Recombinant humanized monoclonal antibody MIL93(Beijing Mabworks Biotech Co., Ltd.)

作者：米朵由于Claudin 18.2在胃癌、胰腺癌等实体肿瘤中具有高度的选择性及稳定的表达，近年来已成为肿瘤领域的热门分子靶点，药物研发路线有单克隆抗体、双特异性抗体、ADC、CAR-T等前沿方向，已成为肿瘤治疗领域的新宠。但是截至目前，全球尚未有一款Claudin18.2产品获批上市。首款Claudin18.2产品何时到来一直备受关注，在全球的诸多候选药物中，Zolbetuximab跑得最快，可惜经历了半年多的等待，近日，Zolbetuximab遗憾地等来了被FDA拒批的消息，不禁让人心里充满疑问：Claudin18还值得期待吗？全球首款被FDA拒批的Claudin18.21月9日，安斯泰来收到了FDA发出的暂时拒绝批准Zolbetuximab（IMAB362）的上市申请的完整回复函，Zolbetuximab是全球进展最快的Claudin18.2靶向药，极具“First in class”潜力。Zolbetuximab最早是安斯泰来子公司Ganymed开发的一款Claudin18.2单抗，临床前研究表明，Zolbetuximab通过激活两种不同的免疫系统途径（抗体依赖性细胞毒性和补体依赖性细胞毒性）诱导癌细胞死亡。在2016 ASCO上，Zolbetuximab惊艳亮相并且以优异的临床数据成为当年会议上最大亮点。很快，当时处于II期临床阶段的Zolbetuximab被嗅觉敏锐的安斯泰来看上，并斥资14亿美元收购Ganymed，将Zolbetuximab收入囊中。在安斯泰来手里，Zolbetuximab的研发顺利推进，2022年11月和12月，安斯泰来接连公布Zolbetuximab的两项关键性III期临床SPOTLIGHT和GLOW的实验数据，结果显示其与标准化疗联合使用，可以延长CLDN18.2晚期胃癌或胃食管交界癌患者的生存期，临床数据振奋人心。FDA基于卓越的数据，2023年7月授予了Zolbetuximab用于一线治疗不可切除、局部晚期或转移性、HER2阴性、胃或胃食管交界处 (GEJ) 患者的优先审批资格，目标行动日期定为2024年1月12日。本次FDA的拒批让信心满满的安斯泰来有些猝不及防，也出乎很多人的意料，因为Zolbetuximab的上市申请所依赖的SPOTLIGHT和GLOW研究实验数据不但成功验证了Claudin18.2的成药性，而且数据在安全性、有效性等方面并未出现问题。根据安斯泰来收到的回复函中，FDA并没有对Zolbetuximab的临床数据提出任何疑问，也没有要求开展额外的临床试验，只是指出Zolbetuximab第三方生产工厂未解决的缺陷。对于Zolbetuximab而言，这算是被拒批之外的一大利好消息，安斯泰来表示，这些生产缺陷不会造成任何安全性和有效性数据的隐患，目前正在与FDA和第三方制造商密切合作，以尽快解决该缺陷。此外，除美国，安斯泰来已先后在中国、日本、欧洲提交Zolbetuximab的上市申请，Zolbetuximab依然值得期待。Claudin18.2：消化道癌的潜力靶点Claudin18.2是一种紧密连接蛋白，作为Claudin蛋白家族的一员，最早于1998年被发现，特异性表达于胃上皮细胞，参与构成胃上皮细胞间紧密连接，在维持正常细胞的屏障功能、渗透作用、细胞极性、细胞间传输和信号转导方面发挥重要作用。在恶性肿瘤发生后，紧密连接蛋白会遭到破坏，使肿瘤细胞表面的Claudin18.2表位暴露出来，成为特定的靶点。同时，Claudin18.2基因也会出现异常激活，高度选择性、稳定地表达于特定肿瘤组织。Claudin蛋白结构示意图Claudin18.2最初被发现能持续、稳定地高表达于多种胃癌组织，后来被发现也能在乳腺癌、结肠癌、肝癌、头颈癌、支气管癌以及非小细胞肺癌等多种原发恶性肿瘤中异常激活和过度表达，尤其好发于消化系统恶性肿瘤，包括胃癌（70%）、胰腺癌（50％）、食管癌（30％）等，并且不仅限于原发病灶，在转移灶中也有表达，这使得Claudin18.2的高度选择性使得它成为一个理想的肿瘤治疗靶点（胃癌、胰腺癌等）。据弗若斯特沙利文报告，2025年全球胃癌药物市场规模预计达303亿美元，2023年将达460亿美元，市场需求庞大。由于胃癌患者早期缺乏典型的症状，难以自查，一旦确诊，超过70%的胃癌患者就诊时已为晚期，失去了手术的机会，而且胃癌整体预后较差，5年生存率仅为10%~30%，治疗形势严峻。另外，2022年，全球胰腺癌发病人数达到约51.2万人，预计于2024年增长至54.2万人，并进一步增至2030年的63.9万人，且2030年胰腺癌在全球的死亡率将位居第2位。胰腺癌已被证明难以用常规药物治疗，并且对早期的免疫疗法产生了一定抗性，部分原因是由于肿瘤周围存在着厚厚的纤维冠层，抑制了治疗药物和免疫细胞进入肿瘤，这一领域仍需要更加有效的治疗手段。目前，全球范围内尚无用于胰腺癌的生物制剂，现有的免疫疗法如PD-(L)1对治疗胰腺癌仍缺乏高质量的循证医学证据，而Claudin 18.2在胰腺癌中呈现出高表达的特性，未来有望打破胰腺癌现有的治疗格局。谈到目前已上市的肿瘤靶向药，必定绕不开HER2靶点。至今，因为HER2针对大癌种且是理想的成药靶点，仍是药企攻坚的核心靶点。研究发现HER2基因异常在很多疾病中发生，约20%的乳腺癌中观察到HER2过表达，约22.1%的胃癌为HER2过表达，事实证明HER2靶向药物上市备受青睐，尤其第一三共的Enhertu，一上市就屡创销售神话。Claudin18.2在胃癌患者中的高表达阳性率超过了HER2，极有可能是继HER2之后肿瘤（尤其胃癌、胰腺癌）的第二重要靶点。国内赛道未结果先开“卷”自安斯泰来引进Zolbetuximab，国内外企业的目光开始转移到Claudin18.2身上。之后Zolbetuximab两项Ⅲ期研究达到主要终点，Claudin18.2成药性被验证，Claudin18.2赛道的企业信心倍增，开始无限憧憬Claudin18.2的未来，几年内赛道内外聚集了众多玩家。我国是消化道癌症的高发国家，Claudin18.2在消化道癌症治疗上的巨大潜力，使得国内药企积极投身Claudin18.2靶向药物的研发，目前管线数量和技术路线在全球范围内均处于前沿地位。据医药魔方Nextpharma数据库统计，全球共有近50款处于临床开发阶段的Claudin18.2靶向药物，其中42款来自中国药企。国内Claudin18.2靶点不仅入局者众，角逐的技术路线更是多样，包括单抗、CAR-T、ADC和双抗四大类。临床在研国产CLDN18.2靶向药物从临床进度来看，已披露早期临床结果的Claudin18.2靶向药物共6款，来自科济药业、创胜集团、天广实和启愈生物。创胜集团Osemitamab已完成一项I期研究；科济药业CT041已完成3项I期研究和一项I/II期研究；天广实MIL93已完成一项I期研究；启愈生物Q-1802已完成一项I期研究。由于Claudin18.2在国内多技术路线上百花齐放，近几年，国外市场把目光纷纷投入到国内Claudin18.2在研产品上，国内企业围绕Claudin18.2靶点的license out此起彼伏。2022年开始，Claudin18.2出海脚步加速，仅2022年，就有4笔交易产生，总金额达34.81亿美元。近两年国内Claudin18.2出海情况汇总从出海的Claudin18.2技术路线来看，ADC毋庸置疑更受青睐，2022年之后国内的Claudin18.2共5笔授权交易，4笔围绕Claudin18.2 ADC。据悉，已获批进入临床的Claudin 18.2 ADC共8款，已经有4款成功出海。阿斯利康、默沙东等跨国巨头也纷纷出手从国内引进Claudin18.2潜力管线，尤其阿斯利康活跃度比较高，先后两次分别从双抗、ADC不同技术路线布局Claudin18.2靶点，2023年阿斯利康再次花11.88亿美元购入康方与乐普生物的CMG901，再次将Claudin18.2出海推向高潮。虽然Zolbetuximab被FDA暂时拒之门外，但是Claudin 18.2 作为一个极具潜力的靶点，未来依然可期！参考资料：1、《肿瘤热门靶点介绍-Claudin18.2》北京肿瘤医学院免责声明“药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！

生物医药产业是国际科技与经济竞争的战略制高点。中国制药与生物技术行业市场正保持高速发展，新一轮科技革命如人工智能、细胞与基因疗法、免疫治疗正催生全球生命科学的巨大变革。而近年来，伴随着生物医药产业迅速崛起，园区作为经济发展的主平台，也大量涌现，生物医药产业园区凭借着“产业+服务+政策”等优势，在其中扮演着重要角色。中关村生命科学园历经二十多年的发展已成为中国生命科学领域创新资源最为集中的园区之一，聚集了600余家企业、300余名高端人才，形成了全产业链聚集态势。为进一步加强生物药物创新技术交流，由北京市昌平区人民政府主办，未来科学城管委会（生命园管委会）、北京中关村生命科学园发展有限责任公司、Nature Portfolio、北京中关村生命科学园生物医药科技孵化器有限公司、北京昌平科技园发展有限公司、药融圈承办的药海共潮、创新共舞——药物研发论坛暨中关村生命科学园发展论坛将于11月19日在北京召开，就生物药研发新技术、药物开发实践和行业未满足的临床需求等问题，邀请国内外嘉宾进行分享讨论。（点击图片进入小程序报名）大会信息论坛名称：药物研发论坛暨中关村生命科学园发展论坛时间：2023年11月19日地点：北京中关村生命科学园•泰康研修院（报名即可获取具体会议地点）主办单位：北京市昌平区人民政府承办单位：未来科学城管委会（生命园管委会）、北京中关村生命科学园发展有限责任公司、Nature Portfolio、北京中关村生命科学园生物医药科技孵化器有限公司、北京昌平科技园发展有限公司、药融圈议程揭露09:10-09:30开幕式致辞09:30-10:00Immunotherapy drug discovery based on normalization of tumor microenvironment 陈列平  耶鲁大学医学院免疫学教授、美国国家科学院院士10:00-10:30助力“中国创新”到“全球创新”陈冰  阿斯利康中国副总裁、国际业务拓展合作与战略投资负责人10:30-11:0075%失败率的关键领域——创新药物的临床评价李宁  中国医学科学院肿瘤医院副院长11:00-11:15轻松一刻11:15-11:45Using stem cells to model and treat human diseasesClive Svendsen  西达-赛奈再生医学研究所主任11:45-12:20IO疗法的下一站在哪里Where is the next generation of cancer immunotherapy heading?主持人 ：王兴利  复星医药，执行总裁嘉宾：陈列平  耶鲁大学医学院免疫学教授、美国国家科学院院士陈冰  阿斯利康中国副总裁、国际业务拓展合作与战略投资负责人李宁  中国医学科学院肿瘤医院副院长李锋  天广实生物董事长、总经理12:30-13:10商务社交午餐13:10-13:40Teaching patient’s T cells to target their own tumor antigens: Therapeutic in situ vaccination for lymphoma and breast caJoshua Brody  美国西奈山伊坎医学院副教授13:40-14:10Identification and evolution of novel crispr-cas systems from the human microbiomeAnna Cereseto  意大利特伦托大学分子生物学实验室首席研究员、系副主任14:10-14:40mRNA-based T cell engineering for treatment of virus-related cancer and virus infection.  Antonio Bertoletti  杜克-新加坡国立大学医学院传染病专家、新加坡A*STAR临床科学研究所病毒性肝炎组研究主任14:40-15:10主题待定崔霁松  诺诚健华联合创始人、董事长、CEO15:10-15:40Receptor-Interacting Protein Kinase 1 (RIPK1), Cell Death and Neurodegenerative Diseases袁钧瑛  中国科学院上海有机化学研究所生物与化学交叉研究中心主任、美国国家科学院院士15:40-16:00轻松一刻16:00-17:00未满足临床用药需求和先进技术Unmet Clinical Drug Needs and Advanced Technologies主持人：Amanda，Nature Portfolio编辑嘉宾：Antonio Bertoletti  杜克-新加坡国立大学医学院传染病学家崔霁松  诺诚健华创始人、董事长、CEO 袁钧瑛  中国科学院上海有机化学研究所生物与化学交叉研究中心主任、美国国家科学院院士李文辉  北京生命科学研究所资深研究员最终议程以现场为准重磅嘉宾亮相*部分嘉宾，排名不分先后，按拟定议程排序*外籍嘉宾已安排现场同传陈列平耶鲁大学医学院免疫学教授，美国国家科学院院士陈列平博士是一名免疫学家，主要从事基础T细胞生物学、癌症免疫学和转化研究，以及开发用于治疗包括癌症在内的人类疾病的转化研究。在加入耶鲁大学之前，他曾在任约翰霍普金斯大学医学院和梅奥医学中心任教，并在百时美施贵宝制药研究所担任科学家。陈博士发表了370多篇经同行评审的研究文章。他在发现用于癌症免疫疗法的 PD-1/PD-L1 通路方面的工作被《Science》杂志评为2013年的年度最具突破研究奖，他是美国国家科学院院士、美国癌症研究协会和癌症免疫治疗协会会员。Dr. Lieping Chen is an immunologist interested in basic T cell biology, cancer immunology, and translational research to develop new treatments for human diseases including cancer. Prior to joining Yale, he was a faculty member at Johns Hopkins University School of Medicine and Mayo Clinic, and a scientist in Bristol-Myers Squibb Pharmaceutical Research Institute.Dr. Chen has published over 370 peer-reviewed research articles. His work in the discovery of the PD-1/PD-L1 pathway for cancer immunotherapy was cited as the #1 breakthrough of the year by Science magazine in 2013. He is a member of the National Academy of Sciences and a fellow of the American Association for Cancer Research and the Society for Immunotherapy of Cancer.陈冰阿斯利康中国副总裁，国际业务拓展合作与战略投资负责人陈冰先生现任阿斯利康中国副总裁，国际业务拓展合作与战略投资负责人。此外，他还是阿斯利康国际业务部iBD hub负责人，领导团队助力优秀本土医药国际化发展，并加深阿斯利康国际业务与中国业务发展的双向合作。作为阿斯利康中金医疗产业基金创始管理合伙人，他携手战略伙伴中金资本，致力于从资本到商业化多方位赋能本土医药创新。目前，该基金在管金额已超30亿元人民币。在此岗位上，陈冰先生用其丰富的行业经验及敏锐的商业判断力为战略合作及外部合作项目带来新的领导力和新视野成功带领团队完成了多项与国内外医药企业的战略合作，持续助力业务增长。陈冰先生还拥有丰富的跨国、跨行业的多元化经验。在加入阿斯利康之前，他曾在麦肯锡公司服务近7年，任大中华区全球副董事，专注于医疗健康及其他相关行业的战略咨询工作，业务范围涵盖医药行业整个产业链。在进入战略咨询和医药行业之前，他曾在北美有十多年的工作学习生活经历，并致力于IT和互联网相关的初创企业工作。Mr. Chen Bing is currently VP of AstraZeneca China, Head of International Business Development and Venture Fund of AstraZeneca China. As a member of China Senior Management Team, he reports directly to Michael Lai, General Manager of AstraZeneca China. He is also in charge of the iBD hub in the international region of AstraZeneca, leading the team to drive the internationalization of top-tier local pharmaceutical companies and deepen the two-way collaborations between AstraZeneca’s business development in international region and China market.Mr. Chen Bing serves concurrently as the Managing director and Co-founder of AZ-CICC Healthcare Investment Fund. Joining hands with the strategic partner, CICC Capital, he has been committed to empowering the innovation of local pharmaceutical companies including capital and commercialization. So far, the fund has managed a total amount of over 3 billion yuan.Bing joined AstraZeneca China in May 2013 and subsequently held various roles including Marketing Director, Regional Sales Director (Zhejiang and Jiangxi provinces) of GRA BU, and Executive Marketing Director of RIA BU. Since July 2017, he has been officially promoted to VP of AstraZeneca China, Head of Alliances and Business Development. In this position, Mr. Chen Bing has brought new leadership and vision to strategic cooperation and external partnership projects with his rich industrial experience and business insights, and successfully led the team to complete a number of strategic cooperation with domestic and international pharmaceutical enterprises, which has helped drive business growth continuously.Bing possesses a wealth of multinational and cross-sector experience. Prior to joining AstraZeneca, he served at McKinsey & Company for almost seven years, as Associate Principal, Greater China, specializing in strategic consulting for healthcare and other related industries, the scope of his work spanning the entire healthcare value chain. Prior to joining McKinsey, he lived in North America for over 10 years where his focus was on IT- and Internet-related start-ups.Bing holds a Bachelor’s degree in Electrical and Computer Engineering from the University of British Columbia, and an MBA from MIT Sloan School of Management.李宁国家癌症中心·中国医学科学院肿瘤医院副院长李宁，中国医学科学院肿瘤医院副院长，主任医师，教授，博士生导师，临床研究国家级质量评价和促进中心常务副主任，中国医疗器械行业协会临床试验分会副主任委员，北京肿瘤学会副理事长兼秘书长。2005年博士毕业于中国协和医科大学八年制直博临床医学专业；2011年在美国哈佛大学医学院学习肿瘤免疫、靶向、基因治疗；将国际最新肿瘤治疗方法和理念引进国内，牵头进行多种新型药物和治疗方法的研究，中国医学科学院临床研究（GCP）平台建设首席专家。专注于抗肿瘤新药临床试验，罕见肿瘤的个体化精准治疗，肺癌的外科及围手术期靶向和免疫治疗，恶性实体肿瘤的多学科精准治疗，细胞和基因治疗，新药临床试验转化研究。以通讯作者在Lancet Oncology，JAMA Oncology，Cancer Cell，Nature子刊，Journal of Thoracic Oncology等刊物上发表肿瘤专业学术文章五十余篇，总影响因子500余分。担任国家973项目分课题负责人，国家重点研发计划精准医学专项，国家自然科学基金，临床试验能力提升（GCP）平台建设等研究项目负责人。首创针对每一位患者采用精准分子诊断，个体化制定适宜的靶向、细胞、抗体、纳米、疫苗等新方法用以治疗难治、复发、治疗失败肿瘤患者的诊疗体系，获得国际认可。Li Ning, Vice President of Cancer Hospital Chinese Academy of Medical Sciences, Chief Physician, Professor, Doctoral Supervisor, Executive Deputy Director of National Center for Quality Evaluation and Promotion of Clinical Research, Deputy Director of Clinical Trial Branch of China Association for Medical Devices Industry (CAMDI), Vice President and Secretary General of Beijing association of oncology. 2005, he obtained his doctoral degree in Clinical Medicine from Peking Union Medical College through an eight-year program. 2011, he studied tumor immunology, targeting, and gene therapy at Harvard Medical School. He has introduced the latest international methods and concepts of cancer treatment into the country, leading research on various new drugs and treatment methods. He is the chief expert in the construction of the Clinical Research (GCP) platform at the Chinese Academy of Medical Sciences.He focuses on clinical trials of anti-tumor new drugs, personalized precision treatment for rare tumors, surgical and perioperative targeted and immunotherapy for lung cancer, multidisciplinary precision treatment for malignant solid tumors, cell and gene therapy, and translational research of new drug clinical trials.He has published over 50 academic articles in various important academic journals in the field of oncology, including Lancet Oncology, JAMA Oncology, Cancer Cell, Nature sub-journals, Journal of Thoracic Oncology, etc. The total impact factor of these articles exceeds 500. He serves as the principal investigator of a sub-project of the National 973 Project, the leader of the National Key Research and Development Program for Precision Medicine, the National Natural Science Foundation of China, and the Clinical Trial Capability Enhancement (GCP) Platform, among other research projects. He has pioneered the use of precise molecular diagnosis for each patient and personalized the appropriate methods such as targeted therapy, cell therapy, antibody therapy, nanotechnology, and vaccines for the treatment of refractory, recurrent, and treatment-failed cancer patients. This diagnostic and treatment system has gained international recognition.Clive Svendsen西达-赛奈再生医学研究所主任Clive Svendsen博士是雪松西奈理事会再生医学研究所(RMI)的创始人，该研究所拥有30多名教职员工。svensen博士的实验室专注于使用人类诱导多能干细胞来模拟各种神经系统疾病。他的实验室的另一个重点是使用干细胞和生长因子组合的尖端临床试验。Dr. Clive Svendsen is the founder of the Cedars-Sinai Board of Governors Regenerative MedicineInstitute (RMI) with over 30 faculty members.  Dr. Svendsen’s lab focuses on using human induced pluripotent stem cells to model a wide range of neurological diseases.   The other focus of his lab is cutting-edge clinical trials using combinations of stem cells and growth factors.李锋 天广实生物董事长兼总经理李锋博士，中国籍，博士，国家人才获得者。现任北京天广实生物技术股份有限公司董事长兼总经理。李锋博士有近十年在美国生物医药研发部生产工艺及产业化部门的经验， 2011年9月李锋博士回国，引进了有美国产业化经验的4名科学家组成的核心技术团队，在积极引进吸收国外前沿技术的同时，一直坚持自主创新，积极分析把握国际抗体技术发展的最新趋势。结合我国产业发展的具体情况，带领公司团队建立了国内少数拥有完整创新抗体药物研发及产业化技术平台的生物药企之一，主要产品为MIL62、MIL93、MBS303、MBS314等，多年来积极开发了十余个旨在满足国内患者重大需求的抗体产品，临床适应症涵盖肺癌、淋巴瘤、胃癌、狼疮性肾炎、膜性肾病等多个治疗领域。Dr. Li Feng, Chinese nationality, Ph.D., National Talent Recipient. Dr. Li is the President and General Manager of Beijing Mabworks Biotech Co.Ltd. Dr. Li Feng has nearly a decade of experience in the production process and industrialization department of the U.S. Biopharmaceutical R&D Department. In September 2011, Dr. Li returned to China and established a core technology team consisting of four scientists with experience in industrialization in the U.S. While actively introducing and absorbing cutting-edge technologies from abroad, he consistently emphasized independent innovation and has been actively analyzing and grasping the latest trends of the development of international antibody technology.combined with the specific conditions of China's industrial development, leading the company to establish itself as one of the few domestic biopharmaceutical enterprises with a comprehensive innovative platform for antibody drug research, development, and industrialization. The company's primary products are MIL62, MIL93, MBS303, MBS314, etc., and over the years, actively developed more than 10 antibody products d  aimed at meeting the significant needs of domestic patients.  These products cover various therapeutic areas, including lung cancer, lymphoma, gastric cancer, lupus nephritis, membranous nephropathy, and more.Joshua Brody美国西奈山伊坎医学院副教授Joshua Brody医学博士是西奈山Tisch癌症研究所淋巴瘤免疫治疗项目的主任，也是伊坎基因组学研究所的教员。自他2011年加入西奈山医院以来，就发展了一个重点临床项目，以及一个转化性的癌症免疫治疗实验室，该实验室致力于基础和应用肿瘤免疫学的研究，以开发新的疗法，尤其是针对淋巴瘤、乳腺癌和头颈癌。相关的研究成果已在《Nature Medicine》和《Cancer Discovery》等顶级期刊上发表。Joshua Brody医学博士开创了一种原位疫苗接种的方法，该方法在肿瘤部位诱导抗肿瘤免疫，可实现全身肿瘤的消退。他还开发了一种与干细胞移植结合的方法，提高免疫治疗药物对难治性淋巴瘤的疗效。近期，他的团队发现了一种通过阻止肿瘤逃避CAR-T和双特异性抗体疗法的常见逃逸机制来改善免疫疗法的新方法。Brody博士的研究得到了许多资助机构的支持，包括美国国立卫生研究院、癌症研究协会、Damon Runyon癌症研究基金会、滤泡淋巴瘤研究基金会和淋巴瘤研究基金会。。他也是许多专业组织的成员，包括癌症免疫治疗学会和肿瘤学临床试验联盟。Joshua Brody, MD, is the Director of the Lymphoma Immunotherapy Program at The Tisch Cancer Institute at Mount Sinai and a faculty member of the Icahn Genomics Institute. Since joining Mount Sinai in 2011, he has developed a robust clinical program, as well as a translational Cancer Immunotherapy Lab which investigates basic and applied tumor immunology for the development of novel therapies, particularly for lymphomas, breast cancer, and head/neck cancer with results published in top-tier journals including Nature Medicine and Cancer Discovery.  Dr. Brody has pioneered a therapeutic vaccine approach—in situ vaccination—that induces anti-tumor immunity at the tumor site and can also cause regression of tumors throughout the body. He has also developed a way to use increase the power of immunotherapy drugs against treatment-resistant lymphomas by combining them with stem cell transplantation.  Recently, his group discovered a novel approach to improve immunotherapies by preventing a common escape mechanism that tumors use to evade CAR-T and bispecific antibody therapies.Dr. Brody’s research receives funding from numerous grantors, including the National Institutes of Health, the Cancer Research Institute, the Damon Runyon Cancer Research Foundation, the Follicular Lymphoma Research Foundation and the Lymphoma Research Foundation. He is a member of many professional organizations, including the Society for the Immunotherapy of Cancer and the Alliance for Clinical Trials in Oncology.Anna Cereseto 意大利特伦托大学分子生物学实验室首席研究员、系副主任Anna Cereseto是意大利特伦托大学细胞、计算和整合生物学系（CIBIO）的正教授，也是意大利特伦托大学分子病毒学实验室的研究小组负责人。1990年，她在热那亚大学获得生物科学硕士学位；1992年，她获得合格的专业生物学家资格证书，1997年，获得分子生物学博士学位。她曾在意大利比萨的高等师范学院担任分子生物学副教授，并在西奈山医学院担任讲师，此外，她还在康奈尔大学和美国国立卫生研究院（NIH）的国家癌症研究所进行了博士后研究。她领导的研究小组在推动基于CRISPR-Cas系统的基因组编辑技术方面做出了重大贡献，并证明了这些技术在逆转导致最常见的遗传疾病之一，囊性纤维化的遗传缺陷方面的有效性。她的研究得到了欧洲社区（Horizon 2020）以及美国和意大利囊性纤维化基金会的支持。截至2023年3月，她共发表/合著65篇论文，在Science、Nature Med等期刊上发表过论文，在欧洲和美国的逆转录病毒学和基因编辑领域，她与多个实验室合作开展研究。2019年，她共同创立了一家名为Alia Therapeutics的初创公司，致力于基因组编辑治疗，她目前担任该公司的创始人、董事和CSO SAB主席。Anna Cereseto is Full Professor of Full Professor, Department of Cellular, Computational and Integrative Biology (CIBIO) at the University of Trento and group leader of the Molecular Virology Lab at the CIBIO Department. In 1990, she obtained a Master's degree in Biological Sciences from the University of Genoa. In 1992, she qualified Professional Biologist (Esame di Stato di abilitazione all’esercizio della professione di Biologo). In 1997, she obtained a doctoral degree in molecular biology. During her career she was Associate Professor of Molecular Biology at Scuola Normale Superiorein Pisa. Before that she was Instructor at the Mount SinaiSchool of Medicine and postdoctoral fellow at the CornellUniversity and at the National Cancer Institute of the NIH inBethesda.1990 Master degree in Biological. She is leading a research group that gave major contribution in advancing genome editing technologies based CRISPR-Cas systems and proved their efficacy in reversing genetic defects causing one of the most frequent genetic disease, cystic fibrosis. Her research is supported by the European Community (Horizon 2020) and by the US and Italian Cystic Fibrosis Foundations. As of March 2023, she has published/co authored a total of 65 papers and has published papers in journals such as Science and Nature Med. In the fields of retrovirology and gene editing, she has collaborated with multiple laboratories in Europe and the United States. In 2019 she co-founded a start-up, Alia Therapeutics, working on genome editing treatments where she is currently founder, Director and CSO SAB chair.Antonio Bertoletti杜克-新加坡国立大学医学院传染病专家、新加坡A*STAR临床科学研究所病毒性肝炎组研究主任Antonio Bertoletti, MD是病毒性肝炎领域的专家，擅长研究乙型肝炎（HBV）感染的免疫病理机制。他在意大利帕尔马大学攻读医学学位期间就开始从事病毒性肝炎方面的研究。1991年，他在斯克利普斯研究所（拉霍利亚）攻读传染病专业医学博士学位，在此期间，他花了两年时间首次确定了人类乙型肝炎病毒（HBV）特异性细胞毒性 T 细胞反应的特征。他回到帕尔马大学，在传染病系担任临床科学家，继续研究人类乙型肝炎病毒特异性 T 细胞。Bertoletti博士于1995年加入冈比亚的MRC单位，担任高级免疫学家，研究HIV-2特异性T细胞免疫，1997年，他在英国伦敦大学学院的 "UCL 肝病研究所 "担任高级讲师。2006年，他移居新加坡，现任杜克新加坡国立大学医学院新兴病毒性疾病项目的教授。2015年，他创立了Lion TCR Pte（http://liontcr.com）， 这是一家生物技术公司，针对病毒相关癌症（HBV-HCC 和 EBV 相关恶性肿瘤）和慢性病毒感染开发基于免疫的治疗方法。他目前的研究重点是开发用于治疗慢性乙型肝炎病毒（HBV）感染和肝细胞癌的新型免疫疗法（TCR-定向 T 细胞），并对慢性HBV患者的抗病毒免疫进行表征。在过去的两年里，自COVID-19大流行开始以来，他的实验室一直积极参与对COVID-19和SARS康复者以及健康个体的SARS-COV2特异性T细胞免疫反应的研究，并开发了新的方法来表征它们的T细胞反应。Antonio Bertoletti, MD is an expert in the field of viral hepatitis, with a specific interest in the immunopathogenesis of HBV infection. He began working in viral hepatitis as a medical student at the University of Parma (Italy). During his MD specialization (1991) in Infectious Diseases he spent two years at The Scripps Research Institute (La Jolla) characterizing for the first time the Hepatitis B virus (HBV) specific cytotoxic T cell response in man. He returned to the University of Parma, where he worked in the Department of Infectious Diseases as a Clinical Scientist continuing his study of human HBV specific T cells. Dr. Bertoletti then joined (1995) the MRC Unit in the Gambia, as Senior Immunologist, to study HIV-2 specific T cell Immunity before accepting a position of Senior Lecturer at “The UCL Institute of Hepatology” at University College of London (UK) (1997).  In 2006 he moved to Singapore where is now Full Professor, at the Emerging Viral Disease Program at Duke-NUS Medical School. In 2015 he founded Lion TCR Pte (http://liontcr.com), a biotech company developing immune-based treatments for virus-related cancers (HBV-HCC and EBV related malignancies) and chronic viral infections. His current research is focus on the development of new immunological based therapies (TCR-redirected T cells) for the treatment of HBV chronic infection and Hepatocellular carcinoma and on the characterization of antiviral Immunity in chronic HBV patients. In the last 2 years, after the start of the COVID-19  pandemic, his laboratory has been actively involved in the characterization of SARS-COV2 specific T cell immune response in COVID-19 and SARS convalescent and healthy individuals and in the development of new methods to characterize their T cell response).崔霁松诺诚健华创始人兼CEO崔霁松博士，1962 年 10 月出生，美国国籍，拥有中华人民共和国永久居留权，自 2015 年 11 月 3 日起担任公司董事，2016年 8 月 18 日起任行政总裁。2019年 9 月 27 日起，崔霁松博士担任公司执行董事，并当选为公司董事会主席，一直为公司主要管理层成员之一。崔霁松博士在医药行业的研发及公司管理方面拥有逾 20 年经验。1996年 10 月至 2010 年 10 月 崔霁松博士在美国默克（Merck & Co.）任职，后成为该公司在美国的早期开发团队的负责人；2010 年 11 月至 2011 年 8 月，在 Hua Medicine（华领医药）担任副总裁；2011 年 8 月至 2015 年 8 月期间，担任保诺科技（北京）有限公司的总经理。Jiso崔霁松博士为美中医药开发协会（Sino-American Pharmaceutical Association）第17 届主席，也是该协会第 1 位女性主席。崔霁松博士于 1983 年 7 月取得山东大学的微生物学学士学位，1992年 12 月取得普渡大学（Purdue University）的生物科学哲学博士学位，并于 1996 年 9月在霍华德·休斯医学研究所（The Howard Hughes Medical Institute）完成心血管研究的博士后培训。Dr. Jisong Cui, born in October 1962, a U.S. citizen with permanent residency in the People's Republic of China. has served as a director of the Company since November 3, 2015, and as Chief Executive Officer since August 18, 2016.Since September 27, 2019, Dr. Jisong Cui has served as an executive director of the company and was elected Chairman of the Board of Directors, and has been one of the members of the key management of the Company.Dr. Jisong Cui possesses over 20 years of experience in research and development as well as company management in the pharmaceutical industry. From October 1996 to October 2010, Dr. Cui served at Merck & Co. in the United States, where she later became the head of the company's early development team in the U.S. From November 2010 to August 2011, she held the position of Vice President at Hua Medicine. Between August 2011 and August 2015, Dr. Cui served as the General Manager of BioDuro (Beijing) Company Limited. Dr. Jisong Cui is the 17th Chairperson of the Sino-American Pharmaceutical Association and the first female Chairperson of the association.Dr. Jisong Cui received his B.S. in Microbiology from Shandong University in July 1983, his Ph.D. in Biological Sciences from Purdue University in December 1992, and completed his postdoctoral training in cardiovascular research in September 1996 at The Howard Hughes Medical Institute.Dr. Cui Jisong obtained a Bachelor's degree in Microbiology from Shandong University in July 1983. Her Ph.D. in Biological Sciences from Purdue University in December 1992, and completed his postdoctoral training in cardiovascular research in September 1996 at The Howard Hughes Medical Institute.袁钧瑛中国科学院上海有机化学研究所生物与化学交叉研究中心主任，美国国家科学院院士袁钧瑛于1982年在中国上海复旦大学获得本科学位，1989 年获得哈佛大学神经科学博士学位。袁博士的博士论文是在麻省理工学院 H. R. Horvitz 实验室完成的。1992 年，她被哈佛大学医学院任命为助理教授，并成为麻省总医院心血管研究中心的首席研究员。她于 1996 年加入哈佛大学医学院细胞生物学系，并于 2000 年被任命为细胞生物学教授。2014年,获得哈佛大学ElizabethD.Hay教授称号。（该教授职位是为了纪念哈佛大学医学院历史上第一位女性正教授、已故的伊丽莎白-海教授（Elizabeth D. Hay）。）袁博士于2020年回国，加入上海有机化学研究所，担任生物与化学跨学科研究中心主任。袁博士是细胞死亡领域的先驱和有影响力的领导者。她发表的254篇论文被高度引用，总引用次数超过11.6万次（H指数133）。在细胞凋亡（apoptosis）和程序性细胞坏死（necroptosis）的工作中做出了里程碑式的发现。她发现了哺乳动物的半胱天冬酶（caspases），引领了细胞凋亡研究的分子时代。她利用化学生物学证明了可调控的细胞坏死方式，即程序性细胞坏死（necroptosis），在人类炎症性和神经退行性疾病中的存在和重要性，并揭示了RIPK1作为necroptosis的关键介导因子的作用。由袁博士首次发现的 RIPK1 抑制剂已进入人体临床试验阶段，用于治疗全球范围内的人类炎症和神经退行性疾病，如肌萎缩性脊髓侧索硬化症（ALS）和阿尔茨海默病（AD）。袁博士的成就获得了许多奖项，包括乳腺癌研究创新奖、美国国立卫生研究院院长先锋奖、安捷伦科技思想领袖奖以及中国旅美科技协会颁发的杰出科学家奖。她是美国国家科学院院士、美国艺术与科学院院士和美国科学促进会院士。Junying Yuan received her undergraduate degree from Fudan University, Shanghai, China, in 1982 and her Ph.D. in Neuroscience from Harvard University in 1989. Dr. Yuan carried out her Ph.D. thesis work at the Massachusetts Institute of Technology in the laboratory of H. R. Horvitz. She was first appointed as Assistant Professor at Harvard Medical School in 1992, when she became a Principal Investigator of the Cardiovascular Research Center at Massachusetts General Hospital. She joined the Department of Cell Biology in 1996 and was appointed a Professor of Cell Biology at Harvard Medical School in 2000. In 2014, Dr. Yuan was appointed as Elizabeth D. Hay Professor of Cell Biology, a Professorship honors the late Professor Elizabeth D. Hay, the first female full professor in the history of Harvard Medical School. Dr. Yuan returned to China in 2020 and joined Shanghai Institute of Organic Chemistry as the Director of Interdisciplinary Research Center on Biology and Chemistry.Dr. Yuan is a pioneer and an influential leader in the cell death field. Her 254 published papers have been highly cited with collective citations of more than 116,000 times (H index 133). Dr. Yuan made transformative discoveries on two distinct forms of cell death, apoptosis and necroptosis in mammalian cells. Her discovery of mammalian caspases led to a molecular era in apoptosis research. She used chemical biology to demonstrate the existence and significance of a regulated necrosis mechanism, termed necroptosis, in human inflammatory and neurodegenerative diseases and the role of RIPK1 as a key mediator of necroptosis. RIPK1 inhibitors, first discovered and described by Dr. Yuan, have been advanced into human clinical trials for the treatment of human inflammatory and neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), and Alzheimer’s disease (AD) worldwide. Dr. Yuan’s accomplishments have been honored by many awards including the Innovator Award for Breast Cancer Research, NIH Director’s Pioneer award and Agilent Techno李文辉北京生命科学研究所资深研究员李文辉博士实验室的研究兴趣集中于重要病毒感染的分子机制及其防治。近年来，主要致力于乙肝病毒（HBV）研究。乙型肝炎是危害人类健康的严重传染病，全球估计有HBV感染者2.4亿人，其中我国约有9300万人，慢性HBV感染是导致肝硬化、肝癌的重要病因。丁型肝炎病毒（HDV）是HBV的卫星病毒,在所有HBV感染者中，约有1500万人同时感染HDV。李文辉博士带领团队发现HBV及HDV感染肝细胞的关键受体是钠离子-牛磺胆酸共转运蛋白（NTCP），并获得2021年全球乙肝研究领域最高荣誉——巴鲁克·布隆伯格奖；稳定表达人NTCP的HepG2细胞系(HepG2-NTCP)已成为HBV相关基础病毒学研究和抗病毒药物研发的重要平台。目前，对乙肝感染的科学研究及药物开发已进入一个充满生机的新时代。李文辉博士实验室综合运用病毒学，生物化学，免疫学，化学生物学等多学科方法深入剖析HBV及HDV感染过程的分子基础，以帮助理解其病理机制。团队希望研发新的抗病毒药物，为最终有效解除患者的病痛而努力。此外，李文辉博士团队也与相关实验室合作研究NTCP/胆酸等分子在感染及机体代谢过程中的相关作用。李文辉2001年获得中国协和医科大学中国医学科学院 病原生物学博士学位，2001.9-2004.5在哈佛大学医学院做博后，2004.6-2007.9担任哈佛大学医学院Instructor，2007.10-2015.2担任北京生命科学研究所研究员，2015.3至今为北京生命科学研究所资深研究员。Dr.Wenhui Li's laboratory focuses on the molecular mechanisms of important viral infections and their prevention and treatment. In recent years, they have primarily dedicated their research to the study of Hepatitis B virus(HBV). Hepatitis B is a severe infectious disease that poses a significant threat to human health, with an estimated 240 million HBV-infected individuals worldwide, including approximately 93 million in China. Chronic HBV infection is a major cause of liver cirrhosis and liver cancer. Hepatitis D virus (HDV) is a satellite virus of HBV, and approximately 15 million individuals are co-infected with HDV among all HBV-infected individuals.Dr. Wenhui Li, along with his team, discovered that the key receptor for HBV and HDV infection in liver cells is the sodium taurocholate cotransporting polypeptide (NTCP). This groundbreaking discovery earned them the prestigious 2021 Baruch S. Blumberg Prize, the highest recognition in the global HBV research field. The stable expression of human NTCP in the Human hepatocellular carcinomas (HepG2-NTCP) has become a crucial platform for studying HBV-related basic virology and developing antiviral drugs.Currently, scientific research and drug development for hepatitis B infection have entered a vibrant new era. Dr.Wenhui Li's laboratory employs an integrated approach, encompassing virology, biochemistry, immunology, chemical biology, and other disciplines, to delve into the molecular basis of HBV and HDV infection processes, aiding in the understanding of their pathological mechanisms. The team aspires to develop novel antiviral drugs, striving to ultimately alleviate patients' suffering effectively. Additionally, Dr. Li Wenhui's team collaborates with relevant laboratories to investigate the roles of molecules such as NTCP/bile acids in infection and metabolic processes within the body.In 2001, Dr. Li Wenhui obtained his Ph.D. degree in Pathogenic Biology from Peking Union Medical College, Chinese Academy of Medical Sciences. From September 2001 to May 2004, he conducted postdoctoral research at Harvard Medical School. Following that, he served as an Instructor at Harvard Medical School from June 2004 to September 2007. From October 2007 to February 2015, he held the position of Researcher at the Beijing Institute of Life Sciences. Since March 2015, he has been a Senior Researcher at the Beijing Institute of Life Sciences.最终议程以现场为准活动亮点融全球智力，为中国新药。Lieping Chen，Clive Svendsen，Antonio Bertoletti等海外科学家专程乘机24小时至北京，全盘呈现当今新药格局，共享行业热点，分享自己的国际前沿进展。汇聚时下热门研发热点话题：肿瘤免疫、细胞疗法，干细胞，神经，内卷，基因疗法，Protac......国内外顶尖专家学者和企业家们将头脑风暴式探讨未来战略与产业化热点，带您在新药开发的征途上披荆斩棘！同行交流，强强联手。集高端思维，诉所思所感，您将有机会如此近距离和国内及国际顶尖科学家讨论问题，碰撞灵感火花，只要你提的问题有质量就能被关注到。下沉一线找问题，倾听企业真实呼声。圆桌讨论的问题将来自于对中关村生命科技园内600家企业的调研，打通常规信息屏障，实实在在解决企业一线问题。参会报名参会有礼注册并报名成功，转发本文至朋友圈，且前100名现场签到观众即可免费领取精美参会礼+商务午餐券1份，先到先得，送完即止。精美好礼现场领参会咨询郑王曦   15857107124蒋晓华   13551362642李亚玲   18215607723个别展位及其他商务合作联系李晓林  18801007371张   玲  15005862516关于中关村生命科学园中关村生命科学园是于2000年建设的国家生物医药产业基地，在北京国际科技创新中心建设中发挥着重要支撑作用。经过二十年发展，中关村生命科学园已形成集合基础研究、中试研发、生产流通、终端医疗的全产业链聚集态势，建设成为中国生命科学领域创新资源最为集中的园区之一。生命园始终对标全球顶尖医药健康产业园区、聚焦发展所需，致力于建设成为政府支持、资本敢投、企业家敢闯、科学家敢干的创新创业氛围，打造具有全球竞争力的医药健康产业发展高地。关于药融圈药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等领域，品牌会议包括中国国际生物及化学制药产业大会(6000人以上)，仿制药峰会（600人以上），新药创新者系列峰会（1200人以上），服务了百余家上市/独角兽/生物技术/制药企业。药融圈生物医药生态圈合作伙伴：凌凯医药、福抗药业、汇宇制药、深圳华溶、君达合创、健元医药、济民可信、则正医药、亚瑟医药、欣诺科催化剂、苏州亚科、青木制药、有济医药、阳光诺和、博腾制药、百诚医药、汉康医药、美迪西、玻思韬、Flamma、以岭万洲、艾奇西医药、海纳医药、天吉生物、江苏诺泰澳赛、中肽生化、成都海通、杭州澳亚、天津信诺、珠海亿胜、慧泽医药、成都先导、赛默飞、梅特勒、ProteinSimple、赛多利斯、思拓凡、晶泰科技、英矽智能、苏州晶云、中科普瑞昇、康日百奥、宜明细胞、三优生物、杭州皓阳、申基生物、金斯瑞蓬勃、明迅生物、凌科药业、翰思生物、益方生物、宁丹新药、迈威生物、华津医药、STD扬信医药、微谱集团、镁伽科技、嘉树医疗、浙江齐蓁、精金石、毕得医药、伊诺凯……END