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復宏漢霖(02696.HK):HLX01漢利康的新適應症補充申請獲藥監局受理
格隆匯 05-19 18:26

格隆匯5月19日丨復宏漢霖(02696.HK)宣佈,近日,公司全資子公司上海復宏漢霖生物製藥有限公司收到國家藥品監督管理局("NMPA")核准簽發的HLX01漢利康(利妥昔單抗注射液)新適應症補充申請《受理通知書》(受理號:CYSB2000106國、CYSB2000107國)。HLX01漢利康(利妥昔單抗注射液)就新增兩項適應症遞交補充申請。

此次HLX01漢利康(利妥昔單抗注射液)的新適應症補充申請若順利獲得NMPA批准,將為國內濾泡性淋巴瘤和慢性淋巴細胞白血病患者提供更多的用藥選擇。

據悉,HLX01漢利康(利妥昔單抗注射液)是公司自主研發的首個國產單抗生物類似藥,於2019年2月22日獲批於中國大陸境內上市,獲批適應症為:(1)復發或耐藥的濾泡性中央型淋巴瘤;(2)先前未經治療的CD20陽性III-IV期濾泡性非霍奇金淋巴瘤;(3)CD20陽性瀰漫大B細胞性非霍奇金淋巴瘤(DLBCL)。2019年12月,原研利妥昔單抗美羅華?於中國境內獲批兩項新適應症:初治濾泡性淋巴癌患者經美羅華®聯合化療後達完全或部分緩解後的單藥維持治療,與氟達拉濱和環磷酰胺(FC)聯合治療先前未經治療或複發性╱難治性慢性淋巴細胞白血病(CLL)患者。 

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