协作进度亚盛药业(6855.HK)今天公布,与复宏汉霖(2696.HK)达到战略合作协议,将相互探寻企业在研原自主创新靶点Bcl-2可选择性抑制剂APG-2575与复宏汉霖首例获准发售的商品汉利康®(利妥昔单抗注射剂)联合治疗漫性淋巴细胞败血症(CLL),促进其在我国的临床研究协作科学研究。亚盛药业:APG-2575APG-2575是亚盛药业在研的新式内服Bcl-2可选择性抑制剂,根据可选择性抑止Bcl-2蛋白质大家族组员Bcl-2来修复肿瘤干细胞程序性致死体制(细胞坏死),进而杀掉恶性肿瘤,拟用以治疗多种多样血夜肿瘤。2019年7月,APG-2575用以治疗血夜肿瘤的I期临床研究在我国起动,并完成第一例病人给药,此项临床实验的适用范围群体包含漫性淋巴细胞败血症、非霍奇金淋巴瘤等。APG-2575是首例进到临床医学的国内Bcl-2可选择性小分子水抑制剂。先前,APG-2575对于治疗血夜恶性肿瘤的I期临床研究已在国外和加拿大起动,值得一提的是,截至2019年8月13号,现有一例CLL病人恶性肿瘤容积变小超出60%,做到一部分减轻(PR)规范;另有三例接纳400mg使用量组的CLL病人,该三例病人的重要功效指标值之一的外周血絕對淋巴细胞记数(ALC)在治疗第一周期时间内即做到完全缓解(CR)规范。至今未观查到恶性肿瘤融解综合症(TLS),显示信息本科学研究药品具备优良的安全系数。除此之外,APG-2575的多种临床医学前研究进展在2019年的英国癌证科学研究研究会(AACR)年会议发言稿得到现身,并呈现了其在相互用药层面的发展潜力。 复宏汉霖:汉利康®汉利康®是中国首例获准的微生物相近药,适用于非霍奇金淋巴瘤的治疗。2019年2月,汉利康®宣布得到国家食药监局药物发售申请注册准许,用以1)发作或抗药性的滤泡性中央政府型淋巴瘤;2)此前没经治疗的CD20 阳型III-IV 期滤泡性非霍奇金淋巴瘤;3)CD20 阳型弥漫着大B体细胞性非霍奇金淋巴瘤 (DLBCL)的治疗,即获准原研利妥昔单抗在我国的全部适用范围。一直以来,利妥昔单抗联合放化疗是是非非霍奇金淋巴瘤的规范治疗。汉利康®的发售巨大地丰富多彩了淋巴瘤病人的治疗挑选,发售首月即造福逾1000名病人。本次联合治疗法合作合同的达到,针对彼此常有关键实际意义。Bcl-2抑制剂在治疗B体细胞肿瘤病症上具备宽阔的运用市场前景,其联合利妥昔单抗将针对治疗漫性淋巴细胞败血症有重大意义,并有发展潜力拓展至别的B体细胞肿瘤适用范围。亚盛药业老总兼ceo杨大俊博士研究生表达:“人们非常高兴与复宏汉霖达到此项战略合作协议。做为首例进到临床医学的国内Bcl-2可选择性小分子水抑制剂,APG-2575是亚盛药业细胞坏死商品管道的关键在研种类,在血夜系统软件肿瘤治疗层面展现很大发展潜力。汉利康®是中国首例获准的微生物相近药,丰富多彩了淋巴瘤病人的治疗挑选。联合治疗是将来的发展趋势,亚盛药业将与复宏汉霖精英团队密不可分协作,相互对于2个药品的联合治疗进行深入分析。人们十分希望APG-2575与汉利康®联合治疗漫性淋巴细胞败血症的潜在性协同作用,为中国病人出示大量的治疗概率。”复宏汉霖创始人、总裁兼ceo刘世高博士研究生表达:“人们非常高兴同亚盛药业达到该项战略合作协议。汉利康®是复宏汉霖首例获准发售的商品,得到了原研利妥昔单抗在我国获准的全部适用范围,为淋巴瘤病人出示了大量的治疗挑选,而APG-2575 为原技术创新内服 Bcl-2 可选择性抑制剂,做为单一药物用以治疗多种多样血夜恶变病症,在相互用药层面也显示信息出了发展潜力。将来,复宏汉霖将同亚盛药业紧密配合,进一步推动2个药品的联合治疗法科学研究。人们期待汉利康®和APG-2575就治疗漫性淋巴细胞败血症适用范围造成不错的协同效应,为中国病人出示大量的治疗挑选。”有关亚盛药业亚盛药业(6855.HK)是一家立足于中国、朝向全世界的处在临床医学环节的原創新药研究公司,着眼于在恶性肿瘤、乙肝病毒及与衰退有关的病症等治疗行业开发设计自主创新药品。企业有着独立产品研发的蛋白质-蛋白质相互作用力靶向治疗药物设计方案服务平台。亚盛药业产品研发商品管道关键专心致志细胞坏死途径重要蛋白质的抑制剂,根据抑止BCL-2、IAP 或 MDM2-p53 等,重新启动肿瘤干细胞的细胞凋亡程序流程;第二代和第三代的对于癌症治疗中出現的激酶突变体的抑制剂等。企业目前8个1类药物已进到到中国、英国及加拿大的I/II期临床医学产品开发阶段。2019年10月28日,亚盛药业香港联合交易中心有限责任公司主板接口取得成功登录发售。有关复宏汉霖复宏汉霖(2696.HK)是一家中国领跑的生物制药公司,致力于为全世界病人出示质天价优和自主创新生物药,商品遮盖恶性肿瘤、本身自身免疫病等行业。自2010年创立至今,企业以全世界协同、融合自主创新为产品研发核心理念,在我国上海市、中国台北和美国德州均下设产品研发核心,具有了协作提质增效的凸出优点。复宏汉霖关键的产品研发对策是仿创融合,从微生物相近药发展,逐渐开发设计技术创新单抗商品,融合独立开发设计的抗PD-1和PD-L1单抗,在中国新一轮发布免疫力联合治疗法,创新性合理布局了一个多样化、自主创新单抗及肿瘤免疫联合治疗法管道,打造科学研究、开发设计、产品化生产制造的综合型生物技术产业链服务平台。2019年9月25日,复宏汉霖香港联合交易中心有限责任公司主板上市,股票号:2696。Ascentage Pharma and Henlius Form a Combination Therapy Strategic CollaborationAscentage 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 collaboratio