恆瑞醫藥(01276.HK):阿得貝利單抗注射液新適應症藥品上市許可申請獲國家藥監局受理
格隆匯9月23日丨恆瑞醫藥(01276.HK)發佈公告,近日,公司子公司上海盛迪醫藥有限公司收到國家藥監局下發的《受理通知書》,公司阿得貝利單抗注射液新適應症的藥品上市許可申請獲國家藥監局受理。
根據披露,本品聯合含鉑化療作爲新輔助治療,術後繼續以本品作爲單藥輔助治療,用於治療可手術切除的Ⅱ、ⅢA和ⅢB期且無已知表皮生長因子受體(EGFR)突變或間變性淋巴瘤激酶(ALK)重排的成人非小細胞肺癌(NSCLC)患者。公司阿得貝利單抗注射液已於2023年2月獲批上市,獲批的適應症爲與卡鉑和依託泊苷聯合用於廣泛期小細胞肺癌患者的一線治療。
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