- Prestigious peer-review validates HCB101’s differentiated mechanism and translational strength.
- Clinical data show a nearly 90% partial response rate in 2L gastric cancer (combo) and safe escalation to 30 mg/kg (mono)
[TAIPEI and SHANGHAI and SAN FRANCISCO, Oct. 23, 2025 ]/PRNewswire/ – HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies, today announced that its manuscript describing the discovery and preclinical development of HCB101, an engineered SIRPα-Fc fusion protein, has been published in the Journal of Hematology & Oncology (SCI Impact Factor 40.4; for reference, leading journals in the field of immuno-oncology include Journal of Clinical Oncology (impact factor 41.9), The Lancet Oncology (35.9), and Nature Cancer (28.5)).
The publication, titled “HCB101: A Novel Potent Ligand-Trap Fc-fusion Protein Targeting the CD47-SIRPα Pathway with High Safety and Preclinical Efficacy for Hematological and Solid Tumors,” describes the rational protein engineering that enabled HCB101 to restore macrophage-mediated phagocytosis and bridge innate and adaptive immune responses while reducing red blood cell binding. In preclinical studies, HCB101 showed broad activity across more than 80 xenograft and PDX tumor animal models with a safety profile that differs from first- and second-generation CD47-targeting agents.
HanchorBio’s CD47-SIRPα Therapeutic HCB101 Published in Journal of Hematology & Oncology, Demonstrating High Safety and Preclinical Efficacy
Notably, a US competitor focusing on CD47/SIRPα published findings in JHO in November 2020, reporting on a third-generation anti-CD47–SIRPα therapy. This underscores the journal’s strong recognition within the field. The continued publication of anti-CD47 biologics in JHO highlights both the scientific importance of ongoing advancements and the journal’s role as a leading international platform for preclinical and translational research on anti-CD47 therapies.
“Publication in the Journal of Hematology & Oncology affirms the scientific rigor and innovation behind HCB101 and emphasizes its differentiated preclinical foundation,” said Scott Liu, PhD, Chairman, CEO, and Founder of HanchorBio. “Importantly, these insights are being directly translated into clinical studies: combined with standard-of-care, HCB101 has demonstrated a clear dose-dependent efficacy profile in 2L gastric cancer, culminating in a nearly 90% partial response rate at 5.12 and 8.0 mg/kg. In parallel, we have now escalated monotherapy dosing to 30 mg/kg without safety concerns. These milestones highlight HCB101’s potential to serve as a backbone immunotherapy across solid tumors and hematologic malignancies and lay the groundwork for expanding into autoimmune indications where CD47-SIRPα biology is also potentially useful in creating a new B-cell depletion therapy.”
Clinical Progress Strengthens Differentiated Best-in-Class Profile
HCB101 is currently being evaluated in multinational Phase 1 and Phase 1b/2a trials:
- Monotherapy (HCB101-101, NCT05892718):
The Safety Review Committee (SRC) has reviewed the safety data up to 30 mg/kg weekly and found no dose-limiting toxicities, confirming a wide therapeutic window. Early signs of efficacy included two confirmed partial responses (PRs) in head and neck squamous cell carcinoma and marginal zone lymphoma, along with stable disease (SD) in nine patients, including over 40 weeks of disease control in platinum-resistant ovarian cancer. - Combination (HCB101-201, NCT06771622):
In the triplet regimen for 2L-gastric cancer (HCB101 + ramucirumab + paclitaxel), emerging activity was first observed at 2.56 mg/kg, where evaluable patients achieved SD with modest tumor shrinkage, averaging a 6% reduction in tumor size in the dose cohort. At 5.12 mg/kg, all three evaluable patients achieved confirmed PRs (33%–46% tumor reductions). At 8.0 mg/kg, all three evaluable patients have now achieved confirmed PRs (tumor shrinkage up to -78%) after extended follow-up. Together, these results represent a nearly 90% confirmed response rate (6 of 7 patients) at ≥ 5.12 mg/kg dose level — a striking outcome in a setting where the typical overall response rate (ORR) for the SOC is only 26.5%.
“The data now published in JHO validate the design strategy that made HCB101 possible – balancing high efficacy with a clean safety margin where earlier CD47-targeting agents failed,” added Wenwu Zhai, PhD, Chief Scientific Officer of HanchorBio. “Seeing those preclinical insights translate into durable monotherapy activity and remarkable combination dose-dependent responses in gastric cancer provides confidence not only for oncology but also for new areas such as autoimmunity. HCB101’s differentiated mechanism and safety profile open the door to rational combinations and next-generation applications well beyond cancer.”
About HCB101: A Differentiated CD47-SIPRα Blockade
HCB101 is a 3.5th-generation, affinity-optimized SIRPα-Fc fusion protein with intact IgG4 effector function, developed using HanchorBio’s proprietary FBDB™ platform. Engineered for selective CD47 blinding on tumors with low affinity for red blood cells, HCB101 avoids the hematologic toxicities commonly associated with anti-CD47 monoclonal antibodies, while preserving strong antibody-dependent cellular phagocytosis (ADCP) and innate-to-adaptive immune bridging.
Key Differentiators of HCB101:
- Enhanced safety: Low RBC binding minimizes anemia and thrombocytopenia risk.
- Robust immune activation: Engineered to enhance ADCP and innate-to-adaptive bridging.
- Broad tumor applicability: Demonstrated activity in >80 PDX/CDX preclinical models.
- Clinical translation: Early efficacy as monotherapy with durable disease control, and 100% ORR and disease control rate (DCR) at the middle dose cohort in combination with standard-of-care for 2L-gastric cancer.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TPEx), a global biotechnology company specializing in immuno-oncology, is led by an experienced team of pharmaceutical industry veterans with a proven track record of success in biologics discovery and international development, aiming to rewrite cancer therapies. Committed to reactivating the immune system to fight diseases, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By making breakthroughs in multi-functional innovative molecular configurations in R&D and improving the manufacturing process in CMC, HanchorBio develops transformative medicines to address unmet medical needs.
漢康生技-KY（7827，HanchorBio）作為活躍於腫瘤免疫學領域的全球生技公司，近年來積極投入癌症生物藥研發，憑藉其專有的「基於 Fc 設計的生物製藥（Fc-Based Designer Biologics，FBDB™）」技術平台，開發出一系列具市場競爭力的候選藥物。繼較早前創新三功能融合蛋白 HCB301 的臨床前研究摘要獲美國免疫腫瘤學會（SITC）接受，將於 11 月初亮相 SITC 2025 年會之後，漢康團隊日前宣布，旗下核心產品 HCB101 的研究成果已獲國際頂尖期刊《Journal of Hematology & Oncology（JHO）》接受發表。
JHO 是全球最具影響力的腫瘤學期刊之一，2024 年影響因子（Impact factor）高達 40.4（參照同領域知名期刊，《Journal of Clinical Oncology》同期為 41.9；《Lancet Oncology》為 35.9，而《Nature Cancer》則為 28.5）。此次獲 JHO 接受刊登之文章題目為《HCB101：針對 CD47-SIRPα 途徑的全新高效配體捕獲型 Fc 融合蛋白，展現卓越安全性與臨床前療效，適用於血液及實體腫瘤》（HCB101: A Novel Potent Ligand-Trap Fc-fusion Protein Targeting the CD47-SIRPα Pathway with High Safety and Preclinical Efficacy for Hematological and Solid Tumors），作者群均為漢康的研發人員。該文章揭示了 HCB101 的蛋白質工程設計，不僅使融合蛋白能成功恢復巨噬細胞介導的吞噬作用、啟動先天與適應性免疫反應，同時也顯著降低對紅血球的結合風險。
另外值得一提的是，同腫瘤免疫治療領域中一家美國的競爭對手也曾於 2020 年 11 月在 JHO 中發表關於第三代抗 CD47-SIRPα 藥物的研究成果，可見這個期刊的地位深受同行認可。再者，隨著不同世代的抗 CD47 生物藥於 JHO 中曝光，不僅反映相關的技術突破和產業創新受到學術界高度關注，也代表 JHO 已成為抗 CD47 療法的臨床前期與轉譯階段成果的主要國際發表平台。
延伸閱讀：漢康生技研發成果獲國際肯定，三功能融合蛋白亮相美國 SITC 舞台
促進腫瘤細胞吞噬且不傷紅血球，HCB101 突破傳統抗 CD47 療法困局
漢康開發的免疫腫瘤生物藥主要靶向細胞表面的 CD47 蛋白。作為一個免疫檢查點（Immune checkpoint），研究發現不少腫瘤細胞都存在 CD47 過度表達的現象，當 CD47 與巨噬細胞表面的信號調節蛋白 α（SIRPα）結合，就會向巨噬細胞傳達「不要吃我」的信號，使腫瘤細胞能避過巨噬細胞的攻擊。透過靶向 CD47 的藥物抑制 CD47-SIRPα 路徑，有助阻斷此信號傳遞，重啟巨噬細胞對腫瘤的殺傷作用。然而由於 CD47 也廣泛表達於紅血球和血小板等正常血細胞，早期的抗 CD47藥物（主要為單株抗體）由於也會結合紅血球等正常血細胞的CD47，往往引發巨噬細胞吞噬紅血球等正常細胞，存在血液毒性的疑慮。後來改用野生型 SIRPα 雖然安全性相對較佳，但僅針對血液癌症較有療效，在實體瘤治療方面則未見突破。
HCB101 是利用 FBDB™ 平台開發的第 3.5 代解決方案。透過基因工程技術改良 SIRPα 和 Fc 蛋白結構，搭配 AI 結構預測與大規模 SIRPα 變異體篩選，研發出具高度選擇性的 Fc 融合蛋白。這一創新設計能顯著促進腫瘤細胞吞噬而不損害紅血球，因此不會觸發血液毒性而導致貧血，同時兼顧抗腫瘤效果與用藥安全性，有望為此治療領域帶來重大突破，在多種 CD47 高表達的實體及血液腫瘤派上用場。
臨床前數據獲 JHO 接受發表，藥物效能與安全性均表現優異
目前 HCB101 已推進至臨床 1b/2 期，並持續於美、中、台三地多中心收案，已有多個二期臨床適應症的數據觀察到療效潛力，且大多隨著療程越久，腫瘤持續縮小。根據於 JHO 發表的臨床前數據指出，這款第 3.5 代融合蛋白具備以下特點，凸顯 FBDB™ 平台在開發差異化腫瘤免疫療法方面的優勢：
- 高親和力結合腫瘤細胞表面的 CD47，有效清除腫瘤細胞；
- 對比其他靶向 CD47 的單株抗體或融合蛋白，單藥即可對血液腫瘤及實體瘤展現強效的抗腫瘤活性，涵蓋逾80 種異種移植及病人來源腫瘤（PDX）動物模型
- 與抗 HER2 或抗 EGFR 單株抗體合併使用時，能呈現顯著協同作用；
- 可重塑腫瘤微環境，誘導腫瘤相關巨噬細胞轉為促發炎、抗腫瘤型；
- 展現出有別於第一代與第二代 CD47 靶向藥物的優異安全性，在動物模型中未出現劑量限制毒性或血液學副作用。
漢康生技董事長、執行長暨創辦人劉世高博士表示：「HCB101 的研究成果得以在《Journal of Hematology & Oncology》中發表，充分肯定了這款融合蛋白的科學嚴謹性與創新性，並突顯其具差異化優勢的臨床前研究基礎。」他又強調：「更重要的是，這些研究洞見正直接轉化為臨床成果：在與標準治療併用的研究中，HCB101 在二線胃癌患者中展現出明顯的劑量依賴性療效，在 5.12 與 8.0 mg/kg 劑量下部分的緩解率目前達到 近90%。同時，單藥試驗的劑量已安全提升至 30 mg/kg，未見安全性疑慮。這些里程碑顯示 HCB101 具備成為橫跨實體與血液腫瘤之核心免疫治療的潛力，並為拓展至 CD47-SIRPα 機制同樣具潛力的自體免疫疾病領域，開啟新型 B 細胞清除療法奠定基礎。」
科學長翟文武博士補充：「此次發表於《Journal of Hematology & Oncology》的研究數據驗證了促成 HCB101 誕生的設計策略 ── 在早期 CD47 靶向藥物無法兼顧用藥安全及抗腫瘤效果的情況下，HCB101 成功平衡了高效能與優異的安全性。更令人振奮的是，這些臨床前的洞見已在臨床試驗中得到印證：HCB101 不僅展現出持續穩定的單藥療效，亦在胃癌的聯合治療中呈現明顯的劑量依賴性反應，這不僅強化了我們對開發腫瘤治療藥物的信心，也激發我們嘗試拓展適應症至自體免疫疾病等新應用領域。HCB101 具差異化的作用機制與安全性特質，為聯合治療與新一代應用開啟了嶄新的可能。」