Cibinetide ARA-290 EPO-R激动剂 神经保护 组织修复 ≥98%

Molecular Formula

C51H84N16O21

Molecular Weight

1257.32 g/mol

Sequence

GGTYSCHFGPLTWVCKPQ (with disulfide bridge: Cys7-Cys17)

Appearance

White to off-white lyophilized powder

Solubility

Soluble in water and aqueous buffers

Storage

Store at -20°C, protected from light and moisture

Pharmacological Class

Innate repair receptor (IRR) agonist / Tissue-protective peptide

Indication

Diabetic peripheral neuropathy, small fiber neuropathy, and tissue repair (clinical development)

Administration Route

Subcutaneous (SC) injection

Purity

>= 98.0% (by HPLC)

Tissue-Protective EPO Mimetic 组织保护性EPO模拟物

Selectively activates the innate repair receptor (IRR) complex to deliver EPO-like tissue protection without stimulating erythropoiesis or increasing hematocrit. 选择性激活先天修复受体（IRR）复合物，提供类似EPO的组织保护作用，但不刺激红细胞生成或增加红细胞压积。

Avoids the cardiovascular and thrombotic risks associated with recombinant EPO therapy while preserving neuroprotective benefits. 避免重组EPO治疗相关的心血管和血栓风险，同时保留神经保护效益。

Neuropathic Pain Target 神经病理性疼痛靶点

Demonstrated efficacy in Phase II trials for painful small fiber neuropathy and sarcoidosis-associated neuropathy through IRR-mediated nerve repair mechanisms. II期临床试验中显示对痛性小纤维神经病变和结节病相关神经病有效，通过IRR介导的神经修复机制发挥作用。

Addresses a significant unmet medical need in diabetic and chemotherapy-induced peripheral neuropathy treatment. 满足糖尿病和化疗引起的周围神经病变治疗中重大未满足医疗需求。

Non-Hematopoietic Safety 非造血安全性

Unlike full-length EPO, Cibinetide does not bind the classical EPOR homodimer, eliminating hematocrit elevation and related adverse events. 与全长EPO不同，西比尼迪不结合经典EPOR同源二聚体，消除红细胞压积升高和相关不良事件。

Favorable safety profile supports outpatient administration and chronic use scenarios without hematologic monitoring. 良好的安全性特征支持门诊给药和慢性使用，无需血液学监测。

Novel Mechanism of Action 新颖作用机制

First-in-class peptide targeting the IRR (EPOR/CD131 heterocomplex), representing a paradigm shift in tissue-protective therapeutics. 首个靶向IRR（EPOR/CD131异源复合物）的肽类药物，代表组织保护性治疗的范式转变。

Strong intellectual property and differentiation potential for partners developing next-generation neuropathic pain therapies. 强大的知识产权和差异化潜力，适合开发下一代神经病理性疼痛疗法的合作伙伴。

Clinical Stage Validation 临床阶段验证

Completed Phase II studies with positive efficacy signals in multiple neuropathic pain indications. 完成II期研究，在多种神经病理性疼痛适应症中显示积极疗效信号。

De-risked development pathway with established clinical proof-of-concept for licensing and co-development opportunities. 已确立临床概念验证，降低开发风险，适合授权许可和合作开发机会。

GMP-Ready Supply GMP就绪供应

Available from research-grade to GMP-compliant API with full CMC documentation, stability data, and validated analytical methods. 从研究级到GMP合规API均可提供，附带完整CMC文件、稳定性数据和经验证的分析方法。

Supports seamless progression from preclinical studies through clinical trials to commercial manufacturing. 支持从临床前研究到临床试验再到商业化生产的无缝推进。

Integrated API Procurement 集成API采购

Single-source supply of API, reference materials, and regulatory packages with full batch traceability and quality assurance. API、参考材料和法规文件包的单一来源供应，具备完整批次可追溯性和质量保证。

Simplifies vendor management and accelerates development timelines for biotech and pharma partners. 简化生物技术公司和制药合作伙伴的供应商管理，加速开发时间表。