Akeso 的 ivonescimab 获得了中国对高级肺癌的“突破疗法”命名,支持了第三阶段的关键试验。 Akeso’s ivonescimab gets China’s Breakthrough Therapy Designation for advanced bile duct cancer, supporting a key Phase III trial.

Akeso, Inc. 已经从中国的NMPA获得第五个“突破治疗”称谓,用于二元抗体IVonescimab, 用于一线治疗高血道癌症。 Akeso, Inc. has received its fifth Breakthrough Therapy Designation from China’s NMPA for ivonescimab, a bispecific antibody, in first-line treatment of advanced biliary tract cancer. 这项指定支持一项III期试验,该试验将伊西马布加化学疗法与杜尔瓦卢马布加化学疗法进行比较,并完成了招募. The designation supports a Phase III trial comparing ivonescimab plus chemotherapy to durvalumab plus chemotherapy, with enrollment completed. 早期试验数据表明,回复率为63.6%,疾病控制率为100%,中位存活率为16.8个月。 Earlier trial data showed a 63.6% response rate, 100% disease control, and median survival of 16.8 months. 《BTD》可加快中国的发展和审查。 The BTD may speed development and review in China.