Jiabao Yaoyin's First-in-Class CSF1R Inhibitor JDB383 Granted IND Approval for Tenosynovial Giant Cell Tumor Following Validation in Proprietary Humanized PDX Model

On June 2, 2022, JDB383 tablets, an oral, highly selective, Class 1 targeted small-molecule innovative anticancer drug independently developed by Shanghai Jiabao Yaoyin Pharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of Chengdu Jiabao Yaoyin, received the Notice of Approval for Drug Clinical Trials issued by the National Medical Products Administration (NMPA). The approved indication is tenosynovial giant cell tumor.

JDB383 is a colony-stimulating factor 1 receptor (CSF1R) inhibitor validated using pioneering humanized patient-derived xenograft (PDX) models. CSF1 is a disulfide-linked dimeric glycoprotein primarily located within the bone marrow cavity, where it regulates cellular processes such as macrophage growth, proliferation, and differentiation. As the cell surface receptor for CSF1, CSF1R effectively modulates macrophage survival, proliferation, and differentiation. Preclinical studies in humanized PDX models have demonstrated that JDB383 exhibits significant efficacy with a dose-dependent response. Furthermore, preclinical pharmacokinetic data indicate that JDB383 is rapidly absorbed and has favorable bioavailability.

Jiabao Yaoyin was established in 2019, dedicated to developing Class I innovative drugs urgently needed in clinical practice. Its current primary R&D pipeline includes: the drug-resistant tuberculosis medication with the highest global clinical safety profile; a first-in-class combination therapy targeting tumor immunity and anti-tumor angiogenesis, capable of rescuing patients who have failed PD-1 inhibitor treatment; a BTK inhibitor featuring ultra-high selectivity and excellent blood-brain barrier penetration; and a colony-stimulating factor inhibitor validated by a globally first-in-class PDX model, among others. Jiabao understands the real needs of patients, adopts a clinical-oriented approach to address practical clinical challenges, and continues to deepen its expertise across numerous therapeutic areas.