On July 25, 2024 Bio-Thera Solutions Inc. (688177: SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported that dosing has recently begun in an integrated Phase I / Phase III clinical study for BAT3306, a proposed biosimilar of Keytruda (pembrolizumab) (Press release, BioThera Solutions, JUL 25, 2024, View Source;phase-iii-clinical-trial-for-bat3306-a-proposed-biosimilar-of-keytruda-pembrolizumab-302206502.html [SID1234645094]). 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.

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"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.