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MEDIA

Date:2021-03-13

Microbio announced its subsidiary, Microbio Shanghai received written acceptance from CDE under NMPA on the NDA application for the DFU new drug:ON101

 
SEQ_NO
 1
Date of announcement
2021/03/13
Time of announcement
21:15:42
Subject
Microbio announced its subsidiary, Microbio
Shanghai received written acceptance from CDE under
NMPA on the NDA application for the DFU new drug:ON101
Date of events
 2021/03/13
To which item it meets
paragraph 53
Statement
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
  ”subsidiaries”):Subsidiary
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
(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.
6.Countermeasures:None
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
   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.