velinotamig (GR-1803) / Genrix Bio, Cullinan Therap, Fosun Pharma - LARVOL DELTA

Fifteen-Month Follow-up From a Pivotal Trial of GR1803 in Patients With Relapsed/Refractory Multiple Myeloma (IMS 2026) - P2 | "GR1803 exhibited profound and sustained responses in RRMM, with high MRD negativity and excellent response in extramedullary RRMM. CRS and infections were generally manageable with established protocols and aligned with that of other BCMA-CD3 bispecific therapies."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Nephrology • Neutropenia • Pneumonia • Pulmonary Disease • Respiratory Diseases • Thrombocytopenia

The Company plans to share the following immunology...pipeline updates in Q4 2026 (The Manila Times) - "CLN-978 (CD19xCD3 T cell engager): treatment-refractory moderate to severe systemic lupus erythematosus (SLE), difficult-to-treat rheumatoid arthritis (RA), and treatment-refractory moderate to severe Sjögren’s disease (SjD): Multi-dose and single target dose regimen data in SLE, RA, and SjD in December...Velinotamig (BCMAxCD3 T cell engager): treatment-refractory autoimmune diseases driven by long-lived plasma cells: Multi-dose regimen data from the ongoing Genrix Bio Phase 1 dose escalation study in SLE to be shared in poster session at ACR Convergence 2026 on November 8, 2026, 10:30 a.m. to 12:30 p.m. ET."

P1 data • Immunology • Rheumatoid Arthritis • Sjogren's Syndrome • Systemic Lupus Erythematosus

Initial Results of GR1803 (BCMA×CD3 TCE) Therapy in Patients with Refractory Systemic Lupus Erythematosus: a Phase 1b/2a Study (ACR Convergence 2026) - No abstract available

Clinical • P1/2 data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Fosun Pharma’s Velinotamig Wins NMPA Conditional Approval for Relapsed or Refractory Multiple Myeloma (flcube.com)

China approval • Multiple Myeloma

Velinotamig (BCMAxCD3 T cell engager): treatment-refractory autoimmune diseases driven by long-lived plasma cells (GlobeNewswire) - "Additional multi-dose regimen data from the study are expected to be shared in Q4 2026....Cullinan plans to initiate a global Phase 1/2 basket study in early 2027 in patients with autoimmune cytopenias, including immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA)."

New P1/2 trial • P1 data • Autoimmune Hemolytic Anemia • Immune Thrombocytopenic Purpura • Systemic Lupus Erythematosus

A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA (clinicaltrials.gov) - P1/2 | N=72 | Not yet recruiting | Sponsor: Cullinan Therapeutics Inc.

New P1/2 trial • Anemia • Autoimmune Hemolytic Anemia • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

Velinotamig (BCMAxCD3 T cell engager): Treatment-refractory autoimmune diseases driven by long-lived plasma cells (Yahoo Finance) - "In the first two patients with refractory SLE...both patients experienced rapid and marked reductions in SLEDAI-2K scores and proteinuria and both achieved complete renal response: SLEDAI-2K scores were 16 and 14 at baseline, respectively, and at the latest follow-up at week 8 were 0 and 2, respectively; Clinical improvements correlated with pharmacodynamic changes consistent with the mechanism of action of velinotamig...Additional multi-dose regimen data in patients with SLE from the Genrix Bio clinical trial in China expected to be shared in Q4 2026; Cullinan plans to initiate a Phase 1/2a clinical trial in Q1 2027 in patients with autoimmune cytopenias, including immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA), autoantibody-mediated diseases with high unmet need."

New P1/2 trial • P1 data • Autoimmune Hemolytic Anemia • Immune Thrombocytopenic Purpura • Systemic Lupus Erythematosus

Cullinan Therapeutics to Host Immunology Day to Showcase Promising Initial Clinical Data in Autoimmune Diseases for CLN-978, a CD19 T Cell Engager, and Velinotamig, a BCMA T Cell Engager (The Manila Times) - "CLN-978 (CD19xCD3 T cell engager): treatment-refractory moderate to severe SLE and difficult-to-treat RA: Single target dose escalation data in SLE and RA, as reported at EULAR 2026 Congress on June 6, 2026; Initial data from the first multi-dose cohort of the RA study; Next steps in global clinical development...Velinotamig (BCMAxCD3 T cell engager): treatment-refractory autoimmune diseases driven by long-lived plasma cells: Initial data from the first multi-dose cohort of the Genrix Bio study in China; Next steps in global clinical development."

P1 data • Immunology • Rheumatoid Arthritis • Systemic Lupus Erythematosus

GR1803-002: GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P2 | N=116 | Active, not recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2026 ➔ May 2027

Enrollment closed • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Portfolio Highlights and 2026 Milestones (The Manila Times) - "Initial clinical data in SLE and RA for CLN-978, a CD19 T cell engager, to be presented at the EULAR 2026 Congress in June; multi-dose regimen data in RA expected in Q3 2026...OUTRACE SjD: In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data....Genrix Bio is enrolling a Phase 1 study in China in patients with autoimmune diseases, starting with moderate to severe SLE and to be followed by planned expansion into other indications. Initial multi-dose regimen data from the dose escalation phase in patients with SLE are expected to be shared in Q4 2026."

Enrollment status • P1 data • Rheumatoid Arthritis • Sjogren's Syndrome • Systemic Lupus Erythematosus

A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=358 | Recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=358 | Not yet recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Portfolio Highlights and 2026 Milestones:…Velinotamig (BCMAxCD3 bispecific T cell engager) (GlobeNewswire) - "Genrix Bio is enrolling a Phase 1 study in China in patients with autoimmune diseases, initially in patients with SLE, followed by future planned expansion into other indications and initial clinical data from the study are expected to be shared in Q4 2026....Following completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases."

Enrollment status • P1 data • Pipeline update • Systemic Lupus Erythematosus

A Study of GR1803 in Systemic Lupus Erythematosus (clinicaltrials.gov) - P1/2 | N=44 | Recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

New P1/2 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases (The Manila Times) - "In December 2025, Genrix Bio initiated a Phase 1 study in China in patients with autoimmune diseases, and initial clinical data from the study will be shared in Q4 2026. 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."

P1 data • Trial status • Immunology

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