|No||1||Date of announcement||2020/11/05||Time of announcement||19:15:48|
|Subject||Oneness submits an IND to TFDA on a phase II
clinical trial of FB704A, a mAb developed from its own
platform, for treating severe neutrophilic asthma.
To which item it meets
|paragraph 10||Date of events||2020/11/05|
2.Mass production date:NA
3.Effect on company finances and business:
(1)New drug name or code: FB704A
(2)Purpose: FB704A, anti-IL6 fully human monoclonal antibody, for the treatment of severe neutrophilic asthma.
(3)Planned development stages：Phase II clinical trial/ Phase III clinical trial/NDA
(4)Current development stage:
The phase I study of FB704A has been completed in US and demonstrated pharmacokinetic parameters, safety profiles and pharmacological activity. An IND application for the phase II study in severe neutrophilic asthma has been submitted to explore the potential indication in order to increase the drug value of FB704A.
A.File application: File phase II investigational new drug (IND) application for severe neutrophilic asthma to the Food and Drug Administration of the Ministry of Health and Welfare of Taiwan (TFDA).
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
The global population affected by neutrophilic asthma is about 110 million people. Severe asthma accounts for 5% of total asthma patients, so it is estimated that there will be 5.5 million severe neutrophilic asthma patients. Sever neutrophilic asthma is a refractory disease that causes huge medical expenditure and cannot be effectively controlled by drugs currently on the market. There remains no effective biologics approved for treating severe neutrophilic asthma, either. The role for IL-6 in the pathology of this disease shows that FB704A has the potential to fulfil the unmet medical need in severe neutrophilic asthma. The global biologics market for treatment in severe neutrophilic asthma is estimated to reach US$90 billion by multiplying patient number and the average annual cost of biologics treatment at US$16,425.
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 to domestic or overseas regulatory authorities.(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.