newsbuilder – Microbio

The finding on MS-20 combined with anti-PD1 antibody enhancing the cancer treatment response was accepted for publication by Gut Microbes(2023 IF: 12.2).

newsbuilder — Wed, 31 Jul 2024 07:39:03 +0000

SEQ_NO	1	Date of announcement	2024/07/31	Time of announcement	18:19:09
Subject	The finding on MS-20 combined with anti-PD1 antibody enhancing the cancer treatment response was accepted for publication by Gut Microbes(2023 IF: 12.2).
Date of events	2024/07/31	To which item it meets	paragraph 53
Statement	1.Date of occurrence of the event:2024/07/31 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: (1)Microbio’s Symbiota products: MS-20 is a cutting-edge postbiotic successfully developed from Microbio’s proprietary symbiotic anaerobic fermentation technology using multi-strain probiotics. It is the first approved new drug as an oral adjuvant for cancer therapy in Taiwan. (2)The study showed that MS-20 in combination with anti-PD1 antibody significantly inhibited tumor growth through increasing activated CD8+ T cells and decreasing suppressive CD8+ T cells in the tumor microenvironment of animal models. MS-20 also modulated the microbiota of cancer patients ex vivo and increased the abundance of bacteria species associated with good immunotherapy responses. The finding was accepted and published by a SCI journal, Gut Microbes. 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 and achieved US GRAS （Generally Recognized as Safe）conclusion this month, which is equivalent to obtaining international market sales qualification. The finding on MS-20, which also belongs to the Symbiota portfolio, in combination with anti-PD1 therapy was accepted for publication by a renowned international journal, which has positive benefits on the international market entry for the products. (2)Although immunotherapy has been regarded as a promising treatment for cancer, the response rate was low. Modulation of gut microbiota has been regarded as a potential strategy to elevate the efficacy of immunotherapy. MS-20 enhances the gut microbiota-associated antitumor effects of anti-PD1 antibody and the clinical trial of MS-20 in combination with anti-PD1 antibody is conducted in Kaohsiung CGMH, TMUH, SHH, WFH, KMUH, EDAH and Linkou CGMH. (3)Gut Microbes is a renowned international journal that published top research articles on Microbiology and is ranked the 8th out of 143 journals in the Gastroenterology and Hepatology category, and is ranked the 9th out of 161 journals in the Microbiology category. (4)The article published in Gut Microbes is available to access via link as https://doi.org/10.1080/19490976.2024.2380061

Symbiota exclusively developed by Microbio Co., Ltd. achieves an Independent/Self-affirmed GRAS conclusion according to the U.S. FDA regulations.

newsbuilder — Mon, 22 Jul 2024 07:38:09 +0000

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.

Microbio (Shanghai) and Oneness have entered into an exclusive agreement of Fespixon commercialization with China Resources Double Crane Pharmaceutical Co., Ltd.

newsbuilder — Sun, 21 Jul 2024 07:36:13 +0000

SEQ_NO	1	Date of announcement	2024/07/21	Time of announcement	22:41:05
Subject	Microbio (Shanghai) and Oneness have entered into an exclusive agreement of Fespixon commercialization with China Resources Double Crane Pharmaceutical Co., Ltd.
Date of events	2024/07/19	To which item it meets	paragraph 53
Statement	1.Date of occurrence of the event:2024/07/19 2.Company name:Microbio (Shanghai) Co., Ltd. 3.Relationship to the Company (please enter “head office” or “subsidiaries”):subsidiary 4.Reciprocal shareholding ratios:NA 5.Cause of occurrence: (1)Counterparty to the contract or commitment: China Resources Double Crane Pharmaceutical Company Limited (2)Relationship with the Company:NA (3)Starting and ending dates (or rescission date) of the contract or commitment:2024/07/19 (4)Major content (not applicable where rescinded): A.Subsidiary Microbio (Shanghai) (hereinafter referred to as MBS, Microbio has direct and indirect ownership of 58.32% shares) and Oneness Biotech Co., Ltd. (hereinafter referred to as Oneness) have jointly entered into an exclusive agreement of commercial license in China (hereinafter referred to as the Agreement) of Fespixon with China Resources Double Crane Pharmaceutical Company Limited (hereinafter referred to as CR Double-Crane). CR Double-Crane will have the exclusive right of sales and marketing of Fespixon in the licensed territory. The business transaction will be made between CR Double-Crane and MBS according to the pre-agreed supply cost and MBS will place the order request to Oneness. B.According to the Agreement, CR Double-Crane will make an upfront payment of up to US$34 million to MBS and sales milestones of US$13.6 million based on every RMB 1 billion integer (the calculation each time minus the paid sales milestones).The agreement term is 20 years and expires in 2043. Three-fifth of the upfront payment shall be made by CR Double-Crane to MBS in 30 working days after the first custom clearance of Fespixon, and one-fifth of the upfront payment shall be made in 6 months after the first portion of upfront payment was made. The remaining one-fifth upfront payment will be made if Fespixon is included in the National Reimbursement Drug List (NRDL) in the pre-agreed timeline. In case the first NRDL price meets the mutual expectation, the remaining upfront payment will be exempted. C.Fespixon will be manufactured and supplied by Oneness Nanchou Plant. (5)Restrictive covenants (not applicable where rescinded):Per the agreement (6)Commitment (not applicable where rescinded):Per the agreement (7)Any other important agreement (not applicable where rescinded):NA (8)Effect on company finances and business:Positive to finances and business (9)Concrete purpose/objective: A.The exclusive agreement of Fespixon commercial license in China will bring substantial benefit resulted from the successful research and development of the new drug and product launch to the shareholders’equity. B.The commercialization of Fespixon is anticipated to significantly decrease the amputation of diabetic patients and bring important health benefits to the patients. 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.): A.According to the license agreement signed with Oneness, MBS will pay Oneness a certain proportion of royalties based on MBS’s net sales. B.According to the cooperation agreement signed with Haihe Biopharma Co., Ltd., Shanghai (hereinafter referred to as Haihe), MBS will pay Haihe a certain proportion of the net sales of the drug developed through cooperation. C.Current Market : Diabetes is a prevalent disease in China. According to the international epidemiology literatures, the number of adult diabetic patients in China has reached 148 million. The DFU incidence is up to 8.1% among diabetic patients aged above 50 years so the DFU patient number has increased accordingly. It is estimated that there are over 8.3 million DFU patients in China. Due to the complexity of DFU etiology, dressings, growth factors, hospital pharmacy compounding, and Chinese OTC topicals for burns are not effective. This imposes a huge unmet medical need in the treatment and an estimation of 1.6 million amputations. According to Chinese guideline on prevention and management of diabetic foot(2019 edition), the diabetic foot, the serious chronic complication, is the leading cause of amputation and death among diabetic patients. The patients often ended up with amputation. The amputation rate is 19% among DFU patients, and the mortality rate is up to 50% in 5 years after amputation. It is estimated that a diabetic amputation occurs every 20 seconds globally, which is life-threatening. The significant costs of diabetic foot treatment is contributing to one third of the diabetes medical expenses,, causing huge burden to individuals, families, hospitals, and societies. D.CR Double-Crane is a public-listed company on Shanghai Stock Exchange (ticker : 600062) with business in new drug development, pharmaceutical finished products manufacturing, sales and marketing, API manufacturing, etc. Please visit：https://www.sse.com.cn/home/search/index.shtml?webswd=600062 for its related finances and business information. E.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.

Announces the information about the 1st online investor’s conference of 2024.

newsbuilder — Fri, 19 Jul 2024 07:35:07 +0000

SEQ_NO	1	Date of announcement	2024/07/19	Time of announcement	16:39:32
Subject	Announces the information about the 1st online investor’s conference of 2024.
Date of events	2024/07/26	To which item it meets	paragraph 12
Statement	1.Date of institutional investor conference:2024/07/26 2.Time of institutional investor conference:15:00 (GMT+8) 3.Location of institutional investor conference:Online Investor Conference 4.Outline of institutional investor conference: Update the company’s important new drug development progress and operating status. Internet site: https://reurl.cc/Ejk3Xg 5.Any other matters that need to be specified: The presentation slides will be made publicly by being uploaded to Market Observation Post System according to the regulation. The Q&A from the investor’s conference will be published on the Microbio official website after the meeting.

Microbio Co., Ltd. receives a U.S. patent on the new drug MS-20 (CHEMO YOUNG).

newsbuilder — Mon, 15 Jul 2024 14:35:34 +0000

SEQ_NO	1	Date of announcement	2024/07/15	Time of announcement	18:46:32
Subject	Microbio Co., Ltd. receives a U.S. patent on the new drug MS-20 (CHEMO YOUNG).
Date of events	2024/07/15	To which item it meets	paragraph 53
Statement	1.Date of occurrence of the event:2024/07/15 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: The Company has been informed by the patent agency that the new drug, MS-20, has been granted a U.S. patent titled “COMBINED CANCER THERAPY WITH IMMUNE CHECKPOINT MODULATORS AND FERMENTATION PRODUCTS BY SYMBIOTIC MICROBIOTA” under patent number 12,023,380. 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)The new drug MS-20 has obtained patents from the U.S., the Republic of China, Japan, the People’s Republic of China, the Hong Kong Special Administrative Region, Europe, Korea, Indonesia, India, Canada, Singapore, Malaysia, Brazil, United Arab Emirates, and Australia. (2)This patent presents a combination therapy with Chemo young (MS-20) and anti-PD1 antibody to enhance the anti-cancer efficacy of immune checkpoint modulators.

Annouce the change of the general manager.

newsbuilder — Tue, 11 Jun 2024 14:37:03 +0000

SEQ_NO	1	Date of announcement	113/06/11	Time of announcement	17:01:02
Subject	Annouce the change of the general manager.
Date of events	2024/06/11	To which item it meets	paragraph 6
Statement	1.Date of the board of directors resolution or date of occurrence of the change:2024/06/11 2.Position (Please enter chairperson or president/general manager): general manager 3.Name of the previous position holder:Kuo,Hsien-Shou 4.Resume of the previous position holder: Representative juristic-person director and the chairperson of Microbio Co. Ltd. 5.Name of the new position holder:Chen,Tzen-Wen 6.Resume of the new position holder: Representative juristic-person director and the chairperson of Microbio Co. Ltd. 7.Circumstances of change (Please enter “resignation”, “dismissal”, “term expired” , “job relocation”, “severance”, “retirement”, “death” or “new appointment”):dismissal 8.Reason for the change:dismissal 9.Effective date of the new appointment:2024/06/11 10.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 6 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.):None.

To announce the list of BOD members newly elected at the 2024 Annual Shareholders’Meeting.

newsbuilder — Thu, 30 May 2024 15:02:33 +0000

SEQ_NO	2	Date of announcement	2024/05/30	Time of announcement	18:35:37
Subject	To announce the list of BOD members newly elected at the 2024 Annual Shareholders’Meeting.
Date of events	2024/05/30	To which item it meets	paragraph 6
Statement	1.Date of occurrence of the change:2024/05/30 2.Elected or changed position (Please enter institutional director, institutional supervisor, independent director, natural-person director or natural-person supervisor): Institutional director, natural-person director, independent director 3.Title and name of the previous position holder: Directors (1)Kingbird Tech Co., Ltd. Representative：Kuo,Hsien-Shou (2)Kingbird Tech Co., Ltd. Representative：Yang,Pan-Chyr (3)Huang,Cheng-Chun Independent directors (1)Lai,Yuan-Ho (2)Tsai,Kao-Chung (3)Han,Li-Chun (4)Liang,Chi-Ming 4.Resume of the previous position holder: Directors (1)Kingbird Tech Co., Ltd.：Director of Microbio Co.,Ltd Representative：Kuo,Hsien-Shou：Director of Oneness Biotech Co., Ltd. (2)Kingbird Tech Co., Ltd.：Director of Microbio Co.,Ltd Representative：Yang,Pan-Chyr：Professor of Internal Medicine, National Taiwan University School of Medicine (3)Huang,Cheng-Chun：Supervisor of Hedonist Biochemical Technologies Co., Ltd. Independent directors (1)Lai,Yuan-Ho：The Director’s Representative of Chilisin Electronics Corp. (2)Tsai,Kao-Chung：Chairman of Yiyou Management Consulting Co., Ltd (3)Han,Li-Chun：Chairman of President Futures Corporation. (4)Liang,Chi-Ming：Director of Taiwan Bio-development Foundation 5.Title and name of the new position holder: Directors (1)Kingbird Tech Co., Ltd. Representative：Chen,Tzen-Wen (2)Lee,Tsu-Der (3)Lu,Ching-Hung Independent directors (1)Han,Li-Chun (2)Liang,Chi-Ming (3)Chang,Chun-Chao (4)Wu,Wen-Mien 6.Resume of the new position holder: Directors (1)Kingbird Tech Co., Ltd.：Director of Microbio Co.,Ltd Representative：Chen,Tzen-Wen：Adjunct Professor, Department of Internal Medicine, College of Medicine, Taipei Medical University (2)Lee,Tsu-Der：Director of Taipei Medical University (3)Lu,Ching-Hung：Corporate Director Representative of Xinyao Biotechnology Investment Co., Ltd. Independent directors (1)Han,Li-Chun：Chairman of President Futures Corporation. (2)Liang,Chi-Ming：Director of Taiwan Bio-development Foundation (3)Chang,Chun-Chao：Associate Dean, Department of Medical Education, Taipei Medical University Hospital (4)Wu,Wen-Mien：Assistant Professor, Department of Nutritional Sciences, College of Human Ecology, Fu Jen Catholic University 7.Circumstances of change (Please enter “resignation”, “dismissal”, “term expired”, “death” or “new appointment”):term expired 8.Reason for the change:Term will expired and full re-election early. 9.Number of shares held by the new position holder when elected: Director：Kingbird Tech Co., Ltd. 45,412,227 shares Representative：Chen,Tzen-Wen： 0 shares Director：Lee,Tsu-Der 0 shares Director：Lu,Ching-Hung 0 shares Independent director：Han,Li-Chun 0 shares Independent director：Liang,Chi-Ming 0 shares Independent director：Chang,Chun-Chao 0 shares Independent director：Wu,Wen-Mien 0 shares 10.Original term (from __________ to __________):2021/08/20~2024/08/19 11.Effective date of the new appointment:2024/05/30 12.Turnover rate of directors of the same term:N/A 13.Turnover rate of independent directors of the same term:N/A 14.Turnover rate of supervisors of the same term:N/A 15.Change in one-third or more of directors (Please enter “Yes” or “No”):Yes 16.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 6 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.):None.

To announce the election of the chairperson of the board of directors.

newsbuilder — Thu, 30 May 2024 15:01:31 +0000

SEQ_NO	3	Date of announcement	2024/05/30	Time of announcement	18:36:02
Subject	To announce the election of the chairperson of the board of directors.
Date of events	2024/05/30	To which item it meets	paragraph 6
Statement	1.Date of the board of directors resolution or date of occurrence of the change:2024/05/30 2.Position (Please enter chairperson or president/general manager):chairperson 3.Name of the previous position holder:Kuo,Hsien-Shou 4.Resume of the previous position holder: Director of Oneness Biotech Co., Ltd. 5.Name of the new position holder:Chen,Tzen-Wen 6.Resume of the new position holder: Adjunct Professor, Department of Internal Medicine, College of Medicine, Taipei Medical University 7.Circumstances of change (Please enter ”resignation”, ”dismissal”, ”term expired” , ”job relocation”, ”severance”, ”retirement”, ”death” or ”new appointment”):term expired 8.Reason for the change:Term will expired and re-elected early. 9.Effective date of the new appointment:2024/05/30 10.Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 6 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.):None.

To announce the list of election of the audit committee

newsbuilder — Thu, 30 May 2024 15:00:28 +0000

SEQ_NO	4	Date of announcement	2024/05/30	Time of announcement	18:36:30
Subject	To announce the list of election of the audit committee
Date of events	2024/05/30	To which item it meets	paragraph 6
Statement	1.Date of occurrence of the change:2024/05/30 2.Name of the functional committees:Audit committee 3.Name of the previous position holder: (1)Tsai,Kao-Chung (2)Lai,Yuan-Ho (3)Han,Li-Chun (4)Liang,Chi-Ming 4.Resume of the previous position holder: (1)Tsai,Kao-Chung：Chairman of Yiyou Management Consulting Co., Ltd (2)Lai,Yuan-Ho：The Director’s Representative of Chilisin Electronics Corp. (3)Han,Li-Chun：Chairman of President Futures Corporation. (4)Liang,Chi-Ming：Director of Taiwan Bio-development Foundation 5.Name of the new position holder: (1)Han,Li-Chun (2)Liang,Chi-Ming (3)Chang,Chun-Chao (4)Wu,Wen-Mien 6.Resume of the new position holder: (1)Han,Li-Chun：Chairman of President Futures Corporation. (2)Liang,Chi-Ming：Director of Taiwan Bio-development Foundation (3)Chang,Chun-Chao：Associate Dean, Department of Medical Education, Taipei Medical University Hospital (4)Wu,Wen-Mien：Assistant Professor, Department of Nutritional Sciences, College of Human Ecology, Fu Jen Catholic University 7.Circumstances of change (Please enter “resignation”, “dismissal”, “term expired”, “death” or “new appointment”):term expired 8.Reason for the change:Term will expired and full re-election early. 9.Original term (from __________ to __________):2021/08/20~2024/08/19 10.Effective date of the new member:2024/05/30 11.Any other matters that need to be specified:None

To announce the resolution of BOD to appoint the sixth term of remuneration committee

newsbuilder — Thu, 30 May 2024 14:59:12 +0000

SEQ_NO	5	Date of announcement	2024/05/30	Time of announcement	18:36:54
Subject	To announce the resolution of BOD to appoint the sixth term of remuneration committee
Date of events	2024/05/30	To which item it meets	paragraph 6
Statement	1.Date of occurrence of the change:2024/05/30 2.Name of the functional committees:Remuneration committee 3.Name of the previous position holder: (1)Tsai,Kao-Chung (2)Lai,Yuan-Ho (3)Han,Li-Chun 4.Resume of the previous position holder: (1)Tsai,Kao-Chung：Chairman of Yiyou Management Consulting Co., Ltd (2)Lai,Yuan-Ho：The Director’s Representative of Chilisin Electronics Corp. (3)Han,Li-Chun：Chairman of President Futures Corporation. 5.Name of the new position holder: (1)Han,Li-Chun (2)Liang,Chi-Ming (3)Chang,Chun-Chao 6.Resume of the new position holder: (1)Han,Li-Chun：Chairman of President Futures Corporation. (2)Liang,Chi-Ming：Director of Taiwan Bio-development Foundation (3)Chang,Chun-Chao：Associate Dean, Department of Medical Education, Taipei Medical University Hospital 7.Circumstances of change (Please enter “resignation”, “dismissal”, “term expired”, “death” or “new appointment”):term expired 8.Reason for the change:Term will expired and full re-election. 9.Original term (from __________ to __________):2021/08/20~2024/08/19 10.Effective date of the new member:2024/05/30 11.Any other matters that need to be specified:None.