Oneness Biotech Co., Ltd. announced that TFDA notified Oneness of submitting supplementary information for a rebuttal of FB704A Phase II clinical trial application for severe neutrophilic asthma. Taiwan Food and Drug Administration (TFDA) requires Oneness to submit a rebuttal within four months with requested information or submit a new application. This is the first anti-IL-6 new drug clinical trial application for severe neutrophilic asthma in the world. Oneness has completed FB704A functional mechanism experiments and safety evaluation. Based on therapeutic mechanism and risk consideration of the subjects, TFDA requires Oneness to submit a rebuttal with required information within four months or submit a new application. Oneness will submit a rebuttal in accordance with TFDA's requirements and also apply for a face-to-face consultation meeting next week. 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. 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.