Rituximab biosimilar is under clinical development by Shanghai Henlius Biotech and currently in Phase II for Follicular Lymphoma. According to GlobalData, Phase II drugs for Follicular Lymphoma have a 46% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Rituximab biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Rituximab biosimilar overview

Rituximab (Hanlikangt, Rituximab Biosimilar) is a monoclonal antibody acts as an anti neoplastic agent. It is formulated as injectable solution for intravenous route of administration. Hanlikang is indicated for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, diffuse Large B-cell non-Hodgkin’s lymphoma, relapsed or refractory follicular lymphoma and it is in combination with methotrexate indicated for the treatment of moderately-to severely-active rheumatoid Arthritis (RA) in adult patients with who have inadequate response to one or more TNF-alpha antagonist therapies.

Rituximab biosimilar (HLX-01) is under development idiopathic membranous nephropathy (iMN), follicular lymphoma, Extranodal marginal zone B-cell lymphoma (mucosa-associated lymphoid tissue or MALT-Lymphoma), splenic marginal zone B-cell lymphoma. The drug candidate is administered as intravenous injection. It was also under development for follicular lymphoma.

Shanghai Henlius Biotech overview

Shanghai Henlius Biotech (Henlius), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co Ltd, is a biopharmaceutical company, which is involved in the research, development, production, and marketing of monoclonal antibody products. It develops medicines primarily for oncology, autoimmune and ophthalmic diseases. The company’s key products include Rituximab injection for treating chronic lymphocytic leukemia and non-Hodgkin lymphoma; Trastuzumab for breast cancer, metastatic gastric cancer and metastatic breast cancer; and Adalimumab injection for ankylosing spondylitis, rheumatoid arthritis, plaque psoriasis and uveitis. It also offers Bevacizumab Injection and Serplulimab Injection. Henlius is engaged in developing other products such as HLX14, HLX10, Serplulimab+Chemo, HLX208, HLX13 and HLX71 among others, which are under research and clinical trials. The company operates research and development centers in Shanghai, China, and California, the US. Henlius is headquartered in Shanghai, China.

For a complete picture of Rituximab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.