復宏漢霖-B(02696.HK):阿達木單抗注射液新增適應症補充申請獲國家藥監局受理
格隆匯1月18日丨復宏漢霖-B(02696.HK)發佈公吿,近日,公司自主開發的HLX03漢達遠(阿達木單抗注射液)就新增葡萄膜炎適應症的補充申請獲國家藥品監督管理局(NMPA)藥品審評中心受理。
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,於2020年12月獲批於中國境內(不包括港澳台地區,下同)上市,獲批適應症為:類風濕關節炎;強直性脊柱炎;銀屑病。
本次申請增加原研藥修美樂(阿達木單抗注射液)在中國境內已獲批准的葡萄膜炎適應症。該適應症外推主要基於HLX03漢達遠(阿達木單抗注射液)與修美樂已被證實的相似性結論,外推適應症的作用機制相同,且關鍵臨牀試驗選擇了敏感人羣及合適的適應症,有充分的安全性和免疫原性數據,符合《生物類似藥研發與評價技術指導原則(試行)》、《阿達木單抗注射液生物類似藥臨牀試驗指導原則》等國內法規政策對適應症外推的要求。
本次新增適應症的補充申請若順利獲得NMPA批准,將進一步擴大HLX03漢達遠(阿達木單抗注射液)的適用患者羣體,為國內葡萄膜炎患者提供更多的治療選擇,助其改善生活質量。
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