Saphnelo (Anifrolumab), First-in-Class Therapy for Systemic Lupus Erythematosus, Officially Launched in Guangdong-Hong Kong-Macao Greater Bay Area

China Finance and Economics News, October 21st: AstraZeneca announced today that Saphnelo (Anifrolumab) has been officially approved by the Guangdong Provincial Drug Administration for introduction to designated medical institutions in the Greater Bay Area under the Pharmaceutical and Medical Device Connectivity Program. It will be used as an add-on therapy for adult patients with moderate to severe active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard treatment.

Thanks to the "Hong Kong-Macao Medicine and Device Access Policy" in the Greater Bay Area, Avelumab has recently been introduced at the University of Hong Kong Shenzhen Hospital.

Avuliyu Monoclonal Antibody is the world's first and only* approved targeted drug for SLE treatment that targets the Type I interferon pathway. The Type I interferon pathway is a key mechanism driving the onset and progression of SLE. By specifically binding to the Type I interferon receptor, Avuliyu Monoclonal Antibody can simultaneously block the effects of multiple subtypes of Type I interferons, thereby achieving therapeutic effects for SLE. Studies show that Avuliyu Monoclonal Antibody can improve clinical manifestations in patients, reduce disease activity, decrease disease recurrence, and help patients achieve better disease prognosis.

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease, characterized by the presence of various autoantibodies in the serum, affecting multiple organs and systems throughout the body, including the skin, mucous membranes, kidneys, cardiovascular system, lungs, nervous system, digestive system, hematological system, and eyes. In China, the prevalence of SLE is 30-70 per 100,000 people, and it predominantly affects women of childbearing age, with most female patients being between 15-40 years old.

Professor Zeng Xiaofeng from Peking Union Medical College Hospital, the Leading Principal Investigator (Leading PI) of the AZALEA Phase III clinical trial in Asia, stated that systemic lupus erythematosus is a common autoimmune rheumatic disease, but currently, there is a significant lack of drugs that can balance efficacy and safety in clinical practice. Avrilumab is a monoclonal antibody targeting the type I interferon receptor and represents an innovative drug with a new therapeutic target. "The approval of Avrilumab for early use in the Greater Bay Area under the 'Hong Kong-Macao Drug and Device Access' policy is good news for both SLE patients and clinicians. Additionally, the Phase III clinical trial of Avrilumab in Asia, the AZALEA study, is currently underway in China. We hope this drug can receive full approval as soon as possible to benefit more SLE patients!"

"The side effects brought by long-term use of hormones are an unavoidable issue in the clinical treatment of SLE. I am very pleased that our hospital has been able to introduce the breakthrough innovative therapy, Avolimumab, through the 'Hong Kong-Macao Medicine and Device Connect' program. We look forward to patients being able to better control disease activity, improve prognosis, and enhance their quality of life with the help of this drug. We also hope that Avolimumab will be officially approved in mainland China as soon as possible, bringing more innovative treatment options to Chinese SLE patients," 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, Autoimmune Biopharmaceuticals, Vaccines, and Immunotherapy Division, stated that Avulizumab is AstraZeneca's first innovative product in the autoimmune field in China. He expressed delight at its rapid implementation in the Greater Bay Area through the "Hong Kong-Macao Medicine and Device Access Scheme," providing patients with systemic lupus erythematosus in Guangdong-Hong Kong-Macao and other regions of China access to world-leading treatment options. "In the future, we will continue to accelerate R&D innovation, strengthen our product pipeline, and actively expand early access to innovative drugs, further improving the survival and quality of life for patients with autoimmune diseases in China."

AstraZeneca's General Manager for China, Hong Kong, and Macao, Wu Shan, stated that the Greater Bay Area (GBA) has a solid foundation and broad prospects for development in the biopharmaceutical and health industry. Thanks to the "Hong Kong-Macao Medicine and Device Connect" policy, pharmaceutical resources across Hong Kong, Macao, and Guangdong are transcending regional boundaries, becoming closely interconnected, and accelerating benefits for GBA residents. "AstraZeneca is actively supporting the government’s initiatives to accelerate the introduction of innovative drugs through concrete actions. We believe that as policies continue to advance, more innovative collaboration models will also benefit a wide range of patients in China."

Avrilumab was approved by the U.S. Food and Drug Administration (FDA) on July 30, 2021, for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), and subsequently received approval for marketing in Japan and the European Union in September 2021 and February 2022, respectively. It was also approved for marketing in Hong Kong, China, in December 2022. Since 2022, AstraZeneca has been progressively submitting product marketing applications worldwide.

　　*As of October 17, 2024