April 13, 2026
Source: drugdu
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On April 9, 2026, Fosun Pharma subsidiary Henlius announced that its supplemental applications for two new indications for rituximab ( Hanlikang® ) , developed and manufactured in-house, were approved by the NMPA (National Medical Products Administration). As the first biosimilar in China, rituximab now fully covers all indications approved for the original rituximab in China , including non-Hodgkin's lymphoma , chronic lymphocytic leukemia, and rheumatoid arthritis, which was not approved in China for the original drug. This makes it the rituximab with the most approved indications in China*. Public information shows that rituximab injection is a monoclonal antibody that targets CD20 . It binds to CD20 molecules expressed on the surface of B lymphocytes and kills tumor B cells through antibody-dependent cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). It is used to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia and other non-tumor diseases.It is understood that rituximab was originally developed by Roche's Genentech. After a decade of dedicated effort, Fosun Pharma, starting with its biopharmaceutical innovation platform Henlius in 2009, culminated in the launch of Hanlikang® ( rituximab ) in 2019, filling the gap in domestically produced CD20 monoclonal antibodies and biosimilars . Related statistics show that in 2022, the total sales of rituximab injections in China's three major terminal markets and six major markets exceeded 5 billion yuan , making it a true blockbuster drug.According to the National Cancer Center's 2022 National Cancer Report, nearly 100,000 new cases of lymphoma are diagnosed in China each year , of which about 70% are non-Hodgkin lymphoma. Diffuse large B-cell lymphoma (DLBCL) is its most common aggressive subtype, with a relatively poorer prognosis.Rituximab ( Hanlikang® ) is the first monoclonal antibody biologic independently developed by Henlius Biotech, and also the first biosimilar developed and approved for the Research and Evaluation of Biosimilars (Trial)" issued in 2015. The results of ongoing similarity studies have demonstrated that Hanlikang® and the reference rituximab are highly similar in structure, biological characteristics, and clinical pharmacokinetics/pharmacodynamics, and are equivalent in the treatment of diffuse large B-cell lymphoma. The results of its pivotal Phase III HLX01-NHL03 study were officially published in the internationally renowned journal BMC Cancer in January 2024.Previously, Hanlikang® had been approved for four indications in DLBCL. The two newly approved indications in China are for the treatment of previously untreated adult patients with DLBCL in combination with velpotuzumab , cyclophosphamide, doxorubicin and prednisone; and for the treatment of adult patients with relapsed or refractory DLBCL in combination with bendamustine and velpotuzumab who are not suitable for hematopoietic stem cell transplantation. This covers the two key treatment stages of first-line and relapse/refractory DLBCL.In recent years, Fosun Pharma has focused on innovative drugs, centering on three core areas: oncology (solid tumors and hematologic malignancies), immune and inflammatory diseases, and neurodegenerative diseases. It has continuously strengthened its pipeline through independent research and development, collaborative development, and licensing agreements. For example, in the oncology field, by 2025, Fosun Pharma will strengthen its innovative pipeline layout around key indications such as breast cancer and lung cancer.Data shows that the self-developed small molecule innovative drug Fumining (Ruvometinib tablets) has been approved in China for dual indications, providing a new treatment option for rare tumors in China; the CDK4/6 inhibitor Futonin (vovecilide citrate capsules) has been launched for two indications, bringing new treatment options to breast cancer patients; and the anti-PD-1 monoclonal antibody slulimab injection has been approved in Europe and several emerging markets, becoming the first-line anti-PD-1 monoclonal antibody approved in the EU for the treatment of extensive-stage small cell lung cancer (ES-SCLC), etc.According to the company's financial report, in 2025, the company's revenue from innovative drugs reached 9.893 billion yuan, a year-on-year increase of 29.59%, accounting for 33.16% of the pharmaceutical business revenue, becoming the core engine of performance growth. Meanwhile, the development of the company's innovative drugs is inseparable from continuous investment in research and development. The report shows that in 2025, the company's total R&D investment totaled 5.913 billion yuan, a year-on-year increase of 6.46%, of which R&D investment related to innovative drugs reached 4.303 billion yuan, a year-on-year increase of 15.98%, accounting for 80.26% of the pharmaceutical business's R&D investment.
https://mp.weixin.qq.com/s/fhYMKvRZgPPB4vqeTxWhfw
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