亞盛醫藥(06855.HK)新藥奧雷巴替尼獲歐盟委員會孤兒藥資格認定
亞盛醫藥-B(06855.HK)公布,歐盟委員會(EC)日前授予公司類新藥奧雷巴替尼(Olverembatinib,HQP1351)孤兒藥資格認定,用於治療慢性髓細胞白血病(CML)。
「孤兒藥」又被稱為罕見藥,奧雷巴替尼獲此項孤兒藥認定,將有助於藥物在歐盟的後續研發和商業化開展等方面享受政策支持,包括臨床研究計劃援助、相關費用減免、特別是在批准上市後可享有十年市場獨佔權。
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