智通财经APP讯，山东新华制药股份(00719)发布公告，近日，山东新华制药股份有限公司(以下简称“新华制药”或“本公司”)收到国家药品监督管理局核准签发的硫酸氨基葡萄糖胶囊(以下简称“本品”)《药品注册证书》。
2024年8月，新华制药向国家药品监督管理局药品审评中心(CDE)递交硫酸氨基葡萄糖胶囊上市许可注册申报资料并获受理，2026年2月获得《药品注册证书》，审评结论为批准注册。本品临床主要用于治疗塬发性及继发性骨关节炎。
本品属于《国家基本医疗保险、工伤保险和生育保险药品目录(2025年)》乙类品种。根据相关统计数据，2024年中国公立医疗机构硫酸氨基葡萄糖胶囊销售额约为人民币8.5亿元。
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