Oneness Biotech Co., Ltd. announced that it has been approved as Class 1.1 natural new drug by National Medical Products Administration (NMPA) in China. Product: FESPIXON, a new drug for the treatment of diabetic foot ulcers, has a generic name approved in China as Xianglei Tangzu Gao. Effect on company finances and business: New drug name or code: FESPIXON (research code: ON101).

Purpose: 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): The new drug application (NDA) of FESPIXON, the new drug in treatment of diabetic foot ulcers.

The approved generic name is Xianglei Tangzu Go, and the approval number is ZC20230001. Once disapproved by competent authority or each of clinical trials (include interim analyses) results less than statistically significant sense, the risks and the associated measures the Company may occur: After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Microbio (Shanghai) Co. Ltd. will be responsible for the marketing and sales of FESPIXON.

Accumulated investment expenditure incurred: No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies. Upcoming development plan: Scheduled completion date: The second phase 3 trial in the US is scheduled to complete in 3-4 years after initiation accroding to the current plan. 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.