5 月 23, 2025

HanchorBio to Present Interim Clinical Data at ASCO 2025 Annual Meeting 漢康生技將於2025年美國臨床腫瘤學會(ASCO)年會發表HCB101初步臨床數據

【TAIPEI, SHANGHAI, and SAN FRANCISCO, May 23, 2025】– HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today announced that interim clinical data from its lead immunotherapy product, HCB101, has been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 – June 4 in Chicago, Illinois. 
The accepted abstract (#2584: Phase 1 trial of HCB101, a novel Fc-based anti-SIRPα-CD47 fusion protein, in subjects with advanced cancers) highlights emerging data from the ongoing Phase 1 dose-escalation trial (NCT05892718) of HCB101, a differentiated SIRPα-Fc fusion protein rationally engineered to enhance phagocytosis and innate immune activation, without the hematologic toxicity that has hindered earlier CD47-targeting therapies. HCB101 is being evaluated as monotherapy in patients with advanced solid tumors or relapsed/refractory (R/R) non-Hodgkin lymphomas (NHLs). The poster presentation is scheduled for June 2, 2025, during the ASCO Immunotherapy session.
“HCB101 was designed to unlock the full potential of macrophage checkpoint inhibition by overcoming key limitations of legacy CD47 programs,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “The ASCO presentation represents an important step in our strategy to build durable, best-in-class immunotherapies driven by innate immunity. We look forward to engaging with the oncology community, including scientific leaders, collaborators, and potential partners, as we advance HCB101 into the next phase of clinical development.”
HCB101 was developed using HanchorBio’s proprietary FBDB™ platform, which combines Fc engineering and SIRPα optimization to achieve high-affinity binding and immune effector activation. Preclinical studies demonstrated robust anti-tumor activity and favorable tolerability, supporting its clinical advancement.
HanchorBio is actively exploring strategic collaborations to accelerate global development and unlock the full potential across oncology and autoimmune indications.
【台北、上海與舊金山 — 2025年5月23日】– 漢康生技是一家專注於腫瘤與自體免疫疾病創新免疫療法的全球臨床階段生技公司,今日宣布,其免疫療法候選藥物 HCB101的初步臨床數據已獲選於2025年美國臨床腫瘤學會(ASCO)年會發表。該年會將於2025年5月31日至6月4日在美國芝加哥舉行。
入選摘要(#2584:Phase 1 trial of HCB101, a novel Fc-based anti-SIRPα-CD47 fusion protein, in subjects with advanced cancers)為HCB101持續進行中的第一期劑量爬升臨床試驗(NCT05892718)揭示初步數據。HCB101是一種經精準設計的差異化 SIRPα-Fc融合蛋白,具備增強吞噬作用與活化先天免疫的能力,同時避免傳統CD47靶向療法常見的血液毒性。該藥目前正在以單一療法方式進行臨床試驗,針對晚期實體腫瘤與復發/難治型非何杰金氏淋巴瘤(R/R NHL)病患進行評估。海報預定於2025年6月2日ASCO的免疫療法專場發表。
「HCB101的設計旨在突破傳統CD47抑制劑的關鍵瓶頸,全面釋放巨噬細胞檢查點抑制的臨床潛力,」漢康生技創始人、董事長兼執行長劉世高博士表示。「此次於ASCO的發表,是我們致力於打造藥效持久、Best-in-Class免疫療法策略中的重要里程碑。我們期待與腫瘤學界的科學領袖、策略合作夥伴及潛在夥伴密切交流,共同推進HCB101的下一階段臨床發展。」
HCB101為漢康生技專有的FBDB™平台所開發,該平台整合Fc工程技術與SIRPα結構優化,大幅提升結合親和力與免疫效應功能。前臨床研究已顯示其具有強勁的抗腫瘤活性與良好的耐受性,支持其邁入臨床開發階段。
漢康生技正積極尋求全球策略合作機會,以加速HCB101在腫瘤與自體免疫領域的開發進程,發揮其最大潛能。
4 月 15, 2025
HanchorBio Announces Second Taiwan TFDA Approval for HCB101 Combination Therapy in Advanced Head and Neck Cancer 漢康生技宣布第二項HCB101聯合療法於台灣獲 TFDA 批准用於晚期頭頸癌
HanchorBio Inc., a global biotechnology company developing innovative immuno-biomedicines to address significant unmet medical needs in oncology, today announced that the Taiwan Food and Drug Administration (TFDA) has approved a second investigator-initiated trial (IIT) evaluating the safety and efficacy of HCB101 in combination with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who are refractory to platinum-based chemotherapy. The study will take place at Taipei Veterans General Hospital and Linkou Chang Gung Memorial Hospital. This marks the second TFDA-approval IIT of HCB101 in combination with standard-of-care (SOC) therapies, following the recently announced IIT approval for a metastatic colorectal cancer (mCRC) study. The new approval underscores HanchorBio’s strategic focus on expanding HCB101’s clinical development MOA (mode of action) based immunotherapy combinations across multiple solid tumors with unmet medical needs.
6 月 03, 2025
HanchorBio Presents Promising Phase 1 HCB101 Data at ASCO 2025 – Confirmed Partial Response Observed in Solid Tumor and Lymphoma Patients漢康生技在 2025美國臨床腫瘤學會 ASCO 年會發表 HCB101 一期試驗佳績 —— 實體腫瘤與淋巴瘤患者皆觀察到腫瘤顯著部分縮小(緩解)
HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today presented interim data from its lead immunotherapy product, HCB101, following its poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31 – June 4 in Chicago, Illinois. The data, featured in a poster session, demonstrated favorable safety, high CD47 receptor occupancy, and early clinical signs of anti-tumor activity, including confirmed partial response (PR) in patients with head and neck cancer (HNSCC) and marginal zone lymphoma.