The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approvals to two investigational drugs from US-based Eli Lilly (NYSE: LLY): peresolimab, a PD-1 agonist, and LOXO-783, a PI3Kα H1047R inhibitor. These approvals pave the way for further clinical development of the drugs in China.
Peresolimab: Targeting Rheumatoid Arthritis
Peresolimab is a humanized immunoglobulin (Ig) G1 monoclonal antibody (mAb) designed to bind with human PD-1 and act as its agonist. By inhibiting the activation and expansion of lymphocytes, it stimulates the physiological immunosuppressive pathway and restores immune regulation. This mechanism makes it a potential treatment for moderate to severe active rheumatoid arthritis. A Phase II study is currently underway, assessing the drug’s efficacy and safety in 101 subjects across 26 global centers.
LOXO-783: Targeting Solid Tumors with PIK3CA H1047R Mutation
LOXO-783 is a PI3Kα H1047R inhibitor that has demonstrated significant tumor regression in multiple breast cancer animal models. These models feature positive estrogen receptors (ERs), negative human epidermal growth factor receptor 2 (HER2), and mutant PI3Kα H1047R. In vivo studies have shown that LOXO-783 has the potential to penetrate the blood-brain barrier. The drug is being evaluated for safety and preliminary efficacy in advanced breast cancer and other solid tumors with PI3Kα H1047R mutation, both as a standalone treatment and in combination with other therapies outside of China.-Fineline Info & Tech
