By Fineline Cube 
On August 21, 2025, China-based Bio-Thera Solutions, Ltd. (SHA: 688177) announced a strategic adjustment to the registrational clinical study for BAT3306. The revised plan involves conducting a multi-center, randomized, double-blind, parallel-controlled trial to assess the pharmacokinetics, immunogenicity, safety, and efficacy of BAT3306 compared to Keytruda in patients with Stage IB-IIIA non-small cell lung cancer.
Termination of Previous Study
In May 2025, Bio-Thera terminated the BAT3306-002 study, a Phase I/III trial evaluating BAT3306 combined with chemotherapy in Stage IV non-small cell lung cancer patients. This decision aligned with the evolving regulatory practices in the U.S. and Europe, where comparative efficacy studies are no longer essential for biosimilar approvals.
New Development Strategy
The new study reflects Bio-Thera’s adaptation to dynamic drug regulatory policies and its latest R&D plan. It aims to meet regulatory requirements for BAT3306’s approval in the U.S. and Europe, focusing on pharmacokinetics and safety rather than comparative efficacy.-Fineline Info & Tech