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華東醫藥(000963.SZ):HDM2006片藥品臨牀試驗申請獲得美國FDA批准
格隆匯 01-13 17:33

格隆匯1月13日丨華東醫藥(000963.SZ)公佈,2025年1月10日,華東醫藥股份有限公司全資子公司杭州中美華東製藥有限公司收到美國食品藥品監督管理局通知,由中美華東申報的HDM2006片藥品臨牀試驗申請已獲得美國FDA批准,可在美國開展I期臨牀試驗,適應症為晚期惡性腫瘤。

HDM2006片是由中美華東自主研發的靶向HPK1(Hematopoietic Progenitor Kinase-1,造血祖激酶1)的新型、強效、高選擇性、可口服吸收的蛋白降解靶向嵌合體(PROTAC)1類化學藥品,中美華東擁有全球知識產權。臨牀前研究結果顯示,HDM2006具有良好的成藥性、安全性和有效性;HDM2006可特異性與人HPK1、E3連接酶結合形成三元複合物,進一步被泛素化和蛋白降解,從而解除HPK1對人T淋巴細胞、B淋巴細胞、DC細胞的負調控,激活免疫細胞、逆轉腫瘤微環境中的免疫抑制和T細胞耗竭,進而發揮抗腫瘤作用;HDM2006在多個腫瘤模型中表現出顯著的抗腫瘤效果,與PD-1/PDL1抗體聯用具有協同抗腫瘤作用。

2024年11月,中美華東完成向美國FDA遞交HDM2006片的臨牀試驗申請,並於近日獲得FDA批准。此外,HDM2006片在中國的臨牀試驗於2024年10月獲得國家藥品監督管理局批准,適應症為晚期實體瘤。2024年12月,HDM2006片在晚期實體瘤患者中安全性、耐受性、有效性及藥代動力學的I期臨牀研究在復旦大學附屬腫瘤醫院完成首例受試者入組及給藥。

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