China’s NMPA Conditionally Approves GenrixBio’s Velinotamig for Heavily Pretreated Multiple Myeloma
China’s National Medical Products Administration (NMPA) has granted conditional approval to velinotamig (GR1803), a BCMA×CD3 bispecific antibody developed by Genrix Bio and partnered with Fosun Pharma’s YaoPharma, for adults with heavily pretreated relapsed or refractory multiple myeloma (R/R MM).
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.
A BCMA×CD3 Bispecific With Asymmetric Affinity
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.
Cullinan Holds Rights Outside Greater China
Velinotamig also has a global development partner.
In June 2025, Genrix licensed exclusive rights outside Greater China to U.S.-based Cullinan Therapeutics (Nasdaq: CGEM).
Under that agreement, Cullinan paid Genrix $20 million upfront, with Genrix eligible for up to $292 million in development and regulatory milestones and another $400 million in sales-based milestones.
The total potential deal value therefore reaches $712 million, excluding tiered royalties ranging from the mid-single digits to mid-teens on net sales. (sec.gov)
Cullinan holds exclusive global rights to develop and commercialize velinotamig outside Greater China across all fields of use.
Expanding Beyond Multiple Myeloma
Genrix and its partners are already looking beyond the newly approved indication.
In addition to multiple myeloma, velinotamig is being explored as a potential therapy for autoimmune diseases, leveraging BCMA-directed depletion of antibody-producing plasma cells.
Genrix initiated a Phase I study in China in patients with autoimmune disease in December 2025, beginning with systemic lupus erythematosus (SLE). Initial multidose data from the program are expected in the fourth quarter of 2026. (investors.cullinantherapeutics.com)
Genrix is also developing a subcutaneous formulation of velinotamig. In May 2026, the formulation received NMPA clearance to enter clinical testing in R/R multiple myeloma, potentially offering a more convenient alternative to intravenous administration. (en.yaopharma.com)
Another China-Developed Bispecific Moves to Market
Velinotamig’s conditional approval illustrates the continued maturation of China’s bispecific-antibody sector.
BCMA has become one of the most clinically validated targets in multiple myeloma, with both CAR-T therapies and bispecific T-cell engagers demonstrating substantial activity in heavily pretreated patients. Competition is increasingly shifting toward improving response durability, safety, convenience and performance in difficult-to-treat populations.
Velinotamig enters this landscape with several potentially differentiating features: its approximately 100-fold BCMA-versus-CD3 affinity differential, an 89.5% ORR across evaluable Phase I patients, an 87.5% ORR at the 180 μg/kg RP2D, and meaningful activity among patients with extramedullary disease.
Its commercial structure is also notable. Genrix has effectively divided global rights between two partners — Fosun Pharma/YaoPharma in Greater China and Cullinan Therapeutics outside Greater China — while the ongoing autoimmune and subcutaneous programs could further broaden the asset’s long-term opportunity.
The NMPA approval now provides the first major regulatory validation of that strategy and brings a new BCMA×CD3 treatment option to Chinese patients with heavily pretreated relapsed or refractory multiple myeloma.
References
- Genrix Bio. Announcement on Conditional Marketing Approval of Velinotamig (GR1803) Injection. August 28, 2026. Read the NMPA approval announcement
- Fosun Pharma. Announcement Regarding Registration Approval of Licensed Drug GR1803. August 28, 2026. Read Fosun Pharma’s approval disclosure
- YaoPharma. YaoPharma Enters into Exclusive Licensing Agreement with Genrix Bio for Velinotamig (GR1803) in Greater China. May 29, 2026. Read the YaoPharma announcement
- Fangda Partners. Genrix Bio and YaoPharma Exclusive Greater China Licensing Collaboration for BCMA×CD3 Bispecific Antibody. May 2026. Read the transaction summary
- Cullinan Therapeutics / U.S. SEC. License Agreement for Velinotamig (GR1803). June 4, 2025. View the SEC filing
- Phase I GR1803 Study. A Phase I Monotherapy Study Assessing the Safety and Efficacy of GR1803, a BCMA×CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma. Data cutoff July 1, 2025; presented at ASH 2025. View the study abstract
- Cullinan Therapeutics. Velinotamig Clinical Development Status in China. 2026 corporate presentation. View the development update
