论文部分内容阅读
Senhwa生物科学公司宣布FDA授予CX-4945治疗晚期肝小胆管癌的罕见病药设计认可。该药是新一代小分子药物,抑制蛋白激酶CK2,在癌细胞DNA损害的修复机制中具有重要作用。药物研究证明其安全性、药代动力学和治疗晚期肝小胆管癌药效学性质较佳。肝小胆管癌早期难以诊断,治疗方法有限,5年存活率约为20%。此药在新药批准后可享受额外的7年专销权。目前正在进行治疗晚期肝小胆管癌的Ⅱ期临床试验。
Senhwa Biosciences Announces FDA Approval of CX-4945 for the Rare Drug Design for Advanced Hepatociliary Cholangiocarcinoma. The drug is a new generation of small molecule drugs, inhibit protein kinase CK2, plays an important role in the repair mechanism of DNA damage in cancer cells. Drug studies have shown that its safety, pharmacokinetics and treatment of advanced hepatolithiasis better pharmacodynamic properties. Small early diagnosis of cholangiocarcinoma is difficult, the treatment is limited, 5-year survival rate of about 20%. The drug can enjoy an additional seven years of exclusive marketing rights after the new drug is approved. Currently in the treatment of advanced hepatolithiasis phase Ⅱ clinical trials.