東曜藥業(01875.HK)抗體偶聯藥物TAA013三期臨牀試驗完成首例患者給藥
格隆匯7月23日丨東曜藥業-B(01875.HK)宣佈,集團自主研發的HER2靶向的在研抗體偶聯藥物(“ADC”)TAA013於近日達成關鍵性臨牀階段里程碑。TAA013已完成關鍵性III期註冊臨牀試驗的首例患者給藥,該研究的目的是評價TAA013對比拉帕替尼聯合卡培他濱在經曲妥珠單抗治療失敗的、不可切除的局部晚期或轉移性HER2陽性乳腺癌患者中的有效性和安全性。如果成功,該研究將用於支持TAA013在中國的新藥上市申請。
關於HER2陽性乳腺癌:據公開資料顯示,乳腺癌位居女性惡性腫瘤發病率首位,而HER2陽性乳腺癌為一種常見的乳腺癌。抗HER2治療是目前全球HER2陽性乳腺癌廣泛應用的治療方案,可顯著延長HER2陽性晚期乳腺癌患者的生存時間。集團希望該研究結果可以使HER2陽性乳腺癌患者獲益,並給臨牀醫生提供更好的治療選擇。
關於TAA013:TAA013是一種含有曲妥珠單抗-美坦新衍生物(曲妥珠-MCC-DM1)的在研ADC藥物,旨在成為Kadcyla的實惠替代藥物,用於治療HER2陽性乳腺癌。TAA013通過單抗的靶向性將高活性細胞毒藥物精準遞送到腫瘤細胞中,進而殺死腫瘤細胞。藉助單抗藥物靶向性強和細胞毒藥物殺傷性強的特點,ADC藥物能充分發揮兩種藥物的抗腫瘤優勢,具有選擇性好、藥效高、副作用低的優點。
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