{"id":4046,"date":"2026-10-23T21:00:00","date_gmt":"2026-10-23T13:00:00","guid":{"rendered":"https:\/\/www.junshipharma.com\/junshi-biosciences-announces-completion-of-first-patient-dosing-in-the-phase-3-clinical-trial-of-js203-in-combination-with-chemotherapy-for-the-treatment-of-diffuse-large-b-cell-lymphoma\/"},"modified":"2026-11-02T14:41:53","modified_gmt":"2026-11-02T06:41:53","slug":"junshi-biosciences-announces-completion-of-first-patient-dosing-in-the-phase-3-clinical-trial-of-js203-in-combination-with-chemotherapy-for-the-treatment-of-diffuse-large-b-cell-lymphoma","status":"publish","type":"post","link":"https:\/\/www.junshipharma.com\/en\/junshi-biosciences-announces-completion-of-first-patient-dosing-in-the-phase-3-clinical-trial-of-js203-in-combination-with-chemotherapy-for-the-treatment-of-diffuse-large-b-cell-lymphoma\/","title":{"rendered":"Junshi Biosciences Announces Completion of First Patient Dosing in the Phase 3 Clinical Trial of JS203 in Combination with Chemotherapy for the Treatment of Diffuse Large B-cell Lymphoma"},"content":{"rendered":"\n

SHANGHAI, China, October 23, 2026 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (\u201cJunshi Biosciences,\u201d HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the first patient dosing has been completed in a randomized, open-label, multicenter phase 3 clinical study of the company\u2019s product, a recombinant humanized anti-CD20\/CD3 bispecific antibody (code: JS203), in combination with chemotherapy compared to rituximab in combination with chemotherapy in patients with relapsed\/refractory diffuse large B-cell lymphoma (R\/R DLBCL) (the JS203-003-III-DLBCL Study; NCT07808827). This study is the first<\/strong> registrational clinical study for JS203.<\/p>\n\n\n\n

DLBCL is one of the most common types of non-Hodgkin lymphoma (NHL), accounting for approximately 40% of adult NHL cases in China. According to GLOBOCAN 2022 statistics, there are approximately 45,000 new cases of DLBCL in China each year, and the incidence rate shows a slow increasing trend. DLBCL<\/sup> is characterized by high aggressiveness and rapid progression. A retrospective study in an Asian population showed that, even after active treatment, patients with relapsed or refractory DLBCL had a median overall survival (mOS) of over one year and a 5-year survival rate of approximately 30%, which necessitates the exploration of more proactive and effective treatment options.<\/p>\n\n\n\n

JS203 is a recombinant humanized anti-CD20\/CD3 bispecific antibody self-developed by Junshi Biosciences. It consists of anti-CD20 segment and anti-CD3 segment. By associating and activating lymphoma cells (binding to CD20) and T cells (binding to CD3), JS203 can enable T cells to kill lymphoma cells effectively. Results from a phase 1 clinical study showed that, for JS203 monotherapy at the recommended phase 2 dose (RP2D) administered with step-up dosing (SUD) to 30 mg for the treatment of patients with CD20-positive relapsed or refractory B-cell non-Hodgkin lymphoma, the objective response rate (ORR) reached 72.4%. Among patients with DLBCL, the ORR was 69.7%, and the complete response rate CRR was 39.4%, with persistent relief observed. Meanwhile, the overall safety profile was manageable, with a cytokine release syndrome (CRS) incidence rate of only 27.3% and no occurrence of immune effector cell-associated neurotoxicity syndrome (ICANS).<\/p>\n\n\n\n

The JS203-003-III-DLBCL Study is a randomized, open-label, multicenter phase 3 clinical trial, with Professor Yuqin SONG of Beijing Cancer Hospital serving as the principal investigator. It aims to compare the efficacy and safety of JS203 in combination with chemotherapy compared to rituximab in combination with chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma. The study plans to enroll 282 subjects, with overall survival (OS) as its primary endpoint. This study is the first registrational clinical study for JS203.<\/p>\n\n\n\n

The JS203-003-III-DLBCL study team<\/strong> commented: \u201cEarly clinical studies have shown encouraging efficacy and a favorable safety profile for JS203 in combination with chemotherapy in patients with R\/R DLBCL, reinforcing our confidence in the ongoing Phase 3 study. We are committed to advancing the study with rigor and efficiency, with the aim of making a new treatment option available to patients as soon as possible.\u201d<\/p>\n\n\n\n

<\/p>\n\n\n\n

\u3010Reference\u3011<\/h5>\n\n\n\n
\n
1.Sun J, Yang Q, Lu Z, et al. Distribution of lymphoid neoplasms in China: analysis of 4,638 cases according to the World Health Organization classification[J]. American journal of clinical pathology, 2012, 138(3): 429-434.
2.Shi Y, Han Y, Yang J, et al. Clinical features and outcomes of diffuse large B-cell lymphoma based on nodal or extranodal primary sites of origin: Analysis of 1,085 WHO classified cases in a single institution in China[J]. Chinese Journal of Cancer Research, 2019, 31(1): 152.
3.Pan T, Zhang J, Wang X, et al. Global burden and trends of hematologic malignancies based on Global Cancer Observatory 2022 and Global Burden of Disease 2021[J]. Exp Hematol Oncol, 2025, 14: 98.
4.LIM N-A, SUN Y, TAN J Y, et al. Outcomes in relapsed\/refractory diffuse large B-cell lymphoma in an Asian tertiary cancer center: real-world interventions as benchmark for novel therapy[J]. ESMO Real World Data and Digital Oncology, 2025, 10: 100195.
5.Xie Y, Jing H, Li Y, et al. JS203, a CD20\u00d7CD3 bispecific antibody, demonstrated promising anti-cancer activity in patients with relapsed or refractory (R\/R) B-cell non-Hodgkin lymphoma (B-NHL): Updated results from a phase I study. Blood. 2025; 146 (Suppl 1): 1957. doi: 10.1182\/blood-2025-1957.<\/h5>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

First patient dosing has completed in the Phase 3 clinical trial of JS203 (CD20\/CD3 bsAb) for the treatment of R\/R DLBCL.<\/p>\n","protected":false},"author":6,"featured_media":4038,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[147,148,146],"class_list":["post-4046","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-cd20-cd3-en","tag-dlbcl-en","tag-js203-en"],"yoast_head":"\nFirst Patient Dosing Completed in the Phase 3 Study of JS203 (CD20\/CD3 bsAb) for the Treatment of R\/R DLBCL<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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