On December 25th, 2025, RabPharma Biopharma Co., Ltd. (“RabPharma”) announced that the Investigational New Drug (IND) application for a new indication of its core pipeline candidate, RAB001 for injection, has been approved by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The newly approved indication expands the clinical development of RAB001 into knee osteoarthritis, marking the second IND approval obtained for this innovative bone regenerative therapy. The IND approval (Acceptance No. CXHL2501164) represents an important milestone in broadening the clinical application of RAB001 from osteonecrosis to osteoarthritis, one of the world’s most prevalent degenerative musculoskeletal diseases.

Osteoarthritis is a common chronic disease characterized by cartilage degeneration, synovial inflammation, and osteophyte formation, with a particularly high prevalence among individuals over the age of 65. Despite significant global clinical demand, there are currently no approved disease-modifying osteoarthritis drugs (DMOADs) available worldwide.

The newly approved candidate, RAB001d, was developed based on RabPharma’s core regenerative medicine platform RAB001 and optimized specifically for osteoarthritis treatment through intra-articular injection delivery. Preclinical studies have demonstrated that intra-articular administration of RAB001d effectively alleviated joint pain in rat models of osteoarthritis while helping preserve the integrity of the osteochondral unit. The therapy also demonstrated potential benefits in reducing joint inflammation, improving structural outcomes, and slowing disease progression.

RabPharma plans to advance clinical studies of RAB001d in patients with osteoarthritis to further validate its therapeutic mechanism through both clinical efficacy endpoints and imaging-based assessments. Planned evaluation endpoints include improvements in pain and joint function, MRI-based assessment of bone marrow edema volume, synovitis/effusion and cartilage morphology measured through MOAKS scoring, as well as bone and cartilage turnover biomarkers including CTX-I and CTX-II. The company believes RAB001d has the potential to become the world’s first approved DMOAD therapy, addressing a significant unmet clinical need in the global osteoarthritis treatment market.