Gelonghui October 24th, YAHONG Pharmaceuticals (688176.SH) announced that it has received a letter from the US Food and Drug Administration (FDA) approving the company's independently developed APL-2302 for the treatment of advanced solid tumors. APL-2302 is a ubiquitin-specific protease 1 (USP1) inhibitor independently developed by the company, which exerts antitumor effects through a mechanism of "synthetic lethality." Preclinical studies have shown that APL-2302 monotherapy and combination therapy demonstrate good in vitro and in vivo antitumor activities. APL-2302 has the potential to be a new option for the treatment of late-stage solid tumors with specific biomarkers positive (such as BRCA gene mutations) such as breast cancer, ovarian cancer, and prostate cancer.

The approved study is a Phase I/IIa, open-label, multicenter, dose-escalation, and expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of APL-2302 in patients with advanced solid tumors. After the FDA approval of the APL-2302 clinical trial application, the company will promptly submit a new drug clinical trial application (IND) to the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) of China, actively promoting the global implementation of this clinical trial.