Ziconotide 齐考诺肽 非阿片类镇痛肽 API级 慢性疼痛研究 ≥98%

Molecular Formula

C102H172N36O32S7

Molecular Weight

2639.18 g/mol

Sequence

CKGKGAKCSRLMYDCCSGSCRSGKC-NH2 (Disulfide bridges: 1-16, 8-20, 15-25)

Appearance

White to off-white lyophilized powder

Solubility

Soluble in water and physiological saline

Storage

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

Pharmacological Class

N-type calcium channel blocker (Cav2.2 selective)

Indication

Management of severe chronic pain in patients intolerant of or refractory to other analgesics

Administration Route

Intrathecal (IT) administration via implanted pump

Purity

>= 98.0% (by HPLC)

First-in-Class Non-Opioid Analgesic 首创非阿片类镇痛药

First FDA-approved intrathecal analgesic that works through a non-opioid mechanism by selectively blocking N-type calcium channels (Cav2.2) in the spinal cord. 首个FDA批准的通过非阿片类机制发挥作用的鞘内镇痛药，选择性阻断脊髓中N型钙通道（Cav2.2）。

No risk of respiratory depression, opioid-induced hyperalgesia, tolerance development, or addiction - addressing critical unmet needs in chronic pain management. 无呼吸抑制、阿片诱导痛觉过敏、耐受性或成瘾风险 - 满足慢性疼痛管理中的关键未满足需求。

Potent & Selective Action 强效选择性作用

Three disulfide bridges stabilize the conformation for high-affinity binding to Cav2.2 channels, providing potent analgesia at nanomolar concentrations. 三个二硫键稳定构象，以高亲和力结合Cav2.2通道，在纳摩尔浓度下提供强效镇痛。

Superior pain relief for patients with neuropathic pain, cancer pain, and opioid-refractory conditions. 对神经病理性疼痛、癌痛和阿片类药物难治性病症患者的疼痛缓解效果优异。

No CNS Side Effects 无中枢副作用

Intrathecal delivery bypasses systemic circulation, minimizing central nervous system and systemic adverse effects common with oral/systemic analgesics. 鞘内给药绕过全身循环，最大限度地减少口服/全身镇痛药常见的中枢神经系统和全身不良反应。

Improved patient quality of life and compliance compared to systemic opioid therapy with equivalent or superior efficacy. 与全身阿片类药物治疗相比，疗效相当或更优，患者生活质量和依从性得到改善。

Complex Peptide Manufacturing 复杂肽合成能力

25-amino acid peptide with three critical disulfide bridges requires advanced synthetic expertise; supplied at >=98.0% purity with full analytical documentation. 含三个关键二硫键的25氨基酸肽需要先进合成技术；提供>=98.0%纯度及完整分析文件。

Access to a rare and technically challenging API backed by validated synthesis and quality control processes. 获得稀有且技术要求高的API，以经过验证的合成和质量控制流程为后盾。

Complete Regulatory Package 完整法规包

Comprehensive CMC documentation including detailed synthetic route, impurity profile, and stability data for global registration support. 全面的CMC文件，包括详细合成路线、杂质谱和稳定性数据，支持全球注册。

Accelerated market entry for generic developers and formulation partners targeting chronic pain therapeutics. 加速仿制药开发商和制剂合作伙伴进入慢性疼痛治疗市场。

Scalable Supply 可扩展供应

Production capacity from gram-scale for R&D to kilogram-scale for commercial supply, with consistent batch-to-batch quality. 从克级研发到公斤级商业供应的生产能力，批次间质量一致。

Supports seamless transition from clinical trials to commercial launch with reliable supply chain planning. 支持从临床试验到商业上市的平稳过渡，供应链规划可靠。

End-to-End Procurement 端到端采购

Single-source supply of API, reference standards, stability-indicating methods, and regulatory submission packages. API、对照品、稳定性指示方法和法规申报包的单一来源供应。

Reduces procurement complexity and ensures full traceability from synthesis to final delivery. 降低采购复杂性，确保从合成到最终交付的完整可追溯性。