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康方生物-B(09926.HK):AK105治療r/r cHL最新研究數據在SITC 2020上呈列
格隆匯 11-12 06:20

格隆匯 11 月 12日丨康方生物-B(09926.HK)發佈公告,公司與中國生物製藥(01177.HK)共同開發的PD-1單抗藥物派安普利單抗(安尼可)(研發代號:AK105)治療復發或難治性經典型霍奇金淋巴瘤(“r/r cHL”)最新安全性及有效性數據在第35屆腫瘤免疫治療學會年會(“SITC 2020”)上以突破性成果(Late Breaking Abstract)形式發佈,標題為《PD-1單抗派安普利在復發或難治性經典型霍奇金淋巴瘤患者中開展的II期臨牀研究》。

研究顯示,派安普利單抗在至少進行了2次療效評估的r/r cHL受試者中表現出了顯著的臨牀獲益。其中,客觀緩解率(ORR)達到83.6%,完全緩解率(CR)達到 49.3%,明顯高於歷史對照,且優於目前有條件獲批上市的PD-1單抗已公佈數據。

研究還顯示,派安普利單抗在r/r cHL受試者中表現出良好的安全性特徵,與國內有條件獲批上市的PD-1單抗產品相比,總體藥物相關不良事件(“TRAE”)、 3級及以上的TRAE、藥物相關的嚴重不良反應(SAE)、導致藥物停用的TRAE、導致藥物暫停的TRAE及免疫治療相關的不良反應(irAE)的發生率均較低,具有潛在的安全性優勢。

公告表示,派安普利單抗(AK105, PD-1單抗)由公司與中國生物製藥(01177.HK)旗下正大天晴藥業集團股份有限公司所設立的合營企業共同開發及商業化。派安普利是中國生物製藥唯一可用於開發基於PD-1抗體的單一療法或聯合療法的新藥,亦是公司處於臨牀開發後期、具差異化且可能是同類最創新的PD-1單克隆抗體候選藥物之一。派安普利的Fc受體和補體介導效用功能通過Fc區域突變而完全去除,同時與國外已上市PD-1抗體相比抗原結合解離速率較慢。這些特點使得派安普利具有更有效地阻斷PD-1通路的活性,並維持更強的T細胞抗腫瘤活性,有可能成為臨牀獲益更好的抗PD-1藥物。

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