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先聲藥業(02096.HK)國家藥品監督管理局批准重組人血管內皮抑制素注射液恩度®增加新適應症臨牀III期試驗申請
格隆匯 03-21 19:05

格隆匯 3 月 21日丨先聲藥業(02096.HK)公吿,於2021年3月19日,中國國家藥品監督管理局批准(重組人血管內皮抑制素注射液)("恩度®")增加新適應症的臨牀III期試驗申請。根據該批准,公司計劃開展重組人血管內皮抑制素注射液聯合順鉑對比安慰劑聯合順鉑腔內注射治療惡性胸腹腔積液的隨機、對照、雙盲的多中心Ⅲ期註冊臨牀研究。

胸腹腔積液是惡性腫瘤的常見併發症,顯著影響患者的生活質量和生存時間,頑固難治性的胸腹腔積液在臨牀上缺乏標準的治療藥物和方案,預後較差。

中國臨牀腫瘤學會抗腫瘤藥物安全管理專家委員會、中國臨牀腫瘤學會血管靶向治療專家委員會,於2020年9月在《臨牀腫瘤學雜誌》發表了"重組人血管內皮抑制素治療惡性漿膜腔積液臨牀應用專家共識"(以下簡稱"專家共識")。專家共識彙總分析了恩度®治療惡性漿膜腔積液的轉化研究、臨牀試驗以及真實世界的實踐經驗。專家共識顯示,恩度®腔內灌注治療惡性漿膜腔積液的療效確切,能夠顯著抑制積液的產生,減輕有關臨牀症狀,改善患者生活質量,有助於延長生存時間,且安全性和耐受性良好,在臨牀腫瘤學界已經獲得廣泛認可。

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