勵晶太平洋(00575.HK):江蘇萬邦醫藥已取得藥品審評中心的臨牀試驗審批
格隆匯 2 月 9日丨勵晶太平洋(00575.HK)披露有關FortacinTM在中國的審批及商業化進展。
誠如先前所公佈,國家藥品監督管理局已在中國對SenstendTM的臨牀試驗審批進行正式審閲。就此而言,公司於中國的商業戰略伙伴及一間上海復星醫藥(集團)股份有限公司的全資附屬公司-江蘇萬邦生化醫藥集團有限責任公司("江蘇萬邦醫藥")於2021年2月7日吿知公司,其已於2021年2月5日取得藥品審評中心的臨牀試驗審批。此為集團的重要里程碑,江蘇萬邦醫藥因此現時須支付公司款項320萬美元(扣除中國預扣税前)或288萬美元(扣除中國預扣税後)。
集團現時將盡全力展開隨機化臨牀試驗工作,該計劃將於2021年四月份/五月份開始,預計於此後12個月內達至完成。就此而言及誠如先前所述,江蘇萬邦醫藥已委聘一間領先的合同研究機構進行第三期雙盲多中心隨機化臨牀試驗,為集團期望在中國內地進行SenstendTM商業化的下一關鍵步驟。
倘臨牀研究達至完成及國家藥品監督管理局授予SenstendTM進口許可,江蘇萬邦醫藥將須向集團支付500萬美元(扣除中國預扣税前)。此外,SenstendTM在中國首次商業銷售後,江蘇萬邦醫藥將須向集團支付200萬美元(扣除中國預扣税前)。此外,集團亦將按江蘇萬邦醫藥在中國的SenstendTM淨銷售額收取低至中雙位數之特許權使用費。
公司行政總裁Jamie Gibson表示:"我們對於SenstendTM在中國成功商業化推出過程中達成此一重要里程碑感到十分欣喜。在為集團帶來可觀收入的同時,亦有助於在其他地區推出該項產品時提高我們的聲譽。"
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