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上海医药(02607.HK):SPH8216(TK216)注射液获得 II 期临床试验批准通知书
格隆汇 04-27 17:11

格隆汇 4 月 27日丨上海医药(02607.HK)公布,近日,公司以及全资子公司 Shanghai Pharmaceutical(USA) Inc.(以下简称"上药美国")开发的"SPH8216(TK216)注射液"(以下简称"该项目")收到国家药品监督管理局(以下简称"国家药监局")核准签发的《药物临床试验批准通知书》,将于近期启动国内 II 期临床试验,该项目为美国 OncternalTherapeutics, Inc.(以下简称"Oncternal")公司开发。

据悉,SPH8216(TK216)注射液是一种 first-in-class 小分子药物,具有抑制尤文氏肉瘤细胞增殖、促进细胞凋亡的肿瘤治疗效果。在美国进行的该项目治疗复发或难治性尤文氏肉瘤患者的临床研究中,该项目表现出良好的耐受性和安全性。FDA 已授予该项目孤儿药称号,并批准该项目获得快速审批通道资格。2020 年10 月,FDA 授予该项目治疗尤文氏肉瘤儿童罕见病资格。

2018 年 9 月,上药美国通过参股 Oncternal,获得该项目在中国开发和商业化的独家权益。2021 年 2 月,该项目递交的临床试验申请获得国家药监局正式受理。近日,该项目获得国家药监局核准签发《药物临床试验批准通知书》,同意按照已提交的方案开展新药临床试验。

截至目前,该项目公司已累计投入研发费用约 671.7 万元人民币。

根据我国药品注册相关的法律法规要求,该项目在获得临床试验通知书后,还需开展临床试验并经国家药监局审评、审批通过后方可生产上市。

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