德琪医药新药希维奥上市申请获批
3月5日，德琪医药-B（06996）发布公告，印度尼西亚食品药品监督管理局已批准希维奥®（塞利尼索片）用于三项适应症的新药上市申请。这些适应症包括：与硼替佐米和地塞米松联用治疗成年患者的多发性骨髓瘤；联合地塞米松治疗既往接受过至少四次治疗且对多种药物难治的复发或难治性多发性骨髓瘤；以及作为单药治疗复发或难治性弥漫性大B细胞淋巴瘤的成年患者。
希维奥®是全球首款获批准的核输出蛋白口服选择性XPO1抑制剂，具有新颖的作用机制，在联合治疗中表现出协同作用。公告中提到，自2017年以来，公司已建立了一条由9款临床到商业化各阶段的肿瘤药物产品管线，其中6款具有全球权益。希维奥®目前已在多个国家和地区获得新药上市批准，包括中国大陆、台湾、香港、澳门、韩国、新加坡、马来西亚、泰国、印度尼西亚及澳大利亚。
（文章来源：财中社）
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