GUANGZHOU, China , July 25, 2024 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177: SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that dosing has recently begun in an integrated Phase I / Phase III clinical study for BAT3306, a proposed biosimilar of Keytruda ® (pembrolizumab). The clinical study is a randomized, double-blind, parallel group, active control study to compare the pharmacokinetics, efficacy and safety of BAT3306 to Keytruda ® in non-squamous non-small cell lung cancer (nsNSCLC) patients.
The study is expected to enroll approximately 676 patients. "Keytruda is the most important innovative cancer therapy currently in use," said Shengfeng Li , CEO at Bio-Thera. "Bio-Thera is committed to expanding access to this important cancer therapy with the development of BAT3306.
" Bio-Thera Solutions is developing a large pipeline of biosimilars that include BAT1806, a tocilizumab has been approved by FDA, EMA and NMPA, BAT1706, a bevacizumab has been approved by FDA and NMPA. BAT2206, a ustekinumab has been filed with FDA, EMA and NMPA. Bio-Thera Solutions is also pursuing biosimilar versions of golimumab, secukinumab, and mepolizumab.
About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou , China , is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune , cardiovascular, eye disea.