勵晶太平洋(00575.HK):合作夥伴萬邦醫藥臨床試驗申請獲准提交
勵晶太平洋(00575.HK)就有關Senstend╱Fortacin之營運最新情況作出公布,商業戰略夥伴江蘇萬邦醫藥已獲得國家藥監局批准提交試驗性新藥申請以就一款許可產品開展人類臨床試驗,作為達成批准在中國市場推廣Senstend之重要里程碑。
因此,公司附屬Plethora已向江蘇萬邦醫藥出具80萬美元的發票,須於30個營業日內支付。
國家藥監局將正式審閱臨床試驗審批,而公司接獲江蘇萬邦醫藥通知,將會於提交日期起計60個工作天內(即明年第一季度完結之前)取得藥品審評中心的臨床試驗審批。成功獲得藥監局批准開始臨床試驗後,320萬美元將會到期並需支付。
根據早前許可協議,Plethora將治療早洩藥品Fortacin於內地商業化權利授予萬邦醫藥。在達到與中國銷售有關之若干里程碑後,集團將有權收取最多為3,800萬美元之付款,不包括特許權使用費。
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