时间：2026年5月7日
Date: May 7, 2026
中国创新药企InnoCare自主研发TYK2抑制剂ICP-488获批干燥综合征II期临床
InnoCare Announces Approval of Phase II Clinical Trial of TYK2 Inhibitor ICP-488
摘要 :
中国创新生物制药公司InnoCare Pharma宣布，国家药品监督管理局药品审评中心正式批准其自主研发的TYK2变构抑制剂ICP-488开展干燥综合征II期临床试验。这是全球范围内首次有靶向疗法获批进入这一适应症的开发阶段，有望为约500万中国患者带来突破性治疗选择。
ICP-488是一种口服、高选择性TYK2变构抑制剂，通过与TYK2 JH2结构域结合，阻断IL-23、IL-12、1型干扰素及其他炎性细胞因子的信号转导，从而抑制自身免疫和炎性疾病的病理进程。干燥综合征是一种以淋巴细胞增殖和进行性外分泌腺损伤为特征的慢性炎性自身免疫疾病，在中国患病率约0.33%-0.77%，估计患者约500万人。目前，全球范围内尚无获批的干燥综合征靶向疗法。InnoCare联合创始人、董事长兼CEO崔霁松博士表示，ICP-488在多种自身免疫疾病中展现广泛治疗潜力，此次获批将进一步丰富公司自身免疫治疗产品管线。
Summary :
InnoCare Pharma, a leading Chinese innovative biopharma company, announced that China’s Center for Drug Evaluation (CDE) has approved its TYK2 allosteric inhibitor ICP-488 for Phase II clinical trial in Sjögren’s syndrome. This marks the world’s first targeted therapy to enter clinical development for this indication, potentially offering breakthrough treatment for approximately 5 million Chinese patients.
ICP-488 is an oral, highly selective TYK2 allosteric inhibitor that blocks signal transduction of IL-23, IL-12, type 1 IFN and other inflammatory cytokines by binding to the TYK2 JH2 domain, thereby inhibiting pathological processes of autoimmune and inflammatory diseases. Sjögren’s syndrome is a chronic inflammatory autoimmune disease characterized by lymphoproliferation and progressive exocrine gland injury, with prevalence in China ranging from 0.33% to 0.77%, affecting approximately 5 million patients. Currently, there are no approved targeted therapies for Sjögren’s syndrome globally. Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, stated that ICP-488 demonstrates broad therapeutic potential across multiple autoimmune diseases, and this approval will further enrich the company’s autoimmune therapeutic pipeline.
入选理由 :
这项突破性进展标志着中国创新药研发在全球自身免疫治疗领域实现了”从0到1″的跨越。干燥综合征作为一种影响数百万患者的慢性疾病，长期缺乏有效靶向药物，ICP-488的成功获批不仅为患者带来新希望，更向世界展示了中国药企在原创新药研发方面的强劲实力。此消息对全球生物医药投资界具有重要的风向标意义。
Why Selected：
This breakthrough marks a significant “zero-to-one” advancement for Chinese innovative drug R&D in the global autoimmune treatment field. Sjögren’s syndrome, affecting millions of patients, has long lacked effective targeted drugs. ICP-488’s successful approval not only brings hope to patients but also demonstrates China’s strong capabilities in original new drug development. This news holds significant benchmark importance for the global biomedical investment community.
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