和誉医药创新PRMT5*MTA抑制剂ABSK131完成1期临床首例患者给药

2025年7月23日，和誉医药（港交所代码：02256）宣布，其自主研发的高选择性小分子PRMT5*MTA抑制剂ABSK131已完成首例患者给药。今年3月，ABSK131获中国国家药品监督管理局药品审评中心（CDE）批准治疗晚期实体瘤患者的临床研究许可。去年12月，其临床试验已被美国FDA批准。

2. Bertino JR, Waud WR, Parker WB, Lubin M. Targeting tumors that lack methylthioadenosine phosphorylase (MTAP) activity: current strategies. Cancer Biol Ther. 2011;11(7):627-632. doi:10.4161/cbt.11.7.14948.

23 July 2025, Shanghai—Abbisko Therapeutics Co., Ltd. (“Abbisko”) today announced that it has dosed the first patient in a Phase 1 clinical trial of ABSK131, an investigational and novel PRMT5*MTA inhibitor in patients with advanced or metastatic solid tumors with MTAP deficiency. In March 2025, ABSK131 received IND clearance from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). In December 2024, ABSK131 received IND clearance from the U.S. Food and Drug Administration (FDA).

The ongoing clinical study is conducted under the title “A Phase 1, First-in-Human, Multicenter, Open-Label Study of ABSK131 to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Patients with Advanced/Metastatic Solid Tumors with MTAP deficiency." 

Approximately 15% of solid tumors lack expression of methylthioadenosine phosphorylase (MTAP), a tumor suppressor gene^[1]. Solid tumors with high rates of MTAP deficiency include non-small cell lung cancer (NSCLC) (15.7%), pancreatic cancer (21.7%), esophageal cancer (28.4%), mesothelioma (32.2%), and gastrointestinal cancer (10.4% of gastric and 1% of colorectal cancer)^[2], of which mesotheliomas and pancreatic cancers have no approved targeted therapies. Recent studies have demonstrated that selectively targeting PRMT5*MTA shows promise as a therapeutic strategy for MTAP-deficient cancers.

About ABSK131

ABSK131 is a novel, small molecule MTA-cooperative PRMT5 inhibitor in development by Abbisko Therapeutics. In preclinical studies, ABSK131 demonstrated excellent selectivity for MTAP-deleted cancer cells, as well as favorable drug metabolism and pharmacokinetic properties for oral dosing.

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关于和誉

和誉医药（香港联交所代码：02256）成立于2016年，是一家立足中国，着眼全球的创新药研发公司。公司的创始人和管理团队拥有多年顶尖跨国药企的研发和管理经验，并参与了多个临床及上市新药的研发。和誉医药专注于肿瘤新药研发，以小分子肿瘤精准治疗和小分子肿瘤免疫治疗药物为核心，着眼病患及医药市场的需求，秉承国际新药开发的理念和标准，致力于开发新颖及高潜力药物靶点的潜在first-in-class或best-in-class创新药物，用于改善中国及全球病人的生活质量。自成立以来，和誉医药已经建立了丰富的创新产品管线，涵盖肿瘤精准治疗领域以及肿瘤免疫治疗领域。

更多信息，欢迎访问 www.abbisko.com。