On July 18, Oneness Biotech announced that its new drug Fespixon, developed for the treatment of diabetic foot ulcers, has been granted marketing authorization by Indonesia’s National Agency of Drug and Food Control (BPOM).

The company stated that it received notification from its Indonesian consulting firm that the drug registration for Fespixon had been approved by BPOM. Following the commercial launch of this new drug in Indonesia, Oneness Biotech will pay a sales royalty to the licensor in accordance with the terms of their licensing agreement.

According to data from the International Diabetes Federation (IDF), there are approximately 20.4 million people with diabetes in Indonesia as of 2024, and this number is expected to rise to 28.6 million by 2050. Currently, there are around 2 million patients suffering from diabetic foot ulcers, with an increasing number of cases leading to amputation, posing a significant healthcare burden.

Oneness Biotech emphasized that Fespixon is the world’s first innovative drug developed specifically to address the pathogenesis of diabetic foot ulcers. Phase III clinical trials and post-marketing studies have demonstrated its ability to rapidly promote wound healing in diabetic foot ulcers, including chronic and hard-to-heal wounds, while also offering favorable pharmacoeconomic benefits. The company adopts a dual strategy of drug and medical device pathways for its wound care products and has already obtained market access in major diabetes-affected countries and regions as of 2025. Commercial negotiations in other markets are ongoing.

Resource: 合一生技新藥「速必一」 獲印尼食品與藥物管理局核發藥證