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友芝友生物通過港交所聆訊,預期核心產品M701治療MA患者的II期臨牀試驗第四季度完成
格隆匯 09-01 19:38

9月1日,友芝友生物提交聆訊後資料集,港股IPO步伐更進一步。公司的獨家保薦人為中信建投國際。

公司成立於2010年,是一家致力於開發用於治療癌症相關併發症、癌症及老年性眼科疾病的基於雙特異性抗體(BsAb)療法的生物技術公司。公司已設計和開發了七種臨牀階段候選藥物管線,包括公司的核心產品M701,一種重組BsAb,公司目前正在進行治療惡性腹水(MA)患者的II期臨牀試驗及治療惡性胸水(MPE)的Ib/II期臨牀試驗,及其他六種處於不同臨牀階段的候選藥物。公司目前正在開發的M701主要是用於MA及MPE(為癌症的嚴重併發症,液體在癌症患者的腹腔或胸腔中積聚)的緩解治療,而並非用於治療癌症本身。

公吿稱,公司目前正在進行II期臨牀試驗以評估M701單一療法聯合全身治療(包括靶向療法(一種利用具有特定靶點的干擾癌細胞生長、分裂及擴散,達到治療腫瘤目的的治療方法)、免疫療法(一種通過激活體內免疫細胞及增強機體抗腫瘤免疫應答,清除腫瘤微小殘留病灶、抑制腫瘤生長、打破免疫耐受的治療方法)或化療治療MA患者的療效,並預期於2023年第四季度完成該臨牀試驗。該II期試驗完成後,公司計劃於2024年第一季度在中國開展M701治療MA的關鍵╱III期試驗並於2025年第一季度提交BLA進行備案。此外,公司正在中國進行M701治療MPE的Ib/II期臨牀試驗並預期於2024年第三季度完成。該Ib/II期試驗完成後,公司計劃於2024年第三季度在中國開展M701治療MPE的關鍵╱III期試驗並2025年第四季度提交BLA進行備案。公司計劃於2024年第一季度向國家藥監局提交IND申請,並預計於2024年第二季度獲得IND批准。擬於2024年第二季度在中國開展M701治療實體瘤的I/II期臨牀試驗。

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