英国药品和健康产品管理局（MHRA）正式批准Kalvista Pharmaceuticals（KALV）旗下创新药物Ekterly®（Sebetralstat）上市。这款突破性口服疗法成为全球首个且唯一针对遗传性血管水肿（HAE）的按需治疗药物。
此次获批基于Ekterly满足MHRA孤儿药认定标准，突显其在治疗罕见病领域的重大价值。根据监管规定，该药物同时获得在英国市场长达十年的独家销售权。这一里程碑为Kalvista带来显著竞争优势，有望重塑价值约20亿美元的遗传性血管水肿治疗市场格局。
作为口服速效缓释制剂，Ekterly®突破现有皮下注射疗法的使用限制，使患者能在症状发作初期及时自主用药。临床数据显示，该药物能在两小时内快速缓解急性发作症状，为全球约67,000名遗传性血管水肿患者提供全新治疗选择。
值得注意的是，此次获批将触发Kalvista与默沙东此前达成的1亿美元里程碑付款协议。公司计划本季度启动英国商业上市，并同步推进欧盟及美国监管审批流程。随着全球主要市场准入通道的开启，这款重磅药物有望成为Kalvista业绩增长的核心引擎。
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