Shanghai Junshi Biosciences Co., Ltd (HKG: 1877), a leading biotech company based in China, has received approval from the Pharmaceuticals and Medical Devices Agency of Japan to initiate a global multi-center Phase III study. The study will be a randomized, double-blind, placebo-controlled trial investigating the combination of tifcemalimab (TAB004/JS004) and Tuoyi (toripalimab) as a consolidation therapy for patients with limited-stage small-cell lung cancer (LS-SCLC) who have not progressed after radiotherapy and chemotherapy (CRT). The study aims to enroll 756 patients across China, the US, and Europe.
Tifcemalimab, a monoclonal antibody specifically targeting B- and T-lymphocyte attenuator (BTLA), is currently in multiple Phase Ib/II clinical studies in the US and China, exploring its potential in combination with Tuoyi for various tumor types. Tuoyi, a programmed death-1 (PD-1) inhibitor, made history as China’s first domestic PD-1 inhibitor approved in December 2018 for second-line treatment of melanoma. To date, Tuoyi has received six indication approvals in China, with multiple market filings under review in the US, EU, and UK.- Flcube.com
