On August 25, 2026 Genrix Biopharmaceutical reported China’s National Medical Products Administration (NMPA) has granted conditional approval to velinotamig (GR1803), a BCMA×CD3 bispecific antibody developed by the company and partnered with Fosun Pharma’s YaoPharma, for adults with heavily pretreated relapsed or refractory multiple myeloma (R/R MM).

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The approval covers adult patients who have received at least three prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody.

Velinotamig will be marketed in China under the brand name 维可妥 (Weiketu). The NMPA granted the product conditional approval as a Class 1 therapeutic biologic under approval number S20260066. (vip.stock.finance.sina.com.cn)

The approval represents an important milestone for Chongqing-based Genrix Bio and adds another BCMA-directed T-cell engager to China’s rapidly evolving multiple myeloma treatment landscape.

Velinotamig is a bispecific T-cell-engaging antibody designed to simultaneously bind B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T cells.

By bringing cytotoxic T cells into close proximity with BCMA-expressing tumor cells, the antibody is designed to activate T-cell-mediated killing of malignant plasma cells.

What differentiates velinotamig is its asymmetric affinity design.

According to YaoPharma, velinotamig’s binding affinity for BCMA is approximately two orders of magnitude — roughly 100-fold — higher than its affinity for CD3.

The rationale is to favor tumor-specific binding before strong T-cell engagement. By reducing CD3 affinity relative to BCMA affinity, the molecule is designed to limit nonspecific T-cell activation while retaining potent antitumor activity, potentially reducing toxicity associated with excessive immune activation. (en.yaopharma.com)

Phase I Data Show 89.5% Overall Response Rate
Clinical data presented from the Phase I program have shown deep responses in patients with heavily pretreated R/R multiple myeloma.

In the dose-expansion portion of the study, 60 patients were enrolled across three dose cohorts, including two cohorts receiving the recommended Phase II dose (RP2D) of 180 μg/kg, with or without a priming dose.

Among 57 efficacy-evaluable patients across dose levels, the overall response rate (ORR) was 89.5% (51/57). (researchgate.net)

At the 180 μg/kg RP2D, 48 patients were treated and achieved:

ORR: 87.5% (42/48)
≥VGPR: 70.8% (34/48)
≥CR: 37.5% (18/48)
MRD negativity: 54.2% (26/48)
Responses also appeared durable. At the July 1, 2025 data cutoff, median duration of response had not yet been reached, while the estimated probability of responders remaining in response at nine months was 78.8%.

The median follow-up among responders was 12.4 months, with many responses deepening as treatment continued. (researchgate.net)

Activity in Extramedullary Multiple Myeloma
One particularly noteworthy feature of the dataset was the substantial representation of patients with extramedullary multiple myeloma (EMM), a high-risk manifestation in which malignant plasma cells grow outside the bone marrow and which can be particularly difficult to treat.

Half of the 48 patients treated at 180 μg/kg had EMM at baseline.

Among these 24 patients, velinotamig produced an ORR of 83.3%, including four complete or stringent complete responses, nine very good partial responses and seven partial responses. (researchgate.net)

The median time to response was 2.1 months in the overall study population but only 0.75 months among patients without EMM.

These results suggest substantial antimyeloma activity even in a population containing a high proportion of patients with aggressive extramedullary disease.

Safety Profile
As with other T-cell-engaging bispecific antibodies, cytokine release syndrome (CRS) and hematologic toxicities were observed.

At the 180 μg/kg dose, cytokine release syndrome occurred in 89.6% of patients, but Grade 3 or higher CRS was reported in 6.3%.

Other frequently reported treatment-emergent adverse events included neutrophil-count decreases, white-blood-cell-count decreases, thrombocytopenia, anemia and infections including pneumonia. (researchgate.net)

The molecule’s approximately 100-fold BCMA-to-CD3 affinity differential was specifically engineered with the goal of reducing nonspecific T-cell activation and associated toxicity while maintaining effective recruitment of T cells against BCMA-positive myeloma cells. (en.yaopharma.com)

Fosun Pharma Secures Greater China Rights in RMB 1.82 Billion Deal
Velinotamig has also attracted significant commercial interest.

In May 2026, Genrix Bio entered into an exclusive licensing agreement with YaoPharma, a subsidiary of Fosun Pharma, covering Greater China.

Under the agreement, YaoPharma obtained exclusive rights to the clinical development and commercialization of velinotamig in mainland China, Hong Kong, Macau and Taiwan, along with specified manufacturing and process-development rights. (en.yaopharma.com)

The deal carries potential payments of up to RMB 1.82 billion, consisting of:

RMB 300 million upfront
Up to RMB 300 million in regulatory approval and technology-transfer milestones
Up to RMB 1.22 billion in sales milestones
Genrix is additionally eligible for tiered royalties ranging from the high-single digits to low-double digits on net sales in the licensed territory. (fangdalaw.com)

The NMPA approval therefore represents an important near-term milestone for the partnership only three months after the Greater China licensing agreement was signed.