創勝集團-B(06628.HK):治療實體瘤的同類首創靶向Gremlin1抗體TST003臨試申請獲國家藥監局批准
格隆匯1月4日丨創勝集團-B(06628.HK)發佈公吿,公司的同類首創,靶向Gremlin1且具有高親和力人源化單克隆抗體TST003的臨牀試驗申請獲國家藥品監督管理局(NMPA) 藥品審評中心(CDE)批准。
集團的全球藥物開發執行副總裁、首席醫學官Caroline Germa博士表示:“靶向 Gremlin1抗體TST003有望成為去勢抵抗性前列腺癌這類存在高度未滿足需求癌症的變革性療法。隨着我們準備在美國啟動首次人體臨牀研究,獲得國家藥監局的授權是實現創勝集團制定符合美國和中國監管機構要求的國際發展戰略雄心的關鍵一步。”
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