On the evening of June 28, Oneness Biotech announced that, based on the FDA's approval of their medical device for certain chronic wound indications, they will complete the required follow-up studies as per the FDA's guidelines. Afterward, they plan to submit a 510(k) application for full-thickness chronic wound indications. Upon approval, this will allow their medical device to be used for all chronic wound indications in the United States. Consequently, they have decided to terminate the Phase III clinical trial ON101CLCT04 for their drug "Fespixon" in the United States.

Oneness Biotech stated that the first phase of their Bonvadis medical device's 510(k) application was approved by the FDA in August 2022 for acute wound indications. The second phase was approved in May 2024 for chronic wound indications, including partial-thickness wounds (such as Grade 1 diabetic foot ulcers, venous leg ulcers, and Stage 1-2 pressure ulcers), post-surgical sutured wounds, and burns (first-degree and superficial second-degree).

Oneness Biotech adopts a dual-strategy approach, utilizing both pharmaceutical and medical device pathways to accelerate market access in multiple international markets. The new drug Fespixon has already obtained regulatory approvals in Taiwan, Singapore, Malaysia, and China. The Bonvadis medical device has received 510(k) approvals for acute wound indications in the United States, India, New Zealand, South Africa, and Thailand, and has also been approved in the EU for scar treatment indications.

Resource (mandarin) : 合一新藥獲美 FDA 醫材核准 決議不再執行三期臨床試驗