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祝賀TAB014 Ⅲ期臨床試驗首名患者入組,東曜藥業賦能商業化生產
Date Time:2022-07-03
近日,東曜藥業合作伙伴兆科(廣州)眼科藥物有限公司(簡稱“兆科廣州”)宣佈:TAB014用於治療新生血管溼性老年黃斑部病變(wAMD)Ⅲ期臨床試驗的首名患者已於2022年6月28日入組,東曜藥業對此表示欣然祝賀,並將持續賦能TAB014的商業化生產。
TAB014是中國首款處於臨床階段用於治療wAMD,基於貝伐單抗的抗體。wAMD是中國及全球50歲以上人群視力受損及失明的首要原因,根據灼識諮詢(CIC)資料,中國wAMD藥物至2030年的市場規模預計將增至35億美元,其市場前景值得期待。
東曜藥業與兆科廣州於2022年3月就TAB014簽訂補充協議,根據協議,兆科廣州成為TAB014在中國(包括香港和澳門地區)整個產品生命週期的藥品上市許可持有人(MAH),東曜藥業則將繼續負責TAB014的商業化生產。
東曜藥業擁有符合GMP規範的大規模生物藥商業化生產基地,單抗產能約20,000L,並採用行業高標準設備,可滿足不同規模的產能需求。同時,東曜藥業的單抗藥物生產車間已通過國家藥品註冊生產現場核查和GMP符合性檢查,並已有市場流通產品生產運行,經驗證的質量管理體系也將持續為TAB014的商業化生產保駕護航。
上一篇:
祝賀!東曜藥業CDMO合作伙伴宜聯生物YL202臨床試驗申請獲美國FDA默認許可
下一篇:
合作共贏,東曜藥業與濟民可信簽訂CDMO戰略合作協議
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