BeiGene’s DLL3/CD3 dual antibody approved for marketing in China

April 13, 2026  Source: drugdu 29

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Recently, BeiGene officially announced that its DLL3/CD3 bispecific antibody talatumab, developed in collaboration with Amgen, has been approved for marketing in China for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have failed at least two lines of prior therapy (including platinum-based chemotherapy).

Talatumab is a bispecific TCE antibody that targets DLL3 and CD3. It employs a novel cell adaptor structure design that can bind to DLL3 expressed on the surface of cells (including tumor cells) and CD3 expressed on the surface of T cells, causing T cell activation, release of inflammatory cytokines, and lysis of DLL3-expressing cells.

SCLC is a highly aggressive and destructive malignant tumor, accounting for approximately 15% of all lung cancer cases worldwide . About 70% of SCLC patients are further diagnosed with ES-SCLC . In China, there are approximately 160,000 new cases of SCLC annually . This disease is characterized by rapid growth, easy metastasis, and high mortality. Currently, first-line treatment for SCLC patients is primarily platinum-based chemotherapy; however, the vast majority of patients experience disease progression within 6 months, and treatment options after recurrence are very limited, with a median survival of only 8-10 months .

In recent years, with breakthroughs in immunotherapy, this type of therapy is expected to become a new standard of care. Up to 96% of SCLC patients have tumor cells that express the DLL3 protein on their surface, while normal cells express almost none, making DLL3 one of the most sought-after targets in the field of small cell lung cancer. The approval of talatumab marks it as the first DLL3/CD3 TCE drug in China to be applied to solid tumors.

https://mp.weixin.qq.com/s/d1JzVUXVJZuJY0sqx9ZIMw

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