東誠藥業(002675.SZ)引進北京腫瘤醫院核藥產品 主要用於特異性乳腺癌前哨淋巴結顯像劑
格隆匯1月12日丨東誠藥業(002675.SZ)公佈，2019年10月31日，公司披露了《關於簽署戰略合作協議的公告》。戰略合作協議簽署後，經過公司與北京腫瘤醫院的溝通協商，就引進北京腫瘤醫院用於檢測乳腺癌前哨淋巴結成像診斷藥物的事項達成協議，並於2020年1月11日正式簽訂了《99m Tc標記美羅華(99m Tc-SLN-F)探針技術轉讓合同》，公司將獲得99m Tc標記美羅華(99m Tc-SLN-F)分子探針產品(“目標產品”)在全球的專利、臨牀開發與註冊、生產和市場銷售的獨家權利。
9m Tc標記美羅華(99m Tc-Rituximab，99m Tc-SLN-F)是由北京腫瘤醫院自主研究開發的藥物，主要用於特異性乳腺癌前哨淋巴結顯像劑。正常淋巴細胞內含有大量的B淋巴細胞，膜表面高度表達CD20抗原分子，Rituximab是一種針對B細胞膜表面CD20抗原的特異性抗體，99m Tc-Rituximab通過與前哨淋巴結內CD20分子結合，定位於SLN內，從而顯像。該產品具有定位靶點明確、SLN攝取率高、SLN顯像或活檢時間不受限、無次級淋巴攝取、可控制每次注射顯像劑的分子總量、注射點滯留率低等優勢特點，目前已成功用於乳腺癌前淋巴結顯像及手術8000餘例，是腫瘤醫院做乳腺癌手術前的常規檢查之一。
公司(甲方)作為一家中國上市公司，是國內放射性藥物的領軍企業，具備已上市的核藥產品以及豐富的核藥生產和商業化管理經驗。東誠藥業為進一步在核醫藥領域佈局加大投資力度，強化在核藥領域的研發管線，有意獨家買斷乙方上述產品的獨家、全球性權利，轉讓完成後，東誠藥業將依靠自身優勢與資源，完成該產品的開發、臨牀試驗、藥品註冊、商業化及產品的全球化佈局等項目。
北京腫瘤醫院(乙方)是集醫、教、研、防於一體的大型現代化三級甲等腫瘤專科醫院，是國家臨牀重點學科、腫瘤科、病理科國家臨牀重點專科建設項目單位，在多種常見腫瘤診治方面在國內乃至國際均處於先進水平，在核醫學科方面亦具備核藥產品的研發優勢。北京腫瘤醫院擁有99m Tc標記美羅華產品的相關權利，包括與99mTc標記美羅華(99m Tc-SLN-F)產品相關的全部專有性技術(“目標技術”，包括但不限於前體及終端製劑的結構、製劑、標記方法、制備工藝、質量控制、檢測方法等全部專有性技術)、與9m Tc標記美羅華(99m Tc-SLN-F)產品關鍵製備工藝相關的在中國註冊的發明專利。
公司通過與北京腫瘤醫院的技術合作，獲取其在乳腺癌相關藥物開發方面的研發優勢，引進對方產品專利及在全球範圍內的臨牀開發、生產和市場銷售權益，對公司短期經營業績不會構成重大影響，但長期來看有助於公司增加核素藥物產品的經營種類，豐富產品管線，拓寬收入和利潤來源，符合公司戰略發展的需要。
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