百奧泰(688177.SH)與STADA簽署授權許可與商業化協議 首付款及里程碑款總金額最高至1.36億歐元
格隆匯8月21日丨百奧泰(688177.SH)公佈,公司與STADA簽署授權許可與商業化協議,將公司的BAT1806(託珠單抗)注射液在歐盟、瑞士、英國、其它部分歐洲國家、部分中東與北非地區(MENA)和部分獨立國家聯合體(CIS)國家市場的獨佔的產品商業化權益有償許可給 STADA(以下簡稱"協議"或"本協議")。首付款及里程碑款總金額最高至 1.36 億歐元,其中包括850萬歐元首付款、累計不超過 1.275 億歐元里程碑付款,以及淨銷售額的兩位數百分比作爲收入分成。
公告顯示,BAT1806(託珠單抗)是百奧泰根據中國 NMPA、美國FDA、歐洲EMA生物類似藥相關指導原則開發的託珠單抗注射液,是一款靶向白介素-6 受體(IL-6R)的重組人源化單克隆抗體,可與可溶性及膜結合型IL-6 受體(sIL-6R和 mIL-6R)特異性結合,並抑制由 sIL-6R 和 mIL-6R 介導的信號傳導。截至公告披露日,BAT1806(託珠單抗)已獲得中國 NMPA、美國FDA、歐洲EMA的上市批準,中國商品名爲施瑞立®,美國商品名爲 TOFIDENCE®。
據悉,STADA 爲一家歷史悠久的歐洲優質醫藥企業,總部位於德國,公司專注於三大支柱戰略,包括消費者健康、仿製藥和特藥。STADA在全球範圍超過 100 個國家銷售其產品。在 2024 財年中,STADA 實現了40.59 億歐元的集團銷售額,經調整的息稅折舊攤銷前利潤(EBITDA)爲8.86 億歐元。STADA 在全球擁有約 11,649 名員工。STADA 與公司及控股子公司不存在關聯關係。
本次協議的簽署,旨在將公司研發成果通過商業合作及許可授權的方式快速轉化爲公司效益,本次公司與STADA 的合作,可以將國際先進的研發、生產質控、技術提升、臨牀應用及商業推廣等方面的優勢進行有機結合,爲公司的全球策略創造有利條件,對提升公司核心競爭力具有良好的推動作用。
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