亚盛医药（6855.HK）近日宣布，与复宏汉霖（2696.HK）达成战略合作，将共同探索公司在研原创新靶点Bcl-2选择性抑制剂APG-2575与复宏汉霖首个获批上市的产品汉利康®（利妥昔单抗注射液）联合治疗慢性淋巴细胞白血病（CLL），推动其在中国的临床试验合作研究。
亚盛医药：APG-2575
APG-2575是亚盛医药在研的新型口服Bcl-2选择性抑制剂，通过选择性抑制Bcl-2蛋白家族成员Bcl-2来恢复肿瘤细胞程序性死亡机制（细胞凋亡），从而杀死肿瘤，拟用于治疗多种血液恶性肿瘤。2019年7月，APG-2575用于治疗血液恶性肿瘤的I期临床试验在中国启动，并已完成首例患者给药，该项临床研究的适应症人群包括慢性淋巴细胞白血病、非霍奇金淋巴瘤等。APG-2575是首个进入临床的国产Bcl-2选择性小分子抑制剂。此前，APG-2575针对治疗血液肿瘤的I期临床试验已在美国和澳大利亚启动，值得一提的是，截止2019年8月13号，已有一例CLL患者肿瘤体积缩小超过60%，达到部分缓解（PR）标准；另有三例接受400mg剂量组的CLL患者，该三例患者的关键疗效指标之一的外周血绝对淋巴细胞计数（ALC）在治疗第一周期内即达到完全缓解（CR）标准。迄今未观察到肿瘤溶解综合征（TLS），显示本研究药物具有良好的安全性。此外，APG-2575的多项临床前研究进展在今年的美国癌症研究协会（AACR）年会上获得亮相，并展现了其在联合用药方面的潜力。
复宏汉霖：汉利康®
汉利康®是中国首个获批的生物类似药，主要用于非霍奇金淋巴瘤的治疗。2019年2月，汉利康®正式获得国家药监局新药上市注册批准，用于1）复发或耐药的滤泡性中央型淋巴瘤；2）先前未经治疗的CD20 阳性III-IV 期滤泡性非霍奇金淋巴瘤；3）CD20 阳性弥漫大B细胞性非霍奇金淋巴瘤 (DLBCL)的治疗，即获批原研利妥昔单抗在中国的所有适应症。长久以来，利妥昔单抗联合化疗是非霍奇金淋巴瘤的标准治疗。汉利康®的上市极大地丰富了淋巴瘤患者的治疗选择，上市首月即惠及逾1000名患者。
此次联合疗法合作协议的达成，对于双方都有重要意义。Bcl-2抑制剂在治疗B细胞恶性肿瘤疾病上具有广阔的应用前景，其联合利妥昔单抗将对于治疗慢性淋巴细胞白血病有积极意义，并有潜力扩展至其他B细胞恶性肿瘤适应症。
亚盛医药董事长兼首席执行官杨大俊博士表示：“我们很高兴与复宏汉霖达成该项战略合作。作为首个进入临床的国产Bcl-2选择性小分子抑制剂，APG-2575是亚盛医药细胞凋亡产品管线的重要在研品种，在血液系统恶性肿瘤治疗方面呈现较大潜力。汉利康®是国内首个获批的生物类似药，丰富了淋巴瘤患者的治疗选择。联合治疗是未来的趋势，亚盛医药将与复宏汉霖团队紧密合作，共同针对两个药物的联合治疗展开深入研究。我们非常期待APG-2575与汉利康®联合治疗慢性淋巴细胞白血病的潜在协同效应，为中国患者提供更多的治疗可能性。”
复宏汉霖联合创始人、总裁兼首席执行官刘世高博士表示：“我们很高兴同亚盛医药达成此项战略合作。汉利康®是复宏汉霖首个获批上市的产品，获得了原研利妥昔单抗在中国获批的所有适应症，为淋巴瘤患者提供了更多的治疗选择，而APG-2575 为原创新型口服 Bcl-2 选择性抑制剂，作为单一药剂用于治疗多种血液恶性疾病，在联合用药方面也显示出了潜力。今后，复宏汉霖将同亚盛医药密切合作，进一步推动两个药物的联合疗法研究。我们期望汉利康®和APG-2575就治疗慢性淋巴细胞白血病适应症产生较好的协同作用，为中国患者提供更多的治疗选择。”
关于亚盛医药
亚盛医药（6855.HK）是一家立足中国、面向全球的处于临床阶段的原创新药研发企业，致力于在肿瘤、乙肝及与衰老相关的疾病等治疗领域开发创新药物。公司拥有自主研发的蛋白-蛋白相互作用靶向药物设计平台。亚盛医药研发产品管线主要专注细胞凋亡路径关键蛋白的抑制剂，通过抑制BCL-2、IAP 或 MDM2-p53 等，重启肿瘤细胞的凋亡程序；第二代和第三代的针对癌症治疗中出现的激酶突变体的抑制剂等。公司现有8个1类新药已进入到中国、美国及澳大利亚的I/II期临床开发阶段。2019年10月28日，亚盛医药在香港联合交易所有限公司主板成功登陆上市。
关于复宏汉霖
复宏汉霖（2696.HK）是一家中国领先的生物制药公司，旨在为全球患者提供质高价优的创新生物药，产品覆盖肿瘤、自身免疫性疾病等领域。自2010年成立以来，公司以全球联动、整合创新为产品开发理念，在中国上海、中国台北和美国加州均设有研发中心，具备了协同增效的突出优势。复宏汉霖主要的产品开发策略是仿创结合，从生物类似药起步，逐步开发创新型单抗产品，结合自主开发的抗PD-1和PD-L1单抗，在国内率先推出免疫联合疗法，前瞻性布局了一个多元化、创新单抗及肿瘤免疫联合疗法管线，打造出研究、开发、商业化生产的综合性生物医药全产业链平台。2019年9月25日，复宏汉霖在香港联合交易所有限公司主板上市，股票代码：2696。
Ascentage Pharma and Henlius Form a Combination Therapy Strategic Collaboration
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 汉利康® (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, 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.
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. 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.“
“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.”
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.