Ascentage Pharma (6855.HK), a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, today announced a combination therapy strategic collaboration with Henlius (2696.HK), working together to conduct clinical trials of the combination therapy between APG-2575, a novel, orally administered Bcl-2 selective inhibitor developed by Ascentage Pharma, and HLX01 (Rituximab Injection), the first launched product by Henlius, for the treatment of chronic lymphocytic leukemia (CLL) in the People’s Republic of China.
APG-2575 is a novel, orally administered Bcl-2 selective inhibitor developed by Ascentage Pharma. It is designed to treat hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. In July 2019, the first patient was dosed successfully in a Phase I clinical trial of APG-2575 for the treatment of hematologic malignancies in China, making APG-2575 potentially the first China-made Bcl-2 inhibitor to enter clinical study. CLL and non-Hodgkin’s lymphoma (NHL) patients are included in this trial. The Phase I clinical trial of APG-2575 in hematologic malignancies has already been initiated in Australia and the U.S. As of Aug. 13, 2019, one patient’s tumor had been reduced in size by over 60%, a response that met the criteria for partial response (PR); there were three patients in the 400mg dose cohort whose absolute lymphocyte counts (ALC), another key efficacy parameter of this study, have reached the criteria for complete response (CR) by the end of cycle 1. No tumor lysis syndrome (TLS) was observed in the study, indicating the favorable safety profile of the investigational agent. Moreover, at the 2019 American Association for Cancer Research (AACR) annual meeting, Ascentage Pharma has already presented results from several preclinical studies that demonstrated APG-2575’s potential in combination therapies.
As the first approved biosimilar in China, HLX01 (Rituximab Injection) is mainly for the treatment of non-Hodgkin’s lymphoma (NHL). In February 2019, China National Medical Products Administration (NMPA) approved HLX01 (Rituximab Injection) for the treatment of adult patients with 1) relapsed or refractory, follicular lymphoma; 2) previously untreated stages III-IV follicular, non-Hodgkin’s lymphoma; and 3) CD20-positive, diffuse large B-cell, non-Hodgkin’s lymphoma (DLBCL), namely all the approved indications of the originator Rituximab in China. Rituximab in combination with chemotherapy has long been the standard treatment of NHL. HLX01 (Rituximab Injection) provides an alternative treatment option for lymphoma patients, as over 1,000 patients benefited in the first month after its commercial launch.