復星醫藥(600196.SH):天津星魅引進美容塑形藥物RZL012注射劑
格隆匯9月17日丨復星醫藥(600196.SH)宣佈,2020年9月17日,公司參與投資的天津星魅與Raziel簽署《License and Supply Agreement》,Raziel授權天津星魅在區域內(即中國大陸及港澳台地區)及領域內(即美容領域或美容適應症)獨家臨牀開發和商業化RZL012。
RZL012是一種活性成分為合成小分子的注射劑,該注射劑中不含有人血來源的物質或動物來源的蛋白。其正在美國進行的針對美容適應症臨牀研究初步表明,該產品注射後可誘導注射部位脂肪細胞減少、減少脂肪層厚度,達到局部塑形的目的。
根據《許可及供應協議》,天津星魅將負責RZL012針對下巴塑形的國際多中心III期臨牀試驗之區域內試驗(如適用)的開展。
目前,RZL012已在美國開展臨牀研究的適應症主要包括美容、治療兩大類。截至該公告日,美容適應症中,針對腹部塑形的IIa期臨牀研究已完成、針對下巴塑形的IIa期臨牀研究正在進行中;治療適應症中,針對痛性脂肪綜合症、脂肪瘤及脂肪水腫的IIa期臨牀研究已完成,其中,RZL012針對痛性脂肪綜合症已獲得美國FDA孤兒藥認證,並正在開展IIb期臨牀研究。
付款方式包括:(1)天津星魅應根據約定向Raziel支付至多2700萬美元的首付款及臨牀開發註冊里程碑;(2)天津星魅應根據產品於區域內淨銷售額累計達成情況,向Raziel支付至少2500萬、至多4700萬美元的銷售里程碑款項;(3)天津星魅應於《許可及供應協議》約定的銷售提成期間內,根據產品年度淨銷售額達成情況、按年度淨銷售額的9%或15%的比例支付銷售提成。
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