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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3日丨復星醫藥(02196.HK)公佈,公司控股子公司浙江星浩澎博醫藥有限公司(以下簡稱"星浩澎博")於近日收到國家藥品監督管理局關於同意XH-S002散(以下簡稱"該新藥")用於缺血性卒中和短暫性腦缺血發作二級預防的臨牀試驗批准。星浩澎博擬於條件具備後於中國大陸境內開展該新藥的I期臨牀試驗。

該新藥為集團(即公司及控股子公司/單位,下同)自主研發的小分子抑制劑,擬用於缺血性腦卒中等血栓相關疾病的治療和預防。

該新藥通過抑制凝血途徑的靶點,進而抑制凝血和血栓的形成。臨牀前研究顯示,該新藥靶點選擇性高,在臨牀前毒理研究中展現了良好的耐受性,安全性風險相對可控。截至公吿日,於全球範圍內尚無同一分子機制的小分子抑制劑獲批上市。

截至2023年7月,集團現階段針對該新藥累計研發投入約為人民幣2,751萬元(未經審計)。

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