Shanghai, China, May 22, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the supplemental new drug applications of its independently developed adalimumab biosimilar HANDAYUAN for the four new indications of polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, Crohn’s disease and pediatric Crohn’s disease have been approved by the National Medical Products Administration (NMPA), providing more treatment options for adult and pediatric patients with autoimmune diseases in China. HANDAYUAN has previously been approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. To date, HANDAYUAN has been approved for eight indications in China, covering all indications of originator adalimumab in China.

It is estimated that approximately 7.6%-9.4% of the global population suffers from various types of autoimmune diseases ^[1]. TNF-α (tumor necrosis factor-α) plays a key role in the pathogenesis of a variety of autoimmune diseases ^[2]. It has been proven that many autoimmune diseases such as rheumatoid arthritis, psoriasis, Crohn’s disease and ankylosing spondylitis are closely related to TNF-α. Adalimumab, a fully humanized anti-TNF-α monoclonal antibody, can reduce the immune response activated by TNF-α through specific binding to TNF-α, thus effectively reducing the inflammatory response and providing effective and long-lasting control of a variety of autoimmune diseases. Adalimumab 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 NMPA Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative) and is also Henlius’ first product approved for the treatment of autoimmune diseases. 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 April 2021, HANDAYUAN was approved for the treatment of non-infectious uveitis, providing a new treatment option for ophthalmology. The addition of the four approved indications this time further expands the therapeutic area to the gastroenterology and pediatrics.

In addition, Henlius is also actively working with partners to expand domestic and overseas markets. Currently, the commercialization of HANDAYUAN in China is handled by Wanbang Pharma. 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, benefiting about 80,000 Chinese patients. In respect of HANDAYUAN, we have established the first whole-course care platform “Da’en Home” targeted for autoimmune patients in China, with an aim to realise the whole-course management of patients from medical treatment to rehabilitation, and have launched the “ASSC Ankylosing Spondylitis Standardised Treatment Project” in collaboration with the National Clinical Research Centre for Skin and Immune Diseases, continuing to bring more benefits to Chinese patients. In 2022, Henlius entered into a collaboration with Getz Pharma to commercialize HANDAYUAN in 11 emerging markets in Asia, Africa and Europe, such as Pakistan, the Philippines, Kenya, etc., bringing affordable and high-quality therapeutic solutions to patients in more countries and regions around the world.

In the future, Henlius will continue to be patient-centered, address unmet clinical needs with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Based on its integrated industrial chain of R&D, manufacturing, and commercialization, Henlius will provide patients with more high-quality and affordable biological medicines, and at the same enhance the accessibility of its products, thus benefiting more autoimmune disease patients.

Reference

[1] 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.
[2] 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.