[Taipei, Shanghai, San Francisco | October 07, 2025] – HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies, today announced the successful completion of its latest Scientific Advisory Board (SAB) meeting. Chaired by Professor Mingyi Chen (UT Southwestern Medical Center), the SAB brings together global leaders from institutions such as The Ohio State University, University of Michigan, Tsinghua University, and National Taiwan University to review HanchorBio’s clinical progress, translational insights, and pipeline strategy across oncology and autoimmune diseases.
The SAB reviewed compelling new clinical data from HCB101, HanchorBio’s best-in-class, engineered SIRPα-Fc fusion, protein designed to overcome the limitations of earlier CD47 approaches. Key highlights included:
- Clinical progress: HCB101 Phase 1a monotherapy study (HCB101-101; NCT05892718) shows clean and manageable safety up to 30 mg/kg with durable partial responses, including in head and neck squamous cell carcinoma (HNSCC) and marginal zone lymphoma. Phase 1b/2a combination study (HCB101-201; NCT06771622) with different tumor cohorts demonstrates striking efficacy in 2L gastric cancer (GC), with 100% confirmed partial response (PR) rate at 5.12-8.0 mg/kg and regressions up to ~78% in total diameter, plus early signals in 1L triple-negative breast cancer (TNBC) and HNSCC, far exceeding historical benchmarks.
- Strategic path: SAB endorsed anchoring registrational strategy where HCB101’s selective CD47 blockade with strong antibody-dependent cellular phagocytosis (ADCP) is most compelling. This includes tumors characterized by strong macrophage involvement and immune evasion, with potential applications from advanced solid tumors to earlier curative-intent settings.
- Regulatory and visibility: Opportunities identified for orphan drug designation (ODD) filings and high-impact publications to establish HCB101 as the first CD47 program with clear, dose-dependent clinical efficacy.
- Pipeline innovation: Review of next-generation assets from HanchorBio’s proprietary multi-specific and immune-modulatory platforms, including:
- HCB302 (CD47 x PD-L1 x CSF-1), a tri-specific targeting tumor immune evasion and myeloid reprogramming.
- RDHCB206 (CD20 x CD47), a bispecific for B-cell driven autoimmune diseases.
“As someone who has studies the CD47-SIRPα axis for many years, I am very impressed by how HCB101 has been engineered to overcome the historic safety and efficacy limitations of this pathway,” said Distinguished Professor Yangxin Fu, M.D., Ph.D., Director of the Immuno-Oncology at Tsinghua University Basic Medical College. “By minimizing binding to red blood cells while retaining potent ADCP to CD47-expressing cancer cells, HCB101 has demonstrated the cleanest clinical safety profile observed to date, even at 30 mg/kg. Importantly, its ability to re-engage macrophages and bridge innate and adaptive immune responses makes it uniquely positioned as a backbone therapy for rational combination strategies in both oncology and autoimmune diseases.”
Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio added, “The SAB’s feedback underscores that HCB101 is not just safer than prior CD47 agents but also capable of delivering clear dose-dependent clinical efficacy, including confirmed responses in solid tumors. With our recent strategic collaboration with Shanghai Henlius and industry momentum highlighted by Genmab’s $8B acquisition of Merus for head and neck cancer assets, HanchorBio is positioned to be at the forefront of next-generation checkpoint innovation. Together with our expanding multi-specific pipeline, including HCB302, RDHCB206 and so on, we are advancing a differentiated portfolio designed to deliver first-in-class and best-in-class therapies to patients with difficult-to-treat cancers and autoimmune diseases.”
About HCB101: A Differentiated CD47-SIPRα Blockade
HCB101 is a 3.5th-generation, engineered SIRPα-Fc fusion protein developed on HanchorBio’s proprietary FBDB™ platform. Designed for selective CD47 blockade with low red blood cell (RBC) binding, HCB101 avoids the anemia and thrombocytopenia commonly associated with earlier CD47 antibodies, while preserving strong antibody-dependent cellular phagocytosis (ADCP) and innate-to-adaptive immune bridging.
Key Differentiators of HCB101:
- Enhanced safety: Demonstrates a cytopenia-sparing profile, with no dose-limiting toxicities observed up to 24 mg/kg and receptor occupancy >90% at ≥28 mg/kg, supporting a broad therapeutic window.
- Robust immune activation: Engineered to enhance ADCP and bridge innate-to-adaptive immunity, with evidence of durable immune-mediated tumor control in monotherapy.
- Broad tumor applicability: Demonstrated activity across >80 PDX and CDX preclinical models, with early clinical signals in gastric cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, non-Hodgkin lymphoma, and ovarian cancer.
- Clinical translation: Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6/6) in second-line gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in first-line TNBC, and second-line HNSCC, substantially exceeding historical benchmarks.
【臺北、上海、舊金山｜2025年10月7日】–漢康生技股份有限公司（TPEx: 7827），全球化的生物科技公司，致力於研發創新免疫生物藥，解決癌症及自體免疫疾病中重大的醫療需求，今日宣布成功召開最新一屆科學顧問委員會（Scientific Advisory Board, SAB）會議。本次會議由美國德州大學西南醫學中心（UT Southwestern Medical Center）陳明義教授主持，並邀集來自俄亥俄州立大學、密西根大學、清華大學與國立臺灣大學等國際頂尖專家，共同審視漢康生技於腫瘤與自體免疫疾病領域的臨床進展、轉譯洞見與管線策略。
SAB會議重點審查了HCB10的最新臨床成果。HCB101 為漢康生技自主研發、同類最佳（best-in-class）的工程化SIRPα-Fc融合蛋白，旨在克服早期CD47藥物在安全性與療效上的限制。
會中呈現的關鍵亮點包括：
• 臨床進展
漢康生技旗下HCB101為同類最佳（best-in-class）的工程化SIRPα-Fc融合蛋白，旨在克服傳統CD47療法的安全性與療效限制。
- 一期單藥試驗（HCB101-101；NCT05892718）：安全性良好且可控，劑量提升至30 mg/kg仍未見劑量限制性毒性（DLT），並觀察到持續的部分緩解（PR），包括頭頸鱗狀細胞癌（HNSCC）與邊緣區淋巴瘤（MZL）。
- 一期b/二期a聯合治療試驗（HCB101-201；NCT06771622）：在第二線胃癌（2L GC）顯示卓越療效，12–8.0 mg/kg劑量組100%病人達到確認部分緩解（PR），腫瘤縮小幅度最高達78%；同時在第一線三陰性乳癌（1L TNBC）與HNSCC中亦出現早期療效訊號，遠超過歷史對照數據。
• 策略方向
SAB委員們一致肯定HCB101的發展策略，建議以選擇性CD47阻斷並具強大抗體依賴性細胞吞噬作用（ADCP）為核心，聚焦於巨噬細胞參與度高且具免疫逃脫特徵的腫瘤類型，從進展期實體瘤延伸至早期具治癒潛力的臨床場景。
• 法規與能見度
專家建議啟動罕見疾病藥物（ODD）申請及高影響力學術發表，以鞏固HCB101作為首個具明確劑量依賴性臨床療效的CD47療法之領先地位。
• 管線創新
會議同時檢視了漢康生技專有多特異性與免疫調控平台的下一代產品，包括但不限於：
- HCB302（CD47×PD-L1×CSF-1）：三特異性分子，針對腫瘤免疫逃脫與骨髓細胞重塑（myeloid reprogramming）。
- RDHCB206（CD20×CD47）：雙特異性分子，用於B細胞驅動的自體免疫疾病。
委員北京清華大學基礎醫學院腫瘤中心主任傅陽心（Yangxin Fu）教授表示：
「作為長期研究CD47–SIRPα路徑機制的學者，我對HCB101的分子設計印象深刻。它成功克服了以往CD47藥物在安全性與療效上的歷史性瓶頸。HCB101透過大幅降低對紅血球的結合力，同時保留對表達CD47的腫瘤細胞之強大抗體依賴性細胞吞噬作用（ADCP），展現出目前所見最乾淨且可管理的臨床安全性，即使劑量提升至30 mg/kg亦維持良好耐受性。更重要的是，HCB101能重新活化巨噬細胞，並橋接先天與適應性免疫反應，使其具備成為腫瘤與自體免疫疾病策略性聯合療法核心骨幹的獨特潛力。」
漢康生技創辦人、董事長暨執行長劉世高博士補充說：
「SAB的建議再次印證，HCB101不僅比以往的CD47藥物更安全，還展現出明確且劑量依賴性的臨床療效，包括在多種實體瘤中觀察到已確認的客觀反應。隨著我們近期與上海復宏漢霖建立策略合作關係，以及產業中以Genmab以80億美元收購Merus的頭頸癌資產為代表的強勁市場動能，漢康生技正站在次世代免疫檢查點創新的前沿。同時，結合我們不斷擴展的多特異性產品管線——包括 HCB302、RDHCB206等其他在研項目——我們正推進一個具高度差異化的研發組合，致力於為難治型癌症與自體免疫疾病患者帶來首創（first-in-class）與最佳（best-in-class）的療法。」
關於 HCB101：差異化的CD47-SIRPα阻斷療法
HCB101是一款第3.5代工程化SIRPα-Fc融合蛋白，由漢康生技透過其專有 FBDB™ 平台開發。該分子具備選擇性 CD47 阻斷功能，並顯著降低對紅血球（RBC）的結合力，從而避免傳統 CD47 抗體常見的貧血與血小板減少副作用，同時保留強大的抗體依賴性細胞吞噬作用（ADCP）與先天免疫與適應性免疫之間的橋接效應。
HCB101 的主要差異化優勢：
- 強化安全性：展現出避免細胞減少（cytopenia-sparing）的安全特徵，劑量最高至 30 mg/kg 皆未觀察到劑量限制性毒性（DLT），且在 ≥1.28 mg/kg 時受體佔有率（RO）超過 90%，顯示其具備寬廣的治療窗口。
- 強勁的免疫活化：分子設計可增強 ADCP 活性並促進先天免疫與適應性免疫之間的橋接，單藥治療已展現出持久的免疫介導腫瘤控制效果。
- 廣泛的腫瘤適用性：在超過 80 種 PDX 與 CDX 前臨床模型中展現抗腫瘤活性，並在臨床早期於胃癌、三陰性乳癌（TNBC）、頭頸鱗狀細胞癌（HNSCC）、非霍奇金淋巴瘤（NHL）及卵巢癌中觀察到療效訊號。
- 臨床轉譯成果：HCB101 單藥治療展現持久的疾病控制，而在第二線胃癌（聯合 ramucirumab 與 paclitaxel）中達到100% 確認部分緩解率（6/6）；此外，在第一線 TNBC及第二線 HNSCC中也觀察到確切反應，明顯優於歷史對照數據。