Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, has announced a strategic expansion in bone health pipeline with the in-licensing of RP901, a potential first-in-class small molecule drug. Its wholly-owned subsidiary, T-mab Bio, has entered into a licensing agreement with Risen (Suzhou) Pharmaceutical Technology Co., Ltd. (Risen Pharma) for RP901. Under the terms of the agreement, Risen Pharma has granted T-mab Bio the rights to research, develop, register, commercialize, and market RP901 and its accompanying diagnostics within the Greater China region, encompassing Mainland China, Hong Kong, Macau, and Taiwan.

RP901 is poised to revolutionize osteoarthritis treatment as a Class I novel drug, administered orally to accumulate in the joint cavity where it can mitigate cartilage destruction. By promoting anabolism and curbing catabolism of joint cartilage, RP901 has demonstrated potent bone protection and therapeutic effects in osteoarthritis patients. Preclinical studies have underscored its high oral bioavailability in rats and monkeys, and isotopically labeled studies have demonstrated that it is well-distributed within the bone joint, while safety profiles from preclinical and Phase I clinical trials have been reassuring. The ongoing Phase II clinical trials in China for RP901 tablets are set to further validate its efficacy in treating knee osteoarthritis.

Mabwell's existing bone health portfolio includes MAIWEIJIAN for bone tumors and MAILISHU for osteoporosis. The addition of RP901 through this licensing agreement is a testament to Mabwell’s commitment to advancing bone health solutions, marking a significant step in broadening its therapeutic offerings in this domain.

Osteoarthritis (OA) is a chronic degenerative joint disease characterized by pain, often due to the deterioration of cartilage. Predominantly affecting the middle-aged and older population, it presents clinically with joint pain, deformity, and limited mobility. Despite its prevalence, no effective Disease-Modifying Osteoarthritis Drugs (DMOADs) are available.

China's aging population and rising obesity rates, driven by economic growth, are key contributors to the increasing incidence of OA. This demographic shift is expanding the market for OA treatments, with expectations of continued growth and a significant demand for effective therapies.