博安生物(06955.HK)地舒單抗注射液國際多中心比對臨牀(3期)試驗完成全部受試者入組
博安生物(06955.HK)公佈,公司自主研發的地舒單抗注射液(BA6101和BA1102)已在歐洲、美國、日本完成國際多中心比對臨牀(3期)試驗的全部受試者入組。BA6101和BA1102分別爲地舒單抗注射液原研藥Prolia和Xgeva的生物類似藥。
根據美國食品藥品監督管理局(FDA)發佈的行業指南《證明與參照藥生物相似性方面的科學考慮》、歐洲藥品管理局(EMA)發佈的《生物類似藥指南》、日本醫藥品醫療器械綜合機構(PMDA)發佈的《生物類似藥的質量、安全性和有效性保證指南》以及公司與FDA、EMA和PMDA的溝通,在完成3期臨牀試驗後BA6101和BA1102可分別在美國、歐洲和日本向FDA、EMA和PMDA提交上市許可申請,申請原研參照藥Prolia和Xgeva的全部獲批適應症。
此前,BA6101(博優倍)已於2022年11月在中國率先上市,成爲中國首個上市的地舒單抗注射液生物類似藥。
公司相信,在龐大的臨牀需求、良好的臨牀價值以及公司的領先研發位置等多種因素的共同推動下,BA6101和BA1102在全球範圍內將具有廣闊的市場前景。
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