中國生物製藥(01177.HK):“阿達木單抗注射液”獲批上市
格隆匯1月20日丨中國生物製藥(01177.HK)發佈公吿,集團研發的首款生物類似藥“阿達木單抗注射液”(商品名:泰博維)已獲中國國家藥品監督管理局頒發藥品註冊證書,獲批准用於類風濕關節炎、強直性脊柱炎、銀屑病三大適應症的治療。臨牀研究結果顯示,與同類產品相比,泰博維安全性更高,能夠顯著降低患者關節外表現發生率。泰博維是集團研發的首款生物類似藥,它的上市是集團自免管線的有力補充,也將加速阿達木單抗在中國市場的潛力釋放。
作為中國第六款上市的阿達木單抗藥物,泰博維明顯的差異化優勢體現在其安全性上。臨牀研究結果顯示,泰博維在藥代動力學、安全性、耐受性和免疫原性方面與原研藥相當;在活動性強直性脊柱炎的治療中,泰博維在肝臟安全性方面表現更優於原研藥。阿達木單抗的原研藥,上市九年來蟬聯全球暢銷藥排名榜首;但在中國由於獲批適應症較少及售價高昂等因素,中國患者使用率不足2%。泰博維獲批上市,將可以有競爭力的市場價格,極大提升患者用藥可及性。
此外,集團是目前國內唯一同時擁有小分子(託法替布)和大分子(阿達木單抗)抗風濕藥物的藥企。這兩種抗風濕藥機制不同,可以在臨牀使用上優勢互補,滿足更多患者的不同治療需求。集團將把握“共病診療”的趨勢,促進骨科與風濕科的“診療結合”,推進新患拓展,以期惠及更多的患者。
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