榮昌生物-B(09995.HK)治療胃癌及胰腺癌藥品獲美國FDA發孤兒藥資格認定
榮昌生物-B(09995.HK)公佈,公司自主研發的創新性抗體偶聯藥物(Antibody-drug conjugates)RC118獲得美國食品藥品監督管理局(FDA)頒發兩項孤兒藥資格認定,分別針對治療胃癌及胰腺癌。
集團表示,RC118目前正在開展治療Claudin 18.2表達陽性患者的局部晚期不可切除或轉移性惡性實體瘤的I期臨牀試驗。目前正在進行劑量爬坡研究,並表現出良好的安全性與耐受性。
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