SEQ_NO
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1
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Date of announcement
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2022/08/23
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Time of announcement
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22:49:32
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Subject
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Microbio (Shanghai) submitted an IND to US FDA for a phase I clinical trial
on the broad-spectrum anti-SARS-CoV-2 siRNA (SNS812) co-developed with Oneness
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Date of events
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2022/08/23
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To which item it meets
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paragraph 53
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Statement
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1.Date of occurrence of the event:2022/08/23
2.Company name:Microbio (Shanghai)
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: SNS812
(2)Purpose:Treatment for COVID-19 infection
(3)Planned development stages:Phase I, Phase II, Phase III, NDA
(4)Current development stage:
A.File application/approved/disapproved/Each of clinical trials (include
interim analysis): Submit an IND application to the US FDA for Phase I
clinical trial.
B.Once disapproved by competent authority or each of clinical trials
(include interim analysis) results less than statistically significant
sense, the risks and the associated measures the Company may occur: Not
applicable
C.After obtaining official approval or the results (include interim
analysis) of statistically significant sense, the future strategy:Not
applicable
D.Accumulated investment expenditure incurred:Considering the future
marketing strategy and to protect the rights and interests of the
company and investors, it will not be disclosed publicly.
(5)Upcoming development plan: Phase I, Phase II, Phase III
A.Scheduled completion date: The actual schedule will depend on the
progress of the US FDA review.
B.Estimate responsibilities: SNS812 is a siRNA new drug co-developed by
Microbio (Shanghai) and Oneness Biotech Co., Ltd..
(6)Market: Based on the data published on August 22, 2022, severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than
596 million people worldwide and caused more than 6.68 million deaths.
With the occurrence of vaccine breakthrough and repeated COVID-19
infections caused by new variants, it is anticipated that the future new
variants will lead to periodic global epidemics. The coexistence of the
SARS-CoV-2 and human beings seems inevitable and the broad-spectrum
therapeutics against SARS-CoV-2 will be able to address the large medical
needs.
6.Countermeasures:None
7.Any other matters that need to be specified:
(1)SNS812 is a broad-spectrum siRNA therapeutic against SARS-CoV-2 variants
covering 99.8% of current SARS-CoV-2 variants and shown a picomolar
inhibition of dominant ones, including Alpha, Delta, Gamma, Epsilon and
Omicron. Moreover, the K18-hACE2-transgenic mice studies demonstrated
that SNS812 could completely inhibit the production of infectious
virions in lungs by prophylactic treatment and decrease 96.2% of virions
by post-treatment. It is also noted that virus-associated extensive
pulmonary alveolar damage, vascular thrombi, and immune cell
infiltrations have been significantly reduced by SNS812 treatment.
(2)The COVID-19 pandemic has continued to evolve. SNS812 is positioned as a
treatment solution to the periodic outbreak of life-threatening COVID-19
in addition to verifying SNS812 in treatment and prevention of SARS-CoV-2
infection.
(3)According to the 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
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.
(4)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.
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