May 18, 2026
Source: drugdu
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On May 15, the NMPA (National Medical Products Administration) announced on its website that AbbVie 's ectorituximab has been approved for marketing. The approved indication is for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in combination with rituximab and lenalidomide. Previously, this marketing application had been included in the priority review pathway, accelerating its approval process.
01
A massive $3.9 billion investment to introduce next-generation innovative dual-antibody drugs.
Icarutumab was originally developed by Genmab . In 2020, AbbVie and Genmab entered into a strategic collaboration worth $3.9 billion to jointly develop and commercialize three of Genmab 's next-generation bispecific antibody products, including Icarutumab .
As an IgG1 type CD20×CD3 bispecific antibody, Icaretimab can simultaneously and precisely bind to CD3 on the surface of T cells and CD20 on the surface of B cells, effectively activating T cells and mediating their direct killing of lymphoma B cells. CD20 is a clinically validated and mature target, widely expressed in various B-cell malignancies such as follicular lymphoma, diffuse large B-cell lymphoma, and mantle cell lymphoma, with clear clinical value.
02
Global commercialization performance is outstanding, and domestic multi-indication deployment is progressing.
Acritumab received its first global approval in the United States in May 2023, and subsequently gained rapid approval in multiple countries and regions, including the European Union and Japan, covering two core indications: relapsed or refractory large B-cell lymphoma and follicular lymphoma. Its commercialization process has accelerated significantly, with global sales reaching $468 million in 2025, making it a blockbuster drug in the field of bispecific antitumor drugs for hematological malignancies. This approval marks the first time Acritumab has entered the Chinese market.
In China, in addition to the EPCORE FL-1 study that has just been approved, AbbVie has simultaneously launched four Phase III clinical trials in the country, comprehensively expanding its indications:
Comparative studies showed that the researchers chose chemotherapy to treat relapsed/refractory diffuse large B-cell lymphoma.
Ectoretumab in combination with R-CHOP for the treatment of newly diagnosed diffuse large B-cell lymphoma;
Ectoretumab in combination with rituximab and lenalidomide (R2) is used for previously untreated follicular lymphoma;
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Ectoretinab in combination with oral lenalidomide tablets is used for relapsed or refractory diffuse large B-cell lymphoma.
CD20×CD3 bispecific antibodies are one of the most popular research directions in the field of hematologic malignancies. With their advantages of being "off-the-shelf," having significant efficacy, and having controllable safety, they have become an important treatment option for patients with relapsed or refractory lymphoma.
According to data from Moshang Pharmaceuticals, there are currently four CD20×CD3 bispecific antibodies approved globally: Roche/Biogen's motuzumab, Roche's grofituzumab, AbbVie/Genmab's icoretuzumab, and Regeneron/Zai Lab's oderoneximab.
In terms of domestic market presence, apart from oderonineximab which is in Phase III clinical trials , the other three have already been approved for marketing, making China one of the most competitive markets for CD20×CD3 bispecific antibodies globally. Furthermore, more than 10 domestically produced CD20×CD3 bispecific antibodies from companies such as Chia Tai Tianqing, Shenzhou Cell, Junshi Biosciences, and Connoya are accelerating their clinical trials and are expected to quickly follow suit, benefiting more domestic patients.
summary
The approval of Aikerutuzumab not only provides a new and highly effective treatment option for patients with relapsed or refractory follicular lymphoma, but also further enriches the product portfolio of dual anti-tumor drugs in the domestic hematologic malignancy field, and promotes the domestic lymphoma treatment into a new era of precision immunotherapy.
https://mp.weixin.qq.com/s/q_sT5c5GbwhZGv9XAJ0oiQ
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