Oneness Biotech Co., Ltd. announced FESPIXON, a new drug for the treatment of diabetic foot ulcers. Planned development stages: The second phase 3 clinical trial (ON101CLCT04) in the US, and other exploratory studies for new indications. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis):Oneness has been informed by the local agent that the DFU new drug, FESPIXON, has been approved by Malaysia National Pharmaceutical Regulatory Agency (NPRA).

Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: NA. C.After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Marketing and sales of FESPIXON in both Singapore and Malaysia will be jointly planned. D. Accumulated investment expenditure incurred:No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies.

(5) Upcoming development plan: A. Scheduled completion date: The second phase 3 trial in the US is scheduled to complete in 3-4 years after initiation. B. Estimate responsibilities: After product commercialization, the company shall pay the licensor a certain percentage of royalties according to the agreement during the validity of licensed patents. Market: The prevalence of diabetes mellitus (DM) in Malaysia is the highest among the ASEAN countries.

According to the systematic review published on Int. J. Environ. Res.

Public Health, 2020, the annual medical costs on DM is USD 600 million per year and one of the most costly complications is amputation which brings a huge medical burden. FESPIXON has been the first Natural Product with Therapeutic Claim applied with and approved by Malaysia NPRA after the guideline of Natural Products with Therapeutic Claim was published by Malaysia NPRA in 2020. With novel mechanism and significant clinical efficacy, FESPIXON is the only new drug approved by NPRA in the classification to treat diabetic foot ulcer.

Currently, FESPIXON has been approved in Taiwan, Singapore and Malaysia. The health authorities in China, the Philippines, Vietnam and Indonesia are reviewing the NDA application of FESPIXON. According to 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.