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中生製藥(01177.HK):自研創新藥”TQ-B3525“被CDE納入突破性治療藥物名單
格隆匯 04-08 12:11

格隆匯4月8日丨中國生物製藥(01177.HK)宣佈,集團自主研發的創新藥”TQ-B3525“已被中國國家藥品監督管理局藥品審評中心(”CDE“)納入突破性治療藥物名單,適應症為既往至少二線治療失敗的復發╱難治濾泡性淋巴瘤。

TQ-B3525是一款新型、選擇性口服PI3K(磷脂酰肌醇3-激酶)α/δ抑制劑。研究表明,PI3K與腫瘤關係密切。TQ-B3525屬於PI3K催化亞基α/δ雙重抑制劑,它既可以克服單獨抑制PI3Kδ亞基時引起的PI3Kα亞基活性上調導致的耐藥問題,同時較之PI3K泛抑制劑又顯著降低了毒副用。集團目前在國內啟動了多項TQ-B3525臨牀研究,主要針對血液瘤,部分已進入II期臨牀。

公吿稱,CDE設立突破性治療藥物程序,旨在鼓勵研究和創制新藥,滿足臨牀用藥需求,加快創新藥品種審評審批速度。被納入突破性治療藥物的創新藥可按照加快程序開展後續溝通交流及審評審批工作。

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