诺诚健华(688428.SH):奥布替尼获得澳大利亚药品管理局批准上市

智通财经
May 27

智通财经APP讯,诺诚健华(688428.SH)发布公告,近日,公司收到通知,奥布替尼(商品名:宜诺凯®,HIBRUKA®)已获澳大利亚药品管理局(TGA)核准签发的上市许可。奥布替尼是公司自主研发的具有高度靶点选择性的新型BTK抑制剂,可有效规避脱靶效应引发的不良反应,显著提升治疗的安全性与有效性。

此前,奥布替尼已在中国获批用于治疗一线慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)、既往至少接受过一次治疗的CLL/SLL、既往至少接受过一次治疗的r/rMCL和既往至少接受过一次治疗的边缘区淋巴瘤(r/rMZL),四项适应症均已纳入国家医保。在国际市场上,奥布替尼已在新加坡获批治疗r/rMCL和r/rMZL成年患者。

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