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ON101

合一生技股份有限公司 / SCIENCE / R & D / ON101

ON101

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, Macau, Singapore, Malaysia, China and Indonesia. Under NDA review in the Philippines (by the FDA Philippines, PFDA) and Vietnam (by Drug Administration of Vietnam, DAV).
  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

ON101-en

Ongoing
Completed
Research Code Therapeutic Area Indication Development Region Pre-Clinical Phase I Phase II Phase III NDA Market More
ON101
 Dermatology Diabetic Foot Ulcer
1. Taiwan, Macau, Singapore, Malaysia, China & Indonesia
2. Southeast Asia

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