On April 12, 2021, Henlius (2696.HK) announced that the supplementary application (sNDA) of its independently developed Han Da Yuan® (HLX03, adalimumab injection) for the treatment of non-infectious intermediate, posterior and total uveitis in adults had recently been officially approved by the National Medical Products Administration (NMPA). This is the fourth approved indication of Han Da Yuan® in China following rheumatoid arthritis, ankylosing spondylitis and psoriasis.
Han Da Yuan® is a biosimilar independently developed by Henlius in accordance with China's biosimilars guidance, and also the first product of the Company to treat autoimmune diseases. In December 2020, Han Da Yuan was approved for marketing by NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis. Moreover, Henlius applied to NMPA for including non-infectious uveitis in the indications of Han Da Yuan® and further expanding the application of Han Da Yuan® to the field of ophthalmic treatment, which were accepted as the sNDA in January 2021. After marketing, Jiangsu Wanbang will be responsible for the commercial sales of Han Da Yuan® in China as it has a considerable scale of rheumatology and immunology business division and a mixed-line sales team for the broad market, which are equipped with high professional communication skills and a high level of medical knowledge and have successful commercialization experience of products in the field of anti-rheumatic therapy. Up to now, Han Da Yuan® has been officially included in the National Drug Catalog for Basic Medical Insurance, and has been sold online successfully in 22 provinces and cities nationwide. In the future, we will also continue to cooperate with Jiangsu Wanbang for the sales preparation of Han Da Yuan® focusing on the field of rheumatism (including indications of ankylosing spondylitis and rheumatoid arthritis (RA)) and the field of dermatology (including the indication of psoriasis), so as to involve more specialists and DTP pharmacies/hospitals within 2021. This will enable Han Da Yuan® to be accessible in terms of channel based on economic accessibility and help Henlius to strive to facilitate patients to buy drugs within its own county.
Based on the existing studies on the similarity between Han Da Yuan® and the adalimumab innovator drug, the mechanism of action of non-infectious uveitis is the same as that of previously approved indications, and sensitive populations and appropriate indications are selected for pivotal clinical studies, with sufficient safety and immunogenicity data obtained, which meet the requirements of national regulations and policies on indication extrapolation such as Technical Guidelines for the R&D and Evaluation of Biosimilar Drugs (Interim) and Guidelines for Clinical Trials of Biosimilars to Adalimumab Injection. This time, the extrapolation of indications of Han Da Yuan® to non-infectious uveitis will further expand its application in the field of ophthalmic treatment, which will bring more affordable and high-quality drug options to patients with autoimmune diseases in China.
At present, we also actively plan and prepare for the supplementary application for other new indications of Han Da Yuan® to continuously expand the treatment of Han Da Yuan® in more disease fields and bring new treatment options to more patients. Following the successful launch of Han Da Yuan® and the gradual addition of more indications, Henlius will work with Jiangsu Wanbang to take advantage of their respective advantages to promote the commercialization of Han Da Yuan® so as to practically help patients with autoimmune diseases who need treatment with biologics as many as possible.
About Non-infectious Uveitis
Non-infectious uveitis encompasses a diverse group of ocular inflammatory disorders that share an underlying immune etiology, which may cause complications such as iris adhesion, glaucoma, cataract, macular oedema and retinopathy, resulting in visual impairment or even blindness. It usually occurs together with immune-mediated systemic diseases such as psoriasis and ankylosing spondylitis. According to the survey, the prevalence of uveitis in China is 152/100,000, of which the patients with non-infectious uveitis account for 41%-55%-2, so the prevalence is estimated to be 62.3-83.6/100,000. At present, glucocorticoids are still the main drug for the treatment of non-infectious uveitis, but this regimen is not suitable for all patients and may bring severe side effects. In recent years, TNF-α inhibitors like adalimumab have been approved for the treatment of non-infectious uveitis in many countries. Studies have shown that adalimumab shows good efficacy in the treatment of non-infectious uveitis, and is characterized by safety, durability, and fewer adverse reactions, providing more drug options for patients with non-infectious uveitis -1.
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 3 products have been launched in China, 1 in Europe and 2 New Drug Applications (NDAs) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established complete and efficient global innovation centers and a Shanghai-based Xuhui Facility certificated by China and the EU GMP. It manufactures and operates in line with global Good Manufacturing Practice (GMP).
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. Apart from Han Li Kang® (rituximab), China's first biosimilar, HAN QU YOU® (trastuzumab, Zercepac® in the EU), China's first self-developed monoclonal antibody approved both in China and in the EU, Han Da Yuan® (adalimumab), the Company's first drug for the treatment of autoimmune diseases which have been approved for marketing successively, the NDAs of HLX04 (bevacizumab) and HLX01 (rituximab) for the treatment of rheumatoid arthritis are under review. Moreover, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. The external authorization of the products fully covers the mainstream biopharmaceutical markets in Europe and the United States, as well as many emerging countries.
References
[1]Hu SXC, Yang P, Huang X. An epidemiological survey of uveitis in Southern China. 2002; 2: 1-3.
[2]Zheng Y, Zhang LX, Meng QL, Zhang M, Cui Y, Liu QY, et al. Clinical patterns and characteristics of uveitis in a secondary hospital in southern China. Int J Ophthalmol. 2015;8:337–41.
[3]Yang P, Zhang Z, Zhou H, Li B, Huang X, Gao Y, et al. Clinical patterns and characteristics of uveitis in a tertiary center for uveitis in China. Curr Eye Res. 2005;30:943–8.
[4]Gao F, Zhao C, Cheng G, Pei M, Liu X, Wang M, et al. Clinical patterns of uveitis in a tertiary center in north China. Ocul Immunol Inflamm. 2017;25(sup1):S1–S7
[5]Hale S, Lightman S. Anti-TNF therapies in the management of acute and chronic uveitis. Cytokine. 2006;33:231-237.
[6]Jaffe G.J. et al, Adalimumab in Patients with Active Noninfectious Uveitis, N Engl J Med 2016;375:932-43.
