On the evening of the 6th, Oneness Biotech announced that their new drug for diabetic foot ulcers, Fespixon, has passed the inspection and registration by the Indonesian Food and Drug Authority (BPOM). This approval opens up the market for treating approximately 2 million diabetic foot ulcer patients in Indonesia.
Oneness Biotech stated in their announcement that they received notification from their Indonesian consulting firm on the 6th that Fespixon’s inspection and registration has been approved by BPOM. The official license will be issued once the leaflet modifications are completed.
According to the International Diabetes Federation (IDF), Indonesia had approximately 19.5 million diabetic patients in 2021, with an expected increase to 28.6 million by 2045. Currently, there are around 2 million patients with diabetic foot ulcers in Indonesia, about 100 times the number in Taiwan. The increasing number of amputations due to these ulcers represents a significant medical burden.
Oneness Biotech highlighted that Fespixon is the world's only innovative drug developed to address the pathogenesis of diabetic foot ulcers. Phase III clinical trials and post-market studies have confirmed that it can rapidly promote the healing of diabetic foot ulcers, including various hard-to-heal wounds, and it offers economic advantages in drug therapy.
The company also noted that their wound care products follow a dual strategy of pharmaceuticals and medical devices, aiming to gain market access in major international diabetes markets by 2025. Fespixon has already received drug approvals in Taiwan, Singapore, Malaysia, and China, with Indonesia becoming the fifth market to grant approval.
Additionally, their medical device, Bonvadis, has obtained approval in the United States for treating acute wounds, partial-thickness chronic wounds (including grade 1 diabetic foot ulcers, venous leg ulcers, and grades 1-2 pressure ulcers), post-surgical wounds, and burns (grade 1 and superficial grade 2). It has also received similar approvals for acute wounds in India, New Zealand, South Africa, and Thailand, equivalent to the US FDA 510(k) clearances. The European Union has granted marketing approval for scar treatment indications.
Resource (mandarin): 合一新藥「速必一」 通過印尼食品藥物管理局查驗登記
