免疫介導疾病的下一代創新生物藥。漢康生技產品線包括臨床階段候選藥物 HCB101 與 HCB301、下一代三特異性候選藥物 HCB303，以及其他針對癌症與免疫介導疾病的開發項目。
前瞻性聲明
本新聞稿包含前瞻性聲明，包括 HCB101 與 HCB301 的臨床開發、初步臨床結果之解讀與潛在意義、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™ 平台的能力與潛力。上述聲明係基於目前之預期與假設，並涉及可能導致實際結果與所述內容存在重大差異之風險與不確定性。臨床結果，包括初步數據，可能隨更多患者納入、數據成熟及分析完成而有所變化。除適用法律另有規定外，漢康生技無義務更新任何前瞻性聲明。