迪诺苏单抗Denosumab (anti-RANK Ligand) 615258-40-7

中文名称：迪诺苏单抗

中文同义词：地诺单抗；德尼单抗；狄诺塞麦；迪诺苏单抗

英文名称：Denosumab(usan)

英文同义词：D03684；Denosumab；Denosumab(usan)；AMG162；IMMunoglobulinG2，antiChemicalbook-(huManosteoclastdifferentiationfactor)(huManMonoclonalAMG162heavychain)，disulfidewithhuManMonoclonalAMG162lightchain，diMer

产品描述

迪诺塞麦类似物是一种能与人RANKL相结合的人源IgG2单克隆抗体，分子量约147kDa，由中国仓鼠卵巢细胞生产。

性质

Name


Biosimilar of Denosumab

CAS NO.


615258-40-7

Type


Whole antibody

Source


Human

Target


RANK ligand

Clone


Monoclone

Molecular Weight


147 kDa

Formula


C6404H9912N1724O2004S50

Antibody Form


Purified immunoglobulin

Physical Form


Solution

Grade Standard


Medicine Grade

Storage


-70±15℃ for long-term storage, 2-8℃ for short-term storage, away from light.

生物活性

Denosumab is designed to target RANKL (RANK ligand), a protein that acts as the primary signal to promote bone removal/resorption. Denosumab prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.

In vivo, treatment with 60 mg of Denosumab resulted in reduction in the bone resorption marker serum type 1 C-telopeptide (CTX) by approximately 85% by 3 days. Consistent with the physiological coupling of bone formation and resorption in skeletal remodeling, subsequent reductions in bone formation markers (i.e. osteocalcin and procollagen type 1 N-terminal peptide [PlNP]) were observed starting 1 month after the first dose of Denosumab.
不同实验动物依据体表面积的等效剂量转换表（数据来源于FDA指南）

小鼠 大鼠 兔 豚鼠 仓鼠 狗
重量 (kg) 0.02 0.15 1.8 0.4 0.08 10
体表面积 (m2) 0.007 0.025 0.15 0.05 0.02 0.5
Km 系数 3 6 12 8 5 20
动物 A (mg/kg) = 动物 B (mg/kg) × 动物 B的Km系数
动物 A的Km系数

例如，依据体表面积折算法，将白藜芦醇用于小鼠的剂量22.4 mg/kg 换算成大鼠的剂量，需要将22.4 mg/kg 乘以小鼠的Km系数（3），再除以大鼠的Km系数（6），得到白藜芦醇用于大鼠的等效剂量为11.2 mg/kg。
储备液配制

以下数据基于产品分子量，对于特殊产品，请参照COA中的储备液配制条件和说明进行操作。
Concentration / Solvent Volume / Mass 1 mg 5 mg 10 mg
1 mM 0.0069 mL 0.0346 mL 0.0691 mL
5 mM 0.0014 mL 0.0069 mL 0.0138 mL
10 mM 0.0007 mL 0.0035 mL 0.0069 mL
参考文献

The relationship of denosumab pharmacology and osteonecrosis of the jaws.
Malan J, et al. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Dec;114(6):671-6. PMID: 23159111.

单抗药物对照品
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阿达木单抗，Adalimumab 帕姆单抗，Pembrolizumab
迪诺苏单抗，Denosumab 阿替唑单抗，Atezolizumab
优特克诺单抗，Ustekinumab 维多珠单抗，Vedolizumab
1、33个产品，三种规格：1mg，2mg，5mg；
2、价格优，全现货；
3、科研产品，仅用科研，禁用临床；

Supplier供应商：BioVector NTCC质粒载体菌株细胞蛋白抗体基因保藏中心
电话：010-53513060
网址http://www.biovector.net