HanchorBio Expands HCB101 Colorectal Cancer Program in Taiwan as Early 2L CRC Data Show 50% ORR and 100% DCR
First patient dosed in Taiwan expands HCB101’s global CRC development following positive responses across multiple treatment regimens and durable clinical benefit with HCB101 plus bevacizumab and chemotherapy
[Taipei, Shanghai, San Francisco | October 14, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced that the first patient in Taiwan has been dosed in the colorectal cancer (CRC)-specific cohort of its global Phase 1b/2a HCB101-201 study (NCT06771622), expanding the Company’s global development program in second-line metastatic CRC.
The Taiwan expansion of the HCB101-201 study is evaluating HCB101, an AI-assisted, structure-guided SIRPα-IgG4 Fc fusion protein developed using HanchorBio’s proprietary FBDB™ platform, in combination with standard-of-care regimens in patients with second-line metastatic CRC.
The expansion builds on encouraging early activity across HanchorBio’s sponsor-led second-line microsatellite-stable CRC cohorts. Among 12 efficacy-evaluable patients who received HCB101 at 5 or 8 mg/kg in combination with different standard-of-care regimens, six achieved partial responses and six achieved stable disease, corresponding to a 50% objective response rate (ORR) and 100% disease control rate (DCR) at first assessment.
“The emerging CRC data are important because the activity is not confined to a single regimen,” said Scott Liu, Ph.D., Founder, Chairman, and CEO (Group) of HanchorBio. “We are seeing responses across multiple standard-of-care backbones, while the earlier investigator-initiated data from Taiwan provides complementary evidence of durable disease control. That combination of breadth and durability strengthens our rationale to expand HCB101 development in second-line CRC.”
Broad Activity Across Multiple Second-Line CRC Backbones
Across the current sponsor-led CRC cohorts, partial responses have been observed with:
- HCB101 + bevacizumab + chemotherapy
- HCB101 + cetuximab + chemotherapy
- HCB101 + ramucirumab + FOLFIRI
The bevacizumab-plus-chemotherapy combination therapy provides a particularly relevant bridge between the sponsor-led program and earlier investigator-initiated clinical data from Taiwan. In sponsor-led HCB101-201 Cohort 3a, four evaluable patients treated with HCB101 8 mg/kg plus bevacizumab and chemotherapy achieved 2 partial responses and 2 stable diseases, corresponding to a 50% ORR and 100% DCR.
Separately, in a Taiwan investigator-initiated study (NCT07204574), three evaluable CRC patients received lower-dose HCB101 2.56 mg/kg plus bevacizumab and chemotherapy. All three achieved disease control at first assessment, including one patient with ongoing clinical benefit beyond 63 weeks and another who maintained disease control for more than 48 weeks before progression.
For clinical context, bevacizumab plus chemotherapy has historically produced ORRs of approximately 5%–23% and median progression-free survival of approximately 5.7–7.3 months in randomized second-line metastatic CRC studies. Cross-trial comparisons should be interpreted cautiously because of differences in study design, patient characteristics, prior therapy, and other factors.
“What stands out is the consistency of the emerging signal,” said Alvin Luk, Ph.D., M.B.A., C.C.R.A., President and Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “Across our current sponsor-led CRC cohorts, HCB101 combinations have produced a 50% ORR and 100% disease control, with responses across anti-VEGF-, anti-EGFR-, and chemotherapy-based treatment architectures. With bevacizumab plus chemotherapy specifically, we have now seen objective responses in the sponsor-led study together with prolonged disease control in the earlier investigator-initiated study in Taiwan. These remain small, early datasets and should not be directly compared or pooled, but the consistency of the observations supports continued prospective development.”
From Early Taiwan Clinical Observations to Global Development
Early investigator-initiated clinical observations in Taiwan contributed important observations to the development of HCB101 in colorectal cancer, particularly regarding the potential durability of disease control with HCB101 in combination with bevacizumab and chemotherapy.
Initiation of HCB101-201 enrollment in Taiwan now extends those early observations into HanchorBio’s global sponsor-led development program, enabling prospective evaluation within a multicenter clinical study.
HCB101-201 is a global, multicenter, open-label Phase 1b/2a study evaluating HCB101 in rational combinations across prioritized solid tumors, including gastric/GEJ cancer, colorectal cancer, head and neck squamous cell carcinoma, and triple-negative breast cancer.
About HCB101
HCB101 is an investigational engineered SIRPα-IgG4 Fc fusion protein developed using HanchorBio’s proprietary FBDB™ platform. HCB101 blocks CD47-SIRPα signaling and is designed to enhance macrophage-mediated antitumor immunity. It is being evaluated as monotherapy (NCT05892718) and in combinations (NCT06771622) across solid and hematologic malignancies. HCB101 has received U.S. FDA Orphan Drug Designation for gastric cancer.
About HanchorBio
HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company focused on inventing and developing next-generation biologics for cancer and immune-mediated diseases using its proprietary FBDB™ platform. HanchorBio’s pipeline includes HCB101, its lead SIRPα-based innate immune checkpoint program; HCB301, a clinical-stage trispecific immunotherapy targeting SIRPα, PD-L1, and TGF-β biology; HCB303, an IND-cleared trispecific immunotherapy integrating SIRPα/CD47, PD-L1/PD-1, and TIGIT/PVR biology; and additional programs across oncology and immune-mediated diseases.
Forward-Looking Statements
This press release contains forward-looking statements regarding the development of HCB101, the HCB101-201 study and its CRC cohorts, HCB101 combination strategies, and HanchorBio’s pipeline and FBDB™ platform. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. Early clinical and investigator-initiated data may not predict results from larger or later-stage studies, and historical results are provided for context only; cross-trial comparisons should be interpreted cautiously. There can be no assurance that HCB101 will demonstrate safety or efficacy or obtain regulatory approval. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.
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漢康生技擴大 HCB101 於台灣結直腸癌臨床開發 二線治療初步數據顯示 ORR 達 50%、DCR 達 100%
台灣首位病人完成給藥，推進 HCB101 全球結直腸癌臨床開發；多種聯合治療方案觀察到腫瘤緩解，HCB101 合併貝伐珠單抗及化學治療亦展現持續性臨床受益
【台北、上海、舊金山，2026 年 10 月 14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，今日宣布，旗下全球第 1b/2a 期 HCB101-201 臨床試驗（NCT06771622）之結直腸癌（CRC）專屬研究組別，已於台灣完成首位病人給藥，進一步擴大公司針對二線轉移性結直腸癌的全球臨床開發計畫。
此次 HCB101-201 試驗於台灣擴大執行，將評估 HCB101 聯合標準治療方案，應用於二線轉移性結直腸癌病人的臨床表現。HCB101 為漢康生技運用自主 FBDB™ 平台，結合人工智慧（AI）輔助及結構導向設計所開發的 SIRPα-IgG4 Fc 融合蛋白。
此次臨床開發擴展係基於漢康生技主導之二線微衛星穩定型（MSS）結直腸癌研究組別所觀察到的初步臨床活性。在接受 HCB101 5 或 8 mg/kg 聯合不同標準治療方案的 12 名可評估療效病人中，6 名達到部分緩解（PR），另 6 名達到疾病穩定（SD）。首次療效評估結果顯示，客觀緩解率（ORR）為 50%，疾病控制率（DCR）達 100%。
漢康生技創辦人、董事長暨集團執行長劉世高博士表示：「此次結直腸癌初步數據的重要性，在於觀察到的臨床活性並非侷限於單一治療方案。我們在多種標準治療組合中均觀察到腫瘤緩解，而先前台灣研究者發起的臨床研究數據，也提供了持續性疾病控制的補充證據。這些涵蓋不同治療組合及疾病控制持續性的臨床觀察，進一步支持我們擴大 HCB101 於二線結直腸癌的臨床開發。」
多種二線結直腸癌聯合治療方案均觀察到初步臨床活性
在目前由漢康生技主導的結直腸癌研究組別中，以下聯合治療方案均已觀察到部分緩解：
- HCB101 ＋ 貝伐珠單抗（bevacizumab）＋ 化療
- HCB101 ＋ 西妥昔單抗（cetuximab）＋ 化療
- HCB101 ＋ 雷莫蘆單抗（ramucirumab）＋ FOLFIRI 化療方案
其中，HCB101 聯合貝伐珠單抗及化學治療的組合，為公司主導的臨床開發計畫與先前台灣研究者發起的臨床研究數據提供了重要連結。
在公司主導的 HCB101-201 第 3a 研究組別中，4 名接受 HCB101 8 mg/kg 聯合貝伐珠單抗及化學治療的可評估病人，有 2 名達到部分緩解、2 名達到疾病穩定，ORR 為 50%，DCR 達 100%。
另一方面，在台灣研究者發起的臨床研究（NCT07204574）中，3 名可評估的結直腸癌病人接受較低劑量 HCB101 2.56 mg/kg，聯合貝伐珠單抗及化學治療。3 名病人於首次療效評估時均達到疾病控制，其中 1 名病人持續獲得臨床受益超過 63 週，另 1 名病人在疾病惡化前維持疾病控制超過 48 週。
作為臨床參考，過往針對二線轉移性結直腸癌的隨機臨床試驗顯示，貝伐珠單抗聯合化學治療的 ORR 約為 5%–23%，中位無惡化存活期（PFS）約為 5.7–7.3 個月。然而，由於不同試驗在研究設計、病人特徵、既往治療及其他因素上存在差異，跨試驗比較仍應審慎解讀。
漢康生技集團總裁暨醫療長、美國子公司執行長陸英明博士表示：「這些初步數據最值得關注的是臨床觀察結果的一致性。在目前由公司主導的結直腸癌研究組別中，HCB101 聯合治療的 ORR 達 50%、DCR 達 100%，且在抗 VEGF、抗 EGFR 及化學治療等不同治療架構中均觀察到腫瘤緩解。特別是在聯合貝伐珠單抗及化學治療方面，我們不僅在公司主導的臨床試驗中觀察到客觀緩解，也在先前台灣研究者發起的臨床研究中觀察到持續較長時間的疾病控制。這些仍屬樣本數有限的早期臨床數據，不應直接比較或合併分析，但觀察結果的一致性支持我們持續推進前瞻性臨床開發。」
從台灣早期臨床觀察推進至全球臨床開發
台灣先前由研究者發起的臨床研究，為 HCB101 在結直腸癌領域的開發提供了重要的早期臨床觀察，特別是 HCB101 聯合貝伐珠單抗及化學治療，在疾病控制持續性方面所展現的潛力。
隨著 HCB101-201 試驗正式於台灣啟動收案，漢康生技將進一步把這些早期臨床觀察延伸至公司主導的全球臨床開發計畫，透過多中心臨床試驗進行前瞻性評估。
HCB101-201 為一項全球多中心、開放標籤的第 1b/2a 期臨床試驗，旨在評估 HCB101 於多種優先開發實體腫瘤適應症中的合理聯合治療策略，包括胃癌／胃食道交界處癌、結直腸癌、頭頸部鱗狀細胞癌及三陰性乳癌。
關於 HCB101
HCB101 為漢康生技運用自主 FBDB™ 平台開發的研究中工程化 SIRPα-IgG4 Fc 融合蛋白，透過阻斷 CD47-SIRPα 訊號傳遞，旨在增強巨噬細胞介導的抗腫瘤免疫反應。
目前 HCB101 正於實體腫瘤及血液惡性腫瘤中進行單藥治療（NCT05892718）及聯合治療（NCT06771622）的臨床評估。HCB101 已獲美國食品藥物管理局（FDA）授予胃癌孤兒藥資格認定（ODD）。
關於漢康生技
漢康生技（TWSE：7827）是一家全球臨床階段生技公司，專注於運用自主研發的 FBDB™ 平台，開發應用於癌症及免疫介導疾病的次世代創新生物藥。
公司產品管線包括主要候選藥物 HCB101，為以 SIRPα 為基礎的先天免疫檢查點治療項目；HCB301，為針對 SIRPα、PD-L1 及 TGF-β 生物學機制的臨床階段三特異性免疫療法；以及 HCB303，為整合 SIRPα/CD47、PD-L1/PD-1 及 TIGIT/PVR 生物學機制，且已獲准進行臨床試驗的三特異性免疫療法。公司亦持續布局其他腫瘤及免疫介導疾病相關研發項目。
前瞻性聲明
本新聞稿包含有關 HCB101 的開發、HCB101-201 臨床試驗及其結直腸癌研究組別、HCB101 聯合治療策略，以及漢康生技產品管線與 FBDB™ 平台的前瞻性聲明。
此類聲明係基於目前的預期，涉及風險與不確定性，可能導致實際結果與預期產生重大差異。早期臨床及研究者發起的研究數據，不一定能預測較大規模或後期臨床試驗的結果；歷史臨床數據僅供參考，跨試驗比較應審慎解讀。
HCB101 未來能否證實其安全性與療效，或取得主管機關核准，均無法保證。除適用法律另有規定外，漢康生技不承擔更新前瞻性聲明的義務。