Oneness Biotech Co., Ltd. held its first-quarter briefing earlier, announcing gradual successes of its diabetic foot ulcer new drug, "Fespixon cream," in domestic and international markets. Oneness Biotechnology stated that "Fespixon cream" has penetrated the systems of Taiwan's top three medical centers, namely National Taiwan University Hospital, Taipei Veterans General Hospital, and Chang Gung Memorial Hospital, in the first quarter of this year. Moreover, shipments to the overseas market in Singapore began in March, with plans to seek medical insurance approval in Mainland China starting from July this year.
Oneness's General Manager, Shu-ling Cheng, emphasized that this year marks a pivotal year for Oneness's business. With the acquisition of the mainland China's new drug certificate for "Fespixon cream" in the fourth quarter of 2023, the product officially transitioned from the research phase to the commercialization phase. Oneness will adopt a dual-track strategy of innovative drugs and medical devices to expand its global market. Regarding innovative drugs, "Fespixon cream" has been approved for listing in Taiwan, Singapore, Malaysia, and mainland China. Additionally, it is undergoing substantial review processes in Indonesia, the Philippines, and Vietnam.
In terms of medical devices, Bonvadis medical devices have obtained general wound and scar medical device permits in the United States, the European Union, India, New Zealand, South Africa, Egypt, Thailand, and Pakistan. The second phase, which involves chronic wound medical device permits, will be submitted to multiple countries according to the plan, with expectations to complete global market listings within this and the following year.
Oneness Biotechnology explained that "Fespixon cream" obtained health insurance pricing in Taiwan last year. In the first quarter of this year, it began entering the systems of National Taiwan University Hospital, Taipei Veterans General Hospital, and Chang Gung Memorial Hospital. Apart from clinical evidence for diabetic foot ulcers, "Fespixon cream" has been used by many doctors to treat more challenging wounds and acute injuries.
Shu-ling Cheng stated that the mainland China market for "Fespixon cream" will adopt an exclusive licensing distribution model. Currently, negotiations are ongoing with several large pharmaceutical companies with nationwide sales channels. Although there have been inquiries about collaboration with China's Sinopharm Double Crane Pharmaceutical Co., Oneness did not provide a direct response. Oneness emphasized that the annual medical insurance negotiations in mainland China from July to December will be a crucial milestone for "Fespixon cream" in the next significant market.
Regarding the Singapore market, Fespixon signed a contract with a local distributor in February, with the first batch of drugs entering Singapore in March. Singapore currently has approximately 70,000 diabetic foot ulcer patients, with estimates suggesting potential market opportunities of over $46 million USD for Oneness in the future. Negotiations with local distributors in Malaysia are also underway, with procurement requests from large local hospitals already received.
For the U.S. market, Bonvadis has obtained medical device permits for general wound indications, with plans to expand into clinical feedback on various indications such as podiatry, dermatology, and surgery. Additionally, Oneness's Bonvadis has received orders from Egypt and is awaiting shipment after signing regional distribution contracts.
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