Microbio Co., Ltd. announced that its subsidiary, Microbio Shanghai received written acceptance from CDE under NMPA on the NDA application for the DFU new drug: ON101. DFU is the major complication of diabetes mellitus that imposes the hugest medical burden According to the national cross sectional study published on BMJ (BMJ 2020;369:m997), the prevalence of diabetes mellitus is 12.8% with an estimate of 130 million of adult DM patients. The systematic review and meta-analysis by Drum Tower Hospital Affiliated to Nanjing University Medical School showed that the prevalence of diabetic foot ulcer in China has reached 5.7%, which means there are more than 7.4 million DFU patients in China. In addition, the 7-year retrospective review article published in Diabetes Metab Syndr Obes. 2020 demonstrated that the number of DFU patients increased along with that of DM patients impacting the national or regional healthcare worldwide financially. These have reflected not only the enormous medical burden imposed by DFUs, but also its impact on the patients and their family as a public health issue in need of effective new drugs urgently. ON101, diabetic foot ulcer new drug developed by Oneness Biotech has been out-licensed to Microbio (Shanghai) for commercialization exclusively in mainland China, Hong Kong, and Macau.