Ascentage Pharma and Henlius Form a Combination Therapy Strategic Collaboration

SUZHOU, China and ROCKVILLE, MD, USA I November 4, 2019 I 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.

The collaboration is of great significance to both companies. Bcl2 inhibitors are a rising star for B cell malignancies and can be applied to the treatment of CLL in combination with rituximab. Potentially this combination could also be extended to other B cell malignancies

Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma, commented: "We are delighted to be entering this collaboration agreement with Henlius. As the first China-made Bcl-2 inhibitor to enter clinical study, APG-2575 is a key candidate in our development pipeline of apoptosis with a great potential in the treatment of hematologic malignancies. HLX01 (Rituximab Injection), as the first approved biosimilar in China, provides a new treatment option for lymphoma patients. Combination therapy is going to be the trend in future. The teams from Ascentage Pharma and Henlius will work closely to explore the clinical utility of this combination therapy. We hope APG-2575 combined with HLX01 will demonstrate synergistic effect in the treatment of CLL, and thereby offer additional treatment options for Chinese patients."

"We are excited to reach the agreement with Ascentage Pharma," said Scott Liu, Ph.D., Co-founder, President and CEO of Henlius. "As the first approved and marketed product of Henlius, HLX01 (Rituximab Injection) is approved for all the indications of the originator rituximab in China, thus providing alternative options for lymphoma patients. APG-2575 is indicated for multiple hematologic malignancies as mono-therapy and shows great potential in combination therapy. We expect the two products to join hand in hand in the treatment of CLL. In future, Henlius and Ascentage Pharma will press forward with the combination therapy, and provide more treatment options for patients in China." 

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases. The Company focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. Ascentage Pharma has built a pipeline of eight drug candidates in clinical development, including a novel, highly potent Bcl-2/Bcl-xL inhibitor, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited.

About Henlius

Henlius (2696.HK) is a leading biopharmaceutical company in China with the vision to offer high-quality, affordable and innovative biologics for patients worldwide with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated and efficient global R&D platform with key facilities in Shanghai, Taipei and California. The three R&D centers closely collaborate with each other to ensure a highly productive and cost-efficient R&D process. Starting from biosimilar, Henlius presses forward with novel mAb products and immuno-oncology combination therapies with proprietary anti-PD-1 and PD-L1 mAbs as backbone. Henlius establishes a diversified product pipeline of biosimilars, bio-innovative drugs and combination therapies, and builds an integrated platform covering the whole product lifecycle including R&D, commercial-scale production and commercialization. On September 25, 2019, Henlius was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 2696.

SOURCE: Ascentage Pharma

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