恩華藥業(002262.SZ):與Complix就中樞神經領域藥物研發事宜進行商談並簽署開發與許可協議
格隆匯7月28日丨恩華藥業(002262.SZ)公佈,公司為了加強新產品的開發力度,豐富公司在中樞神經治療領域的產品線,增強公司的核心競爭力,公司與比利時Complix NV公司(“Complix” 或“許可方”)就中樞神經領域藥物研發事宜進行了商談並簽署了《藥物開發與許可協議》。該事項已經公司第五屆董事會第十八次會議審議通過。
Complix是2008年註冊成立於比利時的生物科技公司,利用其獨特的AlphabodyTM平台,針對具有挑戰性的疾病靶點,開發一系列革命性的細胞跨膜抗體 “Cell Penetrating Alphabodies (CPABs)” 。 除了通過細胞膜外,Alphabody還具有通過血腦屏障治療中樞神經系統疾病的潛力。
恩華與Complix將合作利用Complix專有的細胞跨膜抗體“CPABs”技術平台,針對中樞神經領域的藥物靶點進行創新生物藥的研發。Complix的 “CPABs” 技術針對目前難以成藥的靶點,具有高特異性和高親和力,並且可延長藥物的半衰期。作為細胞靶向技術的先驅,Complix一直致力於開發全新機制的疾病治療藥物,以解決臨牀上未被滿足的需求。
合作事項:(1)雙方將針對商定的中樞神經領域靶點,合作研發基於Complix技術的新型療法並進行商業化; (2)恩華將獲得候選藥物在大中華區的開發、生產、商業化獨佔許可; (3)雙方就候選藥物在世界其他區域進行合作開發和商業化權益共享。
首付款:恩華應在協議生效日期之後30天內向Complix支付55萬美元。
臨牀前研發費用:基於每個靶點候選藥物的臨牀前研發進展,恩華在先導化合物驗收通過之後向Complix支付50萬美元;在臨牀前開發候選藥物驗收通過之後向Complix支付100萬美元。
臨牀里程碑費用:根據每個靶點候選藥物在大中華區的臨牀階段進展及審批情況,恩華依照協議約定針對3箇中樞神經候選適應症向Complix支付最高不超過2250萬美元的臨牀里程碑付款。
銷售提成:合作研發藥物在中國上市後,恩華將從其實現的年度淨銷售額按照約定的比例支付給Complix銷售提成。
此次合作標誌着公司加速佈局中樞神經藥物創新研發管線,且涉足大分子生物藥領域,對於進一步鞏固和發展公司在中樞神經領域的競爭力優勢有着重要意義。
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