Yuandong Biotech (688513.SH): HP-002 tablets initiated phase I/II clinical trials and completed the first case of patient enrollment

Zhitong Finance App News, Yuandong Biology (688513.SH) announced that HP002 tablets, a class 1 innovative chemical drug independently developed by the company's holding subsidiary, Shanghai Chaoyang Pharmaceutical Co., Ltd. (hereinafter referred to as “Shanghai Chaoyang Pharmaceutical”), are undergoing phase I/II clinical trials to treat recurrent or difficult B-cell non-Hodgkin lymphoma (B-NHL), and recently completed the first case of the test subject.

HP-002 tablets are a next-generation proteolytic targeting chimera (PROTAC) molecule with brain penetrating ability and targeting BTK (Bruton tyrosine kinase). It has shown strong anti-proliferative activity against various BTK mutant cell lines in preclinical studies.

The main purpose of this phase I study was to evaluate the safety and tolerability of HP-002 in patients with recurrent or refractory B-cell non-Hodgkin lymphoma (B-NHL) at the dose escalation stage, explore the maximum tolerable dose and determine the recommended dosage for the phase II trial; and also evaluate the pharmacokinetics (PK), pharmacokinetics (PD) characteristics of HP-002 in B-NHL patients, and biomarkers related to initial anti-tumor effects and efficacy. The main purpose of the phase II study was to evaluate the initial efficacy of HP-002 in B-NHL patients during the dose expansion phase, and to evaluate its safety, tolerability, PK and PD characteristics, as well as biomarkers and cerebrospinal fluid PK characteristics related to efficacy. As of the disclosure date of this announcement, the first patient was enrolled in the dose escalation phase I of the study.