翰森製藥(03692.HK)與SCYNEXIS訂立許可協議
格隆匯 2 月 17日丨翰森製藥(03692.HK)宣佈，於2021年2月11日，翰森(上海)健康科技有限公司及江蘇豪森藥業集團有限公司(統稱為"被許可人"，各自為公司的全資附屬公司)已與SCYNEXIS, Inc.(納斯達克股份代號：SCYX)("SCYNEXIS")訂立獨家許可及合作協議。
根據許可協議，被許可人將獲得SCYNEXIS的獨家特許權，在中國研究、開發及商業化ibrexafungerp("該產品")。作為獨家特許權的代價，被許可人同意向SCYNEXIS支付1000萬美元的首付款加潛在的里程碑付款及提成。該等里程碑付款須於達成相關里程碑事件(例如在該地區取得產品監管批准)時方可作實。
該產品是全球首創新型三萜類抗真菌劑，具備廣譜活性，可發揮靜脈和口服制劑的治療優勢。其作用機制是殺死念珠菌屬的真菌，即可消滅真菌細胞，並處於多種適應症(包括威脅住院患者生命的真菌感染)的後期開發階段。
該產品目前正接受美國藥政審批，用於治療陰道酵母菌感染(又稱為外陰陰道念珠菌病("外陰陰道念珠菌病"))。於2020年12月，美國食品藥品監督管理局(美國藥監局)受理該產品的新藥申請，處方藥申報者付費法案(PDUFA)日期為二零二一年六月一日。遞交此項新藥申請是基於兩項三期隨機、雙盲、安慰劑對照、多中心研究(VANISH-303及VANISH-306)的積極結果，其中口服ibrexafungerp在統計學上展現出優異的療效，並對外陰陰道念珠菌病女性患者顯示出良好的耐受性。倘獲批准，該產品可能會成為20多年來首個新抗真菌類，也是首個及唯一的陰道酵母菌感染非唑類療法。
公司認為，與SCYNEXIS合作將豐富集團於抗感染治療領域的研發管線。公司期望通過此次國際性合作，為中國的患者提供更多原創抗感染藥物，改善患者的生活質量。此次合作也增強了集團於抗感染治療領域的領先地位，同時亦拓展了集團的全球業務。
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