復星醫藥(600196.SH):復宏漢霖就BRAF V600E抑制劑與潤新生物簽訂許可協議
格隆匯5月11日丨復星醫藥(600196.SH)公佈,2021年3月27日,公司控股子公司復宏漢霖(02696.HK)與潤新生物簽訂《Binding Term Sheet》,約定由潤新生物授予復宏漢霖在區域內(即中國大陸及港澳台地區)及領域內(即人類疾病治療領域)就靶向人類BRAF蛋白V600E突變的小分子抑制劑RX208(簡稱“許可產品”)進行研發、生產及商業化並使用相關知識產權的權利許可,並約定雙方將共同推進最終許可協議的達成。
2021年5月11日,復宏漢霖與潤新生物簽訂《藥品技術許可協議》(簡稱“《許可協議》”)。根據《許可協議》,復宏漢霖獲潤新生物獨佔許可在區域內及領域內就許可產品進行研發、生產及商業化(即研究、開發、樣品生產、臨牀試驗、申報註冊、商業化、生產、委託生產、使用、進口、出口<僅限向區域內出口>、分銷、銷售、許諾銷售、委託銷售、營銷、推廣以及提供服務等行為)並使用潤新生物相關知識產權。
許可產品是靶向人類BRAF蛋白V600E突變的小分子抑制劑。BRAF蛋白是MAPK/ERK信號通路中重要的上游調節因子,其V600E突變可使BRAF蛋白持續激活,是包括結直腸癌、甲狀腺瘤、黑色素瘤在內的多種腫瘤及脂質肉芽腫等罕見病的潛在靶點。截至該公吿日,許可產品於中國大陸處於I期臨牀階段。
截至該公吿日,於中國大陸已上市的BRAF突變靶向藥主要有Roche Pharma (Schweiz) Ltd.的佐博伏®、Novartis AG的泰菲樂®。根據IQVIA CHPA數據,2020年度,BRAF突變靶向藥於中國大陸的銷售額約為人民幣7786萬元。
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