GSK's Belantamab Mafodotin, the World’s First BCMA-Targeted ADC, Approved in China for Relapsed/Refractory Multiple Myeloma

Apr 17, 2026 16:37 CST Updated 16:38

GSK

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On April 17, 2026, the official website of the National Medical Products Administration (NMPA) released drug approval certificates.GSK's Belantamab Mafodotin Injection Officially Approved for Marketing in China, approved indication is in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

This globally first approved BCMA-targeted antibody-drug conjugate (ADC), after experiencing the曲折历程 of market launch, withdrawal, and resurgence, has ultimately succeeded in landing in China based on重磅 III 期 clinical data, offering a new treatment option for patients with relapsed/refractory multiple myeloma.

Screenshot source: NMPA official website

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The World's First BCMA ADC: From Setbacks in Europe and America to a Comeback

Marabalantuximab is an ADC drug targeting B-cell maturation antigen (BCMA), composed of a humanized anti-BCMA monoclonal antibody conjugated with the cytotoxic agent Auristatin F through a non-cleavable linker.The World's First Approved BCMA ADC。

Its path to market has been nothing short of tumultuous:

1.In August 2020, the drug was approved for marketing by the US FDA and the EU EMA based on the pivotal Phase II DREAMM-2 study data;

2.In 2022, its confirmatory Phase III DREAMM-3 study failed, leading to a rapid withdrawal from the European and American markets;

3. GSK has not abandoned this project, but instead turned to explore combination therapy regimens, eventually inDREAMM-7 Phase III StudyAchieved a breakthrough success in China;

4. In 2025, the mepolizumab combination regimen was successively re-approved in Japan, the UK, the EU, the US, Canada, and other regions worldwide. Its approval in China marked another key milestone.

Core Clinical Data: PFS Extended Nearly 3 Times, Significant Benefits for Chinese Patients

Approved in ChinaFully Based on the Results of the Global Multicenter Phase III DREAMM-7 StudyThis study is an open-label, randomized controlled trial, directly comparing Mabranlimab + Bortezomib + Dexamethasone (BVd regimen) with Daratumumab + Bortezomib + Dexamethasone (DVd regimen) for the treatment of patients with relapsed/refractory multiple myeloma who have progressed after at least one prior line of therapy. A total of 494 subjects were enrolled, with progression-free survival (PFS) as the primary endpoint.

Global Population Core Efficacy Data

Progression-Free Survival (PFS): The median PFS in the BVd group reached 36.6 months, compared to only 13.4 months in the control group,Extended nearly 3 times, the risk of disease progression or death was reduced by approximately 60% (HR=0.41, P<0.00001);
Overall Survival (OS): With a median follow-up of 39.4 months, the risk of death in the BVd group was reduced by 42% (HR=0.58, P=0.00023),3-Year OS Rate 74% vs Control Group 60%；
Alleviation Data: Objective Response Rate (ORR) 82.7% vs 71.3%, Minimal Residual Disease (MRD) negative rate 24.7% vs 9.6%, demonstrating a significant advantage in depth of response;
Benefiting Population: Patients with poor prognoses, such as high-risk cytogenetics and lenalidomide resistance, can all achieve consistent benefits from the regimen.

China Subgroup Data Shines Brighter

The study enrolled 72 Chinese patients, with a median follow-up of 26.5 months:

The median PFS in the BVd group has not been reached, while in the control group it was only 8.4 months (HR=0.24);
Median OS not reached vs 38.4 months (HR=0.29);
18-month PFS rate 85% vs 37%, ORR 81.3% vs 67.5%,Chinese Patients Benefit More Prominently。

Safety Controllable

Ocular adverse reactions related to Mavrilimumab (blurred vision, dry eye, etc.) can be effectively managed and reversed through dose adjustment and regular follow-up.Discontinuation rate due to ocular side effects ≤9%; Grade 3 non-ocular adverse reactions were mainly thrombocytopenia and neutropenia, with overall controllable safety.

BCMA Track Landscape: ADC Scarce, CAR-T and Bispecific Antibody Competition Intensifies

BCMA is a core target for the treatment of multiple myeloma, and the current global research and development landscape showsADC in the doldrums, cell and immune therapies boomingThe Pattern:

BCMA ADC: Only 3 active projects in the global clinical stage, apart from Mavrilimumab, Pamlectamab tisamatinib from Huadong Medicine / Heidelberg, and DXC009 from DuoXi Bio are both in the early clinical stage;
BCMA Immunotherapy：There are 137 CAR-T projects and 17 bispecific antibody projects under research globally, with extremely fierce competition.

In the Chinese market, there are alreadyFive BCMA-targeted drugs approved(2 bispecific antibodies, 3 CAR-T therapies), covering companies such as Pfizer, Johnson & Johnson, Legend Biotech, CARsgen Therapeutics, Innovent Biologics / IASO Biotherapeutics; Zhirong Jintai's BCMA bispecific antibody has also submitted an application for marketing authorization.

With the addition of Maberylan Monoclonal Antibody, BCMA-targeted therapies in China have formed...ADC + Bispecific Antibody + CAR-TThe complete matrix, the treatment of multiple myeloma has entered a new stage of "multiple options available, multi-dimensional benefits."

The approval of Marabandamab in China not only fills the gap in BCMA ADC therapy in the country but also, with the excellent efficacy of combination regimens, provides a better option for the clinical treatment of relapsed/refractory multiple myeloma. As drug accessibility improves in the future, the long-term survival and quality of life of patients with multiple myeloma in China will be further enhanced.

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