科濟藥業-B(02171.HK):與華東醫藥簽訂關於澤沃基奧侖賽注射液的合作協議
格隆匯1月16日丨科濟藥業-B(02171.HK)宣佈,科濟藥業和華東醫藥股份有限公司(股票代碼:SZ.000963)("華東醫藥")全資子公司華東醫藥(杭州)有限公司關於在中國大陸地區商業化科濟藥業的主導候選藥物澤沃基奧侖賽注射液("zevor-cel",產品編號:CT053,一種針對BCMA的自體CAR-T候選產品)簽訂合作協議("協議")。根據協議,華東醫藥被授予澤沃基奧侖賽注射液在中國大陸地區的獨家商業化權益。此次合作將藉助華東醫藥在血液領域強大的商業化能力和佈局來加速澤沃基奧侖賽注射液在中國大陸地區的成功商業化。
根據協議條款,科濟藥業將獲得2億人民幣的首付款,並有權獲得最高不超過10.25億人民幣的註冊及銷售里程碑付款。科濟藥業將繼續負責CT053在中國大陸地區的開發、註冊和生產。
據悉,澤沃基奧侖賽注射液(CT053)是一種用於治療復發╱難治多發性骨髓瘤的全人抗自體BCMA CAR-T細胞候選產品。澤沃基奧侖賽注射液基於中國I/II期臨牀試驗(LUMMICAR STUDY 1)的新藥上市申請已被國家藥品監督管理局受理。科濟藥業正在北美開展1b/2期臨牀試驗(LUMMICAR STUDY 2),以評估澤沃基奧侖賽注射液用於治療復發╱難治多發性骨髓瘤的安全性及療效。公司也計劃進行其他臨牀試驗以開發澤沃基奧侖賽注射液作為多發性骨髓瘤的早線治療方法。
澤沃基奧侖賽注射液於2019年獲得美國FDA的再生醫學先進療法(RMAT)及孤兒藥稱號,以及先後於2019年及2020年獲得歐洲藥品管理局(EMA)的優先藥物(PRIME)及孤兒藥產品稱號。澤沃基奧侖賽注射液也於2020年獲得國家藥監局的突破性治療藥物品種。
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