3D185 is a fibroblast growth factor receptors (FGFR) 1-3 and colony stimulating factor 1 receptor (CSF1R) inhibitor. 3D185 was obtained IND approval from the NMPA in January 2018. We received IND approval from the FDA in September 2019, and completed the Phase I clinical trial in patients with advanced solid tumors in China and the U.S. in August 2021. In October 2022, 3D185 received an orphan-drug designation from the FDA for the treatment of biliary tract cancer. On January 13, 2023, 3D185 was granted the orphan-drug designation by the FDA for the treatment of gastric cancer and gastro-esophageal junction cancer. For exploring and protecting more FGFR inhibitor dosage forms, we submitted one Chinese patent application to the China National Intellectual Property Administration on December 1, 2022. As of the date of this report, a new formulation of 3D185 is being studied in a Phase I clinical trial in China and U.S.
The fibroblast growth factor receptors (FGFRs) is an important tyrosine kinases receptor family. FGFR pathway abnormality is closely related to tumorigenesis and development of many cancer types. FGFR inhibitors have attracted much attention in the field of tumor therapy development recently, with potential to provide more therapy options for cancer patients. 3D-185 is a small molecule inhibitor selectively targeting FGFR1-3, and preclinical studies have demonstrated its anti-tumor activity. The high selectivity of 3D185 provides significant advantages in off-target toxicity reduction, selection of sensitive patients, and the design of combination therapy with other drugs.