HanchorBio Expands Clinical Evidence Supporting Its Macrophage-Directed Oncology Strategy
Expanded second-line colorectal cancer data support HCB101’s potential across gastrointestinal tumors and combination treatment settings
[Taipei, Shanghai, San Francisco | July 22, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and immune-related diseases, today announced updated early clinical observations from its HCB101 program.
The findings further support HanchorBio’s macrophage-directed oncology strategy. HCB101 is being developed as a combination-ready SIRPα-based immune backbone designed to restore macrophage-mediated tumor-cell clearance and complement established standard-of-care therapies across multiple tumor types.
Expanded Colorectal Cancer Data Support HCB101’s Potential Across Gastrointestinal Tumors
As of the July 17, 2026 data cutoff, 11 patients were efficacy-evaluable across four second-line colorectal cancer combination cohorts within the HCB101 clinical program.
Among these patients:
- Six achieved partial responses, with tumor reductions exceeding 30%, representing an objective response rate of 54.5%
- Five achieved stable disease
- The disease control rate was 100%
Objective responses were observed across multiple standard-of-care combination regimens and clinical development settings, supporting continued evaluation of HCB101 as a combination-ready macrophage-directed therapy in gastrointestinal cancers.
The sponsor-led HCB101-201 study contributed emerging evidence of tumor reduction across several second-line colorectal cancer combination cohorts. Separately, an investigator-initiated study in Taiwan continued to demonstrate encouraging durability, including one patient remaining on HCB101-based treatment for more than one year and another maintaining stable disease for more than 48 weeks before progression.
Historical objective response rates (ORR) for currently available second-line colorectal cancer treatment regimens are generally approximately 15% to 25%, depending on patient characteristics, prior treatment exposure, molecular profile, and the specific regimen administered. These historical outcomes highlight the continued need for treatment approaches capable of improving response depth and durability in this setting.
These findings remain preliminary and are based on small, nonrandomized cohorts. Although historical outcomes with currently available therapies underscore the need for continued innovation in this setting, cross-study comparisons should not be made. Additional enrollment and longer follow-up will be required to further characterize response durability, progression-free survival, safety, and the contribution of HCB101 to each combination regimen.
Second-line gastric and gastroesophageal junction cancer remains HanchorBio’s lead clinical development indication for HCB101. The colorectal cancer findings provide complementary evidence supporting further evaluation of the HCB101 macrophage backbone across gastrointestinal tumor types and standard-of-care treatment regimens. By 2036, the potential second-line gastric cancer market opportunity is estimated at approximately US$280 million in China and US$430 million in overseas markets, while the potential second-line colorectal cancer market opportunity is estimated at approximately US$640 million in China and US$2.9 billion in overseas markets.
Clinical experience also continues to accumulate from other HCB101 combination studies, including gastric cancer, head and neck squamous cell carcinoma, and triple-negative breast cancer, helping establish its potential applicability across distinct tumor types and therapeutic settings.
“Our strategy is not simply to expand the number of indications under development,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “We are using clinical evidence to deepen our understanding of macrophage biology and to identify where macrophage-directed therapy may add value to established treatment regimens. The latest colorectal cancer findings further support our evaluation of HCB101 beyond gastric cancer and across a broader range of gastrointestinal tumors.”
“The key clinical finding is the consistency of objective responses across three distinct second-line colorectal cancer treatment backbones,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “A preliminary 54.5% response rate across these heterogeneous cohorts, together with durable disease control observed in the separate Taiwan study, strengthens the rationale for HCB101 as a portable macrophage-directed immune backbone across gastrointestinal cancers. Second-line gastric cancer remains our lead clinical value program, while the colorectal cancer findings expand the clinical evidence supporting the platform.”
About HCB101
HCB101 is HanchorBio’s differentiated engineered SIRPα-IgG4 Fc fusion protein designed to selectively block CD47–SIRPα signaling while reducing red-blood-cell binding. By restoring macrophage-mediated tumor-cell phagocytosis and supporting antigen presentation, HCB101 is being developed as a combination-ready macrophage immune backbone across selected solid tumors.
About HanchorBio
HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company developing next-generation immunotherapies based on a fundamental belief: immunity is not one-dimensional, and the medicines designed to harness it should not be either.
Rooted in Taiwan with operations in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio is advancing a pipeline of immunotherapies for oncology and immune-mediated diseases. The Company’s proprietary Fc-Based Designer Biologics (FBDB™) platform enables the design of multi-functional biologics that bring complementary immune mechanisms together within a single molecular architecture.
HanchorBio’s clinical pipeline is anchored by HCB101, an engineered SIRPα-IgG4 Fc fusion protein designed to restore macrophage-mediated antitumor activity and enable rational combination strategies. Clinical and translational learnings from HCB101 inform the Company’s broader platform expansion, including multi-axis immunotherapies and programs beyond oncology.
Listed on the Taiwan Stock Exchange Innovation Board (TWSE: 7827), HanchorBio is advancing its clinical development, regulatory strategy, and global partnerships from a foundation built in Taiwan and designed for global development.
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 development outcomes, regulatory interactions and decisions, protocol development, execution of collaboration, and market conditions. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.
漢康生技公布主力新藥 HCB101 最新臨床進展 持續深化巨噬細胞導向腫瘤治療策略
二線結直腸癌最新數據支持 HCB101 拓展胃腸道腫瘤應用潛力
漢康生技（HanchorBio，TWSE：7827）今日公布 HCB101 最新早期臨床觀察結果。漢康生技是一家全球臨床階段生技公司，致力於開發應用於腫瘤及免疫相關疾病的次世代免疫療法。
此次更新進一步展現漢康生技以巨噬細胞生物學（macrophage biology）為核心的研發策略。HCB101 為公司核心臨床產品，透過阻斷 CD47–SIRPα 訊號，恢復巨噬細胞清除腫瘤細胞的能力，並定位為可與多種標準治療併用的巨噬細胞免疫骨幹（macrophage immune backbone）。
二線結直腸癌最新數據支持 HCB101 拓展胃腸道腫瘤應用潛力
截至 2026 年 7 月 17 日資料截止日，HCB101 臨床開發計畫的四個二線結直腸癌治療組合中，共有 11 位患者可進行療效評估。
其中：
- 6 位患者達到部分緩解（PR），且腫瘤縮小幅度均超過 30%，客觀緩解率（ORR）為 54.5%
- 5 位患者達疾病穩定（SD）
- 疾病控制率（DCR）達 100%
上述客觀腫瘤反應已於多種二線標準治療聯合方案及不同臨床研究情境中觀察到，支持持續評估 HCB101 作為胃腸道腫瘤聯合治療之巨噬細胞免疫骨幹的發展潛力。
其中，公司主導的 HCB101-201 試驗於多個二線結直腸癌治療組合中持續觀察到腫瘤縮小；另一方面，台灣醫師發起臨床研究（Investigator-Initiated Trial, IIT）亦持續展現具潛力的療效持續性，其中一位患者接受 HCB101 治療已超過一年，另一位患者則維持疾病穩定超過 48 週後才出現疾病進展。
依據現有治療的歷史臨床資料，二線結直腸癌標準治療的客觀緩解率約為 15% 至 25%，實際結果可能因患者條件、既往治療、腫瘤分子特徵及所採用的治療方案而有所不同。相關歷史數據亦顯示，二線結直腸癌仍需要能進一步提升腫瘤反應程度及療效持續性的創新治療選擇。
上述結果仍屬早期臨床觀察，來自樣本數有限且非隨機分派之研究。雖然現有標準治療的歷史臨床結果顯示，二線結直腸癌仍存在顯著未被滿足的醫療需求，但本研究結果不宜與其他臨床試驗進行直接比較。後續仍需持續收案及延長追蹤，以進一步評估反應持續時間、無惡化存活期（PFS）、安全性，以及 HCB101 在不同合併治療中的臨床貢獻。
目前，二線胃癌／胃食道交界癌仍為 HCB101 最重要的核心臨床發展適應症。本次結直腸癌數據則進一步支持 HCB101 巨噬細胞免疫骨幹有望延伸應用至更多胃腸道腫瘤及不同標準治療架構。預估至 2036 年，二線胃癌在中國大陸及海外市場的潛在市場機會分別約為 2.8 億美元及 4.3 億美元；二線結直腸癌在中國大陸及海外市場的潛在市場機會則分別約為 6.4 億美元及 29 億美元。
此外，包括胃癌、頭頸部鱗狀細胞癌（HNSCC）及三陰性乳癌（TNBC）等 HCB101 聯合治療研究亦持續累積臨床經驗，進一步拓展 HCB101 在不同腫瘤生物學及治療組合中的應用基礎。
漢康生技創辦人暨董事長劉世高博士表示：「我們的策略並非只是增加適應症數量，而是透過臨床證據持續引導並深化我們對巨噬細胞生物學的理解。HCB101 幫助我們探索巨噬細胞導向療法如何與現有標準治療互補，並在不同腫瘤類型及治療組合中創造更多臨床價值。本次結直腸癌數據進一步支持我們由胃癌的核心臨床定位，審慎拓展至更多胃腸道腫瘤。」
漢康生技醫療長陸英明博士表示：「此次臨床數據的關鍵，在於三種不同的二線結直腸癌標準治療骨幹中，均觀察到一致的客觀腫瘤反應。這些不同治療組別初步觀察到 54.5% 的客觀緩解率，加上台灣獨立研究中所觀察到具持續性的疾病控制，進一步支持 HCB101 作為可延伸應用於多種胃腸道腫瘤的巨噬細胞導向免疫骨幹。二線胃癌仍是公司最主要的臨床價值開發項目，而此次結直腸癌研究結果則進一步擴大支持平台價值的臨床證據。」
關於 HCB101
HCB101 為漢康生技自主研發之差異化工程化 SIRPα-IgG4 Fc 融合蛋白，可選擇性阻斷 CD47–SIRPα 訊號，同時降低與紅血球的結合。藉由恢復巨噬細胞吞噬腫瘤細胞功能並促進抗原呈現，HCB101 正開發為可與多種標準治療搭配使用的巨噬細胞免疫骨幹，用於多項實體腫瘤治療。
關於漢康-KY：
英屬開曼群島商漢康生技股份有限公司（以下簡稱“漢康-KY”，股票代碼：7827）成立於2020年，由具豐富國際藥物開發與運營經驗的劉世高博士創辦。公司專注於腫瘤免疫藥物研發，透過自主建立的核心「FBDB多功能融合蛋白技術平台」開發出8+種創新蛋白生物藥，具有廣譜抗癌潛力，可抑制多種實體瘤及血液腫瘤，並持續取得多項專利。其中HCB101與HCB301已進入臨床試驗階段，而HCB101在2025年6月更完成首項國際授權，總授權金達2.02億美元。漢康-KY的策略是以多功能生物藥克服現行採取免疫療法與化療並行的高失敗率，同時藉由啟動先天性免疫和適應性免疫體系以摧毀腫瘤，致力提供高效且可負擔的新一代腫瘤免疫治療方案，解決未滿足的醫療需求。
聲明：
本新聞稿及同時發佈之相關資訊內含有預測性敘述；其內容乃根據既有之風險及可能的不確定性進行判斷及預測，包括：市場因素與其他非漢康-KY（以下簡稱本公司）所能掌控之原因。這些預測性敘述是基於現況的預測和評估，除非基於法律的要求，本公司不負日後更新之責。