Fespixon® Gains Regulatory Approval for Diabetic Foot Ulcer Treatment
Fespixon® (Chinese market name: Xianglei DFU Ointment), a groundbreaking new drug co-developed by Taiwanese and mainland Chinese pharmaceutical firms, was officially approved by China’s National Medical Products Administration (NMPA) on November 9, 2023 as the first natural Category 1.1 new drug specifically for the treatment of diabetic foot ulcers (DFU).
This novel drug was developed over a 15-year R&D process by Oneness Biotech Co., Ltd. (Taiwan), a member of the Mycenax/Oneness Biotech Group, in collaboration with Haihe Pharmaceutical in Shanghai.
According to Zhang Yizhong, General Manager of Microbio (Shanghai) Biotech—Oneness’s mainland subsidiary holding a 31.5% stake—DFU remains a critical medical challenge worldwide. In China alone, millions of people with diabetes face amputation each year, and over 10% of the populations in both Taiwan and mainland China are affected by diabetes. The health and economic burden of DFU is especially severe. Fespixon® is the first new drug approved for the targeted treatment of DFU, and discussions are underway with multiple pharmaceutical companies to secure marketing authorization across China in order to address this urgent unmet medical need.
Dr. Ding Jian, Chairman of Haihe Pharmaceutical and an academician of the Chinese Academy of Engineering, explained that Fespixon® works by modulating macrophage activity, correcting imbalances caused by prolonged hyperglycemia, and thereby reducing inflammation and promoting tissue regeneration. He expressed optimism that the drug will significantly reduce suffering among DFU patients in clinical settings.
The drug’s Phase III clinical trial results were published in the internationally renowned peer-reviewed journal JAMA Network Open: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2783718
In the trial, 60.7% of patients in the ON101 group achieved complete wound closure within 16 weeks, compared to 35.1% in the control group (OR: 2.84; 95% CI: 1.66–4.84; P < 0.001). Secondary results also demonstrated faster healing times for ON101 patients, with a median closure time of 98 days. Importantly, both groups showed no significant safety differences, confirming a strong safety profile for the product.
Academician Ning Guang, principal investigator of the China trial, noted that diabetic foot ulcers are a globally unmet medical need, and one of the leading causes of disability and mortality among diabetic patients. Fespixon® has demonstrated clear efficacy and safety, offering hope for improved outcomes and quality of life for patients.
Currently, Microbio (Shanghai) Biotech, the exclusive marketer of the drug in China, is actively in discussions with major pharmaceutical companies focused on diabetes and wound care, as they compete for domestic distribution rights.
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