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：Phase 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.