First Drug Holdings (688197.SH): The fourth-generation ALK inhibitor SY-12321 received a notice of approval for drug clinical trials

Zhitong Finance App News, First Drug Holdings (688197.SH) issued an announcement. The company recently received the “Drug Clinical Trial Approval Notice” approved and issued by the State Drug Administration. As a candidate drug for fourth-generation ALK inhibitors, the clinical trial application for SY-12321 capsules in advanced solid tumors positive for anaplastic lymphoma kinase (ALK) -positive advanced solid tumors was approved.

SY-12321 is a Class 1 innovative chemical drug completely independently developed by the company. It is a fourth-generation small-molecule ALK inhibitor. It is an important candidate product for the company to improve the full life cycle treatment layout for ALK positive tumors. It aims to focus on solving drug resistance problems after treatment with third-generation ALK inhibitors, especially drug resistance mediated by ALK complex mutations. Preclinical studies have shown that SY-12321 showed strong inhibitory activity against ALK wild-type and a wide range of key drug-resistant mutations generated after treatment with first-generation, second-generation, and third-generation ALK inhibitors, covering major single-point drug resistance mutations and various key complex mutations, and showed good tumor inhibitory effects in intracranial tumor models, suggesting that it has the potential to overcome resistance mechanisms associated with ALK inhibitors and control central nervous system lesions across generations.

Based on the above preclinical research results, SY-12321 not only focuses on patients progressing after treatment with third-generation ALK inhibitors, but also has the potential to expand into more advanced treatments in the future. The company will carefully evaluate its development value in different treatment lines based on the results of subsequent clinical studies.