History

2022

  • Oneness Ranked among Top 5% in the 8th Corporate Governance Evaluation
  • Fespixon has been ISO 14040 and 14044 certified for its compliance with the international standards for life cycle assessment.
  • Oneness received Canadian and Korean patents titled “ANTIBODIES TO INTERLEUKIN-6 AND USES THEREOF” on FB704A. 
  • Oneness received a Korean patent titled “TOPICAL FORMULATION FOR PROMOTING WOUND HEALING” on Fespixon cream (Research code: ON101).
  • Oneness received a Korean patent titled “TOPICAL FORMULATION FOR PROMOTING WOUND HEALING” on Fespixon cream (Research code: ON101).
  • The data of SNS812, an anti-Pan-COVID19 siRNA, were published by EMBO Molecular Medicine
  • Oneness is the only biotech in Taiwan included in the 2022 Bloomberg Gender-Equality Index(BGEI)

2021

  • The Ph3 data and the mechanism of action of Fespixon(ON101)have been published on the JAMA Network Open
  • The DFU new drug, ON101 has been granted a US patent titled the Topical Formulation for Promoting Wound Healing
  • FB704A, a monoclonal antibody new drug, has been greenlighted by the US FDA to proceed with a Ph2 clinical trial for the treatment of severe asthma
  • The DFU new drug, Fespixon has been granted a new drug approval by the Taiwan FDA
  • The DFU new drug (research code: ON101) has been granted a Fast Track designation by the US FDA which will facilitate its development in the US for NDA
  • Oneness Nanchou Plant has been GMP and GDP certified by the Ministry of Health and Welfare of Taiwan
  • FB704A, a monoclonal antibody new drug, has been approved by the Taiwan FDA to proceed with a Ph2 clinical trial for the treatment of severe asthma

2020

  • Oneness Biotech Enters Exclusive License Agreement with LEO Pharma for FB825 a Novel Atopic Dermatitis and Asthma Drug Candidate
  • Oneness Biotech is included in 2019 Deloitte Technology Fast 500 Asia Pacific

2019

  • Oneness Biotech was granted Patent for Use of Anti-Cancer Active Substance from Antrodia Camphorate, Method for Preparing the Same and Use Thereof in Taiwan
  • The board of directors of the company decided to merge with Fountain BioPharma
  • The BfArM accepted clinical trial application for the Phase 3 study of ON101 (new drug for diabetic foot ulcers)(ON101CLCT04)
  • Fountain BioPharma was merged into Oneness Biotech on 23 Aug 2019

2018

  • Oneness Biotech was granted Taiwan Patent for Use of Flavonoid Compound in Preparation of Composition for Healing Wound
  • Oneness Biotech was granted US Patent for Use of Anti-Cancer Active Substance from Antrodia Camphorate, Method for Preparing the Same and Use Thereof
  • The ON101 (WH-1) for diabetic foot ulcer was submitted to TFDA for botanical new drug application on 14th May, 2018
  • Oneness Biotech was granted US Patent for Process for the Preparation of Plant Extracts for Treating Skin Disorders
  • The USFDA greenlighted the second Phase 3 clinical trial (ON101CLCT04) of ON101 (WH-1), the new drug for treating chronic diabetic foot ulcers, on 3rd March, 2018
  • Oneness Biotech was granted China Patent for Plectranthus Amboinicus Fraction Having Anti-Arthritis Activity

2017

  • Oneness Biotech and Microbio (Shanghai) has been passed a resolution to develop OB318 (include OB621), an investigational new anti-hepatoma drug, in China, HK and Macao
  • Oneness Biotech and Microbio (Shanghai) has been passed a resolution to develop new drug ON101 for treating chronic diabetic foot ulcer in China, HK and Macao
  • Oneness Biotech was granted the invention patent by the Korea on “PLECTRANTHUS AMBOINICUS FRACTION HAVING ANTI-ARTHRITIS ACTIVITY”
  • Oneness Biotech Co. announced that the multinational phase III clinical trial of ON101, a new drug for diabetic foot ulcer, has been approved by CFDA

2016

  • Sod-turning Ceremony for Oneness Biotech Nan-cho Plant
  • The Microbio Group Proposed Suggestions in the Enterprise Guide for Ministry of Economic Affairs
  • The New Drugs ON101 (WH-1) of Oneness Biotech Meet the Phase III Clinical Trials Interim Requirement and is going to initiate Phase III Clinical Trials in China and EU. Oneness Biotech Receives EPC Patent
  • Groundbreaking Ceremony for Oneness Biotech Nan-cho Plant

2015

  • Oneness Biotech’s Anti-Hepatoma New Drug OB318 Was Granted the Invention Patent in Japan
  • Oneness Biotech’s Investigational Anti-Hepatoma New Drug OB318 Approved for Phase I Clinical Trials by Ministry of Health and Welfare
  • The TFDA approved the pharmacodynamics study in human of ON101 (WH-1), the new drug for treating chronic diabetic foot ulcers
  • Oneness Biotech Co., Ltd. organized capital increase by cash and issued new shares worth NTD 250 million, was approved by The Financial Supervisory Commission (FSC)

2014

  • The USFDA approved the Phase 1 clinical trial of OB318, the new drug for anti-liver cancer
  • The “Antrodia cinnamomea Mycelia Capsule” awarded the top prize in Health Food category of the “2014 National Biotechnology Medical Care Quality Awards”
  • The Department of Health of Hong Kong approved the phase 3 clinical trial of ON101 (WH-1), the new drug for treating chronic diabetic foot ulcers
  • The wounds healing new drug, WH-2, was issued the India invention patent
  • COMPLEHEAL ANTI-ACNE CREAM was issued the PRC record certificate on imported non-special use cosmetics
  • POGOSTEMON CABLIN ANTI-ACNE CREAM was issued the PRC record certificate on imported non-special use cosmetics
  • The anti-cancer new drug, OB318, was issued the PRC invention patent
  • The Ministry of Health and Welfare approved the international multi-center clinical trial of ON101, the new drug for treating chronic diabetic foot ulcers

2013

  • The technology transfer and patent license agreement for the“Composition For Treating Diabetes and Metabolic Diseases and A Preparation Method Thereof”was terminated
  • The anti-cancer new drug, OB318, was issued the ROC invention patent
  • The “Top-notch Antrodia cinnamomea Mycelia Capsule” were registered with the government as “Liver-preserving Health Food.”
  • Oneness Biotech was accredited by the Taiwan Corporate Governance Association on September 23, 2013 in accordance with the CG6008 corporate governance system
  • “ON101, the new drug for treating chronic diabetic foot ulcers” won the silver prize for technology transfer in the 2013 Taipei Biotech Award
  • Oneness Biotech signed the Letter of Intent for new drugs and products with the CSPC Pharmaceutical Group Limited, China
  • OB318, the anti-cancer new drug made of Antrodia cinnamomea, and OB412, the new drug treating diabetes and metabolic syndrome were qualified for the investment incentives under the Act for the Development of Biotech and New Pharmaceuticals Industry
  • The Department of Health, Executive Yuan approved the addition of clinical trial centers for ON101 (WH-1), the new drug for treating chronic diabetic foot ulcers
  • The US FDA approved the conduct of the Phase 3 clinical trial of ON101 (WH-1), the new drug for treating chronic diabetic foot ulcers, in Asia

2012

  • Enrollment for the Phase 3 clinical trial of WH-1, the new drug for treating chronic diabetic foot ulcers), began
  • The technology transfer and patent license agreement was entered into for the “Composition for Treating Diabetes and Metabolic Diseases and A Preparation Method Thereof”
  • The Phase 2 clinical trial of ON101 (WH-1), the new drug for treating chronic diabetic foot ulcers, successfully passed GCP inspections
  • The Phase 3 clinical trial of ON101 (WH-1), the new drug for treating chronic diabetic foot ulcers, was approved and enrollment began

2011

  • Oneness Biotech’s stock was approved by the Taipei Exchange (TPEx) to be registered and traded over the counter
  • The Taiwan Food and Drug Administration (TFDA) approved the Phase 3 clinical trial of WH-1, the new drug for treating chronic diabetic foot ulcers
  • The Phase 2 clinical trial of WH-1, the new drug for treating chronic diabetic foot ulcers, was completed.
  • The “Development Program of Antrodia cinnamomea Mycelia Products as Liver-preserving Health Food” received sponsorship under the Industrialization and Promotion Plan for Biotechnology Research and Development Results of the Industrial Development Bureau, Ministry of Economic Affairs
  • The efficacy of Plectranthus amboinicus extract new drug ON102 in treating rheumatoid arthritis was demonstrated

2010

  • The technology transfer and license agreement was entered into for the “Methods and Mechanism of Lectin Recombinant Protein in the Authentication of Polysaccharides and Dengue Fever Treatment”
  • WH-1, the new drug for treating chronic diabetic foot ulcers, was honored with the Symbol of National Quality
  • The exclusive license agreement for the anti-liver cancer new drug made of Antrodia cinnamomea was entered into with the National Taiwan University
  • The development, mass production, and marketing of new products Relief Cream and Indian Mint Cream were completed
  • Oneness Biotech Co., Ltd. relocated its office to 7F-1, No. 3-1, Yuanqu Street, Nangang District, Taipei City.
  • The development, mass production, and marketing of new Glucosamine drinks were completed
  • The application for review of “the Letter of Comments issued by the competent authority for the exchange or OTC listing of stock applied for by technology businesses”  was submitted to the Industrial Development Bureau, Ministry of Economic Affairs
  • Plectranthus amboinicus GAP cultivation bases were established in Beinan, Taitung and Meinong, Kaohsiung
  • The Phase 2 clinical trial of WH-1 in the treatment of chronic diabetic foot ulcers was again selected by the Center for Drug Evaluation (CDE) to be the “index case for key pathways of new medicinal products.”

2009

  • The process and formulation technology of Plectranthus amboinicus were utilized to produce and sell skin care creams
  • Capital was increased by cash and new shares were issued to total NTD 449 million. The paid-in capital size was NTD 1 billion
  • Taichung Hospital and Chiayi Chang Gung Memorial Hospital were added as study sites for the Phase 2 clinical trial of the new drug, WH-1
  • The humanized antibody for CLEC5A (protein-based drug treating dengue fever) was developed through collaboration with TPG Biologics, Inc
  • Oneness Biotech’s stock was approved by the GreTai Securities Market to be registered and traded over the counter
  • Oneness Biotech was determined by the Ministry of Economic Affairs to be a biotech new pharmaceuticals company and qualified for incentives under the Act for the Development of Biotech and New Pharmaceuticals Industry
  • The exclusive technology license agreement was entered into with the Academia Sinica for the “Methods and Mechanismof Lectin Recombinant Protein in the Authentication of Polysaccharides and Dengue Fever Treatment”
  • Linkou Chang Gung Memorial Hospital and Chung Shan Medical University Hospital were added as study sites for the Phase 2 clinical trial of the new drug, WH-1
  • The development of the new drug, WH-1, in treating chronic diabetic foot ulcers received the grant of NTD 7.12 million under the Industrial Technology Development Program of the Ministry of Economic Affairs
  • Public offering took effect
  • Oneness Biotech participated in the capital increase by cash of TaiMed Inc. (Now Oneness Investment Inc.) with NTD 118 million

2008

  • Oneness Biotech organized capital increase by cash and issued new shares worth NTD 380 million. The post-capital increase authorized capital size increased to NTD 1.2 billion and the paid-in capital size was NTD 551 million
  • Office of Oneness Biotech was relocated to Nangang Software Park
  • The Phase 2 clinical trial of WH-1 in treatment of chronic diabetic foot ulcers was selected by the CDE to be the “index case for key pathways of new medicinal products.”
  • To have more professionals available to assist in company governance, an extraordinary general meeting was called to re-elect 5 directors and 2 supervisors
  • Oneness Biotech Co., Ltd. was established. It is a company in charge of researching and developing new drugs, with an authorized capital size of NTD 700 million and paid-in capital size of NTD 171 million
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