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励晶太平洋(00575.HK)药物分别於中美市场 已提交试验申请
阿思达克 11-18 09:29
励晶太平洋(00575.HK)公布,中国之商业战略夥伴江苏万邦医药已於11月16日就临床试验审批提交试验性新药,寻求中国寻求批准将 Senstend(Fortacin於中国推出市场所用的名称)推出市面的第一步,预期可於3个月内,取得国家药品监督管理局药品审评中心的临床试验审批。

集团仍旧维持於今年底前完成Fortacin之第二阶段验证研究,并於明年上半年向美国食品及药品监督管理局提交研究结果的目标。假设试验足以说服美国食品及药品监督管理局就早泄烦恼评价调查问卷能够作为支持标示之适当措施,则至为关键之第三阶段研究可於2021年下半年展开,并於2022年年底提交新药申请,处方药使用者费用法日期因此将为2023年年底。

公司仍在与中东、印度、北美及拉丁美洲地区之商业战略夥伴进行讨论。

集团领先产品Fortacin之欧洲市场推广及分销夥伴以意大利为基地,故集团一直在与Recordati磋商,以评估2019冠状病毒病疫情引致之局势及其对继续推出Fortacin之影响。在此方面,Recordati已告知集团,於第三季度,其参考市场继续受到2019冠状病毒病疫情影响,原因为全境均实施遏止疫症措施,以及批发商谨慎控制存货。Recordati表示,2019冠状病毒病疫情将继续影响其第四季度的销售数字。

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