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先聲藥業(02096.HK)注射用SIM0500(人源化GPRC5D-BCMA-CD3三特異性抗體)獲授美國食品藥品監督管理局快速通道資格
格隆匯 04-09 21:37

格隆匯4月9日丨先聲藥業(02096.HK)公吿,於北京時間2024年4月9日,集團自主研發的抗腫瘤新藥人源化GPRC5D-BCMA-CD3三特異性抗體注射用SIM0500獲美國食品藥品監督管理局("FDA")授予一項快速通道資格,以用於既往接受過≥3線治療(包括一種蛋白酶體抑制劑(PI)、一種免疫調節劑(IMiD)及一種抗CD38單克隆抗體),且對於已知可以提供臨牀獲益的標準治療耐藥或無法耐受的多發性骨髓瘤患者。

FDA快速通道資格是一種加速開發和審批潛在藥物的方法。被授予快速通道資格的藥物旨在治療嚴重疾病並解決未滿足的醫療需求,其可能是針對特定疾病的首個療法,或與現有療法相比更具顯著臨牀優勢,或可令對現有療法效果不佳或不耐受的患者獲益。

SIM0500是一種人源化GPRC5D-BCMA-CD3三特異性抗體,基於臨牀前數據其是治療多發性骨髓瘤的潛在同類最佳(BIC)藥物。SIM0500系通過集團自有的T細胞銜接器多特異性抗體藥物研發平台,與集團自研低親和力高靶向激活的CD3抗體,及抗腫瘤相關抗原的抗體組合,形成腫瘤靶向的T細胞激活藥物,具有對腫瘤殺傷效果優,耐受性好等優勢。SIM0500可潛在克服現有治療手段所導致的耐藥,在臨牀前多種不同表達水平的BCMA或GPRC5D動物藥效模型中顯示了優異的抗腫瘤活性,且具有起效劑量低,停藥後腫瘤不復發等多重優勢。

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