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恆瑞醫藥(600276.SH):環磷酰胺膠囊擬納入優先審評程序
格隆匯 10-14 15:45

格隆匯10月14日丨恆瑞醫藥(600276.SH)宣佈,近日,公司的環磷酰胺膠囊被國家藥品監督管理局藥品審評中心納入擬優先審評品種公示名單,公示期7日。

環磷酰胺膠囊擬定適應症(或功能主治):惡性淋巴瘤(Ann Arbor分期III期和IV期),霍奇金淋巴瘤,淋巴細胞性淋巴瘤(結節性或瀰漫性),混合細胞型淋巴瘤,組織細胞性淋巴瘤,伯基特淋巴瘤;多發性骨髓瘤;白血病:慢性淋巴細胞性白血病,慢性粒細胞性白血病(急性原始細胞危象通常無效),急性髓性和單核細胞性白血病,急性淋巴細胞性(幹細胞)白血病(緩解期間給予環磷酰胺可有效延長緩解期);蕈樣真菌病(晚期);成神經細胞瘤(彌散性疾病);卵巢腺癌;視網膜母細胞瘤;乳腺癌。

環磷酰胺涉及腫瘤細胞DNA的交聯作用,主要通過混合功能微粒體氧化酶系統在肝臟中生物轉化為活性烷基化代謝產物。這些代謝產物可干擾敏感的快速增殖的惡性細胞的生長。環磷酰胺膠囊由HIKMA PHARMACEUTICALS USA INC開發,2013年9月在美國獲批上市。截至目前,國內暫無環磷酰胺膠囊上市。經查詢,2020年環磷酰胺相關劑型全球銷售額約為3.38億美元。

截至目前,環磷酰胺膠囊相關項目累計已投入研發費用約為454萬元。

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