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東曜藥業-B(01875.HK)與科興製藥(688136.SH)簽訂海外市場獨家商業化許可合作協議

格隆匯1月11日丨東曜藥業-B(01875.HK)發佈公吿,於2022年1月11日,公司全資附屬公司東曜藥業有限公司與科興製藥(688136.SH)簽訂海外市場獨家商業化許可合作協議,據此,科興製藥獲授予在除中國(包括中國大陸、香港、澳門和台灣地區)、歐盟(以2021年成員國為準)、英國、美國和日本以外所有國家和地區就樸欣汀(貝伐珠單抗注射液,擬使用英文商品名稱:Pusintin)的獨家商業化許可。

根據許可合作協議,作為授予獨家商業化許可的代價,蘇州東曜有權向科興製藥收取以下款項:(i)首付款及研發里程碑款,總計人民幣3,000萬元;(ii)銷售里程碑款,最高可達人民幣3.8億元,取決於樸欣汀在合作區域內的累計淨銷售額;及(iii)銷售提成,等於樸欣汀?在合作區域內的累計淨銷售額之低兩位數至高個位數百分比,按照遞減階梯式比例計算。

據悉,樸欣汀(貝伐珠單抗注射液,擬使用英文商品名稱:Pusintin)是由蘇州東曜自主開發的生物抗體藥物,於近期獲得中國國家藥品監督管理局的上市批准,用於治療晚期、轉移性或複發性非鱗狀非小細胞肺癌(nsNSCLC)和轉移性結直腸癌(mCRC)。樸欣汀是安維汀(Avastin)的生物類似藥,後者在中國已獲批用於治療nsNSCLC、mCRC、膠質母細胞瘤(GBM)、肝細胞癌(HCC)、卵巢癌和宮頸癌。樸欣汀採用集團自主開發的灌注-批式混合培養技術(PB-Hybrid技術)進行單抗藥物商業化生產,可通過25升WAVE生物反應器進行種子擴增,並直接擴展到2,000升規模的生物反應器,該技術相較於行業慣用技術,簡化了工藝流程、縮短生產週期、降低生產成本,更具成本優勢。

董事會認為,與科興製藥簽訂許可合作協議,有利於提升集團產品的國際競爭力,推動樸欣汀海外市場佈局,為新興國家癌症患者提供高品質且價格合理的國產藥物。

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