Shanghai, China, 7th December, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the adalimumab biosimilar 汉达远Ⓡ (HLX03), developed and manufactured by the Company independently, has been approved by the National Medical Products Administration (NMPA) for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis (AS) and plaque psoriasis (Ps). It is the third monoclonal antibody (mAb) developed by Henlius and approved in China, after 汉利康Ⓡ, the first China-developed biosimilar and 汉曲优Ⓡ (ZercepacⓇ in the EU), the first China-developed mAb biosimilar approved both in China and in the EU. 汉达远Ⓡ is also Henlius first product approved for the treatment of autoimmune diseases. The development of 汉达远Ⓡ has received support from National Science and Technology Major Project in the 12th & 13th Five-Year Plans of China-Major New Drug Research&Development Project. Its successful development is based on the integrated biopharmaceutical platform of Henlius. The Company’s Xuhui Manufacturing Facility and its quality management system have obtained China and EU GMP certificates, making 汉达远Ⓡ the first China-developed adalimumab biosimilar that is manufactured in a China and EU GMP certificated manufacturing site.

Mr. Wenjie Zhang, Chief Executive Officer and President of Henlius, said, “汉达远Ⓡ is Henlius third mAb product approved in China after 汉利康Ⓡ and 汉曲优Ⓡ, and also the second product successfully launched by Henlius this year. The approval of this product marks the expansion of the Company's commercial pipeline into the field of autoimmune diseases and the scope of patients that can benefit from Henlius products is further broadened. Henlius will continue optimizing and upgrading the product, and cooperating with Wanbang Biopharma to promote the commercialization of 汉达远Ⓡ, so as to bring high-quality treatment options to patients suffering from autoimmune diseases."

Totality of the evidence supports the high similarity between 汉达远Ⓡ and the originator

During the development process of 汉达远Ⓡ, Henlius strictly followed the NMPA Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative) and has taken multiple head-to-head comparisons between 汉达远Ⓡ and the reference adalimumab. Results from analytical studies, non-clinical studies and clinical studies showed that 汉达远Ⓡ is highly similar to the reference adalimumab in terms of quality, safety and efficacy. Different from currently marketed adalimumab biosimilars in China, 汉达远Ⓡ is the only adalimumab biosimilar evaluated in a Phase III clinical study among Chinese patients with Ps, which helps to accumulate valuable clinical evidence among this patient population.

The leading principal investigator of the Phase III clinical study of 汉达远Ⓡ, Professor Jianzhong Zhang of Peking University People’s Hospital, said, “Results from clinical studies showed that 汉达远Ⓡ were highly similar in efficacy and safety to the reference drug. We hope that the approval of 汉达远Ⓡ will provide high-quality and affordable biologics for the long-term treatment of patients with autoimmune diseases such as psoriasis, and can make contributions for the fight against these diseases.”

Effective control of autoimmune diseases

Autoimmune diseases are diseases caused by the body's immune system attacking its own organs or tissues[1]. About 7.6% to 9.4% of people worldwide are suffering from various types of autoimmune diseases[2], such as RA, AS, Ps etc. This kind of diseases usually affect patients’ quality of life or in some cases can even be life-threatening. Most patients with autoimmune diseases will need long-term to lifelong medication. TNF-α (tumor necrosis factor-α) is one of the major cytokines that can induce inflammation and other immune responses, and plays a key role in the pathogenesis of a variety of autoimmune diseases[3]. 汉达远Ⓡ 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.

As a fully humanized anti-TNF-α monoclonal antibody, adalimumab originator has been approved for over 10 indications worldwide. Due to its significant efficacy, it has been recommended by guidelines for different autoimmune diseases in North America and Europe. In China, it has been approved by NMPA for the treatment of RA, AS, moderate to severe Ps, moderately to severely active Crohn's disease, non-infectious intermediate, posterior and panuveitis, juvenile idiopathic arthritis and pediatric Ps. Among them, its application in RA, AS and Ps has been included in China’s National Reimbursement Drug List (NRDL). According to the "Interim Measures for the Administration of Drugs in the NRDL", drugs in the NRDL are managed by their common names, and drugs with common names that have been listed in the NRDL will automatically enter the NRDL.

Fulfilling every patient’s treatment needs for biologics

According to IQVIA CHAPTM, the sales of adalimumab in China in 2019 and the first half of 2020 were estimated to be 32 million and 45 million RMB respectively and with a still increasing trend, reflecting the recognition of adalimumab’s efficacy by doctors and patients. However, due to the complicated pathology, the diversity in autoimmune diseases, patients’ lack of knowledge of the disease and financial reasons, there is still a significant amount of patients that cannot access or afford adalimumab in China. To improve the current situation and help patients understand biologic treatment correctly and receive standardized biologic treatment, Henlius has reached an agreement with Wanbang Biopharma (Wanbang), which is a subsidiary of Fosun Pharma and has been deeply engaged in the field of rheumatology for many years. Under the agreement, Wanbang will be responsible for the commercialization of 汉达远^® in China.

Mr. Shengli Li, Vice President and Chief Growth Officer of Fosun Pharma, Chairman and Chief Executive Officer of Wanbang Pharma Distribution, said, "Wanbang will leverage its enriched experience in commercialization in the field of rheumatology, and will use online hospitals such as '优医邦' to provide more training resources for doctors in suburban and rural areas and more convenient disease management services for patients. At the same time, Wanbang will take advantage of the resources of Fosun Pharma, to help reduce the burden of patients by providing charity funds and insurance services to benefit more patients." 

Mr. Yifang Wu, Chairman and Chief Executive Officer of Fosun Pharma, said, "Focusing on the unmet medical needs, Fosun Pharma will always take R&D innovation as the core driving force and continue exploring more quality and affordable innovative drugs and treatment for patients. We believe that the approval of 汉达远^® would benefit more patients with autoimmune diseases in China."

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. 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 commercialisation. It has three R&D facilities in Shanghai, Taipei and California and a Shanghai-based manufacturing facility certificated by China and the European Union (EU) 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. Up to date, Henlius has launched three mAbs developed independently: 汉利康^® (HLX01, rituximab), the first China-developed biosimilar, 汉曲优^® (HLX02, trastuzumab, Zercepac^® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU and 汉达远^® (HLX03, adalimumab). In addition, the New Drug Application of HLX04 (bevacizumab) of the Company is under review, and Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. Products have been licensed out to nearly 100 countries and regions.