君圣泰医药-B(02511):HTD1801随机对照临床研究获积极评价

智通财经
Jul 10

智通财经APP讯,君圣泰医药-B(02511)发布公告,近日,继本公司核心产品HTD1801联合二甲双胍治疗2型糖尿病的III期临床研究(SYMPHONY-2)结果在国际知名医学期刊《新英格兰医学杂志》(NEJM)临床证据子刊《NEJM Evidence》发表之后,《NEJM Evidence》进一步刊发题为《Berberine-Ursodeoxycholate — Bringing Traditional Chinese Medicine to Our World》的社论(Editorial)。该社论对HTD1801随机对照临床研究的严谨设计及持续积累的临床证据给予积极评价,并指出HTD1801的研究为通过高质量临床研究推动源于中国传统医药智慧的创新药物走向世界提供了参考。上述研究结果及社论的发表,进一步体现了HTD1801的临床成果获得国际学术界的广泛关注与认可。

目前,本公司正积极推进HTD1801的上市及商业化相关工作,并正与若干潜在合作伙伴就HTD1801首个上市适应症在中国的潜在授权及商业化合作进行磋商。有关潜在合作项下,可能支付予本公司潜在首付款、潜在开发里程碑付款、潜在销售里程碑付款及销售提成。本公司将按进展适时发布进一步公告。

HTD1801是一款全球首创的新分子实体,旨在解决心肾代谢系统疾病(CKM)的未满足临床需求。HTD1801作为单一分子,是具有独特双机制的口服抗炎及代谢调节剂(AIMM),通过激活AMPK及抑制NLRP3炎症小体发挥其生物学活性;这种互补协同的双机制作用可有效解决代谢问题。全球多项临床结果验证HTD1801能够为患者带来综合获益,包括改善胰岛素敏感性、血糖控制、血脂降低、肾脏保护、体重减轻、肝脏获益及抗炎等。基于此,HTD1801有潜力成为CKM领域的基础性治疗药物。

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