1.Product:FB704A
2.Mass production date:NA
3.Effect on company finances and business:
(1)New drug name or code:FB704A
(2)Purpose:
A.FB704A, an anti-IL6 fully human monoclonal antibody.
B.Information Website: NA
(3)Planned development stages：NA
(4)Current development stage:
A.File application/approved/disapproved/Each of clinical trials (includeinterim analysis):
1.FB704A is an anti-IL6 fully-human monoclonal antibody under the US FDAIND for a Phase 2 clinical trial. The Phase 2 is currently undergoing and aiming to treat the severe asthma which is currently unmet medically in the world.
2.The escalating pandemic in Taiwan this March increased the number of severe COVID-19 infections and impacted the medical system with a huge burden. Also, the marketed anti-IL6R, Tocilizumab, by Roche started to be used in inhibiting cytokine release syndrome triggered due to over-reaction of immune cells in the patients with severe COVID-19. The clinical evidence suggested that Tocilizumab could decrease the death rate among the patients with severe COVID-19. Based on the above, the Company has filed an IND application with the US FDA in June this year for the use of FB704A in treatment of severe COVID-19.

3.During the IND application period, the US FDA has granted EUA to the use of Tocilizumab as part of standard of care in the treatment of COVID-19 infection. The Taiwan FDA also started to provide reimbursed Tocilizumabs subsequently. After evaluation, the Company considers the allocation of significant resources to the same indication will not be meaningful for the drug development.
4.SNS812 which the Company collaborate to develop with Microbio (Shanghai) is a siRNA new drug for treating and preventing the COVID-19 infection. It has been completed on 6 animal challenge studies and is undergoing an analysis on the critical data. According to the completed analyses, SNS812 has demonstrated potential in treating COVID-19 infection so the Company has decided to prioritize the development of SNS812 as a COVID-19 therapy.
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: Not disclosed
(5)Upcoming development plan:NA
A.Scheduled completion date:NA
B.Estimate responsibilities:NA
(6)Market:NA
4.Any other matters that need to be specified:
(1)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 or new drug application 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.
(2)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.