Janssen Submits New Indication Application in China for First-in-Class BCMA×CD3 Bispecific Antibody Talvey (Teclistamab) in Relapsed/Refractory Multiple Myeloma

On April 17, the CDE website showed that Johnson & Johnson'sTelituximabSubmission of a new indication for marketing approval has been made in China and accepted for review. Based on the drug's research progress and the registration status in China, the indication applied for in this submission is likely to be used forSecond-line Treatment for Adult Patients with Relapsed or Refractory Multiple Myeloma。

Source: CDE Official Website

Talquetamab is a bispecific antibody that can simultaneously target BCMA and CD3. The drug was first approved in August 2022 and isThe World's First Approved BCMA×CD3 Bispecific AntibodyTelituximab has been approved for marketing in Europe, the United States, China, and Japan, as a monotherapy for the last-line treatment of multiple myeloma. In March this year, the U.S. FDA approved a new indication for telituximab, which is used in combination with subcutaneous daratumumab injection for the treatment of multiple myeloma.In 2025, Teclistamab generated $670 million in revenue, representing a year-over-year increase of 22.1%.。

In China, Teclistamab was approved for the first time in August 2024, as a single agent for patients who have received at least three prior lines of therapy.(Including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody)Adult patients with relapsed or refractory multiple myeloma.

On April 16, a new indication application for Teclistamab was included in the priority review list by the CDE for the treatment ofAdult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapyIn March this year, Johnson & Johnson also submitted a marketing application for the indication of teclistamab to the European EMA.

Source: CDE Official Website

In the Phase III MajesTEC-9 trial, researchers evaluated teclistamab in combination with standard treatment regimens.(Pomalidomide, Bortezomib, and Dexamethasone or Carfilzomib and Dexamethasone)Efficacy and safety in 614 patients with relapsed/refractory multiple myeloma.

MajesTEC-9 study results show that, even in second-line treatment, teclistamab significantly improves progression-free survival compared to standard treatment. (PFS) And Overall Survival (OS), includingReduced the risk of disease progression or death by 71%, andReduce the risk of death by 40%。

The safety profile of telitacicept monotherapy was favorable, consistent with the known safety characteristics, and no new safety signals were identified.

Despite significant advances in first-line multiple myeloma treatment, including quadruple therapies based on anti-CD38, most patients eventually relapse. Once patients become resistant to key backbone therapies,(e.g., anti-CD38 monoclonal antibody and lenalidomide)The development of drug resistance leads to an especially poor prognosis. For a long time, treatment options for these patients have been limited, and the second-line treatment pathway has also been challenging. If teclistamab is approved, it will offer a new treatment option for such patients.

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