At a recent press conference on the 20th, BioGend Therapeutics Chairman Te-Li Chen outlined the company's strategy for advancing its bone growth factor (OIF) product. By the end of this year, the company plans to discuss Phase III clinical trial planning with Japan's Pharmaceuticals and Medical Devices Agency (PMDA). If approved for a trial with a small patient cohort, BioGend intends to conduct a Phase III clinical trial in Taiwan as well, aiming for regulatory approval in both Taiwan and Japan. The clinical trial report for bone non-union in Japan has already been released, demonstrating that the bone growth factor can effectively regenerate new bone. Additionally, the Phase II clinical trial report for open tibial fractures in Taiwan and the U.S. is expected by the end of the year. BioGend plans to use this report, along with the completed Phase II trial data from Japan, to advance international licensing discussions. Meanwhile, their joint venture in China is actively preparing for a Phase III clinical trial set to launch next year.
Chen highlighted that currently, Medtronic's Infuse is the only FDA-approved bone regeneration product on the global market. Since its launch in 2002, Infuse has dominated the market for over 20 years, with annual sales reaching $500-600 million, despite the infection risks associated with its bovine-derived components. However, no competing products have yet emerged to challenge its market dominance. BioGend's bone growth factor is designed to avoid the infection risks linked to animal-derived ingredients, giving it both a technical and cost advantage. The company's goal is to capture a significant share of the global market currently held by Infuse.
BioGend's cartilage regeneration product, RevoCart, has already been adopted by over 100 orthopedic surgeons and successfully treated hundreds of patients with joint cartilage issues, accumulating a wealth of experienced clinicians and post-market clinical data. Chen emphasized that the feedback from clinicians and the positive outcomes for patients are crucial for international licensing negotiations. Potential licensing partners are keen to interview clinicians directly to understand the product's efficacy and therapeutic results. Compared to other products that have not yet completed Phase III clinical trials and obtained regulatory approval, RevoCart's proven performance reduces technical risks and makes it easier to assess its licensing value.
Chen also noted that biotech R&D is a capital-intensive industry. Many companies face setbacks due to insufficient funding, leading to interrupted R&D or even premature closure before achieving licensing success. BioGend's business strategy is to not only push forward with high-end product development but also to generate stable cash flow through product sales, effectively mitigating operational risks. Currently, revenue from product sales is sufficient to cover most of the company's operating expenses, with losses primarily due to ongoing R&D efforts. Excluding R&D expenditures, the company would already be breaking even. BioGend remains committed to achieving its goals of survival (breaking even), thriving (profitability), and excelling (successful licensing).
Resource (mandarin): 博晟佈局國際授權 規劃骨生長因子台/日三期臨床
