Innovative Multiple Myeloma Drug Velinotamig Approved in China for R/R Patients After Multiple Lines of Treatment

Multiple myeloma (MM) is a malignant tumor of plasma cells. Although treatment options have expanded in recent years, relapsed or refractory disease after multiple lines of treatment remains a significant clinical challenge.

On August 25, 2026, China’s NMPA approved the innovative multiple myeloma drug Velinotamig for adults with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior lines of treatment.

The approval of the innovative multiple myeloma drug Velinotamig further expands treatment options for patients with R/R MM and advances the development of BCMA-targeted therapies.

This article from DengYueMed provides an overview of Velinotamig, including its basic information, mechanism of action, eligible patient population, clinical and safety data, China NMPA approval status, and ongoing formulation development.

What Is Velinotamig? How Does It Work?

Velinotamig is an innovative multiple myeloma drug developed independently by Genrix. It is a BCMA/CD3 bispecific antibody.

Unlike traditional monoclonal antibodies that primarily target a single antigen, bispecific antibodies can simultaneously recognize two different targets.

Velinotamig binds to B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on the surface of T cells. By bringing T cells into close proximity to tumor cells, it promotes T-cell activation and mediates tumor cell killing.

Basic Information About Velinotamig

Which Multiple Myeloma Patients Is Velinotamig Approved For?

According to its approved indication in China, Velinotamig is indicated for adults with relapsed or refractory multiple myeloma who have received at least three prior lines of treatment, including:

• A proteasome inhibitor (PI)
• An immunomodulatory drug (IMiD)
• An anti-CD38 monoclonal antibody

The innovative multiple myeloma drug velinotamig is therefore intended for adults with R/R MM who have received multiple prior lines of therapy.

Why Does Relapsed or Refractory Multiple Myeloma After Multiple Lines of Treatment Remain a Challenge?

Multiple myeloma can often be controlled long term with treatment but remains difficult to cure. Although some patients achieve remission after initial therapy, disease relapse or progression may occur.

After multiple lines of treatment, patients with R/R MM may have fewer therapeutic options, highlighting the need for new treatment approaches with different mechanisms.

BCMA has emerged as an important therapeutic target in multiple myeloma.

As a BCMA/CD3 bispecific antibody, the innovative multiple myeloma drug velinotamig provides a targeted approach for patients with R/R MM and supports the continued development of BCMA-targeted therapies.

What Do Clinical Studies Show About Velinotamig?

At the 2025 Annual Meeting of the American Society of Hematology (ASH), Genrix presented Phase 1 clinical data for Velinotamig in patients with R/R MM.

As of July 1, 2025, a total of 60 patients had been enrolled and received treatment, including 48 patients treated at 180 μg/kg, which was selected as the recommended Phase 2 dose (RP2D).

Among the 57 patients who received at least one post-baseline efficacy assessment:

These data provided clinical support for the further development of Velinotamig in R/R MM and its subsequent regulatory approval in China.

👩‍⚕️ It is important to note that these results were generated from an early-phase clinical study. Further studies are needed to evaluate the long-term efficacy, safety, and clinical value of Velinotamig across different patient populations.

What Is Known About the Safety of Velinotamig?

In the Phase 1 study, 48 participants experienced at least one treatment-emergent adverse event (TEAE).

Publicly disclosed Grade 3–5 TEAEs included hypokalemia, cytokine release syndrome (CRS), decreased blood cell counts, increased AST, infections, diarrhea, and anemia.

CRS is an important safety event requiring attention with BCMA/CD3 bispecific antibodies.

The safety profile of Velinotamig should be assessed based on adverse event incidence and severity, management, and longer-term follow-up, rather than early-phase data alone.

How Is the Formulation of Velinotamig Being Further Developed?

The currently approved formulation of the innovative multiple myeloma drug velinotamig is administered by intravenous injection.

In addition to intravenous administration, Genrix is also developing a subcutaneous formulation of Velinotamig.

In May 2026, the subcutaneous formulation of Velinotamig received approval from China’s Center for Drug Evaluation (CDE) to initiate a clinical trial in R/R MM.

The development of the subcutaneous formulation is intended to further explore the convenience of administration and evaluate its efficacy and safety.

Conclusion

The approval of the innovative multiple myeloma drug Velinotamig in China provides a new treatment option for patients with relapsed or refractory disease after multiple lines of treatment.

As BCMA-targeted therapies continue to develop, future competition in multiple myeloma treatment is likely to extend beyond efficacy to areas including safety, route of administration, patient access, and global commercialization.

As a Chinese pharmaceutical wholesaler, DengYueMed continues to monitor Chinese innovative medicines and their global development. Through its China pharmacy wholesale online platform and professional pharmaceutical supply and distribution network, DengYueMed connects Chinese medicines with international markets.

FAQ about Innovative Multiple Myeloma Drug Velinotamig