中国首个自主研发的EZH2抑制剂获批上市

Core Viewpoint - Heng Rui Medicine has received conditional approval from the National Medical Products Administration for its innovative drug, Zemeituosita Tablets, which is the first self-developed EZH2 inhibitor in China, providing a new treatment option for adult patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) [1][2] Company Summary - Heng Rui Medicine has developed Zemeituosita Tablets, a highly selective oral EZH2 inhibitor, which works by inhibiting histone methyltransferase EZH2, reversing abnormal epigenetic programming in tumor cells, and inducing cell cycle arrest and early apoptosis [2] - The company has successfully launched 24 first-class innovative drugs in China, with over half being anti-tumor drugs, and has more than 100 self-innovated products in clinical development, along with over 400 clinical trials ongoing domestically and internationally [2] Industry Summary - Peripheral T-cell lymphoma (PTCL) accounts for approximately 25-30% of non-Hodgkin lymphoma patients in China, significantly higher than in Western countries, with a median onset age of 52-57 years [2] - The clinical treatment of PTCL is challenging, as most patients experience relapse or become refractory after initial treatment, with a recent study showing a median progression-free survival of only 5.2 months for patients entering second-line treatment [2] - The approval of Zemeituosita Tablets highlights the need for innovative treatment options in the R/R PTCL patient population, which currently lacks standardized treatment protocols and effective therapeutic options [2]