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

AstraZeneca's First Innovative Product in the Field of Autoimmunity in China Approved in the Greater Bay Area

October 21, 2024——AstraZeneca announced today that Saphnelo (Anifrolumab) has been officially approved by the Guangdong Provincial Medical Products Administration and introduced to the designated medical institutions under the Greater Bay Area's "Hong Kong-Macao Medicine and Device Connect" 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 but still show inadequate response. Thanks to the Greater Bay Area’s "Hong Kong-Macao Medicine and Device Connect" policy, Anifrolumab has recently been initially implemented at The University of Hong Kong-Shenzhen Hospital.

Avrilumab is the world's first and only* approved targeted drug for SLE that targets the Type I interferon pathway.¹Type I interferon pathway is a key mechanism driving the occurrence and development of SLE. Avolimumab, by targeting and binding to the type I interferon receptor, can simultaneously block the effects of multiple subtypes of type I interferons, thereby achieving therapeutic effects for SLE. Studies show that avolimumab can improve clinical manifestations in patients, reduce disease activity, decrease disease recurrence, and help patients achieve better disease prognosis.²。

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.³In China, the prevalence of SLE is 30-70 per 100,000 people, and it mostly occurs in women of childbearing age, with the female onset age typically between 15-40 years.⁵Hormone therapy has always been a part of the treatment cycle for SLE patients with mild, moderate, and severe disease levels.⁵, but its side effects cannot be ignored. SLE patients who take hormones over a long period are not only prone to osteoporosis and fractures⁵, which will also weaken the body's inherent immune system defense⁴, increasing the risk of infection, which has become the leading cause of death for SLE patients in China.⁵The advent of Afilimumab has brought a new treatment option for SLE patients who have long suffered from the disease.

Professor Zeng Xiaofeng, Leading PI of the AZALEA Phase III Clinical Trial in Asia, from Peking Union Medical College Hospital"SLE is a common autoimmune rheumatic disease, but currently, there is a significant lack of drugs in clinical practice that can balance efficacy and safety. Avolimumab is a monoclonal antibody targeting the Type I interferon receptor and also an innovative drug with a new target. The approval of avolimumab for early use in the Greater Bay Area under the 'Hong Kong-Macao Medicine and Device Pilot Program' is great news for both SLE patients and clinicians. Additionally, the Phase III clinical trial of avolimumab in Asia, the AZALEA study, is currently underway in China. It is hoped that this drug will soon receive full approval to benefit more SLE patients!"

Professor Zhang Lijun, Director of the Rheumatology and Immunology Department at The University of Hong Kong-Shenzhen Hospital"It is difficult to avoid the side effects brought by long-term use of hormones in the clinical treatment of SLE. We are very glad that our hospital has been able to introduce the breakthrough innovative therapy, Avolimumab, through the 'Hong Kong-Macao Medicine and Device Connect'. We look forward to patients being able to better control disease activity, improve prognosis, and enhance quality of life with the help of this drug. We also hope that Avolimumab can be officially approved in mainland China as soon as possible, bringing more innovative treatment options to Chinese SLE patients."

Chen Xi, Vice President of AstraZeneca China, Head of Respiratory, Autoimmune Biopharmaceuticals, Vaccines and Immunotherapy Division"AstraZeneca has been deeply rooted in the Chinese market for over 30 years, always adhering to a patient-centered approach and focusing on unmet healthcare needs of Chinese patients. Avacopan is AstraZeneca's first innovative product in the field of autoimmune diseases in China, and we are delighted to see it being introduced to the Greater Bay Area through the 'Hong Kong-Macao Drug and Device Access' fast track. This allows patients with systemic lupus erythematosus in Guangdong-Hong Kong-Macao and even other regions of China to access 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."

Sandy Wu, General Manager of AstraZeneca Hong Kong and Macao, China"The Greater Bay Area has a solid foundation and broad prospects for development in the biomedicine and health industry. Thanks to the 'Cross-Border Pharmaceutical and Medical Device Policy,' medical resources in Guangdong, Hong Kong, and Macao are crossing regional boundaries, becoming closely connected, and accelerating benefits for residents of the Greater Bay Area. AstraZeneca is actively supporting the government's efforts 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."

Avalumab 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).⁵, and was successively launched in Japan in September 2021 and February 2022.⁶And the EU⁷Approved for marketing, December 2022 in Hong Kong, China⁸Approved for marketing. Since 2022, AstraZeneca has been filing product marketing applications worldwide.

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About Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that can affect multiple organs and systems, including the kidneys, cardiovascular system, lungs, nervous system, digestive system, blood system, and eyes. Its serum contains various autoantibodies, such as antinuclear antibodies, anti-dsDNA antibodies, and anti-Sm antibodies. In China, the prevalence of SLE is 30-70 per 100,000 people, with a higher incidence in females, particularly women of childbearing age between 15-40 years.⁵。

In China, despite standard treatment, SLE still exhibits poor disease control, low target achievement rates, high recurrence rates, and persistently high doses of corticosteroids. There remains a need to develop new therapies that can reduce overall disease activity, decrease the combined use of oral corticosteroids (OCS), minimize disease flares and complications, and lower the risk of long-term organ damage.

About Avelumab

Avalumab is a fully human monoclonal antibody that can bind with high specificity and affinity to subunit 1 of the type I interferon receptor, inhibiting type I IFN signaling and thereby blocking the activation of the type I interferon pathway.⁹Type Ⅰ interferons such as IFN-α, IFN-β, and IFN-κ are cytokines involved in regulating the SLE pathway.^{10,11,12,13,14}Most adult SLE patients exhibit increased type I interferon signaling, which is associated with heightened disease activity and severity.¹⁵。

*As of October 17, 2024

Disclaimer: This drug has not been approved in China; this drug can only be used in designated hospitals in the Greater Bay Area that have obtained the license to use this drug. AstraZeneca does not recommend the use of any unapproved drugs.

Source: Press Release (Internal Approval Number: CN-143832)

References:

1.Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus (astrazeneca.com)

2.Morand E, et al. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020;382(3):211-221. Accessed July 2021.

3. Zeng Xiaofeng, et al. Guidelines for the Diagnosis and Treatment of Systemic Lupus Erythematosus [J]. Chinese Journal of Internal Medicine, July 2023, Vol. 62, No. 7

4. Guidelines for the Clinical Application of Glucocorticoid Drugs (2023 Edition) [J]. Chinese Journal of Endocrinology and Metabolism, 2023, 39(4): 289-296.

5.Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus (astrazeneca.com)

6.Saphnelo approved in Japan for systemic lupus erythematosus (astrazeneca.com)

7.Saphnelo approved in the EU for the treatment of moderate to severe systemic lupus erythematosus (astrazeneca.com)

8.SAPHNELO Hong Kong Registered Pharmaceutical Product Search https://www.drugoffice.gov.hk/eps/drug/productDetail2/tc/consumer/148801

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10.Lauwerys BR, et al. Type I interferon blockade in systemic lupus erythematosus: where do we stand? Rheumatol. 2014;53:1369-1376. Accessed July 2021.

11.Sarkar MK, et al. Photosensitivity and type I IFN responses in cutaneous lupus are driven by epidermal-derived interferon kappa. Ann Rheum Dis. 2018;77:1653-1664. Accessed July 2021

12.Mai L, et al. The baseline interferon signature predicts disease severity over the subsequent 5 years in systemic lupus erythematosus. Arthritis Res Ther. 2021;23:29. Accessed July 2021.

13.López de Padilla CM, et al. The Type I Interferons: Basic Concepts and Clinical Relevance in Immune-mediated Inflammatory Diseases. Gene. 2016;576(101):14-21. Accessed July 2021.

14.Rönnblom L, et al. Interferon pathway in SLE: one key to unlocking the mystery of the disease. Lupus Sci Med. 2019;6(1):e000270. Accessed July 2021.

15.Crow MK. Type I Interferon in the Pathogenesis of Lupus. J Immunol. 2014;192(12):5459-5468. Accessed July 2021