On the 8th, Taiwan Bio Therapeutics announced that its cell therapy drug for knee osteoarthritis, Chondrochymal, has received approval from the Taiwan Food and Drug Administration (TFDA) to proceed with Phase III clinical trials. Since the drug has already been successfully licensed out, the company will assist its partner in completing the transfer of the trial sponsor and jointly advance patient recruitment, aiming to complete the Phase III trial by 2028.
Taiwan Bio Therapeutics stated that under a cooperation agreement signed last December with Singapore-based Senectus Pte. Ltd., Senectus was granted an option for exclusive rights to develop and commercialize Chondrochymal in the Asia-Pacific region. Senectus formally exercised this option on March 19 this year, activating the license.
Taiwan Bio Therapeutics CEO Cyrus Yang said that following the license activation, Senectus will lead the multinational, multicenter clinical trials, regulatory submissions, and product marketing within the licensed territories, including Taiwan, and will bear all related costs. Taiwan Bio Therapeutics will continue to support Senectus with process development and updating CMC documentation. According to Senectus’s plan, the initial focus will be on establishing a presence in the regenerative medicine market in Southeast Asia, gradually expanding to the entire Asia-Pacific region.
Yang further explained that Taiwan Bio Therapeutics is the sole global supplier of Chondrochymal. Once Phase III patient recruitment begins, the company will provide clinical drug supplies to Senectus at a fixed price per dose, which will generate early new drug revenue for the company. After the drug’s market launch, Taiwan Bio Therapeutics will also participate in sales profit sharing.
Current treatments for knee osteoarthritis mainly involve short-acting pain relief medications. For severe patients, highly invasive joint replacement surgery is the standard, while there remains a lack of long-acting pain control or disease-modifying therapies. In terms of cell therapy for knee osteoarthritis, only one autologous chondrocyte implantation product has been approved by the U.S. FDA, leaving significant unmet medical needs.
Chondrochymal uses revitalized allogeneic bone marrow mesenchymal stem cells, which possess higher cell activity compared to many competitors that use frozen cell preparations. Phase II clinical trial data showed that all participants receiving a single dose of Chondrochymal experienced significant relief from pain and stiffness caused by knee osteoarthritis after 24 weeks, with good safety and no serious adverse events related to the trial. Imaging data also demonstrated significant improvements in joint structure. A full Phase II clinical trial analysis report is expected by August this year.
The approved Phase III clinical trial will recruit 222 knee osteoarthritis patients at Taichung Veterans General Hospital. It will be a placebo-controlled, parallel-group study administering intra-articular injections to evaluate the long-term efficacy and safety of Chondrochymal. The company remains optimistic about the Phase III trial and hopes to offer new treatment options to patients as soon as possible.
Knee osteoarthritis, also known as degenerative knee arthritis, is one of the most common joint diseases in the elderly. With the global aging trend accelerating, demand for related therapies continues to grow. According to a report by Global Market Insights Inc., the global market for knee osteoarthritis drugs was valued at $6.7 billion in 2024 and is projected to reach $14.3 billion by 2034, with a compound annual growth rate of 8%.
Resource: 台寶生醫膝骨關節炎新藥 獲TFDA核准三期臨床
