1.Date of occurrence of the event:2021/03/13
2.Company name:Microbio (Shanghai) Co., Ltd.
3.Relationship to the Company (please enter ”head office” or
4.Reciprocal shareholding ratios:NA
5.Cause of occurrence:
(1)New drug name or code:ON101
(2)Purpose: For the treatment of diabetic foot ulcers (DFU)
(3)Planned development stages：New drug application (NDA)
(4)Current development stage:
A.File application:The Center for Drug Evaluation (CDE) under National
Medical Products Administration (NMPA) accepted the new drug
registration application for ON101, diabetic foot ulcer new drug.
B.Once disapproved by competent authority or each of clinical trials
(include interim analysis) results less than statistically significant
sense, therisks & 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: NA
B.Estimate responsibilities: NA
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.
7.Any other matters that need to be specified:
(1)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.
(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 and new drug registration to domestic or overseas
regulatory authorities, receiving approval or disapproval, obtaining the
statistical date of endpoints in each clinical trial (including interim
analysis), or receiving approval or disapproval on drug license
(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.