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方达控股(1521.HK)助力ASG全球唯一吸入性ED治疗药物Beta1吸入粉雾剂通过FDA临床申请

香港智远权证网2025年12月22日 00:00
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全球唯一吸入性 ED 创新药物迎来关键进展。

近日,由方达控股(苏州)有限公司提供研发与申报支持的亚证环球药业(Asia Scientific Global,ASG)主力产品 Beta1 吸入粉雾剂,已正式获得美国 FDA 核准,通过新药临床试验(IND)申请,标志着该创新吸入制剂正式迈入全球临床开发阶段。

Beta1吸入粉雾剂采用改良型药物处方设计,结合喷雾干燥工艺与吸入式药物递送系统,仅需吸入即可完成给药,有望缩短药物吸收时间并提升使用便利性。相较传统给药方式,吸入制剂在起效速度和患者依从性方面具备潜在优势,但同时对生产工艺稳定性、质量控制及注册合规能力提出更高要求。

在项目推进过程中,方达控股依托在吸入制剂领域的技术积累与国际化申报经验,组建专项团队,系统开展工艺优化研究、临床批生产及 IND 申报资料准备工作,并在关键节点与客户保持紧密协作,协同应对核心技术与审评挑战,保障项目顺利通过 FDA 审评。

此次获批不仅是 ASG 国际化研发进程中的重要里程碑,也体现了方达控股在复杂制剂研发、生产与全球注册支持方面的综合能力。面向全球市场,方达控股将携手观合医药,持续推进中美一体化质量体系与项目管理的深度协同,以国际标准与本土执行效率相结合,助力更多创新药物顺利推进全球临床开发与注册申报。

方达控股

方达控股是全方位的医药研发CRO公司,在中国、北美、欧洲分别建有生物分析中心,制剂产品开发中心,临床运营中心,药化中心,药理药效中心和非临床安评中心。为全球药企提供药物化学、药理药效、药学研究、DMPK、非临床安评、生物分析、综合实验室和临床研究等一站式研发外包服务。

方达控股始终坚守“全球同一质量体系”的准则,获得的试验数据支持多国申报。运营20多年来,方达控股建立了经验丰富的科研团队和坚实的质量管理体系,目前已顺利通过70多次美国FDA和160多次NMPA的现场核查。

观合医药

上海观合医药科技股份有限公司成立于2016年,是临床研究行业领先的创新和综合实验室服务平台。公司先后在上海、无锡杭州和香港设立分支机构,已建成中心实验室和生物分析一站式服务能力,是临床试验全链条服务中的重要分支。观合医药已成为泰格医药(300347.sz/3347.hk)控股子公司。

观合医药为创新药企业提供实验室与科学解决方案,以加速新药研发和申报。观合医药提供从生物标志物发现靶点验证、人群富集、PK/PD、安全性评价、疗效评价等实验室科学咨询与样本分析服务,致力于用最前沿的实验室技术助力临床药物研发。截止到2025年6月,观合医药已支持44个新药和治疗产品经批准上市。

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