IDEAYA Biosciences, a precision medicine oncology company, has entered an exclusive licensing agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma, SHA: 600276) for SHR-4849, a DLL3-targeting Topo-I-payload ADC. IDEAYA will develop and commercialize SHR-4849 globally, excluding Greater China.
SHR-4849 is a promising therapeutic candidate targeting DLL3, which is highly expressed in SCLC (~85%) and NETs (20-40%) with limited expression in normal tissues. The ADC is being evaluated in a Phase 1 clinical trial in China (NCT06443489), showing an overall response rate of ~73% among evaluable SCLC patients at therapeutic dose levels. Treatment-related adverse events (TRAEs) were predominantly Grade 1 or 2, and no dose-limiting toxicities were reported. SHR-4849 has demonstrated potential in preclinical studies and early clinical trials, including tumor regression and manageable safety. IDEAYA plans to file a US IND for SHR-4849 in H1 2025.
IDEAYA aims to explore SHR-4849 as a monotherapy in SCLC and NETs and in combination with IDE161, its PARG inhibitor, for enhanced efficacy. Hengrui Pharma will receive up to $1.045 billion in milestone payments, including a $75M upfront payment and royalties on net sales outside Greater China. IDEAYA’s cash runway is projected to last through 2028.
Hengrui Pharma is a global leader in innovative drug development with expertise in ADCs, PROTACs, bispecific antibodies, and AI molecular design. Its commitment to addressing unmet clinical needs aligns with IDEAYA’s precision medicine approach, which integrates molecular diagnostics and synthetic lethality to develop targeted cancer therapeutics.