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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.

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.

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.

HanchorBio Inc., a global biotechnology company dedicated to developing innovative immuno-biomedicines to address significant unmet medical needs in oncology and autoimmune diseases, today announced the successful completion of its 5th semi-annual Scientific Advisory Board (SAB) meeting recently held in Taipei, Taiwan. The meeting brought together globally renowned scientific and clinical experts to provide strategic guidance to HanchorBio’s current preclinical and clinical R&D efforts and future development plans for advancing novel multi-functional biologics to treat cancer and autoimmune diseases.

HanchorBio Inc., a global biotechnology company dedicated to developing innovative immuno-medicines to address significant unmet medical needs in oncology and autoimmune diseases, has been awarded the 2025 Taiwan Biopharma Excellence Award at Biologics World Taiwan, hosted by IMAPAC. The company was also named “Company to Watch Out for in Taiwan”, recognizing its innovation, leadership, and growth potential in biologics development.This industry recognition highlights HanchorBio’s significant progress in advancing its proprietary Fc-Based Designer Biologics (FBDB™) platform and underlines the company’s potential as it prepares for its next phase of corporate growth, including an anticipated IPO in Taiwan.

TAIPEI, SHANGHAI, and SAN FRANCISCO, March 24, 2025 – 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 an investigator-initiated trial (IIT) evaluating HCB101 in combination with cetuximab or bevacizumab and FOLFOX or FOLFIRI for advanced or metastatic colorectal cancer (CRC). The study will take place at Linkou Chang Gung Memorial Hospital under the leadership of Dr. Hung-Chih Hsu. This TFDA approval marks a significant step in expanding and advancing the clinical development of HCB101 through novel combinations with standard-of-care (SOC) therapies to meet unmet medical needs in the immunotherapy of solid tumors, including CRC.

HanchorBio Inc., a global biotechnology company developing innovative immuno-biomedicines to address significant unmet medical needs in oncology, today announced that the first patients with triple-negative breast cancer (TNBC) and gastric cancer (GC), respectively, were dosed in the Phase 1b/2a HCB101-201 clinical trial at Binzhou Medical University Hospital. This milestone marks the first-in-patient administration of HCB101 in combination with standard-of-care (SOC) therapies, leveraging its dual immune-modulating mechanisms to enhance tumor clearance in advanced solid tumors.

6月27日，國際領先的生命科學集團莎多利斯(Sartorius)宣布，與全球性生技新藥開發公司漢康生技(HanchorBio)簽訂合作意向書，藉由莎多利斯在生物藥製程的先進解決方案，與漢康生技在複雜分子構型蛋白藥開發核心技術的整合，共同克服化學製造與管制(CMC)挑戰。漢康生技也成為莎多利斯在臺灣地區第一個簽訂合作意向書的生技新藥開發公司。

HanchorBio Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently developed novel drug candidate, HCB301 today.HCB301-101 is a multiregional, multicenter, open-label, dose-finding, first-in-human (FIH) study of adults with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas in the US, Australia, and Taiwan. The study evaluates the safety, tolerability, pharmacokinetics, and preliminary clinical efficacy of weekly HCB301 intravenous injections. The HCB301 IND is on track to be reviewed by the Australia Therapeutic Goods Administration (TGA) and the Taiwan FDA.漢康生技（HanchorBio Inc.）今天(2024/06/29) 宣佈自主研發的創新型候選藥物HCB301獲得美國FDA授予的新藥臨床試驗（IND）許可，即將開展多地區多中心的臨床試驗。目前於美國、澳大利亞和臺灣開展的多國多中心、非盲、劑量探索的首次人體（FIH）臨床試驗，用於治療晚期實體瘤或復發頑固型經典型霍奇金淋巴瘤的成年患者。研究目的是評估HCB301靜脈注射的安全性、耐受性、藥代動力學和初步臨床療效。HCB301的新藥臨床試驗申請（IND）目前正在接受澳大利亞藥品管理局（TGA）和臺灣TFDA的審查。

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