李氏大药厂(00950.HK)：癌痛药的临床试验申请获批准
格隆汇 11 月 6日丨李氏大药厂(00950.HK)公布，有关公司全资附属公司李氏大药厂(香港)有限公司("李氏香港")所作出有关用于治疗爆发性癌痛的Staccato®芬太尼吸入制剂的临床试验新药申请。
李氏香港已于2020年11月2日获得中国国家药品监督管理局批准进行该临床试验。集团在2018年3月从Alexza引进Staccato®芬太尼吸入制剂。美国早前进行的一项一期临床研究显示，单次吸入芬太尼与静脉注射芬太尼的药物代谢动力学特性相若。Staccato®芬太尼吸入制剂是一种复合型吸入式给药装置，其设计是透过肺部迅速及规律地吸入雾化芬太尼。此项产品结合具有独特给药技术的最新科技，于确保药效的同时防止滥用及过量用药。
集团已在南沙厂房内建立Staccato®芬太尼的新生产设施。Staccato®芬太尼的生产设施涉及复杂的薄涂层工艺及精确控制，将不锈钢底座切下及焊接到位，并将芬太尼药物涂在底座上以完成药物盒的组装。由于Staccato®芬太尼是药物装置的组合，因此装置部件在内部组装及测试。该装置将使Staccato®芬太尼成为唯一内置真正的防止滥用及过量用药功能的鸦片类药物。
即将于中国进行的一╱二a期多中心研究专门评估Staccato®芬太尼在治疗癌症病患的爆发性癌痛的药效及安全程度。研究将分为两个阶段：第一阶段研究专责厘定建议剂量；而第二阶段研究将基于第一阶段能够纾缓病患痛楚的建议剂量，进行药物代谢动力学研究。集团预期于2021年初开展此项Staccato®芬太尼的第一╱二a期临床试验。
根据GLOBOCAN资料库，中国于2018年估计新增430万宗癌症病例，意味着在治疗爆发性癌痛方面存在大量未得到满足的医疗需求，需要一种速效芬太尼药剂，以便有效治疗管理爆发性癌痛，填补中国未得到满足的需求
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
