AstraZeneca (AZ, NASDAQ: AZN), a leading UK pharmaceutical company, has announced that its drug Saphnelo (anifrolumab) has been approved by the Guangdong Medical Products Administration (MPA) bureau to be included in medical institutions as part of the “Hong Kong-Macau Drug and Device Access” policy. This policy, within the Greater Bay Area framework, allows patients to access drugs across Hong Kong, Macau, and various cities in Guangzhou. Saphnelo is indicated as an add-on therapy for adult patients with moderate to severe active, autoantibody positive systemic lupus erythematosus (SLE) who cannot control their disease with standard treatment. The drug has been applied in the University of Hong Kong – Shenzhen Hospital.
Saphnelo is the world’s first and only approved treatment for SLE that targets the type I interferon pathway, a significant mechanism driving the occurrence and development of SLE. By targeting the type I interferon receptor, the drug can block the effects of multiple subtypes of type I interferons, achieving therapeutic effects on SLE. Studies have demonstrated that Saphnelo can improve patient clinical performance, reduce disease activity, decrease disease recurrence, and help patients achieve better disease prognosis.
First approved to treat moderate to severe SLE in the US in July 2021, Saphnelo has since gained approval in Japan, the European Union, and Hong Kong. Market filings for the drug have been made worldwide since 2022, expanding access to this innovative therapy for patients with SLE.- Flcube.com
