长风药业(02652):NMPA受理布地奈德鼻喷雾剂上市许可申请

智通财经
Jan 30

智通财经APP讯,长风药业(02652)发布公告,公司布地奈德鼻喷雾剂的上市许可申请已获中华人民共和国国家药品监督管理局受理。

鼻喷雾剂是技术门槛较高的复合制剂。凭借鼻腔给药技术平台,公司已建立涵盖多种适应症及呼吸道与鼻炎病症全疗程管理的全面产品矩阵。公司在此方面的现有产品组合包括:

氮䓬斯汀氟替卡松鼻喷雾剂(舒霏敏®):国内首款抗组织胺-类固醇复合鼻喷雾剂,于2023年纳入《国家医保药品目录》(国家医保目录);

糠酸莫米松鼻喷雾剂:适用于成人及3岁及以上儿童的过敏性鼻炎的一线药物;

布地奈德鼻喷雾剂(该产品):适用于6岁及以上患者,针对季节性急性发作、常年性维持治疗及鼻息肉;及

奥洛他定╱莫米松鼻喷雾剂:针对12岁及以上青少年及成人中重度过敏性鼻炎症状。

布地奈德鼻喷雾剂申请受理,进一步丰富公司在过敏性鼻炎领域的产品管线,彰显公司深化呼吸系统吸入治疗领域布局的决心及能力,为患者提供优质的治疗选择。集团将积极与NMPA沟通,并根据监管要求推进后续审查程序。

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