艾德生物(300685.SZ)與安進達成靶向藥物臨牀研究合作
格隆匯5月22日丨艾德生物(300685.SZ)公佈，近日，公司與AMGEN INC.(“安進”)簽署了合作協議。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”(即艾惠健®升級版)將用於安進非小細胞肺癌靶向藥物AMG510(針對KRAS基因G12C突變的不可逆抑制劑)在中國的伴隨診斷，並將積極推進其在國家藥品監督管理局的註冊審批。
AMGEN INC.是國際知名的生物技術公司，其致力於生物學潛能的挖掘，深植創新性療法的發現、開發和轉化，服務罹患重疾的患者。安進公司專注於醫療需求未得到滿足的領域，並利用其專業知識來尋求能夠改善健康狀況並顯著改善人們生活的解決方案。AMG510是安進公司研發的針對KRAS G12C突變的抑制劑，該藥物的出現打破了KRAS靶點不可成藥的魔咒。目前該藥物的臨牀申請已獲我國藥品監督管理局藥品審評中心(CDE)受理。
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”(即艾惠健®升級版)將用於安進非小細胞肺癌靶向藥物AMG510(針對KRAS基因G12C突變的不可逆抑制劑)在中國的伴隨診斷，並將積極推進其在國家藥品監督管理局的註冊審批。
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。在PCR技術平台，公司自主研發的“艾惠健®”(可檢測多個肺癌核心驅動基因)已於2018年8月24日獲國家藥品監督管理局批准上市。此次合作正是基於公司自主創新的又一個肺癌多基因聯合檢測產品，為肺癌靶向藥物的精準施用提供快速且全面的伴隨診斷支持。此前，公司ROS1基因融合檢測試劑盒助力輝瑞公司靶向藥物克唑替尼(Xalkori)泛亞太臨牀研究，在日本、韓國、中國台灣獲批上市並納入日本、韓國醫保；2019年6月，“艾惠健®”和“維惠健®”成為禮來RET抑制劑LOXO-292亞洲藥物臨牀試驗的伴隨診斷試劑；2019年11月，公司與日本衞材就其在研膽管癌靶向藥物臨牀上達成合作；2020年3月，公司與強生的靶向藥物在中國臨牀上展開合作，推進“維惠健®”的變更註冊(擴大其伴隨診斷範圍)。此次安進選擇與公司建立伴隨診斷合作關係，是對公司品牌和產品的信任和肯定，對公司未來的發展將產生積極影響。
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