SEQ_NO | 2 | Date of announcement | 2024/07/22 | Time of announcement | 19:51:15 |
Subject | Symbiota exclusively developed by Microbio Co., Ltd. achieves an Independent/Self-affirmed GRAS conclusion according to the U.S. FDA regulations. | ||||
Date of events | 2024/07/22 | To which item it meets | paragraph 53 | ||
Statement | 1.Date of occurrence of the event:2024/07/22
2.Company name: Microbio Co., LTD. 3.Relationship to the Company (please enter ”head office” or ”subsidiaries”): head office 4.Reciprocal shareholding ratios: NA 5.Cause of occurrence: Microbio Co., Ltd. was informed by the consulting firm today that Symbiota,the gut microbiome based products exclusively developed by Microbio, achieves an Independent / Self-affirmed GRAS (Generally Recognized as Safe)conclusion according to the U.S. FDA regulations. 6.Countermeasures:None 7.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 9 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) Symbiota are the gut microbiome based products successfully developed by Microbio’s proprietary symbiotic anaerobic fermentation technology using multi-strain probiotics, which are the cutting-edge “postbiotics” comprises the metabolites from symbiotic fermentation of gut probiotics. MS-20, the first approved new drug as an oral adjuvant therapy for chemotherapy in Taiwan, PrimeEnzyme available in Cotton-Field Organic, Microsoy, Young, TB90010 that is a newly-developed microbiome based product for type2 diabetes management, and LT17 for alleviating liver function are all developed by Symbiota technology with different bacteria strains. (2) According to the GRAS determination, Symbiota can be used in nutritional beverages, protein and nutritional powder, smoothies, and grain drinks, regular and diet sports and energy drinks, regular and diet soft drinks, fruit drinks including unreconstituted powders, dairy drinks, and milk substitutes, gelatin-type candies, ready to eat cereals, and cooked cereals at usage levels up to 20% for the liquid form and 10% for the powdered form. The intake analysis was for all ages (1-110 years). (3) Multiple patents protection cover Symbiota product, technology, and use have been granted by major countries in the world. Symbiota according to the regulations of different countries will adopt a diverse regulatory strategies, including new drug, medical device, medical food, dietary supplement, and regular food to accelerate the global market entry. (4) The achievement of U.S. Independent / Self-affirmed GRAS conclusion for Symbiota is a key market entry strategy of the company. Unlike probiotics, this GRAS conclusion is the first on the postbiotics derived from symbiotic fermentation of multi-strain probiotics in Taiwan, and the GRAS conclusion includes the soybean fermentates generated by multi-strain probiotics and yeasts or mixtures of these strains, which covers all current Microbio’s proprietary microbiome-based portfolio. (5) The clinical trial of MS-20 in combination with Pembrolizumab (anti-PD1 therapy) for the treatment of metastatic non-small cell lung cancer (NSCLC) is currently ongoing. Obtaining the GRAS conclusion will facilitate the product launch to global markets following the completion of the trial. |
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