NEWS

1.Product:FB704A
2.Mass production date:NA
3.Effect on company finances and business:
(1)New drug name or code:FB704A
(2)Purpose:FB704A, an anti-IL6 fully human monoclonal antibody, for the treatment of severe COVID-19.
(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):File a phase II investigational new drug (IND) application for severe COVID-19 to the US FDA.
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 US FDA.
B.Estimate responsibilities:NA
(6)Market:
A.According to data from the World Health Organization (WHO), there have been more than 173 million confirmed cases worldwide of COVID-19, of which about 14% are with severe pneumonia and 5% are critically ill. This is life-threatening, which may cause the exhaustion of medical resources. Clinically available drugs are limited currently. According to NIH's COVID-19 Treatment Guidelines, remdesivir (antiviral), dexamethasone (corticosteroid, immunosuppressive), and Actemra (anti-IL6 receptor, immunosuppressive) are recommended to be used in inhibiting virus replication and rapid respiratory decompensation. However, patients with severe COVID-19 will still die due to cytokine release storm caused by viral infection.
 B.IL6 is one of the key factors that cause the cytokine storm. The machenism of action of FB704A is to inhibit IL6 and block classic-and trans-signaling pathways. IL6 trans-signaling has been closely related to severe COVID-19 according to researches.
C.Many international trials of anti-IL6 antibodies in treatment of COVID-19 have been completed to compare with the dexamethasone treatment (about 77% effective responders),but the primary endpoint of these trials as reduction in the death rate was not met. The trial design of treatment with FB704A will focus on the patients who are non-responsive to dexamethasone treatment. FB704A will be administered early before the disease worsens by suppressing the occurrence of cytokine storm to reduce the disease progression into the severe or critical stage. It is expected that FB704A can help alleviate the disease, reduce the requirement in emergency treatment, and relieve the medical burden.
4.Any other matters that need to be specified:
(1)A phase I study on FB704A was completed in the US. FB704A has been greenlighted by USFDA and TFDA to proceed with phase II study in treatment of severe asthma.
(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 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.
(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.