智通财经APP讯，山东新华制药股份(00719)发布公告，该公司收到国家药品监督管理局核准签发的盐酸曲马多缓释片(以下简称“本品”)《药品补充申请批准通知书》，本品通过仿制药质量和疗效一致性评价(“仿制药一致性评价”)。新华制药为本品国内首家通过仿制药一致性评价的企业。
本品为中枢作用的阿片类镇痛药，适应症为中度至重度疼痛。曲马多缓释片作为阿片类药，属于《国家基本医疗保险、工伤保险和生育保险药品目录(2024年)》乙类品种，据相关数据显示，2023年中国公立医疗机构曲马多制剂销售额约人民币9.13亿元。
新华制药的盐酸曲马多缓释片于2025年1月通过仿制药质量和疗效一致性评价，有利于进一步提升该产品的市场竞争力。
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