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NMPA Has Accepted The NDA of HLX01 (Rituximab Injection) for the Treatment of Rheumatoid Arthritis

Shanghai, China, December 17th, 2020 –Shanghai Henlius Biotech, Inc. (2696.HK) announced that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for a new indication of its rituximab injection HLX01 to treat rheumatoid arthritis (RA). In February 2019, HLX01汉利康®( rituximab injection) had been approved by the NMPA and currently it can be used for the treatment of Non-hodgkin's lymphoma and leukemia. As of now, Henlius has successively launched three in-house developed monoclonal antibodies including 汉利康® (HLX01, rituximab), 汉曲优® (HLX02, trastuzumab, EU brand name Zercepac® ) and 汉达远® (HLX03, adalimumab).

Rheumatoid arthritis (RA) is the most common chronic autoimmune disease of the joints affecting close to 0.5–1.0% of the global population[1]. It affects at least twice as many women as men, and although it can occur at any age, the peak incidence is at the age of 50 years[2]. The common clinical symptoms of RA includes symmetrical, persistent joint swollen and ache, and are often associated with morning stiff. Most mild RA patients are facing damage of articular cartilage and bone, while patients with severe RA can even suffer from joint malformation and loss of function. It can heavily affect patients’ quality of life. Since RA is incurable and can only be alleviated through treatment, lifelong treatment is required.

Safe and effective for the treatment of RA

The new drug application (NDA) of HLX01 (rituximab injection) for RA is based on results from the Phase 1 clinical study (HLX01-RA01) and Phase 3 clinical study (HLX01-RA03). The HLX01-RA01 study data had been presented on the 2019 European Congress of Rheumatology (EULAR) and the results showed that HLX01 was bioequivalent to European-Union (EU) sourced rituximab originator in RA patients and supported the initiation of the following Phase 3 clinical study. HLX01-RA03 is a randomised, double-blind, placebo-controlled, Phase 3 study aimed to evaluate the efficacy and safety of HLX01 (rituximab injection) in combination with MTX in patients with moderate to severe active RA who have had methotrexate-inadequate response (MTX-IR). Professor Xiaofeng Zeng from Department of Rheumatology and Immunology, Peking Union Medical College Hospital is the leading principle investigator of this study. The primary endpoint of the study is the proportion of patients achieving a 20% improvement in American College of Rheumatology criteria (ACR20) at week 24. Secondary efficacy endpoints include Disease Activity Score based on 28 joints, proportions of patients achieving ACR20/50/70 and so on. The safety, pharmacokinetics and immunogenicity of HLX01 are observed and analysed throughout the study. Recently, this study has met the primary endpoints and demonstrated that HLX01 in combination with MTX is safe and effective in MTX-IR patients with moderate to severe active RA.

Differentiated development to cover a broader patient population

HLX01汉利康®( rituximab injection) is the first mAb biosimilar independently developed by Henlius and the first-ever China-manufactured biosimilar approved by the NMPA in accordance with Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative). It has been approved for the treatment of Non-hodgkin's lymphoma and leukemia, covering all the indications approved for the rituximab originator in Chinese Mainland. Since the NDA of the rituximab originator has not been approved for RA in China, Henlius has adopted a differentiated strategy to fully develop the potential of HLX01 (rituximab injection) in RA and to benefit a broader patient population.

Enriching the company's products pipeline in autoimmune diseases

The acceptance of the NDA for RA of HLX01 (rituximab injection) by NMPA indicates that the product is expected to demonstrate its clinical benefit in the field of rheumatology and immunology. Considering the advantages of long half-life and low dosing frequency, HLX01 (rituximab injection) may greatly improve RA patients' adherence to treatment, reduce patients' burden and improve patients' quality of life. Meanwhile, HLX01 (rituximab injection) will also become another important product of Henlius in the field of autoimmune diseases and will enrich the company's products layout.

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 and autoimmune 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 established global R&D centers 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), the Company's first product indicated for autoimmune diseases. In addition, the New Drug Applications of HLX04 (bevacizumab) and HLX01 (rituximab) for the treatment of rheumatoid arthritis are under review, and Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.


[1] Sharif K , Jumah F , Oskouian R , et al. Rheumatoid arthritis in review: Clinical, anatomical, cellular and molecular points of view[J]. Clinical Anatomy, 2017.

[2] Diane, van, der, et al. Update on the epidemiology, risk factors, and disease outcomes of rheumatoid arthritis.[J]. Best Practice & Research Clinical Rheumatology, 2018.