愛美客(300896.SZ)：利多卡因丁卡因乳膏開展用於成人淺層皮膚手術前對完整皮膚的局部麻醉的臨牀試驗獲批
格隆匯10月19日丨愛美客(300896.SZ)公佈，公司全資子公司北京諾博特生物科技有限公司於2021年8月5日申報的利多卡因丁卡因乳膏臨牀試驗申請，已於2021年10月18日獲得國家藥品監督管理局下發的《藥物臨牀試驗批准通知書》。
審查結論：根據《中華人民共和國藥品管理法》及有關規定，經審查，2021年8月5日受理的利多卡因丁卡因乳膏符合藥品註冊的有關要求，同意本品開展用於成人淺層皮膚手術前對完整皮膚的局部麻醉的臨牀試驗。同意開展以參比製劑為對照的等效臨牀試驗，不再要求開展以考察PK特徵為目的的臨牀試驗。
2020年10月，公司以技術受讓方式引進局部外用麻醉產品利多卡因丁卡因乳膏，並啟動該產品在中國的研發及註冊工作。本項目申請的臨牀適應症為用於成人淺層皮膚手術前對完整皮膚的局部麻醉。
根據國家藥品註冊相關的法律法規規定，上述藥物獲得臨牀試驗批准，公司還需開展臨牀試驗並經國家藥監局審評，審批通過後方可生產上市。
該項目產品為利多卡因丁卡因乳膏(商品名為Pliaglis)的化學仿製藥，主要用於成人淺層皮膚手術前對完整皮膚的局部麻醉。Pliaglis是由Zars Pharma，Inc(以下稱Zars)開發，最早於2006年在美國批准上市。隨後，Zars Pharma，Inc歐洲子公司Zars (UK) Ltd在歐洲以分散程序提交Pliaglis上市。迄今為止，Pliaglis已在全球多個國家上市，但在國內未有利多卡因丁卡因乳膏類產品申請註冊及批準上市。
該產品是公司聚焦和圍繞核心醫美主業，縱深開拓產品線的重要業務方向。該產品主要應用於成人淺層皮膚手術前對完整皮膚的局部麻醉，具有起效快、麻醉效果好、自成膜易去除、臨牀使用便利等優勢，本產品作為淺層皮膚手術局麻藥物，未來在醫療美容項目上具有廣泛的使用前景。
該項目的實施是建立在公司現有主營業務基礎上，依託公司雄厚研發實力，結合未來市場發展需求對現有產品的延伸。項目的實施能夠優化產品結構，增加技術儲備，提高產品附加值，開拓新的利潤增長點。
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.
