Med-Fine Family | Kehui Pharma's Class 1 New Drug ARD-885 Receives IND Approvals from NMPA and FDA for Rheumatoid Arthritis

About Rheumatoid Arthritis (RA)

RA is a common chronic, inflammatory, systemic autoimmune disease with a global incidence rate of 0.5% to 1%. Currently, there are over 5 million RA patients in China alone. RA is also a highly disabling disease and an important cause of disability among the Chinese population. As the disease progresses, the disability rate among RA patients continues to rise.

Currently, the conventional treatment drugs for RA are disease-modifying antirheumatic drugs (DMARDs), which include traditional synthetic DMARDs (csDMARDs) such as methotrexate, sulfasalazine, and leflunomide, as well as biological DMARDs (bDMARDs) such as TNFα inhibitors including monoclonal antibody drugs like adalimumab, infliximab, golimumab, and certolizumab pegol. These drugs have issues such as insufficient response rates or significant toxic side effects. In recent years, newly marketed targeted synthetic DMARDs (tsDMARDs) such as JAK inhibitors, including tofacitinib, baricitinib, and upadacitinib, have only achieved an efficacy rate of 30-40% and are accompanied by side effects. Therefore, under the current treatment conditions, the treatment needs of a large number of RA patients, especially those with moderate to severe active RA, are still not fully met, and there is an urgent need to develop RA drugs with new mechanisms.

About ARD-885

ARD-885 is a novel dual-target inhibitor developed by Artivila, targeting both IRAK4 and IRAK1. Its in vivo and in vitro efficacy surpasses that of similar single-target drugs, making it one of Artivila's core products. The successful IND application marks an important milestone in Artivila's new drug development.

ARD-885, as the first dual-target small molecule drug simultaneously targeting IRAK4 and IRAK1, has the potential to provide a new therapeutic strategy for patients with rheumatoid arthritis. Preclinical efficacy data show that ARD-885 can significantly improve clinical symptoms of arthritis in rats, inhibit arthritis clinical scores, reduce paw swelling volume, and dose-dependently improve pathological damage in joint tissues. Preclinical pharmacokinetic and toxicological studies indicate that ARD-885 exhibits favorable pharmacokinetics and safety.

In addition, apart from rheumatoid arthritis, ARD-885 can also expand its indications to other inflammatory and autoimmune diseases, and is expected to be used in cancer treatment, showing broad prospects for clinical development.

About Artivila

Artivila is a new drug research and development company based on an AI-powered innovative drug platform. Its unique data and computation-driven drug discovery platform (AI+HI) integrates artificial intelligence, cloud computing, cheminformatics, bioinformatics, drug design, and the team's extensive industry experience, significantly reducing R&D costs and shortening the R&D cycle. The company has an integrated AI/CADD R&D system and a top-tier team of scientists, with R&D primarily focused on neurodegenerative diseases, oncology, and autoimmune diseases. Artivila currently has five targeted innovative drugs in its pipeline that have reached the preclinical stage, and it has filed nearly 30 patent applications for inventions in China and globally.

Since its establishment, Artivila has completed multiple rounds of financing, gaining recognition from numerous biopharmaceutical professional investors and comprehensive funds, providing a solid guarantee for the company's rapid and steady development. The company's research projects and platform technologies have also received recognition and support from various parties, and have won awards in innovation and entrepreneurship competitions multiple times, including the first prize in the biopharmaceutical category of the "Longgang Dual Innovation Star" competition, the Excellent Enterprise Award of the China Innovation and Entrepreneurship Competition, and the "Top 50 Innovative Enterprises in China," among others.

Artivila, Diligent and Innovative, Committed to Changing the Fate of Patients Worldwide!