科濟藥業-B(02171.HK):CT053在加拿大進入II期臨牀試驗
格隆匯10月3日丨科濟藥業-B(02171.HK)宣佈,公司收到加拿大衞生部關於CT053(一種針對BCMA的自體CAR-T候選產品)進入II期臨牀試驗的無異議函。
CT053是一種升級的、用於治療復發╱難治多發性骨髓瘤的全人抗自體BCMACAR-T候選產品。其融合了科濟藥業設計的升級版CAR結構,具有較低免疫原性和較高穩定性的全人抗BCMA特異性單鏈抗體,在沒有腫瘤相關靶點的情況下,可降低CAR-T細胞的自動激活。
科濟藥業已完成I期試驗,並分別在中國開展I/II期臨牀試驗(LUMMICARSTUDY1)和在北美開展Ib/II期臨牀試驗(LUMMICAR STUDY 2)的關鍵II期試驗部分,以評估CT053用於治療復發╱難治多發性骨髓瘤的安全性及療效。我們計劃於2022年上半年向中國國家藥監局及於2023年上半年向美國FDA提交上市批准的監管申請,以及計劃進行其他臨牀試驗以開發CT053作為多發性骨髓瘤的早線治療方法。
CT053於2019年獲得美國FDA的再生醫學高級療法(RMAT)及孤兒藥稱號,以及先後於2019年及2020年獲得EMA的優先藥物(PRIME)及孤兒藥產品稱號,並於2020年獲得國家藥監局的突破性治療藥物品種。
公司認為,CT053有可能重塑多發性骨髓瘤的治療範式,併成為多發性骨髓瘤患者的基礎性治療方法。
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