Oneness Biotech Co., Ltd.

2024

Bonvadis^® topical cream received medical device marketing authorization approval for all indications in wounds for Saudi Arabia
A US patent titled "Biomarkers for lung cancer stem cells" has been granted
Oneness Biotech Co., Ltd. receives a United States patent titled “TREATING IGE-MEDIATED ALLERGIC DISEASES” on FB825
Oneness has received medical device registration approval on Bonvadis^® Topical Cream for Egypt
SNS812 Phase 2 study demonstrated statistical significance in treating COVID-19 based on its safety, precision and broad-spectrum efficacy
The post hoc analysis of the global novel drug, FESPIXON^® (ON101), on hard-to-heal diabetic foot ulcers has been published in Advances in Wound Care
FESPIXON^®, the new drug in treatment of diabetic foot ulcers has been approved by Indonesia BPOM and the drug license will be collected
FESPIXON^® has been included in CSE Expert consensus on wound treatment of diabetic foot ulcer (2024). The health economics analysis supports its cost-effectiveness.
Oneness and Microbio (Shanghai) have entered into an exclusive agreement of FESPIXON^® commercialization with China Resources Double Crane Pharmaceutical Co., Ltd.
FESPIXON^® is included in the "DAROC Clinical Practice Guidelines For Type 2 Diabetes Care 2022" (2024 update)
U.S. FDA notified Oneness today that Bonvadis^® for partial thickness wounds, closed post-surgical wounds, and burns (1st and superficial 2nd degrees) is 510(k) cleared.
S.C. injection formulation of FB825 has been agreed by US FDA to proceed with Phase 2 clinical trial to treat moderate-to-severe atopic dermatitis.
Oneness Ranked among Top 5% in the 10th Corporate Governance Evaluation
Subcutaneous injection formulation of FB825 to treat moderate-to-severe atopic dermatitis was greenlighted by TFDA to proceed with a Ph2 study
Oneness Biotech Co.,LTD receives a Taiwan patent on antagonistic LAG-3 aptamers.
Oneness Biotech Co. has been selected in the S&P Global Sustainability Yearbook for two consecutive years
FESPIXON^® is included in the 2024 TSOC/TSPS Joint Consensus and has been published by a renowned SCI journal, Acta Cardiologica Sinica
Bonvadis^®, the wound care topical cream has obtained import license in Thailand

2023

Oneness Biotech Co., Ltd. is the first pharmaceutical coompany in Taiwan that has been selected as a member of the Dow Jones Sustainability Emerging Markets Index (DJSI) in the Pharmaceuticals sector.
Oneness Biotech Co., Ltd. receives a Japanese patent titled “TREATING IGE-MEDIATED ALLERGIC DISEASES” on FB825
FESPIXON^®, the new drug has been approved as Class 1.1 natural new drug by National Medical Products Administration (NMPA) in China
FESPIXON^®, the new drug in treatment of diabetic foot ulcers has been approved by Malaysia NPRA
A Russian patent titled “TREATING IGE-MEDIATED ALLERGIC DISEASES” on FB825 was granted
Bonvadis^®, the wound care topical cream has obtained import license in South Africa
SNS812, an anti-Pan-COVID19 siRNA has been agreed by US FDA to proceed with Phase 2 clinical trial
SNS812, an anti-Pan-COVID19 siRNA was greenlighted by TFDA to proceed with a Ph2 study
The National Agency of Drug and Food Control(Badan Pengawas Obat dan Makanan; BPOM) has accepted the NDA application of the diabetic foot ulcer new drug, FESPIXON^®
Oneness Biotech Co., Ltd. receives the United States patent on the producing recombinant glycoproteins with modified glycosylation
SNS812, an anti-Pan-COVID19 siRNA has obtained the results of the Phase 1 clinical trial in the US
Oneness Ranked among Top 5% in the 9th Corporate Governance Evaluation
Bonvadis^® Cream for scar management has been granted import license in Europe
Nanchou Plant had been granted with Medical Devices Quality Management System (QMS) Approval
Oneness was notified today that Bonvadis^®, the wound care topical cream has obtained import license in New Zealand.
Oneness was notified today that Bonvadis^®, the wound care topical cream has obtained import license in India.
Oneness has been selected for the first time for inclusion in the S&P Sustainability Yearbook 2023 and awarded the Industry Mover
Oneness received new drug approval by Singapore HSA on its DFU new drug, FESPIXON^®
Oneness has been included in the Bloomberg Gender Equality Index for two consecutive years
The CEA of FESPIXON^® based on its significant clinical efficacy showed its cost-effectiveness for treating DFUs. The manuscript was published by JAMA Network Open
The exploratory trial result of FESPIXON^® in improving postoperative scar cosmesis has been published by a renowned SCI journal, Aesthetic Surgery Journal.

2022

FESPIXON^® cream received International Innovation Awards from Enterprise Asia for its innovation excellence in treatment of diabetic foot ulcers
Oneness Biotech received Gold Award for Corporate Sustainability Report in 2022 Taiwan Corporate Sustainability Award (TCSA)
FESPIXON^®'s clinical meaningfulness as a macrophage- regulation new drug compared with other DFU treatments has been reviewed and published in Pharmaceutics
SNS812, an anti-Pan-COVID19 siRNA was greenlighted by US FDA to proceed with a Ph1 study
510(k) Premarket Notification of Bonvadis^®, the wound care topical cream, was received from FDA on its substantial equivalence 510(k) Premarket
The Drug Administration of Vietnam has accepted the NDA application of the diabetic foot ulcer new drug, FESPIXON^®
The more in-depth findings on the mechanism of action of FESPIXON^® has been published by JID Innovations
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 European, Indian and Korean patents titled “Methods for Producing Recominant Glycoproteins with Modified Glycosylation”
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
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
An Indian patent on the Anti-CεmX (FB825) antibody was granted.
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
FB704A, a new drug under development, signed a regulatory science consultation agreement with the CDE for the COVID-19 project indicator case.

2020

The United States patent on antagonistic CTLA-4 aptamers has been granted
A Taiwanese patent on the method for producing recombinant glycoproteins with modified glycosylation was granted.
The United States patent on antagonistic PDL1 aptamers has been granted
Oneness Biotech Enters Exclusive License Agreement with LEO Pharma for FB825 a Novel Atopic Dermatitis and Asthma Drug Candidate
A South African patent on the technology for producing monosaccharide antibodies has been granted.
The interim analysis of Phase III clinical trials evaluating ON101(WH-1) for chronic diabetic foot ulcers has demonstrated successful achievement of its primary endpoint
A Japanese patent on the cancer stem cell platform technology has been granted.
Issue Global Depositary Receipts (GDRs) on the Luxembourg Stock Exchange by means of a cash capital increase and a subsequent international offering of ordinary shares.
The phase I of the clinical trial for the new drug FB704A, an anti-IL6 fully human monoclonal antibody, has been completed in the United States.
Nanchou Manufacturing Site Receiving GMP Certification from TFDA on Manufacturing Active Pharmaceutical Ingredient
Oneness Biotech is included in 2019 Deloitte Technology Fast 500 Asia Pacific

2019

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
A US patent on antagonistic PD-1 aptamers has been granted.
The Ministry of Health and Welfare has notified Oneness to proceed with the licensing of the bulk drug substance "Plectranthus amboinicus extract-F4"

2018

The ON101 (WH-1) for diabetic foot ulcer was submitted to TFDA for botanical new drug application on 14th May, 2018
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

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 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 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.
Groundbreaking Ceremony for Oneness Biotech Nan-cho Plant

2015

The new drug for diabetic foot ulcers (ON101) has received funding from the Ministry of Economic Affairs' SBIR program.
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
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 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 “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 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

The technology transfer and patent license agreement was entered into for the “Composition for Treating Diabetes and Metabolic Diseases and A Preparation Method Thereof”

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

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
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”
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.”
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