SHANGHAI, China I February 29, 2024 I Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications (sNDAs) of its adalimumab biosimilar HANDAYUAN for the treatment of polyarticular juvenile idiopathic arthritis,pediatric plaque psoriasis and other indications have been accepted by the National Medical Products Administration (NMPA),bringing new hope to pediatric patients and their families. As of now, HANDAYUAN has been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis  and uveitis.

Autoimmune diseases are a group of diseases caused by the body’s immune system attacking its own organs or tissues[1]. It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases[2]. Currently, autoimmune diseases are difficult to cure, and once it occurs, most patients need long-term to lifelong medication. Some autoimmune diseases are particularly dangerous and severely affect the quality of life of patients, posing a threat to their lives and causing significant burden. Tumor necrosis factor-α (TNF-α) is one of the major cytokines that induce inflammation and other immune responses. It plays a key role in the pathogenesis of a variety of autoimmune diseases[3]. It has been proven that many autoimmune diseases such as rheumatoid arthritis, psoriasis and ankylosing spondylitis are closely related to TNF-α. Adalimumab, a humanized anti-TNF-α monoclonal antibody, can specifically bind to TNF-α and block its interaction with TNF receptors p55 and p75, thereby effectively inhibiting the activity of TNF-α and providing effective and long-lasting control of a variety of autoimmune diseases. With its good efficacy and safety in the treatment of autoimmune diseases, adalimumab has quickly replaced glucocorticoids and nonsteroidal anti-inflammatory drugs as one of prime choices in clinical practice. It has received recommendations from many global authoritative clinical treatment guidelines for autoimmune diseases, including the American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis and the AAD-NPF Guidelines for the Treatment of Psoriasis with Biologics.

HANDAYUAN is a monoclonal antibody biosimilar developed by Henlius in accordance with the Technical Guidelines for R&D and Evaluation of Biosimilars (Trial) and is also Henlius‘ first product approved for the treatment of autoimmune diseases. It received support from the National Science and Technology Major Project (China-Major New Drug Research & Development Project) during the 12th & 13th Five-Year Plans. On the other hand, HANDAYUAN has taken multiple head-to-head comparison studies to the originator adalimumab. Results from the pharmaceutical comparison studies, non-clinical studies and clinical studies showed that HANDAYUAN is highly similar to the originator adalimumab in terms of quality, safety, and efficacy. In December 2020, HANDAYUAN was approved by the NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. In addition, Henlius also submitted the sNDA for the treatment of uveitis and was approved in March 2021, providing a new treatment option for ophthalmology.

Currently, the commercialization of HANDAYUAN in China is handled by Wanbang Pharma which has a sizeable department of rheumatology and immunization and a mixed-line sales team serving the broad market, with successful commercialization experience in autoimmune diseases. Up to date, HANDAYUAN has been included in the national medical insurance catalogue. It has completed tendering process on the procurement platform in 29 provinces and is included into the medical insurance procurement platform in all provinces in Chinese mainland. As more indications submitted and approved of HANDAYUAN, Henlius will deepen the cooperation with Wanbang Pharma to further promote its commercialization to fulfill every patient’s needs.

Looking forward, Henlius will adhere to the principle of patient centricity and take innovation as the driving force to explore and provide patients with more high-quality and affordable biological medicines and maximize the benefits for Chinese patients with autoimmune diseases.


[1] Goodnow C C. Multistep pathogenesis of autoimmune disease[J]. Cell, 2007, 130(1): 25-35.  

[2] Cooper G S, Bynum M L K, Somers E C. Recent insights in the epidemiology of autoimmune diseases: improved prevalence estimates and understanding of clustering of diseases[J]. Journal of autoimmunity, 2009, 33(3-4): 197-207.

[3] Silva L C R, Ortigosa L C M, Benard G. Anti-TNF-α agents in the treatment of immune-mediated inflammatory diseases: mechanisms of action and pitfalls[J]. Immunotherapy, 2010, 2(6): 817-833.

SOURCE: Shanghai Henlius Biotech