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国内第三家! 四环医药(00460.HK)加巴喷丁胶囊获批生产
格隆汇 10-21 12:43

格隆汇10月21日丨四环医药(00460.HK)宣布,集团开发的加巴喷丁胶囊已于2020年10月15日获得国家药监局颁布的药品生产批准。四环医药为中国第三家获得生产该产品批准的企业。

产品属于《国家基本医疗保险、工伤保险和生育保险药品目录》乙类范围的品种,用于治疗:(1)疱疹感染后神经痛:用于成人疱疹后神经痛的治疗;及(2)癫痫:用于成人和12岁以上儿童伴或不伴继发性全身发作的部分性发作的辅助治疗,也可用于3至12岁儿童的部分性发作的辅助治疗。

该产品口服吸收快、耐受性好、毒副作用小及治疗效果好。在体内不代谢,不与血浆蛋白结合及不诱导肝酶。该产品能够穿过人体大脑的血脑屏障,与其他抗癫痫病药物相互作用的可能性很低,可单独用于治疗一般癫痫病外,也可作为难治性癫痫病的叠加用药。该产品与目前使用的同类产品相比,作为难治性癫痫的叠加用药作用尤为突出,且在神经病理性疼痛中具有独特的优势,成为治疗神经病理性疼痛的一线用药。

癫痫是仅次于脑卒中的常见慢性神经系统疾病。在任何年龄、地区和种族的人群中都有发病,以儿童和老年人为两个发病高峰。在中国,癫痫患病人数不少于900万人。随着患者群体逐渐增多,抗癫痫药物市场规模也在飞速攀升。于2018年,在中国公立医疗机构终端化学药抗癫痫药市场规模为人民币49亿元。于2019年,中国公立医疗机构终端化学药抗癫痫药通用名排行榜中该产品排名第七,销售额为人民币2.03亿元,占市场份额约4.14%。由于中国癫痫人群就医率普遍较低,未来抗癫痫用药市场上升空间较大。

作为神经系统疾病领域用药,该产品将和集团在相关治疗领域的药物发挥协同效应,包括已经上市的奥卡西平片,已获得批准即将上市的咪达唑仑口腔黏膜溶液、重酒石酸卡巴拉汀胶囊、左乙拉西坦片,以及正在申报的艾司利卡西平片、拉考沙胺片。通过为患者提供更多更优质的治疗选择,进一步夯实四环医药在此领域的领先市场地位。

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