智通财经APP讯，丽珠医药(01513)公布，近日，该公司全资子公司珠海市丽珠微球科技有限公司(以下简称“丽珠微球”)收到国家药品监督管理局核准签发的《药品注册证书》(证书编号：2025S01188)，注射用阿立哌唑微球获批上市。
注射用阿立哌唑微球于2023年9月递交上市申请，受理号为：CXHS2300080。注射用阿立哌唑微球是丽珠微球自主开发的长效缓释制剂，适应症为成人精神分裂症。注射用阿立哌唑微球每月给药一次，可提高用药依从性，有助于降低复发和入院比率，减轻患者经济负担和社会负担。
截至本公告日，阿立哌唑长效微球制剂仅丽珠微球取得生产批件，全球尚无其他阿立哌唑微球产品上市。根据IQVIA抽样统计估测数据，抗精神病药物2024 年国内终端销售金额约为人民币60.48亿元，其中长效制剂产品约为人民币14.18 亿元。
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