先聲藥業(02096.HK):SIM0500(人源化GPRC5D-BCMA-CD3三特異性抗體)新藥臨牀試驗申請獲美國食品藥品監督管理局批准
格隆匯3月10日丨先聲藥業(02096.HK)發佈公吿,於北京時間2024年3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SIM0500新藥臨牀試驗申請(IND)獲美國食品藥品監督管理局(FDA)批准,擬開展SIM0500用於復發或難治性多發性骨髓瘤患者的臨牀試驗。此外,SIM0500中國IND申請已於2024年1月2日獲得中國國家藥品監督管理局受理。
SIM0500是一種人源性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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