微芯生物(688321.SH):西奧羅尼膠囊臨牀試驗申請獲得受理
格隆匯1月4日丨微芯生物(688321.SH)公佈,公司近日收到國家藥品監督管理局簽發的IND(新藥臨牀試驗申請)《受理通知書》。
產品名稱:西奧羅尼膠囊;適應症:西奧羅尼膠囊治療標準治療失敗的晚期或不可手術切除的軟組織肉瘤患者。
西奧羅尼是公司自主設計和研發的具有全球專利保護的新化學結構體,屬於多靶點多通路選擇性激酶抑制劑。屬於小分子抗腫瘤原創新藥,可選擇性抑制Aurora B、CSF1R和VEGFR/PDGFR/c-Kit等多個激酶靶點。
通過抑制細胞週期調控激酶Aurora B,西奧羅尼可以抑制腫瘤細胞的週期進程,降低腫瘤的增殖活性;通過抑制與血管生成相關的VEGFR和PDGFR,西奧羅尼可以抑制腫瘤的新生血管形成,從而減少腫瘤的血液供應和生長;通過抑制與免疫細胞增殖活化相關的CSF1R,西奧羅尼可以抑制腫瘤局部免疫抑制性細胞的生長,從而提高機體對腫瘤的免疫監測和免疫清除功能。
綜上,西奧羅尼通過上述抑制腫瘤細胞有絲分裂、抑制腫瘤血管生成和調節腫瘤免疫微環境的三種活性機制,實現多通路機制的抗腫瘤藥效,從而發揮綜合抗腫瘤作用,具有相對同類機制藥物更優異的動物藥效活性和良好的安全性。
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