艾德生物(300685.SZ)與廣生堂達成靶向藥物臨牀研究合作
格隆匯12月25日丨艾德生物(300685.SZ)公佈，近日，公司與福建廣生堂藥業股份有限公司(“廣生堂”)簽署了合作協議(“本協議”或“協議”)，公司基於PCR技術平台自主研發的“肺癌多基因聯合檢測產品”(即PCR-11基因)將用於廣生堂MET抑制劑GST-HG161在中國的伴隨診斷，並將積極推進該產品在國家藥品監督管理局的註冊審批。同時公司(含子公司)將為廣生堂MET抑制劑GST-HG161臨牀研究提供樣本檢測服務。協議的主要內容如下：
1、廣生堂委託公司及關聯方就其抗腫瘤藥物GST-HG161臨牀研究提供樣本檢測服務及伴隨診斷相關合作。
2、根據廣生堂藥物研發和推廣需求，公司基於PCR技術平台自主研發的“肺癌多基因聯合檢測產品”(即PCR-11基因，PCR-11基因包含MET基因，“MET伴隨診斷試劑盒”)將用於廣生堂MET抑制劑GST-HG161在中國的伴隨診斷，並將積極推進該產品在國家藥品監督管理局的註冊審批。
3、公司負責MET伴隨診斷試劑盒的研發、NMPA註冊申報及獲批，負責提供廣生堂臨牀試驗藥物GST-HG161臨牀研究所需的相應支持性材料。
4、廣生堂負責提供GST-HG161藥效相關數據用於支持MET伴隨診斷試劑盒在NMPA的評審，並根據約定的里程碑事件進度支付費用。
5、公司及其子公司將為廣生堂MET抑制劑GST-HG161臨牀研究提供分子檢測相關服務，即包括臨牀研究中收集的臨牀樣本的運輸、貯存、檢測分析及出具分析結果報吿等。廣生堂根據約定的服務內容和單價支付費用，具體費用以最終結算時實際發生數為準。
在腫瘤伴隨診斷領域，公司嚴守國家法律和行業規範，構建了完善的、基於多技術平台的基因檢測整體解決方案。公司已獲批的NGS-10基因產品包含Met基因的檢測，可為臨牀提供包括Met基因在內的核心腫瘤驅動基因的檢測。PCR-11基因產品是公司PCR-9基因產品的升級版，在日本國立癌症研究中心組織的性能研究中，該產品以優異的性能、簡便快捷的臨牀應用體驗獲得日本主流臨牀機構的一致認可，是繼納入日本、韓國醫保的ROS1伴隨診斷產品之後的又一重要產品，該產品已完成在日本的註冊臨牀試驗並獲得日本醫藥品醫療器械綜合機構的註冊受理，該產品也是安進、默克、海和等公司靶向藥物的伴隨診斷產品。在NGS平台領域，公司自主研發獲批的NGS-10基因、BRCA1/2基因等產品，全面覆蓋了肺癌、結直腸癌、乳腺癌、卵巢癌等重要癌種的伴隨診斷需求，NGS-10基因是禮來、強生等公司腫瘤產品線伴隨診斷產品。從PCR到NGS、FISH、IHC，艾德生物各技術平台精準佈局，在國內外腫瘤伴隨診斷領域優勢地位和品牌影響力日漸凸顯。
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.
