星光熠熠 | 猜猜哪些科学大咖参加了复宏汉霖SAB会议?

原文始发于微信公众号(药时代):星光熠熠 | 猜猜哪些科学大咖参加了复宏汉霖SAB会议?

星光熠熠 | 猜猜哪些科学大咖参加了复宏汉霖SAB会议?

复宏汉霖(香港联交所代码:2696)于近日召开了第四次科学顾问委员会(Scientific Advisory Board, SAB)会议。本次SAB会议在美国旧金山湾区召开,这里汇集了众多高科技企业和知名科研院所,也是复宏汉霖美国研发中心所在地。

为了能够及时了解国际上癌症和自身免疫性疾病治疗领域中最前沿的研究进展与趋势,与领域内顶尖学者进行深度交流,听取他们的专业建议,复宏汉霖于2018年正式成立了由外部杰出科学家组成的SAB,并定期邀请SAB成员与复宏汉霖上海、台北和加州等三地研发中心的代表以及特邀外部科学家召开SAB会议。每次SAB的召开,都可谓是集结了复宏汉霖内外部的“最强大脑”,着实引人关注。

星光熠熠 | 猜猜哪些科学大咖参加了复宏汉霖SAB会议?

在此次SAB会议上,与会的科学家们主要围绕公司进展较快的研发项目进行了讨论,讨论内容则涵盖了项目的科学支撑依据、竞争格局、最新研发数据和未来计划等方面。SAB专家成员和特邀嘉宾对于公司丰富的研发管线、研发项目的差异化和作用机制的多样性以及关键项目的快速推进表达了高度认可;同时,也对不同研发项目的优先级设置、研发资源分配以及相关生物学内容提出了建设性的意见。

复宏汉霖联合创始人、首席执行官刘世高博士在会议开始简要介绍了复宏汉霖的使命与愿景、发展历程与策略、商业化计划与致力于创新研发的决心。随后,复宏汉霖高级副总裁、首席医学官陆英明博士就临床开发策略与管线进行了总体的概述,并特别针对抗PD-1单抗HLX10相关临床项目进行了重点介绍。

星光熠熠 | 猜猜哪些科学大咖参加了复宏汉霖SAB会议?

抗PD-1单抗HLX10临床研发进展

此次SAB会议的特邀嘉宾—斯坦福大学医学院肿瘤科医学教授Ron Levy围绕靶向肿瘤的抗体疗法和作用于免疫系统的原位疫苗相关研究进展进行了讲解。多年来,Ron Levy教授一直悉心钻研如何利用免疫系统对抗癌症,并取得了卓著的成果。正是他的开创性工作,造就了首个获得美国FDA批准用于癌症治疗的单克隆抗体药物利妥昔单抗。巧合的是,首个在中国获批的生物类似药恰恰也是利妥昔单抗(商品名:汉利康®),汉利康®也是复宏汉霖首个获批上市的产品。近年来,Ron Levy教授实验室在抗肿瘤原位疫苗方面的研究也取得了多项突破性的进展,吸引了极大的关注。

星光熠熠 | 猜猜哪些科学大咖参加了复宏汉霖SAB会议?

美国国家科学院院士、美国国家医学科学院院士

斯坦福大学医学院肿瘤科医学教授

在SAB会议上,Ron Levy教授表示:

生物医药公司与学术科研界的合作非常值得鼓励,有利于分别发挥双方在药物开发和生物学理解上的优势。

Ron Levy教授的这一观点也普遍获得了参加本次会议的SAB专家成员、其他特邀嘉宾和复宏汉霖与会人员的高度认同。目前复宏汉霖也在积极推动多项与国内外知名院校或科研机构的合作项目。会议最后,与会的科学家们就一系列研发相关具体问题展开了深入的讨论,并对研发重心和合作的重要性进行了强调。

SAB主席管坤良教授在会后评价道:

这次SAB会议信息量大,卓有成效。看到复宏汉霖研发项目取得了如此之大的进展,我们都非常高兴。让我们趁热打铁,尽快敲定下一次SAB会议。

SAB专家成员李子海教授认为:

此次会议堪称‘现象级’,复宏汉霖研发项目的进展令人印象深刻。复宏汉霖研发团队对创新展现出了高度的专注,是一支非常具有活力的团队。相信这样的团队必将取得令人瞩目的成绩。

由于大家对于SAB会议效果的评价非常积极,同时考虑到公司研发项目的快速推进,本次会议还决定增加SAB会议频率,以便更加及时地吸取SAB对于研发项目的专业意见,并初步决定下一次SAB会议将于2020年年中召开。

对创新的追求和热情、对彼此的认可与信赖将这些“最强大脑“集结。未来,他们将继续保持深度的沟通交流和思维碰撞,不断地在研发策略和技术攻关等方面为复宏汉霖提供指导。

复宏汉霖科学顾问委员会专家成员简介

星光熠熠 | 猜猜哪些科学大咖参加了复宏汉霖SAB会议?

管坤良博士

Kun-Liang Guan, Ph.D.

复宏汉霖科学顾问委员会主席

加州大学圣地亚哥分校药理学杰出教授

Chairman of Scientific Advisory Board of Henlius

Distinguished Professor of Pharmacology, University of California, San Diego

管博士拥有普渡大学博士学位,1992-2007期间,管博士执教于密歇根大学。管博士专注于细胞生长和肿瘤发生的信号机制研究,尤其关注mTOR和Hippo通路。管博士曾获“麦克阿瑟”奖,并被授予美国生物化学与分子生物学协会青年研究员奖,普渡大学杰出校友称号。同时,管博士作为美国科学促进会会士,也是分子生物学和遗传学领域的高被引研究者。

星光熠熠 | 猜猜哪些科学大咖参加了复宏汉霖SAB会议?

杨一平博士

Yiping Yang, M.D., Ph.D.

美国俄亥俄州立大学血液科主任,医学教授

《临床研究杂志》(JCI)、JCI Insight副主编

Director, Division of Hematology, Professor of Medicine, the Ohio State University

Associate Editor for Journal of Clinical Investigation (JCI) and JCI Insight.

杨博士拥有密歇根大学博士学位,是获得美国内科学委员会认证的淋巴瘤、白血病临床医生。自2008年以来,杨博士一直被评选为美国顶级的肿瘤学家。杨博士专注于免疫学领域的研究,涵盖肿瘤免疫学、免疫疗法、基因疗法以及病毒免疫学,其研究项目获得美国国立卫生研究院和私人基金的资助。杨博士累计在《科学》、《自然免疫学》、《自然遗传学》、《自然医学》、《免疫》、JCI、PNAS等期刊上发表超过100篇同行评议的论文。

星光熠熠 | 猜猜哪些科学大咖参加了复宏汉霖SAB会议?

邹伟平博士

Weiping Zou, Ph.D.

美国密歇根大学医学院Charles B. de Nancrede外科教授

美国密歇根大学医学院肿瘤免疫与免疫治疗中心主任

Charles B. de Nancrede Professor

Professor of Surgery, Immunology, Pathology, and Cancer Biology

Director, Center of Excellence for Cancer Immunology and Immunotherapy, University of Michigan Rogel Cancer Center, University of Michigan School of Medicine

邹博士现执教于密歇根大学。邹博士致力于肿瘤免疫病理学和免疫治疗的研究,在过去的几年中,他带领团队在肿瘤免疫发病机制领域取得重要进展,其研究发现对于确定肿瘤微环境中的免疫反应本质具有重要作用,同时他还提出了肿瘤微环境中免疫抑制网络的概念。邹博士的团队也是肿瘤免疫学领域中被引用最多的团队之一。邹博士是九家学术期刊的编委会成员,曾主讲过200多次专业讲座。同时,邹博士还是包括NIH和DOD在内的15家资助机构以及包括《新英格兰医学杂志》、《细胞》、《科学》和《自然杂志》在内的50多家学术期刊的审稿人。邹博士当选为2018-2019届美国肿瘤研究协会肿瘤免疫学主席。

星光熠熠 | 猜猜哪些科学大咖参加了复宏汉霖SAB会议?

李子海博士

Zihai Li, M.D., Ph.D.

美国俄亥俄州大学(OSU)克洛茨癌症研究纪念讲席教授

James 综合肿瘤中心Pelotonia肿瘤免疫研究所创始所长

中国临床肿瘤协会(CSCO)海外专家协会首任主委

Klotz Memorial Chair in Cancer Research

Professor and Founding Director of the Pelotonia Institute for Immuno-Oncology at The Ohio State University James Comprehensive Cancer Center

Founding Chair of the Committee of Overseas Experts (COE) of the Chinese Society of Clinical Oncology (CSCO)

李子海教授拥有美国纽约西奈山医学院微生物和免疫学博士学位,并持有美国医师资格证书,同时也是美国内科协会指定认可的肿瘤学专家。之前,李子海教授曾任职于美国南卡罗莱纳医科大学(MUSC)与Hollings癌症中心。李教授课题组主要从事肿瘤免疫治疗,包括调节性T细胞生物学、先天免疫、热休克蛋白疫苗及其生物学等方面的研究并取得卓越的成果,他是gp96/grp94分子伴侣领域研发领军人物,也极大地推进了热休克蛋白肿瘤疫苗相关研究,最近首次证明血小板及GARP-TGFb分子轴在肿瘤免疫中的重要性,同时提出并证明CNPY2分子在内质网应激信号传递的新理论。李子海教授的研究近20年一直受到美国国立卫生研究院(NIH)基金的支持。

关于复宏汉霖科学顾问委员会

复宏汉霖科学顾问委员会成立于2018年5月,委员会主席管坤良教授,顾问杨一平教授、邹伟平教授和李子海教授皆为肿瘤生物学、免疫学、癌症治疗领域的杰出科学家或医生。各位科学顾问不仅在公司研发战略方面给予专业指导意见,更为抗体产品的开发与技术攻关提供指导,协助开发更多疗效佳、可负担的靶向药物,进一步完善复宏汉霖的现有产品管线,为新一代免疫疗法开创更多的组合治疗方案。

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.HK。

截至目前,复宏汉霖已有1个产品成功上市,2个产品获得中国新药上市申请受理,1个产品获得欧盟新药上市申请受理,14个产品、7个联合治疗方案在全球范围内开展20多项临床试验。其中,公司首款重磅产品汉利康®(利妥昔单抗注射液)于2019年2月获国家药监局新药上市注册批准,成为中国首个获批上市的生物类似药。HLX03(阿达木单抗注射液)与HLX02(注射用曲妥珠单抗)已获国家药监局新药上市申请受理,现已纳入优先审评程序。HLX02相继在中国大陆、乌克兰、欧盟波兰和菲律宾全面启动国际多中心3期临床试验,成为国内首个开展国际多中心3期临床研究的生物类似药,并于2019年6月获欧洲药品管理局上市申请受理。此外,公司已陆续就HLX10与自有产品HLX04(贝伐珠单抗生物类似药)、HLX07(抗EGFR单抗)以及化疗联用开展多项肿瘤免疫联合疗法,在全球范围内开展多个临床研究。

星光熠熠 | 猜猜哪些科学大咖参加了复宏汉霖SAB会议?

Henlius successfully held its fourth Scientific Advisory Board (SAB) meeting

Henlius Biotech, Inc. (Henlius), a global biologics company specialized in the discovery and development of high-quality and affordable antibodies for the treatment of patients with cancer and autoimmune diseases, recently held its fourth Scientific Advisory Board (SAB) meeting at Bay Area where the United States (US) Research and Development (R&D) site is located. Scientists from R&D groups at Shanghai, Taiwan China and US sites have attended the meeting either in-person or via tele-conference.

During this all-day SAB meeting, the topics focused on the presentation and discussion of Henlius’ most advanced research projects including scientific justification, competitive landscape, data update and future plans. The SAB members provided positive acknowledgement on the broad coverage of research pipeline, diverse mechanism and differentiated strategy, and impressive progress of key projects, as well as constructive feedbacks on project priority, biological insights and resource allocation.

Dr. Scott Liu, Henlius co-founder and Chief Executive Officer, started the meeting with an introduction of Henlius, focusing on Henlius’ vision and mission of affordable innovation, company history and strategy, commercialization plan and commitment to Research. Dr. Alvin Luk, Henlius Senior Vice President and Chief Medical Officer, provided an overview on Henlius Clinical strategy and pipeline, especially HLX10 anti-PD1 programs. Special guest of the meeting Professor Ron Levy from Stanford University gave a lecture on the antibody therapy targeting tumor and in situ vaccination targeting immune system. Dr. Levy was the driving force behind the first FDA-approved monoclonal antibody for cancer treatment, Rituximab, which happens to be the first approved biosimilar in China and the first approved product from Henlius, HLX01 . He also encouraged the collaboration between biotech and academia, leveraging each other’s strength in drug development and biology understanding. His sentiment was also unanimously shared by all the SAB members, guests and Henlius participants, and Henlius already had some specific collaboration initiatives with renowned researchers from academia that can be put into place soon.

“This was a very informative and productive SAB meeting. We are very excited to know the strong progress. Let’s try to find a date that is good for everyone around mid-2020 for the next SAB meeting. Professor Kun-Liang Guan, chairman of Henlius’ SAB acknowledged.

One of the SAB member, Professor Zihai Li, also commented, “Very impressive progress and a phenomenal meeting. The entire team was so engaging and energetic. Great things are bound to happen.”

The meeting was concluded by a panel discussion on a variety of topics, an acknowledgement on the impressive progress, and emphasis on the research focus and collaboration. It is decided that the frequency of the SAB meeting shall be increased and the next SAB meeting is scheduled in mid-2020.

Biographies of Scientific Advisory Board Members

Dr. Kun-Liang Guan is a Distinguished Professor of Pharmacology at the University of California, San Diego. He obtained his BS (1982) at Hangzhou University, China and Ph.D. (1989) at Purdue University. From 1992-2007, Guan was a faculty at the University of Michigan. He received the MacArthur Fellowship, the American Society of Biochemistry and Molecular Biology Young Investigator Award, Distinguished Alumni Award from Purdue University, an AAAS Fellow, and is a highly cited researcher in Molecular Biology & Genetics (Thomson Reuters). Guan studies signaling mechanisms of cell growth and tumorigenesis, particular focusing on the mTOR and Hippo pathways.

Dr. Yiping Yang, Director, Division of Hematology, Professor of Medicine, the Ohio State University. Dr. Yang received his M.D. from Zhejiang University, and Ph.D. from University of Michigan. He then completed his postdoctoral training and Internal Medicine residency at the University of Pennsylvania, and his Medical Oncology fellowship at Johns Hopkins University. He is an ABIM-certified physician with clinical interest in lymphoma and leukemia. He has been selected as America’s top oncologist since 2008. He has also served as Associate Editor for Journal of Clinical Investigation (JCI) and JCI Insight. Funded by grants from National Institute of Health and private foundations, his research focuses on cancer immunology and immunotherapy, as well as gene therapy and viral immunity. He has published more than 100 peer-reviewed papers in journals including Science, Nature Immunology, Nature Genetics, Nature Medicine, Immunity, JCI, PNAS, etc.

Dr. Weiping Zou is a faculty at the University of Michigan. His research interests are in tumor immunopathology and immunotherapy. Over the past few years, his research team has achieved important insights into cancer immunopathogenesis. His research efforts demonstrate that the tumor microenvironment is comprised of immune cells that have been reprogrammed by active tumor-mediated processes to defeat tumor immunity and promote tumor progression in a highly effective manner. These studies have helped define the nature of immune responses in the cancer microenvironment, form the concept of immunosuppressive networks in the cancer microenvironment and provide significant insights into designing current immune therapies including inhibitory B7 checkpoint blockade (PD-L1, B7-H1) to treat cancer patients. The Zou laboratory is one of the most cited research teams in the field of Cancer Immunology. Dr. Zou is/was an editorial board member for 9 scientific journals. He has delivered more than 200 invited lectures. He serves as a reviewer for more than 15 funding agencies including NIH and DOD, and for more than 50 scientific journals including New England Journal of Medicine, Cell, Science, and Nature journals. He is the AACR Cancer Immunology Chairperson-elect 2018-2019.

Dr.Zihai Li is Klotz Memorial Chair in Cancer Research, Professor and Founding Director of the Pelotonia Institute for Immuno-Oncology at The Ohio State University James Comprehensive Cancer Center. He received his Ph.D. in Microbiology & Immunology from Icahn School of Medicine at Mount Sinai, New York. He completed his internal medicine residency in the Montefiore-Einstein Medical Center and his medical oncology fellowship at the Fred Hutchinson Cancer Research Center. Prior to his current position, he was chair of the Department of Microbiology and Immunology and co-leader of the Cancer Immunology Program at the NCI-designated Hollings Cancer Center at the Medical University of South Carolina (MUSC). He is an expert in the field of GP96/GRP94 chaperone and played important roles in advancing HSP–based cancer vaccines. He recently uncovered the roles of platelets especially the TGFbeta-GARP axis on the platelets in immune tolerance and cancer immunotherapy, and discovered CNPY2 as a key initiator of the unfolded protein response. His laboratory has been continuously funded by NIH for the last two decades. Dr. Li has served multiple leadership roles in the American Society of Clinical Oncology (ASCO) and the Chinese American Hematologist and Oncologist Network (CAHON). He has been leading the effort to establish the Committee of Overseas Experts (COE) of the Chinese Society of Clinical Oncology (CSCO) and is the elected founding chair of the CSCO COE (2018-2020).

About Henlius SAB Meeting

The Scientific Advisory Board (SAB) of Henlius was established in May 2018, which consists of world-renowned scientists or physicians including Dr. Kun-Liang Guan, Dr. Yiping Yang, Dr. Weiping Zou and Dr. Zihai Li. These experts of biology, immunology and oncology have not only brought in professional insights on Henlius research strategy, but also provided scientific guidance on antibody discovery and development, helping Henlius to develop high-quality and affordable drugs to enhance the product pipeline and bring effective combo immunotherapies to patients.

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.HK.

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 7 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) and HLX07 (anti-EGFR mab). The global multi-center clinical trials are ongoing in various countries and regions worldwide.

联系方式

媒体:PR@Henlius.com

投资人:IR@Henlius.com

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