Investor Presentaiton
Dermatology
Pipeline for Unmet Medical Needs
ONENESS
Product
Target
Category
Patent
Indication
Discovery/
Pre-
clinical
Phase 1
Phase 2 Phase 3
Regulatory
submission 4
Taiwan
FESPIXON
(ON1011)
M1/M2
Botanical
Global
Diabetic Foot
Ulcer
CN, SG, MY
US
FB825 2
CεmX
mAb
Global
with LEO
Pharma
Atopic Dermatitis
(AD)
US
Allergic Asthma
(AA)
Taiwan, US IND
Neutrophilic
Taiwan, US IND
Asthma
FB704A
IL-6
mAb
Global
Chronic Kidney
Disease
Hepatocellular
OB318
Multiple
NCE
Global
Taiwan, US IND
carcinoma³
SNS812
Virus
Nucleic
Acid
Global
with MBS
COV-Flu
Infection
Immunology
Key milestones
2022: China NDA
2023: Complete US
PIII trial enrollment
2022: Complete
Phase Ila study in AD;
2023: Complete
Phase Ila study in AA
2023: Complete
Phase II trial
2023: Complete
Phase I study
1 ON101 has been completed a Phase 3 clinical trial and is undergoing another one (one for China and Taiwan registration, the other for U.S. registration). Drug approval has been obtained in Taiwan. NDA submitted to the NMPA and health
authorities in South East Asia.. ON101 can potentially be used for treatment of venous leg ulcers and pressure ulcers in the future. 12 China right has been licensed to Microbio Shanghai and worldwide exclusive license jointly licensed with Micorbio
Shanghiai to LEO Pharma | 3 Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer | 4 Regulatory submission includes NDA submission and Pre-NDA submission. | AD: atopic dermatitis; AA: allergic asthma
2022: File IND
| 7View entire presentation