C019199 is an innovative drug candidate developed by the company, designed as a new-generation therapy targeting the the tumor immunosuppressive microenvironment. Its intellectual property is protectedby global patents. C019199 exerts its effects through multiple synergistic mechanisms:1. Inhibition of the CSF-1R signaling pathway - suppresses and polarizes tumor associated macrophages (TAM), thereby lifting suppression on T cells, promoting T cell infiltration, and enhancing T cell cytotoxic function; 2. Inhibition of DDR1 - disrupts the extracellular matrix "physical barrier" of tumor tissue, further increasing infiltration and penetration of immune cells and drugs into tumors; 3. Inhibition of VEGFR2 - induces normalization of tumor blood vessels, enabling immune cells and drugs to better infiltrate the tumor tissue through blood vessels, while simultaneously reducing Treg-mediated suppression, further relieving tumor-induced immune suppression. Together, these mechanisms enhance the efficacy of tumor immunotherapy.
In 2020, C019199 entered Phase I clinical trials at both Beijing Cancer Hospital and the First Affiliated Hospital of Xiamen University. Phase I results demonstrated good absorption in humans and efficacy, significantly fewer adverse reactions compared with similar drugs. These findings suggest that C019199 may synergistically relieve tumor immune suppression through multiple mechanisms, improving the efficacy against various tumors, and presenting sugnificant market potential.
In the first half of 2022, the company completed a Phase Ia clinical trial and subsequently launched exploratory phase Ib clinical studiesin various solid tumors such as tenosynovial giant cell tumor, osteosarcoma, and breast cancer. In the first half of 2023, the IND application for Phase I/II trials combining C019199 with immune checkpoint inhibitors was approved. By December 2023, the dose-escalation Phase I study of the combination therapy was completed. The program then advanced to Phase II studies in multiple advanced solid tumors, including colorectal cancer, gastric cancer, esophageal cancer, head and neck squamous cell carcinoma, pancreatic cancer, triple-negative breast cancer, and osteosarcoma. A Phase III clinical trial is planned for the second half of 2025.
