百濟神州(06160.HK)就安維汀®生物類似藥BAT1706簽訂在中國的授權協定
格隆匯 8 月 26日丨百濟神州(06160.HK)發佈公告，百奧泰生物製藥股份有限公司(688177.SH)和百濟神州8月24日宣佈雙方已就百奧泰的BAT1706 —— 一款在研安維汀®(貝伐珠單抗)生物類似藥籤訂了一項在中國的授權、分銷、供貨協議。國家藥品監督管理局(NMPA)已於近日受理了百奧泰就BAT1706遞交的生物製劑許可證申請(BLA)。貝伐珠單抗在中國已獲批用於治療晚期、轉移性或複發性非小細胞肺癌和轉移性結直腸癌。該協議須待百奧泰於2020年9月召開的股東大會審議通過後方可生效。
根據協定條款，百奧泰已同意授權百濟神州在中國(包括港澳台地區)對BAT1706進行開發、生產及商業化，百奧泰將保留除上述地區以外的全球範圍內的相關權利。百奧泰將獲得一筆首付款，並在達到註冊及商業化里程碑後有資格獲得付款，累計至多1.65億美元。此外，百奧泰還將有資格獲得未來產品兩位元數比例的淨銷售額分級特許權使用費。
百濟神州中國區總經理兼公司總裁吳曉濱博士表示：“百濟神州致力於為全世界患者帶來有意義、可負擔的藥物。BAT1706作為一款潛在的安維汀®生物類似藥，在中國有望成為一項用於治療包括結直腸癌、肺癌和肝癌在內的多項實體瘤適應症的重要治療選項。此次合作不僅能夠進一步拓展我們在中國的現有商業化及註冊階段產品組合，也與我們多款授權引進和自主研發藥物相互補充，包括目前在中國已遞交肺癌、肝癌相關上市申請的抗PD-1抗體百澤安®。”
百奧泰首席執行官李勝峯博士評論道：“百濟神州在腫瘤領域擁有豐富的專業知識和強大的研發管線，我們很高興與百濟神州進行合作。通過此次合作，我們將藉助百濟神州的經驗與專業性，加快推動BAT1706作為單藥或與其他療法聯合的開發與商業化，以確保更多的患者以可負擔的價格從這款重要的癌症藥物中獲益。”
根據披露，BAT1706是一款由百奧泰開發的單克隆抗體，作為安維汀®潛在的生物類似藥。通過與血管內皮生長因數(VEGF)結合而起效。在美國，安維汀®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。BAT1706是一款在研候選藥物，尚未在任何國家或地區獲得藥政批准。中國國家藥品監督管理局(NMPA)於2020年6月受理了BAT1706的生物製劑許可證申請(BLA)。百奧泰計劃將於2020年第四季度在美國和歐盟遞交BAT1706的相關上市許可申請。安維汀®為美國基因泰克公司註冊商標。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of this article is for reference only. It does not constitute an offer, solicitation, recommendation, opinion or guarantee of any securities, financial products or instruments.The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance.
