长风药业(02652)奥洛他定莫米松鼻喷雾剂临床试验申请获NMPA批准

智通财经网

Mar 09

智通财经APP讯，长风药业(02652)发布公告，奥洛他定莫米松鼻喷雾剂的临床试验申请(CTA)已获中华人民共和国国家药品监督管理局(NMPA)批准。公司是中国首家就该产品提交仿制药临床试验申请的企业。

该CTA的获批标志着推进该产品进入临床试验阶段的里程碑。开发固定剂量复方鼻喷雾剂面临重大的技术挑战，特别是在制剂稳定性、悬浮系统、喷雾一致性及规模化生产方面。该产品的进展进一步印证了集团在复杂鼻喷雾制剂及药械整合方面的执行能力。

此外，该产品与集团现有的过敏性鼻炎(AR)及慢性鼻窦炎(CRS)产品组合形成互补，目前该组合包括氮䓬斯汀氟替卡松鼻喷雾剂(舒霏敏®)、糠酸莫米松鼻喷雾剂及布地奈德鼻喷雾剂。该产品组合覆盖了广泛的年龄层及疾病阶段，为上唿吸道疾病提供可及的长期管理方案。公司相信，其在复杂制剂与精准给药方面的综合能力将持续强化其在国内及全球市场的竞争优势。

集团将与NMPA保持积极沟通，并按照监管要求推进后续临床活动。

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