貝達藥業(300558.SZ):BPI-442096片擬用於晚期實體瘤的藥品臨牀試驗已獲NMPA批准開展
格隆匯1月24日丨貝達藥業(300558.SZ)公佈,今日,公司收到國家藥品監督管理局(“NMPA”)簽發的《藥物臨牀試驗批准通知書》(通知書編號:2022LP00095、2022LP00096),公司申報的BPI-442096片擬用於晚期實體瘤的藥品臨牀試驗已獲NMPA批准開展。
BPI-442096是一個由公司自主研發的擁有完全自主知識產權的新分子實體化合物,是一種新型強效、高選擇性的含Src同源2結構域蛋白酪氨酸磷酸酶(Src homology region 2 domain-containing tyrosine phosphatase-2,“SHP2”)口服小分子抑制劑,擬單藥或聯合用於KRAS突變、BRAF第三類突變、NF1失活突變以及RTK突變、擴增或重排等基因異常的組織學或細胞學確診的局部晚期或轉移性的實體瘤患者,包括非小細胞肺癌、胰腺癌、結直腸癌患者或其他確診的實體瘤患者。
臨牀前數據顯示,BPI-442096體內外生物學活性一致,作用機理明確,在多種腫瘤細胞和相應移植瘤藥效模型上展示了明顯的抗腫瘤活性;在多種藥效模型上,其與相關抑制劑聯用可以帶來更好的抗腫瘤效果。BPI-442096在體內有良好的藥代-藥效關係,且體內外藥代動力學性質良好;在多種動物上有較高的口服生物利用度,毒性可控可測,支持進一步在臨牀上評估其風險和效益。
截至公吿披露日,全球尚無SHP2抑制劑獲批上市。BPI-442096屬於“境內外均未上市的創新藥”,其註冊分類為化學藥品1類。
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