Joyo Pharma's JYP0015 Receives CDE Approval for RAS Mutation Cancer Trials

Joyo Pharma’s JYP0015 Receives CDE Approval for RAS Mutation Cancer Trials

China’s Center for Drug Evaluation (CDE) has tacitly approved Joyo Pharma’s Category 1 drug JYP0015, a molecular glue product, for clinical studies in hematological and solid tumors with RAS mutations. The approval follows positive preclinical data and a strategic licensing deal with U.S.-based Erasca, Inc.

Drug Profile
JYP0015, a novel pan-RAS small molecule inhibitor, has shown high anti-tumor activity in preclinical models of RAS mutations. The drug exhibits favorable pharmacokinetic (DMPK) properties, oral bioavailability, and a strong safety profile, positioning it as a promising candidate for RAS-driven cancers.

Licensing Partnership
In May 2024, Joyo Pharma entered a $345 million licensing agreement with Erasca (NASDAQ: ERAS), granting the California firm exclusive global rights (excluding mainland China, Hong Kong, and Macau) to develop and commercialize JYP0015. Erasca has initiated the AURORAS-1 study to evaluate the drug’s efficacy and safety in RAS mutant solid tumors.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry