(Yicai) Feb. 5 -- AstraZeneca’s application to bring its new lupus drug anifrolumab, which treats adult Asian patients with the autoimmune disease systemic lupus erythematosus, to the Chinese market is currently under review, the UK pharmaceutical giant told Yicai recently.

Recent Phase III clinical trial results for anifrolumab showed that, among Asian adults with moderate to severe SLE, the drug delivered statistically and clinically meaningful improvements compared with a placebo, Cambridge-based AstraZeneca said. Patients experienced reduced disease activity and were able to lower their use of oral glucocorticoids.

“The results confirm that anifrolumab can effectively reduce disease activity and cut reliance on oral steroids,” said Zeng Xiaofeng, chief physician in the department of rheumatology and immunology at Peking Union Medical College Hospital and head of the National Clinical Research Center for Rheumatic and Autoimmune Diseases.

SLE affects more than 3.4 million people worldwide, including around one million patients in China. While the disease remains incurable, it can be managed over the long term. Current treatments for lupus nephritis largely rely on steroids combined with immunosuppressants. Although oral glucocorticoids are often used to control symptoms, long-term use can trigger serious systemic side effects, making it difficult for many patients to achieve sustained disease control and reach remission.

The survival rate of patients with SLE has improved significantly in recent years, said Tian Xinping, another chief physician at Peking Union Medical College Hospital’s department of rheumatology and immunology. The 10-year survival rate has reached 90 percent and the 15-year survival rate can reach 80 percent. However, the 20-year survival rate drops sharply to roughly 60 percent, making it a critical turning point. This decline is due both to significant organ damage caused by disease relapses and the long-term effects of steroids and immunosuppressive drugs.

Notably, the US Food and Drug Administration recently rejected AstraZeneca’s application to market a subcutaneous version of anifrolumab, also known as Saphnelo, citing issues related to chemistry, manufacturing and quality controls.

AstraZeneca said on Feb. 3 that it has submitted additional materials in response to the FDA’s complete response letter and will work to “advance the application as quickly as possible.”

Editor: Kim Taylor