Thanks to the "Hong Kong Macau Medical Device Connect" policy in the Greater Bay Area, the first batch of Afulimumab has recently landed at the University of Hong Kong Shenzhen Hospital. AstraZeneca announced today that Saphnelo (Anifrolumab/Afulimumab) has been approved by the Guangdong Provincial Drug Administration and officially introduced into designated medical institutions in the Guangdong Hong Kong Macao Greater Bay Area for use as an additional therapy for adult patients with moderate to severe active systemic lupus erythematosus who still have positive autoantibodies and receive standard treatment.
Professor Zeng Xiaofeng, the lead PI of AZALEA Phase III clinical study in Asia and a professor at Peking Union Medical College Hospital, stated that systemic lupus erythematosus is a common autoimmune rheumatic disease, but currently there is a severe lack of drugs that can balance efficacy and safety in clinical practice. Afulimumab is a monoclonal antibody that targets type I interferon receptors and is also a novel targeted drug. The approval of early use of afliumab in the Greater Bay Area through the 'Hong Kong Macau Medical Device Connect' policy is good news for SLE patients and clinical doctors. In addition, the AZALEA phase III clinical study of afliumab in Asia is also underway in China, and we hope that the drug can be fully approved as soon as possible
The side effects caused by long-term use of hormones are an unavoidable issue in the clinical treatment of SLE. We are pleased that we have been able to introduce the breakthrough innovative therapy of afliumab through the 'Hong Kong Macau Medical Device Connect'. We hope that with the help of this drug, patients can better control disease activity, improve prognosis, and enhance their quality of life, "said Professor Zhang Lijun, Director of the Rheumatology and Immunology Department at the University of Hong Kong Shenzhen Hospital.
Chen Xi, Vice President of AstraZeneca China and Head of the Respiratory and Autoimmune Biopharmaceuticals, Vaccines, and Immunotherapy Business Unit, stated that Afulimumab is AstraZeneca's first innovative product in the field of autoimmunity in China, and they are pleased to be able to land in the Greater Bay Area through the "Hong Kong Macau Medical Device Connect" fast track. Wu Shan, General Manager of AstraZeneca in Hong Kong and Macau, stated that the Greater Bay Area has a solid foundation and broad prospects for the development of the biopharmaceutical and health industries. Thanks to the "Hong Kong Macau Medical Device Connect" policy, the pharmaceutical resources of Guangdong, Hong Kong, and Macau are rapidly benefiting residents in the Greater Bay Area.