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科倫博泰生物-B(06990.HK):核心產品SKB264 (MK-2870)用於治療既往經二線及以上標準治療的不可手術切除的局部晚期、復發或轉移性TNBC患者的III期臨牀試驗達到主要研究終點
格隆匯 08-13 19:53

格隆匯8月13日丨科倫博泰生物-B(06990.HK)宣佈,獨立數據監查委員會("IDMC")達成結論,注射用SKB264(亦稱為MK-2870)對比研究者選擇方案用於治療既往經二線及以上標準治療的不可手術切除的局部晚期、復發或轉移性三陰性乳腺癌(TNBC)患者的隨機、對照、開放性、多中心III期臨牀試驗已達到主要研究終點,即獨立審查委員會(IRC)評估的無進展生存期(PFS)。在預先設定的期中分析中,與接受標準化療的對照組相比,SKB264 (MK-2870)在無進展生存期方面有統計學上的顯著改善。

根據期中分析結果,公司計劃就提交SKB264 (MK-2870)的新藥申請(NDA)事宜與中國國家藥品監督管理局藥品審評中心進行溝通。

SKB264 (MK-2870)是一款新型的抗體藥物偶聯物(ADC),靶向人滋養層細胞表面抗原2(TROP2),公司擁有其自主知識產權。SKB264 (MK-2870)是公司的核心產品,目前研究用於治療晚期實體瘤,包括TNBC、非小細胞肺癌(NSCLC)及HR+╱HER2- 乳腺癌(HR+╱HER2- BC)。

該試驗是SKB264 (MK-2870)在中國的首個註冊III期研究。SKB264 (MK-2870)就治療局部晚期或轉移性TNBC於2022年7月獲中國國家藥品監督管理局藥品審評中心授予突破性療法認定。

於2022年5月,公司向默沙東(美國新澤西州默克公司的商號)授出在大中華區(包括中國內地、香港、澳門以及台灣)以外地區的SKB264 (MK-2870)獨家開發及商業化的權利,並正與該公司就SKB264 (MK-2870)的全球臨牀開發緊密合作。

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