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信达生物(01801.HK):抗IL-23单克隆抗体I期临床研究在中国完成首例受试者给药
格隆汇 09-01 07:34

信达生物(01801.HK)发布公告,公司自主开发的重组抗白介素(“IL”)23p19亚基抗体注射液(IBI-112)的I期临床研究完成中国首例健康受试者给药。该研究是一项评价在中国健康受试者单剂皮下注射或静脉给药时IBI-112的安全性、耐受性(主要目标)、药代动力学和药效学的随机、双盲、安慰剂对照、剂量递增的I期临床研究。

根据披露,目前全世界2-3%的人口患有银屑病,中国银屑病患者约为600万名。炎症性肠病(“IBD”)近年来全球发病率也有明显提高趋势。然而,无论是银屑病还是IBD的治疗药物均尚未满足巨大的医疗需求。近年来,IL-23和其他生物药物因其良好的疗效和安全性引起越来越多的关注,但目前国内尚无自主研发的IL-23p19靶点药物。IBI-112是公司自主研发的创新药,通过特异性结合IL-23p19亚基,阻断IL-23介导信号通路,发挥抗炎作用,具有治疗银屑病、IBD等自身免疫性疾病的潜力。公司看到IBI-112在临床前研究中良好的安全性和有效性数据,相信该临床进展具有重要意义。公司期待IBI-112的后续临床研究结果,希望能为更多有需要的患者提供新的治疗选择。

IBI-112是由公司自主研发的,有自主知识产权的一种重组抗IL23p19亚基单克隆抗体注射液。该产品特异性结合IL-23p19亚基,从而阻止IL-23与细胞表面受体结合,阻断IL-23受体介导信号通路。临床前数据显示IBI-112靶点明确,作用机制清楚,抗炎症作用显着,有望为自身免疫性疾病患者提供更有效的治疗方案。

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