Hangzhou HealZen Therapeutics Co., Ltd recently announced that its independently developed Class 1 innovative drug, HZ-H08905 (CK1ε&PI3Kδ dual-target inhibitor), has been officially approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), China, to conduct a pivotal registration Phase III clinical trial for the treatment of recurrent or refractory peripheral T-cell lymphoma (R/R PTCL).

Peripheral T-cell lymphoma (PTCL) is a group of highly heterogeneous malignant proliferative diseases of lymphoma cells, including mature T-cell and NK-cell tumors originating from the thymus. Most subtypes of PTCL belong to aggressive or highly aggressive lymphomas, which are characterized by rapid progression, high recurrence rate, short survival time, and poor prognosis and are life-threatening diseases. Although the National Medical Products Administration (NMPA) has approved several new drugs for the monotherapy treatment of R/R PTCL, the treatment options for R/R PTCL patients are still limited. There is no standard or optimal treatment method with a significant unmet clinical need. It is urgent to develop new drugs to improve the efficacy and prolong the survival of patients.

HZ-H08905 is a highly selective inhibitor of CK1ε and PI3Kδ, both of which are related to the pathogenesis of lymphoma. Inhibition of CK1ε and PI3Kδ can directly act on lymphoma cells, inducing apoptosis and inhibiting the proliferation of tumor cells.

In addition, CK1ε inhibitors can maintain the survival of Tregs through the Wnt/β-Catenin signaling pathway, regulating immunosuppression. The results of the clinical Phase I study of HZ-H08905 showed good safety and tolerability, with prominent efficacy in treating PTCL. It is expected to become a new therapeutic drug for PTCL.

About HZ-H08905 Tablets

HZ-H08905 is a novel, potent, oral small molecule CK1ε&PI3Kδ dual-target inhibitor independently developed by Hangzhou HealZen Therapeutics Co., Ltd. It has previously been approved to conduct clinical trials for monotherapy of recurrent or refractory non-Hodgkin's lymphoma, as well as combination therapy with HZ-A-018 capsules for treating relapsed or refractory B-cell lymphoma.

About Hangzhou HealZen Therapeutics Co., Ltd

Hangzhou HealZen Therapeutics Co., Ltd is an innovative small-molecule drug development company driven by innovative technology in the clinical stage, dedicated to addressing unmet clinical needs. The company independently develops targeted protein degradation drugs and an intelligent drug development platform, focusing on drug development in disease areas such as hematological tumors and the central nervous system. The company has established project pipelines with over 10 Class 1 new drugs, of which 6 molecules have entered the clinical research stage, 1 molecule is in clinical phase III, and 1 molecule has been recognized as a breakthrough therapy. In addition, the company has accumulated 4 new drug pipelines for external cooperation, and the drug discovery capability has been widely recognized in the industry.