萊美藥業(300006.SZ):康德賽的CUD005注射液獲得藥物臨牀試驗批准通知書
格隆匯3月28日丨萊美藥業(300006.SZ)公佈,近日,重慶萊美藥業股份有限公司參股公司四川康德賽醫療科技有限公司(簡稱“康德賽”)的一款自主研發用於治療失代償期肝硬化的巨噬細胞CUD005注射液(簡稱“CUD005注射液”)獲得藥物臨牀試驗默示許可並取得由國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》。
肝硬化是一種常見的慢性進行性組織損傷肝病,其誘發原因包括長期酗酒、肥胖、代謝紊亂、病毒感染或自身免疫性疾病等,肝硬化會破壞肝臟正常組織結構,導致肝功能喪失,並衍生纖維化瘢痕。
CUD005注射液是以患者自身免疫細胞為基礎,使其分化為成熟、穩定的個體化抗纖維化巨噬細胞,可以通過分泌多種基質金屬蛋白酶來降解胞外基質,減少肝臟瘢痕淤積,此外,CUD005注射液可以釋放抗炎因子,進而抑制炎症反應的發生,改善肝臟炎症微環境,減緩病情發展。
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