Indication 
Type 
Form 
Target 
Clinical progress 
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Research Data
[Biovailability in Beagle Dog: Single-dose h2h PK study]
The AUC of BO-017 mg capsule is 12 times higher than the Rybelsus 7 mg tablet.
[Primate research data: Comparison of promate absorption after a single dose]
|
Item |
Specification |
Subject |
Number |
AVG Cmax (ng/ml) |
AVG T1/2 (hours) |
Bioavailability |
|
Rybelsus |
5 mg |
normal |
n=24 |
8.3 |
7.94 |
0.4~1%(3) |
|
Rybelsus |
7 mg |
normal |
n=6 |
4.37 |
/ |
0.4~1%(3) |
|
BO-01 |
7 mg |
normal |
n=5 |
62.6 |
51.6 |
/ |
(1)Originated from Rybelsus EMA NDA data
(2)In-house data
(3)Originated from Rybelsus FDA NDA data
BO-01 displayed~8 times higher than Rybelsus when concerning their single-dose Cmax.
BO-01 displayed~7 times higher than Rybelsus when concerning their single-dose T1/2.
Project Cooperation
Product License-out
● Biosimilar polypeptide molecules
● 2.2/505b (2) development
● Liscense-out at early/late clinical stage
Technique License-out
● Client's polypeptide
● Type 1 original drug
● Milestone fee
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