Recently, the National Medical Products Administration (NMPA) announced on its official website that Roche's Gavreto (generic name: Glofitamab) injection has been granted conditional approval for marketing in China. The brand name is Columvi, and it is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two prior lines of systemic therapy.
Glofitamab Injection is a bispecific T-cell engager targeting CD20 and CD3. By simultaneously binding to CD20 on the surface of B cells and CD3 on the surface of T cells, it mediates the formation of immune synapses, subsequently leading to T-cell activation and proliferation, cytokine secretion, and release of cytolytic proteins, thereby inducing lysis of CD20-expressing B cells. This provides patients with a new treatment option.Bispecific antibodies are one of Roche's core technologies. Currently, Roche has four bispecific antibody drugs approved for marketing: Emicizumab, Faricimab, Mosunetuzumab, and Glofitamab. Their sales (in billion Swiss francs) from January to September 2023 were: 31.12, 16.13, 0.43, and 0.11, respectively.Emicizumab and Faricimab Are Roche's Growth Drivers, and Also the Best-Selling Bispecific Antibody Drugs Globally, Making a Significant Impact on the Hemophilia and Diabetic Macular Edema Markets.Glofitamab is Roche's second CD3/CD20 bispecific antibody following Mosunetuzumab., they differ not only in structure but also in the layout of indications. The former is used for follicular lymphoma, while the latter is for DLBCL.Gefitumab is the first domestically produced CD3/CD20 bispecific antibody for the treatment of DLBCL in China.。According to incomplete statistics, Roche has 15 bispecific antibody drugs that have entered the clinical stage, among which the LAG3/PD-1-targeted drug RG-6139 has progressed to Phase II clinical trials; indications under research include melanoma, urothelial carcinoma, etc.In recent years, bispecific antibody technology has developed rapidly and has become one of the popular fields that many pharmaceutical companies are accelerating to lay out. According to incomplete statistics, currentlyGlobally, 14 bispecific antibody drugs have been approved for marketing, including 4 in China.Among them, Catumaxomab was withdrawn from the market in 2017. The approved bispecific antibody drugs mainly target CD3, CD20, BCMA, etc., and the indications primarily include hematological diseases such as multiple myeloma and lymphoma.Table 1: Globally Approved Bispecific Antibody Drugs
Data source: Public information,整理by中康产业研究院The market size of bispecific antibody new drugs has significantly increased since 2018, with a growth rate of over 30%. According to incomplete statistics,Global bispecific antibody new drug sales reached $5.868 billion in 2022; From January to September 2023, it has reached $6.267 billion, and the full year is expected to exceed $8 billion.According to Frost & Sullivan, the global bispecific antibody market size is expected to grow at a rate of 29.3% from 2024 to 2030; the growth rate in China will be 54.3%, reachingThe market will reach 10.8 billion US dollars in 2030.Figure 2: Global Bispecific Antibody New Drug Market Size (Partial)Data Source: Medical Notes,整理 by Sino Health Industry Research InstituteBispecific antibodies are a novel and promising technology capable of enhancing drug specificity, thereby achieving more efficient therapeutic effects with fewer side effects. Despite these advantages, the development of bispecific antibody drugs faces significant technical challenges, high costs, and relatively low success rates, indicating that their research and development require long-term investment and continuous technological innovation. However, with ongoing advancements in technology, it is believed that an increasing number of bispecific antibody drugs will be approved and launched in the future, bringing benefits to more patients.
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