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祝賀詩健生物與聯寧生物Trop-2 ADC藥物獲批臨床
Date Time:2021-07-22
東曜藥業(股票代碼:1875.HK)合作伙伴詩健生物和聯寧生物聯合開發的重組人源化抗Trop-2單抗-SN38偶聯物臨床試驗申請(IND)獲得NMPA批准,東曜藥業對此表示祝賀。
該款Trop-2ADC(代號ESG-401)為上海詩健生物科技有限公司和聯寧(蘇州)生物製藥有限公司聯合開發,雙方共同擁有該款ADC的國內國際專利,共同享有產品開發權益。
作為CDMO服務提供者,東曜藥業為ESG-401提供了臨床樣品的GMP級別製劑生產服務。
東曜藥業致力於向創新藥企提供一站式CDMO解決方案,擁有核心偶聯工藝和放大的技術優勢,並搭建了ADC關鍵質量屬性的自主分析能力,能夠保證產品高質量研發;擁有國內少有的符合GMP標準的集原液、製劑和單抗於一體的完整的ADC商業化生產車間,ADC關鍵生產環節可以在一地集中完成,降低風險管控難度;同時具備完善的質量體系,GMP體系符合NMPA、EMA、FDA要求,擁有可追溯的成功申報經驗,能夠配合客戶進行中、美申報。目前,東曜藥業已經與多家公司建立了CDMO合作關係。
上一篇:
提前交付!東曜藥業賦能新冠中和抗體商業化生產
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東曜藥業與博瑞醫藥達成戰略合作,夯實一站式ADC藥物CDMO服務平臺
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