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先聲藥業漲超5% 骨髓保護創新藥注射用曲拉西利上市許可申請獲受理
格隆匯 11-30 10:02
格隆匯11月30日丨先聲藥業(2096.HK)盤初拉昇一度漲5.66%至9.33港元,市值245億港元。公司昨日宣佈,向國家藥品監督管理局遞交的骨髓保護創新藥注射用曲拉西利(Trilaciclib)上市許可申請(NDA)獲受理。曲拉西利為先聲藥業與G1 Therapeutics合作開發的全球首個且唯一具有全面骨髓保護功效的藥物,是可以減少化療導致的骨髓抑制(CIM)的一種全新療法,曾獲美國食品藥品監督管理局(FDA)“突破性療法”認定,並於今年2月在美上市(商品名:COSELA™)。在中國申請的首個適應症為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患者中預防性使用,以降低化療引起的骨髓抑制的發生率。

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