4 月 25, 2023

about HanchorBio Q&A / 關於漢康生技 問與答

4 月 17, 2023
HANCHORBIO ANNOUNCES US IND CLEARANCE FOR THE MULTI-REGIONAL CLINICAL TRIAL OF HCB101 TO TREAT SOLID AND HEMATOLOGICAL MALIGNANCIES / 重大訊息 | 漢康生技首項新藥HCB101的國際多地區多中心臨床試驗獲美國FDA新藥臨床試驗(IND) 許可
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。
7 月 24, 2023
HANCHORBIO ANNOUNCES TAIWAN FDA IND APPROVAL FOR THE MULTI-REGIONAL CLINICAL TRIAL OF HCB101 TO TREAT SOLID AND HEMATOLOGICAL MALIGNANCIES 台灣食藥署批准 HCB101 治療實體瘤和血液惡性腫瘤的多地區臨床試驗
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。