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康方生物-B(09926.HK):伊努西單抗在中國治療原發性高膽固醇血癥和混合型高脂血症III期臨牀試驗提前完成患者入組
格隆匯 12-22 06:33

格隆匯12月22日丨康方生物-B(09926.HK)發佈公吿,公司與東瑞生物投資發展(亞洲)有限公司共同開發的伊努西單抗(PCSK 9單克隆抗體,研發代號:AK102)在中國治療原發性高膽固醇血癥和混合型高脂血症的一項關鍵性註冊性III期臨牀試驗提前完成患者入組。

該臨牀試驗是伊努西單抗用於治療原發性高膽固醇血癥和混合型高脂血症的三項大規模關鍵註冊性臨牀試驗之一。該臨牀試驗設計涵蓋廣泛人羣中未被滿足的臨牀需求,旨在對患有心血管極高危、高危和中低危高脂血症的患者進行長期給藥下,評價伊努西單抗的降脂療效和安全性,為支持產品上市提供更多依據。

公司能提前完成伊努西單抗在中國III期臨牀研究的患者入組,是公司高效臨牀運營體系和創新實力帶來的結果。臨牀研究顯示,伊努西單抗相比同靶點已上市產品能夠更完全的抑制PCSK 9,且均可明顯降低所有給藥患者的膽固醇。公司期待伊努西單抗早日獲批上市,為中國大量心血管病患者提供更優的選擇。

PCSK 9單抗被譽為繼他汀類藥物之後最有效的降脂藥物。目前,全球範圍內已有依洛尤單抗(Evolocumab)和阿利西尤單抗(Alirocumab)兩款PCSK 9單抗獲批上市。2020年PCSK 9單抗的全球市場規模為12.46億美元,權威機構預測從2023年到2030年中國PCSK 9單抗市場複合年均增長率將高達36.9%。

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