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Oneness Has Submitted the Phase 2 Clinical Trial Application for FB704A, a Fully-Human Anti-IL6 Antibody New Drug, in Severe Asthma to TFDA via Fast Track

Subject
Oneness has submitted the phase 2 clinical trial
application for FB704A, a fully-human anti-IL6 antibody
new drug, in severe asthma to TFDA via fast track.
Date of events
 2021/04/07
To which item it meets
paragraph 10
Statement
1.Product:FB704A
2.Mass production date:NA
3.Effect on company finances and business:
(1)New drug name or code:FB704A
(2)Purpose:For the treatment of severe asthma.
(3)Planned development stages%uFF1APhase II clinical trial/ Phase III clinical
   trial/NDA
(4)Current development stage:
A.File application/approved/disapproved/Each of clinical trials (include
  interim analysis):Submission of the phase 2 clinical trial application in
  severe asthma to TFDA via fast track
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:phase II / III clinical trial
    A.Scheduled completion date:The exact completion date is subject to the
      review process of the TFDA.
    B.Estimate responsibilities: NA
(6)Market:
   16.7 million population are affected by severe asthma which is refractory
   and causes huge medical burden. There are currently only a few biologics
   approved for treatment of eosinophilic severe asthma whereas there remains
   no effective drugs to control neutrophilic and mixed granulocytic severe
   asthma.IL-6 is the potential key cytokine to the pathogenesis of these two
   subtypes in severe asthma.
4.Any other matters that need to be specified:
(1)The phase 2 clinical trial has been greenlighted by US FDA to proceed so
   Oneness will submit the same protocol to TFDA via fast track.
(2)The previous application for phase 2 clinical trial in neutrophilic asthma
   will not proceed to rebuttal.
(3)FB704A (anti-IL6 mAb) may improve symptoms of neutrophilic and mixed
   granulocytic severe asthma by inhibition of classic and trans-signaling
   pathways of IL-6. Among the patients with these two subtypes of severe
   asthma, it is likely that FB704A may reduce Th1, Th2 and Th17 inflammation
   as well as airway hyper-responsiveness. The application submitted to TFDA
   is for treatment in patients with severe asthma who have higher neutrophil
   counts in sputum. Such subtype of severe asthma can't be well controlled
   by current treatments and FB704A will explore the possibility of improving
   symptoms on those severe asthma patients with higher neutrophil counts.
(4)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 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.
(5)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.

Oneness has submitted the phase 2 clinical trial
application for FB704A, a fully-human anti-IL6 antibody
new drug, in severe asthma to TFDA via fast track.