復星醫藥(02196.HK)控股子公司獲藥品臨牀試驗批準
格隆匯2月27日丨復星醫藥(02196.HK)公告，上海復星醫藥(集團)股份有限公司(以下簡稱“公司”)控股子公司江蘇星盛新輝醫藥有限公司(以下簡稱“星盛新輝”)於近日收到國家藥品監督管理局關於同意XS-03片(申請註冊分類：化藥1類；以下簡稱“XS-03”)與FOLFOX或FOLFIRI和貝伐珠單抗聯合用於治療RAS突變轉移性結直腸癌(以下簡稱“該治療方案”)臨牀試驗的批準。星盛新輝擬於條件具備後於中國境內(不包括港澳臺地區，下同)開展該治療方案的Ib/II期臨牀試驗。
本次臨牀研究中，XS-03將聯合FOLFOX或FOLFIRI和貝伐珠單抗，擬用於治療RAS突變轉移性結直腸癌。其中，FOLFOX或FOLFIRI聯合貝伐珠單抗是目前晚期轉移性結直腸癌的一線標準治療方案。
該治療方案中所涉XS-03爲本集團(即本公司及控股子公司/單位，下同)自主研發的小分子口服PLK1抑制劑。XS-03主要通過抑制細胞週期調節因子，誘導有絲分裂阻滯，達到抑制腫瘤細胞增殖、促進腫瘤細胞凋亡的抗腫瘤作用。此外，XS-03在機制上與KRAS突變有合成致死性，對攜帶KRAS突變的結直腸細胞有很好的抑制效果。截至目前的研究顯示，XS-03在多種腫瘤模型中展現較爲顯著的抑制腫瘤生長的藥效，且臨牀安全性良好。截至本公告日期(即2025年2月27日，下同)，XS-03單藥用於治療RAS突變晚期實體瘤於中國境內處於I期臨牀試驗階段。
截至2025年1月，集團現階段針對該治療方案的累計研發投入約爲人民幣20萬元(不包括單藥，未經審計)。
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