Yahong Pharmaceutical (688176.SH): APL-2302 completed the first phase A clinical trial enrollment

Zhitongcaijing · 03/13/2025 09:41

Zhitong Finance App News, Yahong Pharmaceutical (688176.SH) issued an announcement. Recently, the phase I/IIa clinical trial (hereinafter referred to as the “study”) conducted by the company to evaluate the safety, tolerability, pharmacokinetics, and initial anti-tumor activity of APL-2302 in advanced solid tumor patients completed the enrollment of the first phase Ia clinical trial.

According to reports, APL-2302 is a ubiquitin-specific protease 1 (USP1) inhibitor independently developed by the company, which exerts an anti-tumor effect through a “synthetic death” mechanism. Preclinical studies suggest that APL-2302 monotherapy and combination therapy showed good activity in vitro and in vivo in tumor suppression. APL-2302 has the potential to become a new option for treating advanced solid tumors (breast cancer, ovarian cancer, prostate cancer, etc.) positive for specific biomarkers (such as BRCA gene mutations, etc.).

This study is a phase I/IIa, open, multicenter, dose-escalation, and expansion study to evaluate the safety, tolerability, pharmacokinetics, and initial antitumor activity of APL-2302 in patients with advanced solid tumors. The study has been approved by the US Food and Drug Administration (FDA) and the National Drug Administration (NMPA), and recently successfully enrolled the first phase Ia clinical trial.