悦康药业(688658.SH)子公司YKYY033注射液获得FDA临床试验批准

智通财经08-12

智通财经APP讯，悦康药业(688658.SH)发布公告，公司子公司北京悦康科创医药科技股份有限公司于近日获得美国食品药品监督管理局(简称“FDA”)关于同意YKYY033注射液用于预防和治疗动静脉血栓临床试验申请的函告。

据悉，该产品已于2026年6月和7月获得国家药品监督管理局(NMPA)多项抗凝相关适应症的临床试验批准，临床Ⅰ期研究正在稳步推进中。本次顺利获得美国FDA临床试验许可，标志着产品正式取得海外临床开发资格。依托已获批的全场景血栓防治适应症矩阵，公司将开展多适应症差异化临床探索，精准对标全球主流抗凝治疗指南与临床标准，助力填补全球及国内高安全性、长效核酸类抗凝药物的市场空白。

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