復星醫藥(02196.HK)控股子公司獲藥品臨牀試驗批准
格隆匯9月27日丨復星醫藥(02196.HK)公吿,公司控股子公司江蘇星盛新輝醫藥有限公司於近日收到國家藥品監督管理局關於同意XS-04片(以下簡稱“該新藥”)用於治療血液系統惡性腫瘤的臨牀試驗批准。星盛新輝擬於條件具備後於中國境內(不包括港澳台地區,下同)開展該新藥的I期臨牀試驗。
該新藥為集團自主研發的小分子創新藥,擬用於治療血液系統惡性腫瘤,尤其是以瀰漫性大B細胞淋巴瘤(DLBCL)為主的B細胞淋巴瘤。截至目前的臨牀前研究顯示,該新藥在多種血液腫瘤模型中展現出較為顯着的抑制腫瘤生長的藥效且安全性良好,有望解決既往BTK共價抑制劑治療併產生耐藥的問題。
截至2024年8月,集團現階段針對該新藥累計研發投入約為人民幣4,147萬元(未經審計)。截至本公吿日期(即2024年9月27日),全球範圍內尚無同靶點的藥物獲批上市。
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