晶泰控股两项突破:Tensotide获美Self-GRAS认证 SIGX2649提前获FDA批件

财中社
May 31

  5月31日,晶泰控股(02228)发布公告,近期公司在自研创新多肽食品原料及孵化企业创新药管线方面取得两项突破性进展。

  首先,公司依托AI多肽发现与优化平台PepiX自主开发的创新多肽食品原料Tensotide,成功获得美国Self-GRAS认证。这是公司在口服食品领域取得的首个国际安全认证,标志着公司在产业化能力上的重要进展。Tensotide是一种具有高活性、高稳定性及低成本易量产优势的创新活性肽,已获得中国发明专利,并完成PCT国际专利申请。

  其次,晶泰孵化企业希格生科自主研发的潜在First-in-class/Best-in-class实体瘤靶向药SIGX2649比预定时间提前获得美国食品药品监督管理局(FDA)的新药临床试验(IND)批件。这是继全球首款靶向药SIGX1094进入Ⅰ期临床后,希格生科进入临床的第二条创新药管线。SIGX2649通过靶向Hippo通路中的核心转录因子YAP的结合蛋白TEAD,抑制实体瘤的增殖和转移,其临床前研究显示出显著的抗增殖活性和良好的药代动力学表现。

(文章来源:财中社)

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