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励晶太平洋(00575.HK)商业战略伙伴获国家药监局批准提交试验性新药申请 批准早泄药SENSTEND在中国市场推广的重要里程碑
格隆汇 12-03 09:15

2020年12月2日,作为专业保健、健康和生命科学的投资集团,励晶太平洋集团有限公司(“励晶太平洋”或“本公司”及其附属公司,统称“本集团”;股份代号﹕0575.HK)欣然宣布其于中国之商业战略伙伴及一间上海复星医药之完全控制公司江苏万邦医药营销有限责任公司(“江苏万邦医药”)已获得国家药品监督管理局(“国家药品监督管理局”)批准提交试验性新药申请以就一款许可产品开展人类临床试验。

根据与江苏万邦医药的许可协议条款,励晶太平洋现有权从江苏万邦医药收取80万美元(约624万港元)的款项。此款项应在30个营业日内支付。国家药品监督管理局将正式审阅临床试验审批,而审评中心之临床试验审批将会于2021年第一季度完结之前取得。另一笔320万美元(约合2496万港元)的款项将于成功获得国家药品监督管理局批准开始临床试验后收取。

励晶太平洋行政总裁Jamie Gibson表示:“此认可绝对是批准在中国市场推广Senstend™之重要里程碑。我们将继续与其现有及潜在商业伙伴全力紧密配合,并在有任何新进展时适时通知股东及潜在投资者。”

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