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康方生物科技(09926.HK)新藥獲同意開展臨床試驗及完成首例患者給藥
阿思達克 05-21 09:04
康方生物科技(09926.HK)公布,PD-1/CTLA-4雙特異性抗體新藥獲得國家藥品監督管理局同意開展三線治療轉移性鼻咽癌患者的註冊臨床試驗及完成首例患者給藥。公布指,研究由中山大學附屬腫瘤醫院院長徐瑞華教授牽頭,主要目的是由獨立評審委員會評估新藥針對二線及以上化療治療失敗的轉移性鼻咽癌患者中的有效性。

公司並指,有關新藥亦正在開展的另外一個II期臨床試驗,針對晚期不可切除或轉移性高度微衛星不穩定型(MSI-H)實體瘤,首例患者也在5月順利入組及給藥。該項研究主要目的是由獨立評審委員會評估新藥針對局部晚期不可切除或轉移性的高度微衛星不穩定型實體瘤經治患者的有效性。

公布指,公司已在中國或全球開展相關新藥針對胃癌、宮頸癌、非小細胞肺癌、肝細胞癌、MSI-H實體瘤、鼻咽癌、食管鱗癌及黑色素瘤等的多項II期臨床試驗,試驗結果預期將陸續在多個國際醫學會議等場合發佈。

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