Joyo Pharma’s JYP0035 Receives Clinical Trial Approval for Breast Cancer Treatment

On March 14, 2025, Joyo Pharma announced that its independently developed next-generation, highly selective Class 1 new drug, the PI3Kα inhibitor JYP0035 capsule, received clinical trial approval from the National Medical Products Administration (NMPA). This marks a significant step forward in the development of targeted therapies for breast cancer patients with PIK3CA mutations, HR positivity, and HER2 negativity.

Drug Profile and Mechanism
JYP0035 is a highly selective small-molecule PI3Kα inhibitor and degrader of mutant PI3Kα. Unlike pure PI3Kα inhibitors, JYP0035 functions as both an inhibitor and degrader, reducing the incidence of clinical side effects such as hyperglycemia by minimizing its impact on wild-type PI3Kα.

Clinical and Preclinical Data
Preclinical study data and clinical study data from the same target drugs in the same patient population suggest that PI3Kα inhibitors like JYP0035, either as monotherapy or in combination with endocrine therapy with or without CDK4/6 inhibitors, may offer significant benefits to the target patient population. This dual-action mechanism positions JYP0035 as a promising candidate for improving treatment outcomes in patients with PIK3CA-mutated, HR-positive, and HER2-negative breast cancer.-Fineline Info & Tech