文章核心观点 临床阶段生物技术公司Chemomab Therapeutics在推进nebokitug 3期项目时获FDA两个重要开发里程碑确认，公司将继续与FDA密切合作确定3期开发项目细节并与潜在战略合作伙伴进行讨论 [1][4] 各部分总结 公司进展 - 公司在FDA 2期结束（EOP2）审查过程中与FDA就多个化学、制造和控制（CMC）主题进行探讨，FDA同意公司及其合同制造合作伙伴提出的CMC策略 [2] - 公司与FDA进行C类会议讨论新药监管途径中非临床胎儿和胚胎发育毒理学研究，FDA同意该毒理学测试可与nebokitug 3期临床试验并行进行并作为生物制品许可申请（BLA）一部分提交 [3] 药物介绍 - nebokitug（CM - 101）是首类双活性单克隆抗体，可中和CCL24，阻断免疫细胞募集和成纤维细胞活化，中断导致纤维化的自我强化循环，在临床和临床前研究中显示出良好安全性，有治疗多种严重威胁生命的纤维炎症性疾病潜力 [5] - nebokitug已在四项临床试验中取得积极结果，包括2期SPRING试验，该试验达到主要安全终点，中度/晚期疾病患者在一系列疾病相关次要终点上有改善，开放标签扩展部分结果证实并扩展了2期初步结果 [5] - nebokitug获FDA和EMA孤儿药指定用于治疗原发性硬化性胆管炎（PSC）和系统性硬化症，获FDA快速通道资格用于成人PSC治疗 [5] 公司概况 - Chemomab是临床阶段生物技术公司，基于可溶性蛋白CCL24在促进纤维化和炎症中的独特作用开发了nebokitug，该药物有疾病修饰潜力 [8] - 基于2期SPRING试验积极数据，公司正为启动nebokitug PSC 3期试验做准备，3期设计为基于临床事件主要终点的单一关键试验，为全面监管批准提供清晰简化途径 [8] - 公司nebokitug治疗系统性硬化症项目有开放的美国研究性新药申请（IND） [8]

—New Patents Covering Use of Nebokitug for the Treatment of Liver Diseases including Primary Sclerosing Cholangitis Issued in China and Russia Providing Coverage Up To 2041— —Further Expands Protections Provided by Nebokitug’s Composition of Matter and Methods and Use Patents Issued in the U.S., Europe, Japan and Additional Key Territories— TEL AVIV, Israel, June 03, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics, Ltd., (Nasdaq: CMMB), a clinical stage biotechnology company developing innovative therapeutic ...

—Reported Positive 48-Week Data from SPRING Trial—Nebokitug Treatment in PSC Patients with Moderate/Advanced Disease Resulted in Continued Improvements across Key Biomarkers of Liver Injury, Inflammation and Fibrosis— —Aligned with FDA on Pathway to Potential Regulatory Approval for the Treatment of PSC with a Single, Clinical-Events-Driven Clinical Trial— —These Major Milestones Support the Advancement of Nebokitug to Phase 3 and Position It to Potentially Become the First FDA-Approved Treatment for PSC— — ...

New Analyses of PSC Data from Phase 2 SPRING Trial Show that Treatment with Nebokitug Is Associated with Dose-Dependent and Significant Improvements in Multiple Inflammatory and Fibrotic Biomarkers Further Confirms the Clinical Potential of Nebokitug As a First-in-Class Novel Treatment for PSC and Other Fibro-Inflammatory Conditions Second EASL 2025 Poster Reports that Pharmacokinetic and Pharmacodynamic Data from the Phase 2 Spring Trial Demonstrates Effective and Dose-Dependent Antibody-Target Engagement ...