By Fineline Cube 
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study for its Category 1 chemical drug, HDM2006, in patients with advanced solid tumors. This marks a significant step forward in the global development of the drug.
HDM2006: Drug Profile and Mechanism
HDM2006 is a hematopoietic progenitor kinase 1 (HPK1) PROteolysis TArgeting Chimera (PROTAC) drug, with global intellectual property rights held by Huadong Medicine. Preclinical studies have demonstrated that HDM2006 possesses favorable drug properties, safety, and efficacy. The drug is designed to specifically bind to human HPK1 and E3 ligases, forming a ternary complex that leads to ubiquitination and protein degradation. This mechanism alleviates the negative regulation of HPK1 on human T lymphocytes, B lymphocytes, and DC cells, thereby activating immune cells and reversing immune suppression and T cell depletion in the tumor microenvironment, ultimately exerting anti-tumor effects. HDM2006 has shown significant anti-tumor activity in multiple tumor models and exhibits synergistic effects when combined with PD-1/PD-L1 antibodies.
Clinical Development Progress
A clinical study for HDM2006 in China was initiated last month, following clearance from the National Medical Products Administration in October of the previous year. The FDA’s approval for the Phase I study in the US further expands the drug’s clinical development footprint, bringing it one step closer to potential global market availability.-Fineline Info & Tech