BioGend Therapeutics has signed an exclusive license agreement with Japanese pharmaceutical company Fujimoto Pharmaceutical Corp. for its Osteo-Inductive Factor (OIF), a bone regeneration product, completing its first international license. The company has also signed exclusive distribution contracts in Hong Kong and Macau for its cartilage restoration product, RevoCart, which will enable it to enter the market of Guangdong, Hong Kong and Macau, which has a population of 60 to 70 million people.
The success of the OIF product in passing international validation will effectively increase the willingness to cooperate with other countries in licensing. BioGend is now actively discussing with its Chinese partners and expect to sign a contract by the end of this year to complete the major markets in the US, Europe, China and Japan.
In addition, BioGend's cartilage regeneration product, RevoCart, is the world's only disposable cartilage repair product, which was homegrown and developed through the joint efforts of US orthopaedic manufacturers and BioGend. To date, more than 200 surgeries have been performed and patients have regained their mobility, many of whom have come from as far as the United States, Malaysia and China.
The company has recently signed exclusive distribution contracts in Hong Kong and Macau to continue to expand its international footprint. It aims to complete the conversion of medical device licenses in Hong Kong and Macau within one year, and upon completion, it will be available to medical institutions in the said markets, which has a population of 60 to 70 million, in accordance with relevant regulations.
According to BioGend, the application for the Hainan Free Trade Port has entered the review process and will be available for sale within one year at the earliest. The earliest the product can be marketed in Malaysia, Vietnam, Hong Kong and Macau is next year. In addition to reducing manufacturing costs, this will also have a positive impact on international manufacturers' assessment of product authorisation and future inclusion in health insurance coverage.
The company added that future R&D spending will be focused on process improvements for OIF, with high levels of R&D investment expected over the next two years, but with a moderate degree of control over R&D progress in the face of global economic uncertainty. With the completion of product development and certification, R&D expenses will be significantly reduced, and with the continued growth in revenue, it is expected that the profit and loss will be double in three years.
