Pfizer Launches New XELJANZ® Family Products Nationwide at the 3rd China JAK Summit

BeijingMay 10, 2022PR Newswire -- On May 8, 2022, the Third China JAK High-level Forum hosted by Pfizer, themed "Targeting a New Pattern, Leading a New Era," was grandly held alongside the national launch event for Xeljanz CR and AS indication in China. Professor Zeng Xiaofeng and Professor Zhao Yan from the Department of Rheumatology and Immunology at Peking Union Medical College Hospital served as the conference chairs and delivered keynote speeches. Professor Janet Pope from St. Joseph's Health Care London, Western University of Canada, joined leading experts and scholars in the field of rheumatology and immunology in China to conduct comprehensive and multi-dimensional discussions on global clinical advancements and academic achievements of JAK inhibitors, safety hotspots, and more. Together, they witnessed the launch of Pfizer’s innovative product for treating rheumatoid arthritis (RA) -- Tofacitinib Citrate Extended-Release Tablets -- and the new indication for Xeljanz in treating ankylosing spondylitis (AS) in China. These developments provide new treatment options for RA and AS patients while ushering in a new chapter in rheumatic disease treatment, leading the new era of JAK-targeted control, and continuously advancing the development of rheumatology and immunology in China to benefit more patients.

Over 10 Million Patients Affected by RA and AS, JAK Inhibitors Bring New Breakthrough in Treatment

Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) are common rheumatic immune diseases characterized by multi-system and multi-organ involvement as well as high disability rates. Patients not only suffer from pain, functional limitations, fatigue, but also often experience negative emotions such as insomnia, depression, and anxiety. These conditions significantly impact daily learning, work, and life, imposing a tremendous disease burden on patients, families, and even the entire society. Data shows that the total number of RA and AS patients in China exceeds 10 million.^[1],[2]。

Currently, commonly used treatments for RA/AS include non-steroidal anti-inflammatory drugs (NSAIDs), conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), glucocorticoids, biologics, and traditional Chinese medicine, among others. Existing treatment methods still have many unmet needs, such as the insufficient efficacy of csDMARDs and the inconvenience of using biologics during the pandemic. Additionally, poor adherence is a significant challenge faced by RA/AS patients in China, which negatively impacts treatment outcomes. There is an urgent clinical need for more treatment options to meet the comprehensive needs of patients.

In recent years, with the advancement of medical technology and in-depth research into rheumatic immune diseases, the discovery of the JAK-STAT pathway and the application of JAK inhibitors have provided groundbreaking treatment options for rheumatic immune diseases. As the world's first JAK inhibitor in the field of rheumatology, Xeljanz (尚杰) entered China in 2017, officially starting China’s JAK journey. By blocking the JAK-STAT pathway, JAK inhibitors can directly or indirectly block the signal transduction of various RA/AS-related cytokines, thereby suppressing inflammation and slowing disease progression. Compared to biologics, JAK inhibitors comprehensively suppress multiple inflammatory factors, avoiding the ceiling effect of single-target biologics, reducing trial-and-error costs for patients, and leading RA and AS into a new era of small-molecule targeted therapy.

Pfizer's Family in China Welcomes New Member, Offering Patients a Minimalist New Choice

As the world's first pharmaceutical company to develop JAK inhibitors for the treatment of inflammatory and immune diseases, Pfizer has been deeply engaged in JAK inhibitor research and development for nearly 30 years. In 2017, Xeljanz, the world’s first JAK inhibitor,^®Approved in China for the treatment of moderate to severe rheumatoid arthritis, after 5 years, the second indication – ankylosing spondylitis – and a new formulation – Xeljanz sustained-release tablets – have been approved for marketing in China, bringing a new treatment option to patients with rheumatic diseases.

Professor Zhang Zhiyi from the Rheumatology and Immunology Department of the First Affiliated Hospital of Harbin Medical University introduced: "Xeljanz is the first and only orally administered small-molecule targeted drug approved in China for the treatment of AS. Its novel mechanism provides clinical experts with a new treatment option, meeting patients' needs for oral therapy. The Phase III clinical study of Xeljanz for AS was a randomized, double-blind, placebo-controlled trial conducted across 75 centers in 14 countries, with Chinese patients accounting for approximately 18% of the enrolled participants. Additionally, the Tofacitinib Citrate Extended-Release Tablets launched this time represent the world's first extended-release JAK inhibitor, taken once daily, one tablet at a time, making it more suitable for patient disease management under the normalized conditions of the pandemic. I am very pleased to see Xeljanz."^® AS Indications and the Launch of Tofacitinib Sustained-Release Tablets in China, Looking Forward to Xeljanz^®"Family brings more treatment options to clinical experts and new hope to RA and AS patients."

"JAK inhibitors, as a new type of oral small-molecule targeted drug, have been on the global market for 10 years and have been available in China for 5 years, receiving widespread attention and importance in the field of rheumatology both domestically and internationally. The clinical evidence and experience with their application are becoming increasingly abundant, promoting the development of the rheumatology immunology discipline, with their clinical value becoming more prominent, gradually becoming one of the preferred second-line treatments for RA/AS." Professor Zeng Xiaofeng from the Department of Rheumatology and Immunology at Peking Union Medical College Hospital stated: "The domestic launch of Xeljanz CR tablets and the AS indication this time will further diversify the treatment options for RA/AS in China, providing patients with advanced and cutting-edge innovative therapies to help RA/AS patients achieve target treatment. In the future, it will be an era where small-molecule targeted drugs and biologics soar together. The JAK Summit Forum hosted by Pfizer has become an academic platform highly regarded by experts in China for discussing the application and development of JAK. We look forward to Pfizer continuing to collaborate with peers in the rheumatology field to explore broader applications of JAK inhibitors in the area of rheumatology immunology diseases; continuously improving the standardized diagnosis and treatment level of rheumatology immunology diseases in China, jointly promoting the development of the discipline, and benefiting Chinese rheumatology immunology patients."

^[1]Zhao J , Huang C , Huang H , et al. Prevalence of ankylosing spondylitis in a Chinese population: a systematic review and meta-analysis[J]. Rheumatology International.2020. 40:859-872.

^[2]Zeng Xiaofeng, Zhu Songlin, Tan Aichun, et al. Systematic Review of the Disease Burden and Quality of Life in Rheumatoid Arthritis in China[J]. Chinese Journal of Evidence-Based Medicine, 2013, 13(3): 300-307. DOI: 10.7507/1672-2531.20130052.