JUNSHI BIO (01877.HK): First Patient Dosed in Phase III Trial of JS203 for r/r DLBCL

NewTimeSpace News: On 23 October 2026, Shanghai Junshi Biosciences Co., Ltd. (stock code: 1877) published a voluntary announcement that the first patient has been dosed in a randomised, open-label, multicentre Phase III study of JS203, its independently developed recombinant humanised anti-CD20 and anti-CD3 bispecific antibody, in combination with chemotherapy versus rituximab plus chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (the JS203-003-III-DLBCL study, NCT07808827). The study is the first registrational clinical study of JS203.

The study is led by Professor Song Yuqin (宋玉琴) of Beijing Cancer Hospital as principal investigator, plans to enrol 282 subjects and has overall survival (OS) as its primary endpoint.

JS203 comprises an anti-CD20 arm and an anti-CD3 arm that link and activate lymphoma cells and T cells, promoting T-cell killing of lymphoma cells; preclinical in vivo studies showed significant tumour inhibition and good tolerability in animals. Preliminary Phase I results presented as a poster at AACR in April 2025 showed that step-up dosing after rituximab pretreatment was generally well tolerated, with an objective response rate (ORR) of 80% and a complete response rate (CRR) of 40% among DLBCL patients treated at 30mg. Updated results presented at the ASH Annual Meeting in December 2025 showed that 30mg monotherapy at the recommended Phase II dose achieved an ORR of 72.4% in CD20-positive relapsed or refractory B-cell non-Hodgkin lymphoma, with an ORR of 69.7% and a CRR of 39.4% in DLBCL patients; cytokine release syndrome occurred in 27.3% of patients and no immune effector cell-associated neurotoxicity syndrome was observed.

DLBCL is one of the most common types of non-Hodgkin lymphoma in China, accounting for about 40% of adult NHL, with about 45,000 new cases each year; the five-year survival rate for relapsed or refractory patients is about 30% even with aggressive treatment. The Company cautioned that pharmaceutical development is lengthy, involves multiple stages and is subject to uncertainties, and investors should exercise caution.