Oneness Biotech introduced its new drug Fespixon cream in a press conference held on 4 July. The drug, according to Mr William Lu, the founder at Oneness Biotech, is the first approved treatment for diabetic foot ulcers (DFUs), its phase III trial has started in the US. The company plans to explore the use of the drug for other ulcers and expects a product launch to global markets by 2030.  

Diabetic foot ulcers are different from normal wound ulcers. DFUs are caused by abnormal immune system due to high blood sugar in one’s body, which makes a wound to develop more likely and harder to heal, Lu said. Many patients are thus at risk of amputation in a deteriorating wound or risk of death.

Foot ulcers have now become a common complication of diabetes with the growing number of patients worldwide. Some statistics shows every year up to 5.8 million patients are amputated globally, of which 13% losing their lives.

None of the new DFU drugs developed since 1997 have been approved by FDA, and neither have them passed in phase three clinical trials.

The Food and Drug Administration in Taiwan has approved Fespixon cream developed by Oneness Biotech. Fespixon can now be prescribed by hospitals in Taiwan.

The company will push ahead the product rollout in global markets by 2030.   

Source in Chinese: https://news.cnyes.com/news/id/4670539