velinotamig (GR-1803) / Zhixiang (Shanghai) Pharma, Cullinan Therap - LARVOL DELTA

A phase I monotherapy study assessing the safety and efficacy of GR1803, a BCMA×CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (ASH 2025) - "Treatment with GR1803 was well tolerated with excellent anti-myeloma activity, especially inpatients with EMM. GR1803 is expected to improve the prognosis of patients with RRMM.Acknowledgments: This study was funded by Chongqing Genrix Biopharmaceutical Co., Ltd."

Clinical • Monotherapy • P1 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Pneumonia • Respiratory Diseases

China‑based Genrix Biopharmaceutical…announced that the…NMPA has granted approval for a new clinical‑trial indication of its self‑developed bispecific antibody, GR1803 injection, for the treatment of…SLE (flcube.com)

New trial • Systemic Lupus Erythematosus

Portfolio Highlights (GlobeNewswire) - "CLN-978...The global Phase 1 study in patients with moderate to severe SLE is enrolling in the United States, Europe, and Australia, and the Company plans to share initial safety data and B cell depletion data from Part A of the study in Q4 2025; The Phase 1 study in patients with active, difficult-to-treat rheumatoid arthritis is enrolling in Europe. This company-sponsored study is being led by sites at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Italy. The Company plans to share initial data from this study during the first half of 2026....Genrix Bio plans to initiate a Phase 1 study in patients with autoimmune diseases in China by the end of 2025. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases."

New P1 trial • P1 data • Trial status • Immunology • Rheumatoid Arthritis • Systemic Lupus Erythematosus

Phase I Trial of GR1803 Injection in Patients With RRMM (clinicaltrials.gov) - P1/2 | N=76 | Completed | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Monotherapy • New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=32 | Not yet recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Cullinan Therapeutics Licenses Rights to Velinotamig, a Clinical-Stage BCMA-Directed Bispecific T Cell Engager, from Genrix Bio for Development in Autoimmune Diseases (GlobeNewswire) - "Cullinan Therapeutics...announced that it has entered into an agreement with Genrix Bio for a global (ex-Greater China), all indication, exclusive license to velinotamig, a BCMAxCD3 bispecific T cell engager....Cullinan will develop velinotamig in autoimmune diseases....Genrix plans to initiate a Phase 1 study in China by the end of this year in patients with autoimmune diseases. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases....Under the agreement, Cullinan will pay Genrix Bio an upfront license fee of $20 million for exclusive rights to develop and commercialize velinotamig in all disease areas globally outside of Greater China."

Licensing / partnership • New P1 trial • Immunology

GR1803 Injection in Patients With RRMM (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Plasmacytoma

GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P2 | N=116 | Recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A PHASE I MONOTHERAPY STUDY ASSESSING THE SAFETY AND EFFICACY OF GR1803, A BCMA×CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (EHA 2024) - "Treatment with GR1803 was well tolerated with excellent anti-myeloma activity,especially in patients with EMM. GR1803 is expected to improve the prognosis of patients with RRMM. Withlonger follow-up, additional efficacy/safety data will be presented."

Clinical • Monotherapy • P1 data • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Leukopenia • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia