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和黃醫藥(00013.HK)在中國啟動抗CD47單克隆抗體HMPL-A83治療晚期惡性腫瘤I期臨牀試驗
格隆匯 07-15 16:34

格隆匯7月15日丨和黃醫藥(00013.HK)發佈公吿,其在中國啟動一項HMPL-A83的I期臨牀試驗。HMPL-A83是一種研究性的新型IgG4型人源化抗CD47單克隆抗體。首名患者已於2022年7月15日接受給藥治療。

該項I期研究是一項多中心、開放標籤的臨牀試驗,旨在評估HMPL-A83治療晚期惡性腫瘤患者的安全性、耐受性、藥代動力學和初步療效。研究的主要終點是劑量限制性毒性(DLT)、安全性、耐受性、II期臨牀試驗推薦劑量(RP2D)以及最大耐受劑量(MTD)。次要終點包括藥代動力學、藥效動力學、免疫原性和初步療效特徵。該研究的牽頭主要研究者為上海市東方醫院的郭曄教授及山東省腫瘤醫院的孫玉萍教授。

和黃醫藥首席執行官兼首席科學官蘇慰國博士表示:“HMPL-A83標誌着我們大分子候選藥物及免疫療法探索的新篇章。HMPL-A83是由我們自有的創新藥研發平台發現和開發的第十三個創新抗腫瘤藥物,並且具有豐富的潛力與我們現有的小分子藥物聯合使用。這是我們多管齊下治療癌症和免疫疾病策略的關鍵部分,我們對推進HMPL-A83的開發感到非常振奮。”

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