1.Product:ON101 Diabetic foot ulcer new drug
2.Mass production date:NA
3.Effect on company finances and business:
(1)New drug name or code:ON101
(2)Purpose:Treatment of Diabetic foot ulcer.
(3)Planned development stages：The second phase 3 clinical trial (ON101CLCT04) in the US, and other exploratory studies for new indications.
(4)Current development stage:
A.File application/approved/disapproved/Each of clinical trials (include interim analysis): CDE under NMPA accepted NDA application for the DFU new drug: ON101
B.Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur: NA
C.After obtaining official approval or the results of statistically significant sense, the future strategy: NA
D.Accumulated investment expenditure incurred:No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies to protect the company and investors interests.
(5)Upcoming development plan:
    A.Scheduled completion date:The second phase 3 trial in the US is scheduled to complete in 2 to 3 years after initiation
    B.Estimate responsibilities: NA
(6)Market:
 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.
4.Any other matters that need to be specified:
(1)The exclusive commercialization right of ON101, diabetic foot ulcer new drug for mainland China, Hong Kong and Macau has been out-licensed to Microbio Shanghai Co., Ltd.
(2)According to Article 2 under Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials or new drug application to domestic or overseas regulatory receiving approval or disapproval, obtaining the statistical date of endpoints authorities, in each clinical trial (including interim analysis ), or receiving approval or disapproval on drug license application.
(3)It takes considerable time and expenses to develop a new drug of which success can’t be guaranteed. Investors shall bear such investment risk that warrants careful assessment before making investment decisions.