万邦德公告,全资子公司万邦德制药集团有限公司收到国家药监局核准签发的《药物临床试验批准通知书》,公司自主研发的WP107口服溶液用于治疗“重症肌无力”的临床试验申请获得批准。此次批准旨在评估WP107口服溶液在全身型重症肌无力受试者中的药代动力学和安全性。公司此前于2023年12月获得美国FDA授予的石杉碱甲治疗重症肌无力的孤儿药认定,于2025年1月WP107口服溶液用于治疗“全身型重症肌无力”获得美国FDA新药临床试验许可。
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