復宏漢霖(02696.HK)：漢利康®(利妥昔單抗注射液)新適應症上市註冊申請(NDA)獲國家藥品監督管理局批准
格隆匯3月1日丨復宏漢霖(02696.HK)公吿，近日，公司自主研發的漢利康®(利妥昔單抗注射液)新適應症的上市註冊申請(NDA)獲國家藥品監督管理局批准，用於治療：與甲氨蝶呤聯合，用於對一種及以上TNF-α抑制劑療效不佳的中重度活動性類風濕關節炎(RA)成人患者。此前，漢利康®(利妥昔單抗注射液)已於中國境內(不包括港澳台地區，下同)獲批非霍奇金淋巴瘤、慢性淋巴細胞白血病適應症(原研利妥昔單抗於中國境內獲批的所有適應症)。
漢利康®(利妥昔單抗注射液)是公司自主研發的首個國產利妥昔單抗生物類似藥，於2019年2月22日獲批於中國境內上市。截至公吿日，漢利康(利妥昔單抗注射液)於中國境內獲批的適應症為：
1、非霍奇金淋巴瘤：(1)先前未經治療的CD20陽性III-IV期濾泡性非霍奇金淋巴瘤患者，應與化療聯合使用；(2)初治濾泡性淋巴瘤患者經利妥昔單抗聯合化療後達完全或部分緩解後的單藥維持治療；(3)復發或化療耐藥的濾泡性淋巴瘤；(4)CD20陽性瀰漫大B細胞性非霍奇金淋巴瘤(DLBCL)應與標準CHOP化療(環磷酰胺、阿黴素、長春新礆、強的松)8個週期聯合治療；2、慢性淋巴細胞白血病(CLL)：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；3、類風濕關節炎(RA)：與甲氨蝶呤聯合，用於對一種及以上TNF-α抑制劑療效不佳的中重度活動性RA成人患者。
2020年4月，漢利康(利妥昔單抗注射液)獲NMPA批准增加原液2,000L生產規模及2,000L生產設備、500mg/50ml/瓶規格等申請。
本次漢利康®(利妥昔單抗注射液)類風濕關節炎(RA)新適應症的上市註冊申請(NDA)獲NMPA批准後，在豐富公司商業化產品線的同時，亦有望通過降低用藥頻率給患者帶來更便捷的治療選擇。
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