中文名稱：迪諾蘇單抗

中文同義詞：地諾單抗；德尼單抗；狄諾塞麥；迪諾蘇單抗

英文名稱：Denosumab(usan)

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

產品描述

迪諾塞麥類似物是一種能與人RANKL相結合的人源IgG2單克隆抗體，分子量約147kDa，由中國倉鼠卵巢細胞生產。

性質

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.
不同實驗動物依據體表面積的等效劑量轉換表（數據來源于FDA指南）

小鼠 大鼠 兔 豚鼠 倉鼠 狗
重量 (kg) 0.02 0.15 1.8 0.4 0.08 10
體表面積 (m2) 0.007 0.025 0.15 0.05 0.02 0.5
Km 系數 3 6 12 8 5 20
動物 A (mg/kg) = 動物 B (mg/kg) × 動物 B的Km系數
動物 A的Km系數

例如，依據體表面積折算法，將白藜蘆醇用于小鼠的劑量22.4 mg/kg 換算成大鼠的劑量，需要將22.4 mg/kg 乘以小鼠的Km系數（3），再除以大鼠的Km系數（6），得到白藜蘆醇用于大鼠的等效劑量為11.2 mg/kg。
儲備液配制

以下數據基于產品分子量，對于特殊產品，請參照COA中的儲備液配制條件和說明進行操作。
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
參考文獻

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.

單抗藥物對照品
貝伐單抗，Bevacizumab 納武單抗，Nivolumab
帕妥珠單抗，Pertuzumab 曲妥珠單抗，Trastuzumab
阿達木單抗，Adalimumab 帕姆單抗，Pembrolizumab
迪諾蘇單抗，Denosumab 阿替唑單抗，Atezolizumab
優特克諾單抗，Ustekinumab 維多珠單抗，Vedolizumab
1、33個產品，三種規格：1mg，2mg，5mg；
2、價格優，全現貨；
3、科研產品，僅用科研，禁用臨床；

Supplier供應商：BioVector NTCC質粒載體菌株細胞蛋白抗體基因保藏中心
電話：010-53513060
網址http://www.biovector.net