On April 9, 2026, Henlius (2696.HK) announced that the supplemental application for two new indications under non-Hodgkin's lymphoma of HANLIKANG (rituximab), independently developed and manufactured by the company, was approved by the National Medical Products Administration (NMPA). As China's first biosimilar, HANLIKANG has fully covered all indications of the original rituximab approved for marketing in China, including non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis, which was not approved for the original drug in China, making it the rituximab with the most approved indications* in the country.
According to the National Cancer Center's 2022 national cancer report, nearly 100,000 new cases of lymphoma are diagnosed annually in China1, with approximately 70% being non-Hodgkin's lymphoma. Diffuse large B-cell lymphoma (DLBCL) is the most common aggressive subtype, with relatively poorer prognosis. HANLIKANG is Henlius's first independently developed monoclonal antibody biopharmaceutical and also China's first biosimilar developed and approved for marketing based on the Technical Guideline for the Research, Development and Evaluation of Biosimilars (“Tentative”) issued in 2015.
Similarity study results have demonstrated that HANLIKANG and reference rituximab are highly similar in structure, biological characteristics, and clinical pharmacokinetics/pharmacodynamics, and exhibit equivalence in the treatment of diffuse large B-cell lymphoma. The key Phase 3 HLX01-NHL03 study results were officially published in the international authoritative journal BMC Cancer in January 2024. Previously, HANLIKANG had been approved for four indications in DLBCL. The two newly approved indications in China are: 1. In combination with polatuzumab vedotin, cyclophosphamide, doxorubicin, and prednisone for the treatment of previously untreated adult patients with DLBCL. 2. In combination with bendamustine and polatuzumab vedotin for the treatment of adult patients with relapsed or refractory DLBCL who are not candidates for hematopoietic stem cell transplant. covering both first-line and relapsed/refractory key therapeutic nodes in DLBCL.
Additionally, HANLIKANG’s development, manufacturing and the quality management system are in line with global standards. Xuhui Facility, the manufacturing facility for HANLIKANG, has obtained Good Manufacturing Practice (GMP) certifications from both China and the EU, making it the first plant in China that has obtained dual GMP certifications from China and Europe to manufacture self-developed antibodies. Also, the facility has successfully passed the on-site inspection conducted by NMPA, the European Medicines Agency (EMA), the EU qualified person, and PIC/S members Indonesia Food and Drug Administration (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), as well as multiple international business partners.
Henlius actively collaborates with commercial partners to continuously expand domestic and international markets for this product. In China, the commercial sales of HANLIKANG are managed by Fosun Pharma. Currently, HANLIKANG has been officially included in China’s National Reimbursement Drug List (NRDL), benefiting over 400,000 Chinese patients cumulatively. According to statistics, after the launch of rituximab including HANLIKANG, the proportion of DLBCL patients receiving immunochemotherapy in China increased by 40%, and the lymphoma diagnosis and treatment capabilities of primary hospitals were simultaneously enhanced. Pharmacoeconomic studies also show that in newly treated DLBCL patients, compared to the original rituximab, HANLIKANG (H-CHOP) can bring more quality-adjusted life years (QALYs) within 10 years while significantly saving medical resources. For overseas markets, Henlius actively collaborates with biopharmaceutical company partners such as Abbott, Boston Oncology, Eurofarma, and FARMA DE COLOMBIA to accelerate global expansion, with approvals for marketing already obtained in several Latin American countries.
In the future, Henlius will continue to uphold a patient-centered philosophy, accelerating the commercialization and accessibility of its products to benefit more patients with high-quality and affordable treatments.
Reference
1. ZHENG R S, CHEN R, HAN B F, et al. Cancer incidence and mortality in China, 2022[J]. Zhonghua Zhong Liu Za Zhi, 2024, 46(3):221-231.
* “最多”是指截至2026年4月9日