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復宏漢霖(02696.HK):HLX01漢利康(利妥昔單抗注射液)補充新藥申請(sNDA)獲批准
格隆匯 04-14 20:41

格隆匯4月14日丨復宏漢霖-B(02696.HK)發佈公告,近日,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)的《藥品補充申請批件》(批件號:2020B02802),獲批增加原液2,000L生產規模及2,000L生產設備等申請。

本次HLX01漢利康(利妥昔單抗注射液)獲批增加2,000L生產規模,將提高 HLX01(漢利康)的產能,保證持續和穩定的市場供應,進一步滿足巨大的市場需求,為患者的藥物可及性提供保障。

截至該公告日,於中國境內上市的利妥昔單抗注射液有上海羅氏製藥有限公司的美羅華、上海復宏漢霖生物技術股份有限公司的漢利康。根據IQVIA CHPA提供的資料(IQVIA是全球領先的醫藥健康產業專業資訊和戰略諮詢服務提供者),於2019年度,利妥昔單抗注射液於中國境內的銷售額約為人民幣25.05億元。 

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