恆瑞醫藥(600276.SH):注射用環磷酰胺通過仿製藥一致性評價
格隆匯9月29日丨恆瑞醫藥(600276.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的《藥品補充申請批准通知書》,公司注射用環磷酰胺通過仿製藥質量和療效一致性評價。
環磷酰胺以聯合化療或單劑治療可用於下列疾病:1.白血病:急性或慢性淋巴細胞性和髓性白血病;2.惡性淋巴瘤:霍奇金淋巴瘤、非霍奇金淋巴瘤、漿細胞瘤;3.轉移性和非轉移性的惡性實體瘤:卵巢癌、乳腺癌、小細胞肺癌、成神經細胞瘤、Ewings肉瘤;4.進行性自身免疫性疾病:類風濕性關節炎、psoriatic關節炎、系統性紅斑狼瘡、硬皮病、全身性脈管炎(例如伴有腎病綜合徵)、某些類型的腎小球腎炎(例如伴腎病綜合徵)、重症肌無力、自身免疫性溶血性貧血、冷凝集素病;5.器官移植時的免疫抑制治療;6.對兒童橫紋肌肉瘤及骨肉瘤有一定療效。
環磷酰胺屬於烷化劑類細胞毒性藥物,可干擾DNA及RNA功能,與DNA發生交叉聯結,抑制DNA合成。注射用環磷酰胺由Baxter Oncology GmbH公司開發,1959年11月在美國獲批上市,現已在包括中國在內的全球多個國家及地區上市銷售。除恆瑞醫藥和Baxter Oncology GmbH公司外,國內另有翰暉製藥、山西普德藥業上市在售,恆瑞醫藥為該品種通過仿製藥一致性評價的首家企業。
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,注射用環磷酰胺在仿製藥一致性評價項目上累計已投入研發費用約為462萬元。
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