天士力(600535.SH):抑郁症治疗药获药物临床试验批准通知书
格隆汇8月5日丨天士力(600535.SH)公布,日前,公司收到国家药监局核准签发用于治疗抑郁症的化学药品1类新药JS1-1-01片《药物临床试验批准通知书》,并将于近期开展临床试验。
JS1-1-01是一种全新结构的5-羟色胺–去甲肾上腺素–多巴胺三重再摄取抑制剂(SNDRIs),同时还可促进脑源性神经营养因子(BDNF)的分泌,从而发挥抗抑郁作用。临床前研究数据证实,JS1-1-01片在疗效和起效时间上优于传统的抗抑郁药物,且安全性好。公司已拥有涵盖JS1-1-01化合物、工艺、适应症及制剂的专利,其化合物专利已在中国、欧洲、美国、日本、韩国、澳大利亚等目标市场取得。全球尚未有同机制药物获批上市,研发进展最快的同类药物处于临床Ⅱ/Ⅲ期阶段。产品研发成功上市后,能为中国乃至全球抑郁症患者带来更多的选择和希望。截至本公告日,公司对该项目的累计研发投入为人民币2241.35万元。
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