Chinese Pharma Companies Rush to Capture $25 Billion Autoimmune Disease Drug Market

　　【Pharmaceutical Network Market AnalysisIn recent years, the market size of autoimmune disease drugs in China has continued to expand. Data shows that in 2022, the market size of autoimmune disease drugs in China reached 24.3 billion yuan. It is predicted that by 2030, this market size is expected to reach 25 billion US dollars, achieving a 10-fold increase compared to 2020.
 

Facing a vast market, pharmaceutical companies in China are also actively increasing their investments in the field of autoimmune disease drugs. Among them, Hengrui Pharma has laid out numerous pipelines in the autoimmune disease drug sector, targeting IL-17A, URAT1, MASP-2, IL-4Rα, TSLP, and others, for the treatment of psoriasis, ankylosing spondylitis, IgA nephropathy, atopic dermatitis (AD), and asthma.
 

Among them, ankylosing spondylitis is an autoimmune disease of unknown cause, characterized by chronic inflammation of the axial joints, and represents one of the common clinical types of spondyloarthritis. It has been reported that the New Drug Application for SHR0302 tablets, a JAK1 inhibitor developed by Hengrui Pharma, intended for adult patients with active ankylosing spondylitis who have had an inadequate response to or are intolerant of nonsteroidal anti-inflammatory drugs, has been accepted by the National Medical Products Administration.
 

Recently, Hengrui Pharma announced that the National Medical Products Administration has approved the clinical trial of its innovative drug Funaqizumab Injection (SHR-1314) for the treatment of children and adolescents aged 6 to less than 18 years with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy.
 

Hengrui Pharma's self-developed biologic product SHR-2173 injection was approved in May this year to commence clinical trials for IgA nephropathy, offering the potential for a new treatment option for patients. IgA nephropathy is a common primary glomerular disease with no specific therapy currently available. SHR-2173 injection aims to improve patient outcomes through its anti-inflammatory and immune-suppressing effects.
 

In addition to Hengrui Pharma, RemeGen is also actively expanding in the field of autoimmune disease drugs. Among them, Telitacicept, a self-developed product by the company, was approved for marketing in March 2021. This drug is an injectable recombinant B lymphocyte stimulator/proliferation-inducing ligand dual-target novel fusion protein product. In the field of autoimmune diseases, there are currently 8 indications at the commercialization or late-stage clinical trial phase.
 

Recently, IASO Bio announced that the IND application for its self-developed fully human BCMA-targeted chimeric antigen receptor autologous T-cell injection (Equecabtagene Autoleucel Injection) has received tacit approval from the U.S. FDA for the treatment of non-renal systemic lupus erythematosus and lupus nephritis. This marks the fifth clinical approval the product has received in the field of autoimmune diseases in both China and the U.S. Previously, Equecabtagene Autoleucel Injection obtained IND approval in the U.S. for two autoimmune diseases, myasthenia gravis and multiple sclerosis, and in China for neuromyelitis optica spectrum disorder (NMOSD) and myasthenia gravis. Additionally, in June 2023, Equecabtagene Autoleucel Injection was approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory multiple myeloma who have progressed after at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent).
 

Yisaipu, a TNF-α inhibitor developed by 3SBio, has been on the market for many years. Known as an evergreen product of 3SBio, Yisaipu has been available for 19 years and is a tumor necrosis factor (TNF-α) inhibitor in China's rheumatology field. Due to its efficacy and first-mover advantage, sales grew rapidly after its launch, bringing significant revenue to 3SBio and driving the company to achieve positive revenue growth for 12 consecutive years. In 2023, Yisaipu's revenue in China increased by 10.50% year-on-year.
 

In addition, Junshi Biosciences owns Adalimumab biosimilar Junmai Kang; CSPC is conducting pivotal Phase II/III clinical trials for CM310 in the treatment of moderate to severe asthma; Quanxin Biologics' Ustekinumab biosimilar QX001S has been accepted for marketing application; Zhirong Jintai's Selicrelumab, targeting moderate to severe plaque psoriasis, is the first domestically produced IL-17 class drug to submit a new drug marketing application.
 

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