HanchorBio to Present Five Clinical Abstracts at CSCO 2026, Including Two Oral Presentations for Lead Program HCB101
Clinical data strengthen HCB101 as a differentiated CD47–SIRPα backbone and support expansion across gastric cancer, HNSCC, and additional solid tumors
TAIPEI, SHANGHAI, and SAN FRANCISCO — September 18, 2026 — HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced that five company-sponsored clinical abstracts have been accepted for presentation at the 29th Annual Meeting of the Chinese Society of Clinical Oncology (CSCO 2026), taking place September 17–19, 2026, in Jinan, China.
Two HCB101 abstracts were selected for oral presentation, highlighting the progression of HanchorBio’s lead macrophage-directed immunotherapy from first-in-human monotherapy validation to combination activity in second-line gastric/gastroesophageal junction (GC/GEJ) cancer. HCB301 was selected for poster presentation, alongside additional HCB101 presentations in head and neck squamous cell carcinoma (HNSCC) and gastrointestinal cancers.
The accepted abstracts demonstrate HCB101’s transition from initial proof-of-concept toward a broadly usable macrophage-directed backbone across multiple indications and standard-of-care regimens, while HCB301 extends the Company’s platform into multi-axis immunotherapy.
“The selection of two oral presentations for HCB101 at CSCO demonstrates that our clinical strategy extends beyond fundamental CD47 biology,” said Scott Liu, PhD, Founder and Chairman of HanchorBio. “We have established a robust clinical safety foundation, demonstrated meaningful combination activity in gastric cancer, and captured positive expansion signals across additional tumor types. As HCB101 combines across multiple standard-of-care regimens, its opportunity expands well beyond a single-indication asset—creating multiple paths to long-term clinical and commercial value.”
HCB101 Monotherapy Establishes the Clinical Foundation
The first oral presentation will summarize the completed Phase 1a HCB101-101 study (NCT05892718).
Among 67 treated patients, dose escalation reached 36 mg/kg without reaching the maximum tolerated dose. Across 59 DLT-evaluable patients, HCB101 demonstrated a differentiated hematologic safety profile, including one Grade 3 anemia event, no Grade 4–5 anemia events, and no bleeding events associated with thrombocytopenia, alongside predictable pharmacokinetics and sustained CD47 receptor occupancy.
Across 56 efficacy-evaluable patients, HCB101 monotherapy produced two confirmed partial responses and 11 stable disease outcomes, yielding a disease control rate (DCR) of 23%. A confirmed partial response in HNSCC remains ongoing beyond 83 weeks, supporting durable monotherapy proof of biology.
These findings establish the safety, exposure, and target-engagement profile required to combine HCB101 with standard-of-care anticancer therapies across broader oncology indications.
Second-Line Gastric/GEJ Cancer Shows the Strongest Combination Signal
The second oral presentation will report updated results from HCB101-201 (NCT06771622), evaluating HCB101 in combination with ramucirumab and paclitaxel in second-line advanced GC/GEJ cancer.
Among 15 efficacy-evaluable patients, the overall objective response rate (ORR) was 60%, highlighted by an 80% ORR in the 5.12–8 mg/kg mid-dose cohorts with a maximum tumor reduction of −78.2%.
For historical context, standard-of-care ramucirumab plus paclitaxel yielded ORRs of approximately 26–28% in the landmark RAINBOW and RAINBOW-Asia trials. While cross-trial comparisons are inherently limited and randomized trials remain required, the magnitude and consistency of tumor shrinkage support second-line GC/GEJ as a primary development path for HCB101. Adding HCB101 to an established global regimen provides a streamlined route toward randomized trials and potential clinical adoption.
Expansion into HNSCC and Multi-Axis Immunotherapy Pipeline
Additional presentations will detail HCB101’s activity in HNSCC and gastrointestinal cancers. In HNSCC, HanchorBio will present durable monotherapy responses alongside emerging combination activity, including a complete response and confirmed partial response from an investigator-initiated study in Taiwan. Evaluation of sponsor-led HNSCC cohorts in combination with PD-1- and EGFR-directed therapies remains ongoing.
HCB301, HanchorBio’s trispecific SIRPα–PD-L1–TGFβ fusion protein, was selected for poster presentation. Updated first-in-human data from the Phase 1 study (NCT06487624) across 29 treated patients (21 efficacy-evaluable) demonstrated an overall DCR of 38.1% and a 75% DCR at 1.2 mg/kg, with disease stabilization observed across multiple solid tumor types.
“CSCO highlights HCB101 as the clinical anchor of our platform,” said Alvin Luk, PhD, MBA, CCRA, President and Chief Medical Officer (Group) & CEO (USA) of HanchorBio. “Monotherapy confirmed that HCB101 is pharmacologically active and well-tolerated. Gastric cancer demonstrates how this biology enhances established standard-of-care regimens, while HNSCC and GI data show its broad applicability. Simultaneously, HCB301 extends this foundation into multi-axis immunotherapy, addressing innate suppression, adaptive checkpoints, and TGFβ exclusion within a single molecule.”
One clinical anchor. Multiple indications. Multiple treatment backbones. A broader platform.
HCB101 is establishing the clinical foundation. HCB301 and the broader FBDB™ pipeline extend the opportunity.
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, alongside additional candidates across oncology and immunology.
Forward-Looking Statements
This press release contains forward-looking statements regarding HanchorBio’s clinical development programs, product candidates, regulatory strategy, and future plans. Actual results may differ materially from those expressed or implied due to various risks and uncertainties, including clinical trial outcomes, regulatory decisions, and market conditions. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.
Investor & Media Contact:
HanchorBio, Inc.
Email: [email protected]
漢康生技五項臨床研究入選 CSCO 2026 HCB101兩項研究獲選口頭發表
臨床數據進一步支持 HCB101 作為具差異化特性的 CD47–SIRPα 治療骨幹，並拓展至胃癌、頭頸癌及其他實體腫瘤
【台北、上海、舊金山，2026 年 9 月 18 日】－全球臨床階段生技公司漢康生技（TWSE：7827）今日宣布，公司共有五項臨床研究摘要獲選於 2026 年 9 月 17 日至 19 日在中國濟南舉行的「第 29 屆中國臨床腫瘤學會年會（CSCO 2026）」發表。
其中，兩項 HCB101 研究獲選為口頭發表，展現漢康核心巨噬細胞導向免疫療法 HCB101，從首次人體單藥治療驗證，進一步推進至二線胃癌／胃食道交界部癌（GC/GEJ）聯合治療的臨床進展。此外，HCB301 獲選海報發表，另有 HCB101 於頭頸部鱗狀細胞癌（HNSCC）及消化道腫瘤的臨床研究成果同步發表。
此次入選的臨床研究顯示，HCB101 正從早期概念驗證進一步發展為可應用於多種癌症適應症、並可搭配不同標準治療方案的巨噬細胞導向治療骨幹；同時，HCB301 則進一步將漢康的技術平台拓展至多重免疫調控機制。此次多項臨床成果集中於大型腫瘤學術會議發表，也進一步展現漢康臨床開發規模持續擴大，並逐步建立跨適應症與多產品線的研發布局。
漢康生技創辦人暨董事長劉世高博士表示：「HCB101 有兩項研究獲選於 CSCO 口頭發表，顯示我們的臨床開發策略已進一步從 CD47 基礎生物學拓展至更廣泛的臨床應用。我們已建立穩健的臨床安全性基礎，並在胃癌聯合治療中觀察到具意義的臨床活性，同時於其他癌別持續累積拓展驗證。隨著 HCB101 與多種標準治療方案進行聯合開發，其潛在應用可望超越單一適應症，為長期臨床及商業價值創造更多發展路徑。」
HCB101 單藥治療建立臨床開發基礎
第一項口頭發表將公布已完成的 HCB101-101 第一期臨床試驗（NCT05892718）結果。
共 67 名病人接受治療，劑量遞增最高達 36 mg/kg，且尚未達到最大耐受劑量。在 59 名可進行劑量限制性毒性（DLT）評估的病人中，HCB101 展現具差異化的血液學安全性表現，包括僅發生一例第 3 級貧血，未觀察到第 4–5 級貧血，亦未出現與血小板減少相關的出血事件；同時呈現可預期的藥物動力學特性，以及持續性的 CD47 受體佔有率。
在 56 名可評估臨床活性的病人中，HCB101 單藥治療觀察到 2 例確認部分緩解（PR）及 11 例疾病穩定（SD），疾病控制率（DCR）為 23%。其中，一名頭頸癌病人的確認部分緩解已持續超過 83 週，進一步支持 HCB101 單藥治療具持續性的生物學活性。
上述結果建立了 HCB101 在安全性、藥物在體內的濃度與持續時間、標的結合方面的臨床基礎，支持其進一步與標準抗癌治療進行聯合開發。
二線胃癌／胃食道交界部癌展現具潛力的聯合治療訊號
第二項口頭發表將公布 HCB101-201 臨床試驗（NCT06771622）的最新結果，評估 HCB101 聯合雷莫蘆單抗（ramucirumab）與紫杉醇（paclitaxel）治療二線晚期胃癌／胃食道交界部癌。
在 15 名可評估臨床活性的病人中，整體客觀緩解率（ORR）為 60%；其中於 5.12–8 mg/kg 中劑量組別，ORR 達 80%，最大腫瘤縮小幅度為 78.2%。
作為歷史性參考，在關鍵性 RAINBOW 與 RAINBOW-Asia 臨床試驗中，標準治療雷莫蘆單抗（ramucirumab）聯合紫杉醇（paclitaxel）的 ORR 約為 26–28%。儘管跨試驗比較本身存在限制，且仍需透過隨機臨床試驗進一步驗證，目前觀察到的腫瘤縮小幅度及一致性，支持二線胃癌／胃食道交界胃食道交界部癌作為 HCB101 的主要臨床開發方向之一。
將 HCB101 加入既有全球標準治療方案，也為後續隨機臨床試驗及潛在臨床應用建立更直接的開發路徑。
拓展至頭頸癌與多重免疫調控產品線
其他研究發表將進一步呈現 HCB101 在頭頸癌及消化道腫瘤的臨床觀察。
在頭頸癌方面，漢康將公布 HCB101 單藥治療的持續性臨床反應，以及聯合治療所觀察到的初步臨床活性，包括一項於台灣進行的研究者發起臨床試驗（IIT）中觀察到的一例完全緩解（CR）及一例腫瘤顯著縮小（PR）。目前，由漢康主導的 HCB101 聯合 PD-1 及 EGFR 標靶治療之頭頸癌研究組別亦持續進行中。
HCB301 為漢康開發的 SIRPα–PD-L1–TGFβ 三特異性融合蛋白，本次亦獲選海報發表。最新首次人體第一期臨床試驗（NCT06487624）數據顯示，共 29 名病人接受治療，其中 21 名可評估臨床活性；整體疾病控制率（DCR）為 38.1%，在 1.2 mg/kg 劑量組的 DCR 為 75%，並於多種實體腫瘤中觀察到疾病穩定。
漢康生技總裁暨集團醫療長、美國執行長陸英明博士表示：「此次 CSCO 的研究成果進一步凸顯 HCB101 作為漢康技術平台臨床支點的角色。單藥治療結果證實 HCB101 具藥理活性與良好的耐受性，而胃癌研究則呈現其與既有標準治療方案結合的潛力；頭頸癌及消化道腫瘤數據則進一步顯示其跨癌別應用的可能性。同時，HCB301 將這項基礎延伸至多重免疫調控，在單一分子中同時針對先天免疫抑制、適應性免疫檢查點及 TGFβ 所介導的免疫排斥機制。」
一個臨床支點，多項適應症、多種治療骨幹，以及更廣泛的平台發展機會。
HCB101 正逐步建立漢康的臨床基礎，而 HCB301 及更廣泛的 FBDB™ 產品線則持續拓展其發展潛力。
關於 HCB101
HCB101 為漢康生技透過自主研發 FBDB™ 平台開發的試驗性工程化 SIRPα–IgG4 Fc 融合蛋白，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 細胞克隆（de novo T-cell clone）的活化。
目前 HCB101 正分別以單藥治療（NCT05892718）及聯合治療（NCT06771622）方式，於多種實體腫瘤及血液腫瘤中進行臨床評估，並已獲美國 FDA 授予胃癌孤兒藥資格認定。
關於 HCB301
HCB301 為試驗性三特異性 CD47–PD-L1–TGFβ 融合蛋白，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，以及 TGFβ 所介導的免疫排斥機制。
目前 HCB301 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）是一家全球臨床階段生技公司，運用自主研發的 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。公司產品線包括已進入臨床階段的 HCB101 與 HCB301，以及多項布局於腫瘤及免疫疾病領域的候選藥物。