China's NMPA Accepts Everest Medicines' Filing to Move VELSIPITY Production Onshore

On September 17, Everest Medicines announced that the Center for Drug Evaluation of China's National Medical Products Administration has accepted its marketing registration application to transfer production of VELSIPITY (etrasimod arginine tablets) from overseas to China, and that the application has been included in the priority review and approval procedure. The local manufacturing project for VELSIPITY was launched in March 2025 at Everest Medicines' global production base in Jiashan, Zhejiang.

Once production begins, annual capacity is expected to reach up to 50 million tablets, which is intended to improve the supply capacity and stability of VELSIPITY in China and the Asia-Pacific market, and to help lower production costs and raise operational efficiency. The base has established a GMP quality management system that complies with Chinese, European Union and WHO standards, and has obtained a production licence issued by the National Medical Products Administration. VELSIPITY is a once-daily oral, highly selective S1P receptor modulator that targets mucosal healing. Mucosal healing is one of the treatment goals in ulcerative colitis, and achieving it early can help reduce relapse rates, hospitalisation rates, surgery rates and the risk of cancer.

The drug promotes mucosal healing by controlling intestinal inflammation, offering an oral treatment option for patients with moderately to severely active ulcerative colitis. VELSIPITY was approved by the National Medical Products Administration in February 2026 for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or are intolerant to conventional therapy or a biologic agent. In March 2026, the first prescription for VELSIPITY was written, marking its entry into clinical use in China, and it took part in the 2026 national medical insurance catalogue negotiations.

Continued treatment for three years can maintain long-term stable efficacy; patients who have received only conventional 5-ASA/thiopurine therapy and those previously treated with biologics can both continue to benefit; patients with mild to moderate ulcerative colitis have also shown treatment benefit; and five-year long-term safety and tolerability are favourable.