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Junshi Biosciences Announces Completion of First Patient Dosing in the Phase 3 Clinical Trial ...
The study will enroll 282 patients and uses overall survival as the primary endpoint after encouraging early results and manageable safety in Phase 1.
On Friday, Shanghai Junshi Biosciences completed first patient dosing in a Phase 3 clinical trial of JS203, a bispecific antibody designed to treat relapsed or refractory DLBCL.
DLBCL accounts for approximately 40% of adult NHL cases in China, with approximately 45,000 new cases annually characterized by high aggressiveness and rapid progression.
JS203 demonstrated a 69.7% objective response rate in DLBCL patients during Phase 1 trials, with a manageable safety profile including a 27.3% cytokine release syndrome incidence.
Led by Professor Yuqin SONG of Beijing Cancer Hospital, the randomized, open-label, multicenter study plans to enroll 282 subjects with overall survival as the primary endpoint.
Headquartered in Shanghai, Junshi Biosciences employs more than 3,000 people globally and maintains an extensive portfolio including toripalimab, approved in over 50 countries and regions.