丽珠医药(01513):注射用布瑞哌唑微球获得药物临床试验批准通知书

智通财经
Mar 26

智通财经APP讯,丽珠医药(01513)发布公告,近日,公司全资控股子公司珠海市丽珠微球科技有限公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》(通知书编号:2026LP00935),同意公司申报的注射用布瑞哌唑微球开展用于成人精神分裂症的临床试验。

注射用布瑞哌唑微球为公司自主研发的缓释微球制剂,是新一代精神分裂症的治疗药物。本品通过对多巴胺 D2、5-HT1A 受体的部分激动以及对去甲肾上腺素等受体的拮抗协同起效,与同代其他药物相比,在多项安全性指标上表现更优。

本品采用长效缓释设计,拟定给药方式为每月一次肌肉注射,可提升患者用药依从性,降低复发风险,解决精神分裂症患者治疗依从性低、复发率高的临床痛点,契合临床长期维持治疗需求。

目前,布瑞哌唑口服制剂已在全球获批多项精神类疾病适应症,尚无布瑞哌唑长效制剂获批上市,本品为填补该临床空白研发的改良型新药。

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