SHR-A1912 / Jiangsu Hengrui Pharma - LARVOL DELTA

2025 ASCO Rapid Oral Report | Hengrui CD79b ADC Innovative Drug SHR-A1912 Combination Therapy Study Data Released for Relapsed and Refractory Diffuse Large B-cell Lymphoma (Jiangsu Hengrui Press Release) - P1b/2 | N=132 | NCT06104553 | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | "On May 31, Beijing time, Professor Li Zhiming of the Cancer Center of Sun Yat-sen University reported the latest data of the study on SHR-A1912 combined with R-GemOx regimen (rituximab, gemcitabine and oxaliplatin) for the treatment of relapsed and refractory diffuse large B-cell lymphoma (DLBCL) at the conference site....As of February 24, 2025, the median follow-up time of 37 relapsed and refractory DLBCL subjects was 6.9 months (range: 0.3, 11.5), and the median treatment cycle was 9 cycles (range: 1, 17). The ORR was 70.3% (95% CI: 53.0, 84.1), the CRR was 54.1% (95% CI: 36.9, 70.5), and the 6-month sustained remission rate was 95.5% (95% CI: 71.9, 99.3). In terms of safety, the overall safety of SHR-A1912 1.8 mg/kg combined with R-GemOx was tolerable."

P1/2 data • Diffuse Large B Cell Lymphoma

CD79b-targeted antibody-drug conjugate (ADC) SHR-A1912 in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) in relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL): Data from a phase 1b/2 study. (ASCO 2025) - P1/2 | "In pts with r/r DLBCL, SHR-A1912 at 1.8 mg/kg in combination with R-GemOx was tolerable and demonstrated a safety profile consistent with its individual components. This combination exhibited potent anti-tumor activity, as well as rapid and durable responses."

Combination therapy • P1/2 data • Anemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD79B

A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P3 | N=280 | Recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Phase 3 Clinical Study of SHR-A1912 Combined With R-GemOx Versus R-GemOx in Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P3 | N=280 | Not yet recruiting | Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

New P3 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A phase 1 study of SHR-A1912, a CD79b targeted antibody-drug conjugate (ADC), in patients (pts) with B-cell non-Hodgkin lymphoma (B-NHL). (ASCO 2024) - P1 | "SHR-A1912 was tolerable up to 3.6 mg/kg and had promising anti-tumor activity in pts with previously treated B-NHL, supporting further investigations of SHR-A1912."

Clinical • P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • CD79B

SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=924 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor

Heavy! Hengrui Medicine’s innovative CD79b ADC drug SHR-A1912 has received fast track designation from the U.S. FDA [Google translation] (Jiangsu Hengrui Press Release) - "...SHR-A1912, an innovative CD79b antibody-drug-conjugate (ADC) drug for injection independently developed by Hengrui Medicine, was granted fast track designation (FTD) by the U.S. Food and Drug Administration (FDA), for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) that has received at least two lines of therapy in the past."

Fast track designation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • EGFR

A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma (clinicaltrials.gov) - P1/2 | N=132 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas (clinicaltrials.gov) - P1 | N=170 | Enrolling by invitation | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting ➔ Enrolling by invitation | Trial primary completion date: Dec 2023 ➔ Mar 2024

Enrollment status • Monotherapy • Trial primary completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma (clinicaltrials.gov) - P1/2 | N=132 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

New P1/2 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Hengrui Medicine: ADC drug HR-A1912 clinical trial approved [Google translation] (pharnexcloud.com) - "...Hengrui Pharmaceutical...announced that the company's subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd. received the approval and issuance of the 'Drug Clinical Trial Approval Notice' for SHR-A1912 for injection from the National Medical Products Administration. Clinical trials will be launched in the near future. A clinical trial of a combination rituximab-containing treatment regimen for B-cell non-Hodgkin lymphoma will be launched....Up to now, a total of approximately 24.35 million yuan has been invested in research and development expenses for SHR-A1912-related projects for injection."

Commercial • New trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas (clinicaltrials.gov) - P1 | N=170 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | N=123 ➔ 170 | Trial completion date: Jun 2024 ➔ Mar 2025

Enrollment change • Trial completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas (clinicaltrials.gov) - P1; N=123; Recruiting; Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas (clinicaltrials.gov) - P1; N=123; Not yet recruiting; Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Clinical • New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology