China’s first domestically developed B‑cell maturation antigen×Cluster of differentiation 3 (BCMA×CD3) bispecific antibody, Vonsetamig Injection, has received official approval from the National Medical Products Administration (NMPA). The new class 1 biologic drug is indicated for adult patients with relapsed or refractory multiple myeloma who have failed multiple lines of prior treatment.
Multiple myeloma ranks as the second most common hematological malignancy worldwide, predominantly affecting elderly populations. Most patients inevitably experience disease relapse after successive rounds of standard therapy, leaving limited effective treatment options for advanced and refractory cases.
As a novel T-cell engager, Vonsetamig simultaneously targets BCMA on myeloma tumor cells and CD3 on human T lymphocytes. It precisely recruits and activates endogenous T cells to eliminate malignant plasma cells, delivering a targeted immunotherapy approach for hard-to-treat multiple myeloma. Engineered with asymmetric affinity design, the antibody significantly reduces the risk of cytokine release syndrome and improves overall safety profiles, making it well-suited for vulnerable late-stage patients.
Fully researched, developed and manufactured by a biotech enterprise in Chongqing International Bio-City, the drug achieves end-to-end domestic industrialization, covering molecular design, cell line construction, formulation development and mass production.
Industry insiders noted that the approval fills a critical gap in China’s domestic bispecific antibody treatment landscape for hematological malignancies. It also marks a major leap forward in the country’s innovative biopharmaceutical sector, breaking the long-term overseas dominance in high-end tumor immunotherapy drugs.
With accelerated research and development progress in domestic cell and antibody therapeutics, a pipeline of homegrown bispecific antibodies and antibody-drug conjugates (ADCs) have recently gained regulatory approval. These breakthroughs substantially improve the accessibility and affordability of advanced tumor treatment regimens for Chinese patients.