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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。

Our mission is to transcend immuno-oncology therapies b […]

HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immuno-biomedicines, announced today that the Taiwan Food and Drug Administration (TFDA) has approved its investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently-developed novel drug candidate, HCB101, for the treatment of patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.以開發創新免疫生物藥物的全球臨床階段生技公司-漢康生技今天宣布，台灣衛生福利部食品藥物管理署 (TFDA) 已批准其在研新藥申請 (IND)，以開展獨立研發的新藥候選物 HCB101 的多區域臨床試驗，用於治療晚期實體瘤或復發難治性非霍奇金淋巴瘤患者。

1. 為何會創立漢康生技？2. 漢康生技創立的時間跟宗旨是？3. 目前為止，漢康生技已獲得哪些研發的成果或是募資上的成功？4. 漢康生技的願景是甚麼?5. 針對生物科技、醫療相關領域，漢康生技能為社會做些甚麼？6. 漢康生技所研發的藥物跟其他傳統藥物的最大區別跟優勢是？關鍵技術是？7. FBDB™是甚麼？特別之處是？它對研發上有哪些幫助？8. 預計受惠者的規模或是程度為何？9. 像這樣多種靶向模式的生物製劑，以重啟免疫系統來對抗疾病的機轉，是否能應用於其他疾病或醫學領域？

HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immuno-biomedicines, announced today that the US. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to initiate a multi-regional clinical trial of its independently-developed novel drug candidate, HCB101, for the treatment of patients with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma.漢康生技（HanchorBio Inc.），一家專注於腫瘤免疫治療新藥研發與臨床的全球生技公司，今日宣佈其自主研發的創新融合蛋白HCB101獲得美國食品藥物管理局（FDA）授予新藥臨床試驗（IND）許可，即將開展多地區多中心的臨床試驗。此藥將用於治療晚期實體瘤及復發難治癒的非霍奇金淋巴瘤。

HanchorBio Inc. completed a face-to-face Scientific Advisory Board (SAB) meeting on March 29, 2023, in Taipei, Taiwan withworld-renowned professors and few Board of Director (BOD) members.漢康生技（HanchorBio Inc.）於2023年3月29日在台北內湖總部成功舉辦了(SAB)科學顧問委員會會議。

HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immuno-medicines, completed a face-to-face Scientific Advisory Board (SAB) meeting on March 29, 2023 in Taipei, Taiwan with world-renowned professors and few Board of Director (BOD) members.