復宏漢霖-B(02696.HK)：HLX03漢達遠®獲批境內上市
格隆匯 12 月 7日丨復宏漢霖-B(02696.HK)宣佈，近日，公司自主開發的重組抗腫瘤壞死因子－α("TNF-α")全人單克隆抗體藥物HLX03漢達遠®(阿達木單抗注射液)的上市註冊申請(NDA)獲國家藥品監督管理局("NMPA")批准，用於治療：1)類風濕關節炎；2)強直性脊柱炎；3)銀屑病。
據悉，HLX03漢達遠®(阿達木單抗注射液)是公司按照中國生物類似藥指導原則自主開發的單抗生物類似藥，主要用於類風濕關節炎、強直性脊柱炎、銀屑病的治療。
2019年1月，HLX03漢達遠®(阿達木單抗注射液)的上市註冊申請(NDA)獲NMPA受理，隨後被納入優先審評程序。2019年7月，HLX03漢達遠®(阿達木單抗注射液)用於治療中重度斑塊狀銀屑病適應症於中國大陸境內完成臨牀3期試驗及臨牀試驗報告，試驗結果顯示，HLX03漢達遠®(阿達木單抗注射液)治療中重度斑塊狀銀屑病的療效等效於原研阿達木單抗，在安全性、免疫原性和藥代動力學方面與原研阿達木單抗相似。2020年9月，公司位於上海市徐彙區的生物藥生產基地("徐匯基地")順利通過上海市藥品監督管理局針對HLX03漢達遠®(阿達木單抗注射液)的原液(DS)生產南線及製劑(DP)生產一線的GMP符合性現場檢查。
此次HLX03漢達遠®(阿達木單抗注射液)獲NMPA上市註冊申請(NDA)批准主要基於對其與原研阿達木單抗進行的多項頭對頭比對研究數據的審查，包括藥學比對研究、非臨牀比對研究和臨牀比對研究相關數據，研究結果證明HLX03漢達遠?(阿達木單抗注射液)在安全性、有效性、免疫原性和質量可控等方面與原研阿達木單抗高度相似。
截至公告日，於中國大陸境內上市的阿達木單抗包括艾伯維的修美樂®、浙江海正藥業股份有限公司的安健寧、百奧泰生物科技(廣州)有限公司的格樂立等。根據IQVIACHAP提供的資料，2019年度及2020年上半年度，阿達木單抗於中國境內的銷售金額分別約為人民幣0.32億元、0.45億元。
公告稱，HLX03漢達遠®(阿達木單抗注射液)是公司繼HLX01漢利康®(利妥昔單抗注射液)、HLX02漢曲優®(注射用曲妥珠單抗)後，第三個於中國境內獲批上市的單克隆抗體生物類似藥產品。HLX03漢達遠®(阿達木單抗注射液)的此次獲批上市標誌着公司的商業化產品線已拓展至非腫瘤領域，在進一步豐富公司商業化產品線的同時，亦為國內類風濕關節炎、強直性脊柱炎、銀屑病患者帶來更多的治療選擇。
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