Shanghai, China, March 1^st, 2022 – Shanghai Henlius Biotech, Inc. (2696. HK) today announced that 汉利康^® (rituximab injection), its first independently developed monoclonal antibody, has been granted approval by the National Medical Products Administration (NMPA) in combination with methotrexate for the treatment of adult patients with moderately-to severely-active Rheumatoid Arthritis (RA) who have inadequate response to one or more TNF-alpha antagonist therapies, providing an alternative treatment option for patients with autoimmune diseases.

汉利康^® is the only rituximab that gets the approval in China to treat rheumatoid arthritis and it was approved by NMPA for the treatment of adult patients in below indications: Non-Hodgkin’s lymphoma includes previously untreated follicular, CD20-positive, stage III-IV non-Hodgkin’s lymphoma, single-agent maintenance therapy after complete or partial response under rituximab in combination with chemotherapy in patients with previously untreated follicular lymphoma, relapsed or refractory follicular lymphoma, CD20-positive, diffuse large B-cell non-Hodgkin’s lymphoma (DLBCL); Chronic Lymphocytic Leukemia includes in combination with fludarabine and cyclophosphamide (FC) in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia (CLL). As of now, 汉利康^® is the rituximab with the largest number of approved indications in China.

“汉利康^® is the first biosimilar approved in China and its indication plan and corresponding clinical research have always been at the forefront of biosimilars. In addition to adalimumab 汉达远^®, the approval for 汉利康^®on rheumatoid arthritis is another milestone of Henlius in rheumatic immunity and will reach more patient population and provide them with alternative treatment options,” said Wenjie Zhang, Chairman, Executive Director and CEO of Henlius.

Unique Superiority Improves Patients' Quality of Life

Rheumatoid arthritis is a chronic progressive autoimmune disease with aggressive arthritis as the main clinical manifestation and its common clinical symptoms include synovitis, most are symmetrical arthritis. With the prolongation of the course of disease, the incidence of disability and functional limitation increases. The incidence rate is 0.5%-1% ^[1] at any age globally and is about 0.42% in Chinese mainland ^[2]. At present, rheumatoid arthritis is incurable and can only be alleviated through treatment, long-term treatment is required. The common treatment for RA patients is to take disease-modifying anti-rheumatic drugs (DMARDs) in which the conventional synthetic DMARDs (csDMARDs) are the basis for the treatment of rheumatoid arthritis. Patients who have inadequate response to csDMARDs are encouraged to try biological DMARDs (bDMARDs), such as methotrexate (MTX) in combination with rituximab to achieve good therapeutic results. For rheumatoid arthritis, the dose regimen of 汉利康^® is twice per course and approximately two courses every year, which is significantly less than that of similar bDMARDs on the market. Furthermore, this rituximab demonstrates sustained efficacy. With these key advantages, 汉利康^® is able to actively improve the convenience of medication and patients’ quality of life.

Professor Xiaofeng Zeng, the leading principal investigator of the Phase III clinical study of 汉利康^® on rheumatoid arthritis, from the Department of Rheumatology and Immunology, Peking Union Medical College Hospital, said, “汉利康^® has shown good efficacy and reliable safety in clinical studies. As the first rituximab approved in China for the treatment of rheumatoid arthritis, 汉利康^® will effectively boost patients' confidence in continuous medication with low-frequency administration and sustained efficacy and make a positive contribution to symptom relief of rheumatoid arthritis.”

Differentiated Strategy Benefits a Wider Patient Population

汉利康^® is the first monoclonal antibody independently developed by Henlius as well as the first biosimilar developed and approved based on the Technical Guideline for the Development and Evaluation of Biosimilars (Tentative) issued in 2015, covering all indications of the originator rituximab approved in China. The originator rituximab for rheumatoid arthritis was approved in the United States and European Union but not listed in China previously. 汉利康^® launched innovative clinical trials on rheumatoid arthritis based on its existing treatment research, opening up a new path for domestic rheumatic immunotherapy with differentiated strategies. On the other hand, upon the superior commercial platform and mature ability of commercialization in rheumatic diseases, Jiangsu Fosun will promote 汉利康^® to the market more efficiently to benefit a wider patient population.

Shengli Li, Executive President and Chief Growth Officer of Fosun Pharma, said, “On the occasion of the 3^rd anniversary of 汉利康^® launched, we are happy to see that its new indication rheumatoid arthritis is approved by the NMPA. Fosun Pharma will fully leverage its successful practices in rheumatism treatment to provide patients with a new more convenient and accessible treatment.”

Yifang Wu, Chairman and Chief Executive Officer of Fosun Pharma, said, “Focusing on the unmet clinical needs, Fosun Pharma will always take innovative R&D as the core driving force and continue exploring quality and affordable innovative drugs and treatment for patients. We believe that the approval of 汉利康^® would benefit more patients with rheumatoid arthritis in China.”

【参考文献】

[1] Smolen, Josef S et al. “Rheumatoid arthritis.” Lancet vol. 388,10055 (2016): 2023-2038.

[2] 医学会风湿病学分会. 2018中国类风湿关节炎诊疗指南[J]. 中华内科杂志, 2018(4).

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, 4 products have been launched in China, 1 in the European Union (EU), 12 indications approved worldwide, 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 global R&D centers and a Shanghai-based manufacturing facility certificated by China and the 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 serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products 汉利康^® (rituximab), the first China-developed biosimilar, 汉曲优^® (trastuzumab, Zercepac^® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU, 汉达远^® (adalimumab) and 汉贝泰^® (bevacizumab), the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDA of serplulimab for the treatment of squamous non-small cell lung cancer is also under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 9 combination therapies worldwide, expanding its presence in major market as well as emerging market.