Since its inception, Oneness Biotech Co., Ltd. has upheld the core values of “science, integrity, and transparency” in its commitment to innovative drug development on a global scale. We conduct in-depth analyses of MOC (mechanisms of action) of drugs by relying on scientific data. Autonomously developed, patented technologies are harnessed for the provision of effective treatment methods and satisfaction of unmet medical needs to create maximum value through scientific and innovative methods.
In 2022, our team made a steadfast commitment to advancing the development of new drugs, promoting clinical trials, and accelerating international market access in the face of the lingering impact of the COVID-19 pandemic. The licensing of the new antibody drug FB825 (US Phase IIa unblinded clinical study for moderate and severe atopic dermatitis completed in the US in the first half of 2022) to international drug manufacturers has been listed as signing bonus revenue. An application for new drug registration has been submitted for the diabetic foot ulcer drug “FESPIXON®” in Singapore, Malaysia, Vietnam, and the Philippines. A new drug license was successfully acquired in Singapore in January. Application documents for Chinese drug licenses have been submitted in accordance with applicable regulations and comprehensive reviews have been completed.
In addition, our R&D team continues to publish articles in international academic journals to demonstrate the therapeutic effects and unique MOC through clinical research data. The pharmacoeconomics article which was published in the renowned, SCI-listed journal JAMA Network Open this January, analyzes the groundbreaking therapeutic effects and cost effectiveness of “FESPIXON®” in the treatment of diabetic foot ulcer through macrophage regulation, which represents a competitive advantage over standard care methods. Fespixon can therefore serve as a standard therapy option that helps save medical expenses and eases the burden on the country, society, medical personnel, and patients. Bonvadis, a topical wound cream, passed the US FDA 510(k) premarket clearance for medical devices and marketing authorization in 2022. Marketing authorization was also obtained in India and New Zealand in the first quarter of this year. The clinical trials for OB318, our antrodia cinnamomea-based anti-cancer drug, FB704A, our anti-IL6 fully-human antibody drug, and SNS812, our anti-COVID siRNA drug are progressing according to plan.
Oneness Biotech makes continued progress in the fields of safeguarding shareholders’ equity, strengthening the structure and operations of the Board of Directors, enhancing information transparency, and promoting sustainable development. Our unrelenting efforts have been recognized with two consecutive rankings in the “Top 5% of the TPEx-listed category” and in the “Top 10% of TWSE- or TPEx-listed companies in the non-finance and non-electronics industry with a market value of TWD10 billion or more” of the annual Corporate Governance Evaluations conducted by the Taiwan Stock Exchange Corporation. On the international stage, we have been invited to participate in the S&P Global Corporate Sustainability Assessment and achieved a ranking in the top 3% of the global pharmaceutical industry in the following criteria: product quality management, innovation management, supply chain management, responsible marketing, and occupational health & safety. On top of that, we were included for the first time in S&P Global’s “Sustainability Yearbook 2023” and earned the exclusive honor of being recognized as the sole “Industry Mover” in the global pharmaceutical industry.
ESG is promoted top-down through the joint efforts of the ESG Committee and executives and rank-and-file employees of each department. By harnessing our core capabilities in new drug development, we have ventured into the field of diabetic foot ulcer care in cooperation with external associations and foundations. Patient care and early treatment are facilitated through subsidies for low-income households. Furthermore, we produce health education videos in cooperation with the Taiwan Association of Hospital Medicine for the benefit of society and have set up a diabetic foot ulcer care network to enhance public knowledge in the field of health education. In the face of climate change, we gradually implement low-carbon operations. In 2022, ISO14067 carbon footprint certification for “FESPIXON®” and ISO14064-1 GHG inventory verification were completed. Moreover, we gradually enhance our energy-use efficiency and have adopted plans to use renewable energy and carbon removal projects with the ultimate goal of achieving a further decrease of carbon emissions. In the field of sustainability reporting, we not only disclose relevant information in accordance with SASB standards and climate-risk related contents in accordance with TCFD in this year’s ESG Report but have also identified seven material topics and related targets through internal discussions pursuant to GRI Standards 2021. Concrete action indicators for 2025 are also reported by responsible departments.
The new drug industry aims to benefit humanity through the solution of human health issues by relying on scientific innovation. Oneness Biotech has made an unwavering commitment to strengthening its R&D capabilities on an ongoing basis to facilitate the development of world-class, innovative drugs. We spare no effort to implement corporate governance, fulfill our corporate social responsibility, preserve a sustainable environment for future generations, and create shared value in the field of sustainability by incorporating corporate sustainability and ESG concepts into our business operations and corporate strategies.