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Congratulations! Henlius and Ascentage Pharma Form a Combination Therapy Strategic Collaboration!


Henlius (2696.HK) recently announced a combination therapy strategic collaboration with Ascentage Pharma (6855.HK), working together to conduct clinical trials of the combination therapy between 汉利康® (Rituximab Injection), the first launched product by Henlius, and APG-2575, a novel, orally administered Bcl-2 selective inhibitor developed by Ascentage Pharma, for the treatment of chronic lymphocytic leukemia (CLL) in China.

As the first approved biosimilar in China, 汉利康® (Rituximab Injection) is mainly for the treatment of non-Hodgkin’s lymphoma (NHL). In February 2019, China National Medical Products Administration (NMPA) approved 汉利康® (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. 汉利康® (Rituximab Injection) provides an alternative treatment option for lymphoma patients, as over 1000 patients benefited in the first month after its commercial launch.

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 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. 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.

The collaboration is of great significance to both companies. Bcl-2 inhibitor is 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.

“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, 汉利康®(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.”

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. 汉利康® (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 汉利康® will demonstrate synergistic effect in the treatment of CLL, and thereby offer additional treatment options for Chinese patients.”

With continuing technology breakthrough and treatment improvement, combination therapy has become the main trend in pharmaceutical industry. Henlius considered the potential of combination therapy within its product portfolio and built a biologics pipeline of immune-oncology, tumor-specific, anti-angiogensis antibodies. In future, Henlius will be dedicated to more collaborations with other companies for combination therapy, thus bringing more effective treatment options to patients.

About Ascentage Pharma

Ascentage Pharma 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.

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.

Until now, in addition to one product launched commercially, two products under New Drug Application (NDA) review and one product under Marketing Authorization Application (MAA) review, Henlius has conducted over 20 clinical studies for 14 products and 6 combination therapies worldwide. HLX01 (汉利康®, rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) have their NDA under priority review by the NMPA. HLX02 is also the first China-manufactured biosimilar developed in a global setting. In June 2019, the MAA for HLX02 was accepted for review by EMA. Moreover, Henlius advances immuno-oncology combination therapies with proprietary mAbs including HLX10 (anti-PD-1 mAb) as backbone in combination with chemotherapy and other mAbs including HLX04 (bevacizumab biosimilar). The global multi-center clinical trials are ongoing in various countries and regions worldwide.