China-based Jiangsu Hengrui Pharmamceuticals (SHA: 600276) has announced that its enhancer for the zeste homolog 2 (EZH2) inhibitor, SHR2554, is set to obtain breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. The designation is for use in relapsed/refractory (r/r) peripheral T-cell lymphoma, marking a significant milestone in the development of this novel therapy.
SHR2554: Mechanism and Development
SHR2554 is described as a novel, highly selective EZH2 inhibitor under development to treat malignant tumors. The EZH2 enzyme is an epigenetic regulator that plays a key role in cell differentiation and oncogenesis. This breakthrough therapy designation underscores the potential of SHR2554 to address significant unmet needs in the treatment of peripheral T-cell lymphoma.
Market Landscape
Other EZH2 inhibitors currently on the market include Daiichi Sankyo’s Ezharmia (valemetostat), HutchMed/Epizyme’s Tazverik (tazemetostat), and Johnson & Johnson’s astemizole. In China, several companies, including Sichuan University, HutchMed, Haihe Bio, Sinovent, and Tarapeutics, are also developing similar drugs. Notably, Tazverik, an oral version, generated USD 30.9 million in global sales in 2021, highlighting the market potential for EZH2 inhibitors.
Future Outlook
With the anticipated BTD status for SHR2554, Hengrui is poised to advance its clinical development program and bring this innovative therapy closer to patients in need. This designation positions SHR2554 as a potential new standard of care for relapsed/refractory peripheral T-cell lymphoma.-Fineline Info & Tech
