復宏漢霖-B(02696.HK):HLX11用於轉移性乳腺癌、早期乳腺癌治療的1期臨牀研究完成首例患者給藥
格隆匯 9 月 20日丨復宏漢霖-B(02696.HK)宣佈,今日,公司研製的重組抗HER2結構域II人源化單克隆抗體注射液HLX11("HLX11")用於轉移性乳腺癌、早期乳腺癌治療的1期臨牀研究於中國大陸完成首例患者給藥。
該研究是一項在中國健康男性受試者中分別比較HLX11與美國、歐盟和中國市售的帕妥珠單抗("原研藥")靜脈注射後的藥物代謝動力學特徵、安全性和免疫原性的隨機、雙盲、單次給藥、平行、4臂的1期臨牀試驗。該研究的主要目的是頭對頭比較HLX11與3種來源的原研藥在藥物代謝動力學方面的生物相似性。次要目的是評估HLX11與原研藥的安全性、耐受性和免疫原性,並進一步描述其藥物代謝動力學特徵。
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