Oneness Biotech was established in June 2008 and has been approved as a “New Drug Biotech” company by the government. In June 2011, Oneness received approval from Securities and Futures Bureau (FSC) to be listed on the stock market and started to be traded since September 23rd 2011 (ticker: 4743). Oneness acquired Fountain Biopharma Inc. in August 23rd 2019.
We have strong R&D team and pipelines. Developing global new drugs is the ultimate goal and we focus on chronic dermatology and immunology. Our pipelines are first-in-class or best-in-class new drugs spanning from Phases I, II, III, to NDA/approval phases. The antibody new drug, FB825 under Ph2 clinical trials has been out-licensed to an international pharma company. The Taiwan FDA approved DFU new drug, FESPIXON® cream, is also planned for accelerated market entry globally. This drug provides the DFU patients with effective solution and aligns with our founding mission of “developing new drugs and caring for life”.
The diabetic foot ulcer drug, FESPIXON® cream is a first-in-class new drug to treat DFUs by regulating macrophages. Its international Phase 3 trial results and novel mechanism have been published on the JAMA Network Open. It has been demonstrated with superior efficacy to the standard of care and robust efficacy in the hard-to-heal ulcer subgroups. This new drug will have revolutionary impact on the future DFU management. FESPIXON® cream has been granted by Taiwan FDA in March 2021. To accelerate the entry into the global market, FESPIXON® cream is under NDA review in China. It has also been under multiple NDA submissions to the South East Asian health authorities while a second phase 3 study is being conducted in the US. Besides, to ensure the drug quality and supplies after the marketing authorization is obtained, Oneness has implemented GACP on the raw material for more than 12 years. A PIC/S GMP manufacturing plant for the API extraction and finish product has also been established in Nanchou, Pingtung in Taiwan with site registration certification and manufacturer’s license. This will be able to supply the APIs and drug product of FESPIXON® cream for the global market demand.
Oneness owns an antibody library and is capable to develop drugs with precise targets | Global patent strategy | In-house innovation and development
Oneness owns a full-human antibody library and a monoclonal antibody drug development platform, and masters the key technologies of new antibody drugs from R (research) to D (development). The R&D team have established multiple antibody technologies, including a fully-human antibody library, high-throughput antibody screening platform, anti-IgE (immunoglobulin E) antibody, and anti-IL6 (interleukin-6) antibody, non-clinical antibody functionality assay, stable and high-yield antibody-producing cell lines and other key technologies, with strong capability for first-class antibody new drugs. At present, FB825 and FB704A have been developed based on those proprietary technologies.
FB704A developed from the “fully-human antibody library” technology platform, is a new anti-IL6 fully human antibody drug. The in vitro analysis and in vivo biological activities show that it can effectively inhibit the secretion of inflammatory cytokines by a variety of cells, inhibit the activity of the inflammatory hormone MCP-1 secreted by synovial membrane cells on the IL6-induced rheumatoid arthritis (RA) patients and also can tumor angiogenesis. FB704A has been greenlighted by the US FDA to proceed with a Ph2 clinical trial. FB825 (Anti-CεmX), a new anti-allergic antibody drug, has been completed various ex vivo, in vivo, clinical and safety studies. It is currently under two Ph2 trials for atopic dermatitis and allergic asthma. This new drug has been out-licensed to LEO Pharma, the medical dermatology leader. Oneness continues to work closely with the partner in order to maximize the development value.
OB318 is an anti-cancer new drug extracted from Antrodia cinnamomea and has been completed mass production and fermentation with more than 98% of its formulation quantitated. This ensures OB318 meet the threshold for the launch of the botanical new drugs with controllable drug quality according to the international regulations for botanical new drugs. It is currently under Taiwan and US IND for a Ph1 clinical trial.
With dedication into the research and development in botanical, small molecule, and antibody new drugs, Oneness continues to focus on chronic dermatology and immunology. We strengthen our collaboration with the global pharmas based on our breakthrough innovation and science. Based in Taiwan, we hope to connect the world with our new drug and make the contribution to the human health.