Kexing Biopharm and Sinotherapeutics Reach Cooperation Agreement to Expand Overseas Markets for FDA-Approved Tofacitinib Product

Article source：Jun 24,2026View： 708

Recently, Kexing Biopharm (688136.SH) and Sinotherapeutics (688247.SH) signed an exclusive commercialization licensing agreement for Tofacitinib Citrate Sustained-Release Tablets in the Kuwait and Mexico markets, jointly advancing the product’s expansion into international markets.

Introducing an FDA-Approved Product to Address the Growing Autoimmune Disease Market

Tofacitinib Citrate Sustained-Release Tablets are an oral small-molecule Janus kinase (JAK) inhibitor and a widely used disease-modifying antirheumatic drug (DMARD) in clinical practice. The product is indicated for adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. It is also indicated for autoimmune diseases such as psoriatic arthritis and ankylosing spondylitis. The extended-release formulation enables once-daily dosing, helping improve patient adherence.

Developed by Sinotherapeutics, Tofacitinib Citrate Extended-Release Tablets received approval from the U.S. Food and Drug Administration (FDA) on September 30, 2025 (ANDA No. 216001). As a high-quality oral extended-release product, this successful collaboration reflects Kexing Biopharm’s global product selection strategy characterized by its “Three Highs and One Fast” standard: high clinical value, advanced technological capabilities, high international quality management and regulatory standards, and rapid commercialization.

Accelerating Overseas Commercialization and Diversifying the Product Portfolio

Having cultivated international markets for many years, Kexing Biopharm has established a commercialization network covering approximately 70 countries and regions worldwide. In recent years, the company has strengthened partnerships with leading Chinese pharmaceutical enterprises to promote the global expansion of high-quality Chinese biopharmaceutical products. It has secured overseas commercialization rights for more than 30 products across key therapeutic areas, including oncology, diabetes, and autoimmune diseases, creating a diversified and product pipeline.

Through its continuously evolving global pharmaceutical commercialization platform, Kexing Biopharm has leveraged its strength in simultaneous multi-country registrations to support the overseas approval and launch of high-quality medicines such as Albumin-Bound Paclitaxel, Infliximab, and Liraglutide. This new partnership further strengthens the company’s product portfolio in both the Middle East and Latin American markets.

Looking ahead, Kexing Biopharm will continue to leverage its global resource integration capabilities, deepen its presence in international pharmaceutical markets, and deliver high-quality medicines to patients worldwide.