微芯生物(688321.SH):滬亞於日本遞交西達本胺上市申請獲受理
格隆匯10月13日丨微芯生物(688321.SH)公佈,公司合作方滬亞生物國際有限責任公司(美國企業,以下簡稱“滬亞”)近日向日本醫藥品醫療器械綜合機構(PMDA)就西達本胺(海外編號:HBI-8000)單藥治療成年人T細胞白血病(ATL)遞交了新藥上市申請(NDA)並獲受理。
西達本胺是公司獨家發現的新分子實體藥物,機制新穎,是全球首個亞型選擇性組蛋白去乙酰化酶(HDAC)抑制劑和全球首個獲批治療外周T細胞淋巴瘤和聯合內分泌藥物治療雌激素受體陽性乳腺癌患者的口服藥物,屬於表觀遺傳調控劑類藥物。
成人T細胞白血病(ATL)是由人T細胞白血病病毒1型或HTLV-1潛伏感染引起的,在日本流行,攜帶者多達100萬人,發病率估計為0.05-0.10%。每年約有2000名病人和多達700至1000人死亡。它主要是一種預後不良的老年人疾病,化療後三年內侵襲性ATL的生存率為25%,除了同種異體骨髓移植和高劑量化療外,在符合條件的患者中很少有有效的治療方案。
公司獨家發現的新分子實體藥物西達本胺在全球近三十個國家和地區獲得發明專利權,公司通過“許可費+里程碑收入+收益分成”的技術授權許可方式將西達本胺在美國、日本、歐盟等國家或的權利授權給滬亞生物國際有限責任公司(美國企業),由其在美國、日本、歐盟等地共同推進西達本胺在不同適應症領域的全球同步開發與商業化。
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