東曜藥業(1875.HK)CDMO合作伙伴新港生物CD79b ADC獲批臨牀
來源：東曜藥業官微
東曜藥業(1875.HK)合作伙伴新港生物旗下產品CD79b ADC(藥物名稱：注射用NBT508，下簡稱NBT508)臨牀試驗申請(IND)獲得國家藥品監督管理局藥品審評中心(CDE，NMPA)批准，用於治療復發/難治性B細胞非霍奇金淋巴瘤，並已啟動I期臨牀試驗。
東曜藥業憑藉對ADC藥物研發的深刻理解以及完善的生產及質量體系，為新港生物NBT508量身定製了個性化的CDMO服務，提供了包括ADC偶聯及製劑工藝開發、GMP生產、質量分析研究及支持IND註冊申報的全流程解決方案，有力地支持了該項目順利推進。
2019年，CD79b ADC新藥Polivy®獲得FDA批准上市，與苯達莫司汀和利妥昔單抗聯合治療至少接受過兩次治療的複發性或難治性瀰漫性大B細胞淋巴瘤(r/r DLBCL)成人患者。目前，該藥品已在全球60多個國家或地區獲批上市，在中國進入臨牀Ⅲ期。
國內以CD79b為靶點的ADC研發佈局幾近空白，這也為本土企業帶來了機遇和挑戰。新港生物作為新理念生物的全資子公司，基於後者特有的定點偶聯技術(即特定藥物/抗體比值(DAR))開發了NBT508。NBT508作為國內首個CD79b靶向新藥，有望為B細胞非霍奇金淋巴瘤帶來新的治療選擇。
東曜藥業首席執行官劉軍博士表示：“東曜藥業對新港生物NBT508獲批臨牀試驗表示祝賀，也欣喜於ADC領域厚積薄發，ADC藥物研發被推上新的高度，有望為患者帶來更好的治療選擇。東曜藥業也將繼續夯實ADC核心偶聯工藝和放大的技術優勢及商業化生產優勢，依託一站式服務平台，賦能合作伙伴，實現合作共贏。”
新港生物首席執行官韓念和博士表示：“東曜藥業在ADC領域擁有豐富的研發和生產經驗，為NBT508的臨牀獲批提供了極大助益。我們也將共同推進NBT508的臨牀和商業化，使其在臨牀前研發中表現出來的優異的安全性和有效性特徵能夠早日在臨牀試驗中得到驗證，讓產品早日造福於患者。”
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