**Treatment for Multiple Myeloma: China’s BCMA×CD3 Bispecific Antibody Proposed for Breakthrough Therapy Designation**

**Treatment for Multiple Myeloma: China’s BCMA×CD3 Bispecific Antibody Proposed for Breakthrough Therapy Designation**

Multiple Myeloma

#MultipleMyeloma #BCMAxCD3 #BispecificAntibody #Immunotherapy #GR1803 #NMPA #RRMM

Recently, GR1803, an injectable solution developed by Genrix Bio, has been proposed for the “Breakthrough Therapy Designation” by the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA). This innovative drug targets relapsed and refractory multiple myeloma (RRMM), especially for patients who have undergone at least three lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

GR1803 is a novel bispecific antibody that simultaneously binds to BCMA and CD3 antigens. Its unique design allows for the effective activation of T-cells to attack tumor cells while minimizing non-specific T-cell activation, reducing potential side effects. In its Phase I clinical trial for RRMM, GR1803 demonstrated an overall objective response rate (ORR) of 85%, with an ORR of 100% in patients with extramedullary plasmacytoma (EMM).

The clinical performance of this product is remarkable, as evidenced by data presented at the 2024 European Hematology Association (EHA) annual meeting. As of January 2024, 40 trial participants have been enrolled, with an ORR of 85%. Notably, in the 180 ug/kg dose group, the median follow-up duration was 15 weeks, and 96% of the patients achieved a significant response.

What’s particularly noteworthy is the rapid response time; patients showed signs of improvement within a median of just 3 weeks. This suggests that GR1803 not only provides effective disease control in the short term but also continues to enhance patients’ conditions as treatment progresses.

The results from Genrix Bio’s research highlight that GR1803 offers new hope for RRMM patients, particularly for those who are unresponsive to conventional therapies. Its high response rate and favorable safety profile suggest that this drug could play a critical role in future cancer treatments.

The development of such groundbreaking drugs and the advancement of breakthrough therapies reflect China’s growing innovation in the global fight against cancer, offering new treatment options for patients worldwide.

🎉🎉To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China  for preliminary evaluation!

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#MultipleMyeloma #CancerTreatment #BreakthroughTherapy #Immunotherapy #BiotechInnovation #GenrixBio #BCMAxCD3 #CancerResearch #OncologyNews #PharmaInnovation