Microbio Co.,Ltd. has submitted a 510(k) application for medical device MB107 cream to the U.S. FDA. Product: MB107 Cream for an external usage of skin care. Effect on company finances and business: New drug name or code: MB107.

Purpose: Skin barrier Repair Cream. Planned development stages: Microbio will register the product on the official FDA website after receiving the Substantial Equivalence approval letter and marketing clearance from U.S. FDA. Current development stage: File application/approved/disapproved/Each of clinical trials (include interim analysis): Microbio has submitted a 510(k) application for medical device MB107 cream to the U.S. FDA.

Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense or an occurrence of other major impacted development of a newly medicinal products, the risks and the associated measures the Company may face: NA, After obtaining official approval, the results of clinical trials (include interim analyses) which are statistically significant, the future strategy of management direction of the company: NA. Accumulated investment expenditure incurred: No disclosure in considerations of future marketing strategies. Upcoming development plan: Scheduled completion date: The review timeline is subject to the review process regulated by the competent authority.

Market: According to the Global Market Analysis report by Grand View Research, the global market for atopic dermatitis drugs reached $12.7 billion in 2021, with the U.S. market accounting for 50% of this share. The market is expected to grow at a compound annual growth rate of 9%, and it is projected that by 2030, the global atopic dermatitis market will double to $27.6 billion. Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.): (1)This case involves the submission of the registration for MB107 cream to the U.S. FDA through the medical device 510(k) regulatory pathway, following which it will undergo regulatory and scientific review processes.

(2)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 a clinical trial to domestic or overseas regulatory authorities with respect to its receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), and/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.