Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced that it has received ethical approval to conduct a pivotal Phase III clinical study for its third-generation anaplastic lymphoma kinase (ALK) inhibitor, SY-3505. The study is a randomized, controlled, multi-center trial designed to assess the efficacy and safety of SY-3505 in treatment-naïve ALK-positive non-small cell lung cancer (NSCLC) patients compared to crizotinib.
The Category 1 drug candidate, SY-3505, has demonstrated a potent inhibitory effect on both wild-type ALK kinases and key drug-resistant mutants of first/second-generation ALK inhibitors. It is capable of blocking their signal transduction pathways, thereby effectively inhibiting the growth of mutant tumors. In prior clinical studies, SY-3505 exhibited significant antitumor activity in patients with resistance to ALK inhibitors, including those resistant to first and second-generation drugs, and was well-tolerated. The drug received Phase II approval in China in March of this year for the treatment of ALK gene fusion-positive advanced NSCLC patients who have experienced disease progression or toxicity intolerance after treatment with second-generation ALK inhibitors.- Flcube.com
