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先聲藥業(02096.HK):注射用曲拉西利上市許可申請獲國家藥品監督管理局受理
格隆匯 11-29 22:29

格隆匯11月29日丨先聲藥業(02096.HK)公吿,2021年11月29日,中國國家藥品監督管理局("NMPA")已受理注射用曲拉西利(英文通用名Trilaciclib)的境外生產藥品註冊上市許可申請,擬在接受含鉑類藥物聯合依託泊苷方案的廣泛期小細胞肺癌(ES-SCLC)患者中預防性使用,以降低化療引起的骨髓抑制的發生率。

注射用曲拉西利(一種細胞週期蛋白依賴性激酶CDK4/6抑制劑)是集團與G1 Therapeutics, INC.合作的創新藥。2020年8月,集團與G1公司達成獨家授權合約,獲得Trilaciclib在大中華地區所有適應症的開發和商業化權益。

2021年2月,G1公司的Trilaciclib(商品名:COSELA)在美國獲得FDA批准上市。除小細胞肺癌外,2021年4月9日及2021年6月10日,該藥又分別獲得NMPA簽發的用於轉移性結直腸癌及三陰性乳腺癌的兩項III期藥物臨牀試驗批准通知書。

G1是一家商業階段的生物製藥公司,專注於發現、開發和交付旨在改善癌症患者生活的下一代療法。

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