SCIENCE

ON101 (FESPIXON®)

Indications

Diabetic Foot Ulcers (DFU)

Mechanism of Action
  • Inhibits inflammation
  • Regulates the generation of collagen
  • Promotes the regeneration of damaged cells
  • Promotes the proliferation of human keratinocytes
  • Reduce inflammatory M1 macrophages, stimulate adipose precursor cells to secrete GCSF and CXCL3, and increase repairing M2a/M2c macrophages, thereby promote complete wound healing. The mechanism of action studies can be referred to JID Innovations (2022).
Current Status
  1. Phase 3 multicenter randomized clinical trials (MRCT) was completed. ON101 has been demonstrated with 60.7% vs 35.1% (p=0.0001) in complete healing rate in 16-week treatment. A subgroup analysis on difficult-to-heal ulcers also shows the stastistical significance, consistency, and robustness of the therapeutic effect of ON101. The related data was published in the international medical journal JAMA Network Open (JAMA Network Open.2021;4(9):e2122607)
  2. Granted a drug approval in Taiwan. Under NDA review in China, Singapore (by the Health Sciences Authority), Malaysia (by the National Pharmaceutical Regulatory Agency, NPRA), and the Philippines (by the FDA Philippines).  
  3. Granted Fast Track Designation by the US FDA.
Product Advantages
  1. Effectiveness: ON101 has been clinically proven with a significant wound healing effect and can reduce the formation of hypertrophic scars.
  2. Cost advantage: Oneness Biotech implements a streamlined controlled from research and development cultivation of the medicinal plants, production, and quality control to ensure global supply capability and competitiveness.
Market Potentials

According to a market research report by Fortune Business Insights, the global market size of diabetic foot ulcer (DFU) treatment was USD 6.6 billion in 2018, with the compound annual growth rate at 6.8%, and the market size of 2026 is estimated to be USD 11 billion.

R&D Progress
Complete
In Progress
Research Code Therapeutic Area Indication Pre-Clinical Phase I Phase II Phase III NDA Market More
  • ON101 (FESPIXON®)
    Dermatology
    Diabetic Foot Ulcer

    ON101 is a first-in-class new drug targeting the subsets of macrophages to promote healing of the chronic wounds. It has been demonstrated with the superior efficacy to the standard care dressing in a Phase 3 MRCT completed in the US, Taiwan, and China. It has been marketed under the trade name FESPIXON® in Taiwan since June 2021 and been granted the Fast Track designation by the US FDA in March 2021. Multiple NDA submissions of ON101 to Asian health authorities are underway

Note:
1.China & Southeast Asia: Under NDA submission
2.US: Fast Track Designation granted by US FDA

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