百奧泰(688177.SH)與諾華達成伐珠單抗海外授權合作
格隆匯9月8日丨百奧泰(688177.SH)公佈,公司與Sandoz簽署授權許可與商業化協議,將公司的BAT1706(貝伐珠單抗)注射液在美國、歐洲、加拿大和大部分其它BAT1706合作未覆蓋的國際市場的排他的產品商業化權益有償許可給Sandoz。在達到約定的條件時,百奧泰可獲得總金額最高1.55億美元的首付款和里程碑款,外加兩位數百分比的利潤分成。
BAT1706是一款由百奧泰開發的單克隆抗體,作為安維汀®(貝伐珠單抗)潛在的生物類似藥,通過與血管內皮生長因子(VEGF)結合而起效。在歐美,安維汀®(貝伐珠單抗)已獲批用於治療以下適應症:轉移性結直腸癌,非鱗狀非小細胞肺癌,複發性膠質母細胞瘤,轉移性腎細胞癌,持續性、複發性或轉移性宮頸癌,上皮性卵巢癌,輸卵管癌或原發性腹膜癌,以及肝細胞癌。
公司於2020年向中國NMPA、美國FDA和歐洲EMA遞交了BAT1706的上市許可申請。通過一系列的生物類似藥研究,包括國際多中心III期臨牀試驗,充分證實了BAT1706在臨牀療效及安全性上與原研藥高度相似。
據悉,Sandoz是諾華的子公司,是全球仿製藥和生物類似藥的領導者。在Sandoz,通過開發和商業化創新的、可負擔的療法來解決未被滿足的醫療需求,幫助全世界的人們獲取高質量的藥物。
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