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Changzheng Xinkai’s Ainuohua Gets SFDA Approval For Treating Lupus Nephritis

This article was originally published in PharmAsia News

Executive Summary

Suzhou Changzheng Xinkai Pharmaceutical has received China's State FDA approval for its Ainuohua (leflunomide tablets), representing the first drug for the treatment of lupus nephritis to be launched in China. In 2000, Changzheng Xinkai applied to expand the drug's indication for adult rheumatic arthritis to lupus nephritis. In 2002, Peking University First Hospital and nine other authoritative healthcare institutions launched a five-year multicenter, controlled clinical trial. The trial results show that Ainuohua achieved an overall response rate of 80 percent in relieving lupus nephritis, effectively reduced 24-hour urine protein and Systemic Lupus Erythematosus Disease Activity Index score, and increased serum albumin and complement level. Particularly noteworthy is the drug's safety and ability to reverse some patients' renal pathological changes. (Click here for more - Chinese Language)



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