励晶太平洋(00575.HK):江苏万邦医药已取得药品审评中心的临床试验审批
格隆汇 2 月 9日丨励晶太平洋(00575.HK)披露有关FortacinTM在中国的审批及商业化进展。
诚如先前所公布,国家药品监督管理局已在中国对SenstendTM的临床试验审批进行正式审阅。就此而言,公司于中国的商业战略伙伴及一间上海复星医药(集团)股份有限公司的全资附属公司-江苏万邦生化医药集团有限责任公司("江苏万邦医药")于2021年2月7日告知公司,其已于2021年2月5日取得药品审评中心的临床试验审批。此为集团的重要里程碑,江苏万邦医药因此现时须支付公司款项320万美元(扣除中国预扣税前)或288万美元(扣除中国预扣税后)。
集团现时将尽全力展开随机化临床试验工作,该计划将于2021年四月份/五月份开始,预计于此后12个月内达至完成。就此而言及诚如先前所述,江苏万邦医药已委聘一间领先的合同研究机构进行第三期双盲多中心随机化临床试验,为集团期望在中国内地进行SenstendTM商业化的下一关键步骤。
倘临床研究达至完成及国家药品监督管理局授予SenstendTM进口许可,江苏万邦医药将须向集团支付500万美元(扣除中国预扣税前)。此外,SenstendTM在中国首次商业销售后,江苏万邦医药将须向集团支付200万美元(扣除中国预扣税前)。此外,集团亦将按江苏万邦医药在中国的SenstendTM净销售额收取低至中双位数之特许权使用费。
公司行政总裁Jamie Gibson表示:"我们对于SenstendTM在中国成功商业化推出过程中达成此一重要里程碑感到十分欣喜。在为集团带来可观收入的同时,亦有助于在其他地区推出该项产品时提高我们的声誉。"
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