Oneness Biotech Co., Ltd. has been informed by the local agent that the DFU new drug, FESPIXON, has been approved by Singapore Health Sciences Authority (HSA). After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Plan for future commercialization and marketing. Upcoming development plan: Scheduled completion date: The second phase 3 trial in the US is expected to be completed in 2025.

Estimate responsibilities: After product commercialization, the company shall pay the licensor a certain percentage of royalties according to the agreement during the validity of licensed patents. FESPIXON is a new drug with novel mechanism of action by inhibiting inflammation and activating specific chemokines to change the polarization of macrophages in chronic wounds. It can transit the M1-macrophage dominant wound microenvironment to be M2-macrophage dominant one.

This can attenuate the wound inflammation and transfer to proliferation to promote ulcer healing.