Recently, Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company will release the Phase 3 clinical study (HLX01-RA03, NCT03522415) results of HLX01 (rituximab injection) in patients with rheumatoid arthritis (RA) at European Congress of Rheumatology 2021 (EULAR 2021) and the 25th National Congress of Chinese Rheumatology Association.
HLX01 ( rituximab injection) is the first monoclonal antibody (mAb) biosimilar independently developed by Henlius and the first-ever China-manufactured biosimilar approved by the NMPA in accordance with the 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 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. In December 2021, the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for a new indication of HLX01 to treat RA.
Details of the publications are as follows:
● European Congress of Rheumatology 2021 (EULAR 2021)
Title: Efficacy and Safety of HLX01 Combined with Methotrexate in Chinese Patients with Moderately to Severely Active Rheumatoid Arthritis Who Had Inadequate Responses to Methotrexate: Results of a Randomised, Double-blind, Placebo-controlled Phase 3 Study
Leading PI: Xiaofeng Zeng, MD, PhD, Peking Union Medical College Hospital
Form: Abstract
Abstract No.: AB0197
Time: EULAR 2021 will be held virtually on June 2 – 5, 2021. The abstract will be available online approximately two weeks prior to the Congress.
● The 25th National Congress of Chinese Rheumatology Association
Title: Efficacy and Safety of HLX01 in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Had Inadequate Responses to Methotrexate: Results of a Randomised, Double-blind, Placebo-controlled Phase 3 Study
Leading PI: Xiaofeng Zeng, MD, PhD, Peking Union Medical College Hospital
Form: Abstract and E-poster
Abstract No.: 2099
Time: The congress will be held on May 20 – 22, 2021.
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 principal 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. As of now, 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.