会议活动丨BioBAY企业免费！2024亚太医疗器械研发与合作大会阵容公布，报名开启！

2023-12-15

带量采购医药出海

随着科技的不断进步，医疗器械领域正在经历革命性的创新，过去 20 年，中国医疗器械行业以“模仿式创新”打破海外垄断，快速缩短与发达国家的差距。中国作为世界上最大的医疗器械消费市场之一，医疗器械行业在中国未来的发展前景备受期待。如今，中国医疗器械市场已成为全球第二大市场，2025 年市场规模将突破 1 万亿元。在这个规模超万亿元的市场，“模仿式创新”显然不再能满足需求。因此，中国医疗器械行业需要从“模仿式创新”转向“基于临床需求的原始创新”。与此同时，科创板、港股 18A、北交所的设立为器械企业提供了更多发展平台和机遇；国家药监局持续深化药品医疗器械审评审批制度改革，集中带量采购和医保支付改革加速市场整合升级；新一轮资本的理性回归，医药医疗器械产业迎来投资新风口；医疗器械数字化、智能化，进口替代时代号角正式吹响等背景下：立足历史新起点，持续深耕底层技术，以临床需求为导向，加强产品自主创新和差异化研发，推动医疗器械数字化创新转型，探索医疗器械产学研合作的创新模式，加快医疗器械创新出海，成为我国医疗器械企业发展的必经之路。基于此，BioBAY与士研咨询联合主办的2024 APMD 亚太医疗器械研发与合作大会作为聚焦医疗器械研发创新的高端峰会，定于 2024 年1月18-19日在苏州盛大召开。我们将重点展示医疗器械产业的最新成果和突破，聚焦创新医疗器械差异化开发，致力于提升器械临床开发效率，加快医疗器械创新出海步伐，推动数字化赋能医疗器械研发创新，深度探索高端医疗器械行业的未来发展新方向；同时，我们也会邀请来自全球的最前沿技术的医疗器械企业参与，分享各自国家和地区的先进技术和成功案例，积极寻求更多全球合作新机遇。组委会阵容主办单位：士研咨询联合主办：BioBAY协办单位：中国医疗器械行业协会外科植入物专业委员会战略联盟：爱尔兰投资发展局、雅法资本关于组委会2024 APMD士研咨询士研咨询成立于2005年，致力于为组织领导者提供沟通交流与专家智库平台。通过二十年沉淀与积累，覆盖了金融与投资、交通与运输、消费与文旅、医药与医疗、能源与资源、高科与电信、公用与政府等产业领域，服务着全球500强和万余家领导型企业，汇聚了百万余名机构决策者，并与千余家产业权威机构建立了战略伙伴关系。土研咨询秉承专业立身的理念发展队伍，现拥有百余名专业的资深人员，核心管理团队都具有十五年以上的专业经验。BioBAY苏州生物医药产业园成立于2007年6月，是苏州发展生物医药产业的创新科技载体，经过十年来的深耕和培育，已聚集620余家生物医药高科技创新企业、35000名高层次科技人才，形成了创新药研发、高端医疗器械、生物技术三大重点产业集群，努力构建世界一流的生物产业生态圈。生物医药产业园自运作以来，以人才为引领，面向海内外集聚了一批高端的生物医药产业人才前来创新创业，包括115位国家级人才、160位省级以上高端人才、287位姑苏领军人才、565位园区领军人才。高端人才的集聚带来的是自主创新能力的跃升。BioBAY, located in Suzhou Dushu Lake Sci-Edu Innovation District, SIP, was founded in June 2007 as an innovative science and technology cradle that was expected to help boost the biomedical industry in Suzhou. After 15 years of growth, BioBAY has now become home to more than 620 innovative biomedical technology enterprises with 35,000 high-level talents. It has fostered three industrial clusters, respectively, focusing on innovative drug research and development, high-end medical devices, and biotechnology, endeavoring to build a world-class bio-industrial ecosystem.With SIP’s strong support for leading scientific and technological talents to launch their own businesses, BioBAY has attracted a cohort of top biotech talents to make innovations or set up startups in it. Among them are 115 under national-level talent programs, 160 under programs at the provincial level or above, 287 “Gusu Leading Talents”, and 565 “SIP Leading Talents”. These talents have helped drive significant improvement in independent innovation capability in BioBAY.中国医疗器械行业协会外科植入物专业委员在中国每天都有数千名患者因为使用植(介)入物产品而受益。为了促进这一行业的健康发展，外科植入物专业委员会自2002年起由部分人士在民间发动组织，其后得到国家食品药品监督管理局(SFDA)和中国医疗器械行业协会(CAMDI)的支持和指导，经国务院国资委批准、民政部备案，于2004年3月在北京正式成立，在全国范围内从事专业性活动。所辖专业：外科植入物专业委员会由境内外从事骨科、心血管、神经外科和有源等植入物及其器械的研发、生产、经营、产品检测、中介服务、教育培训及产业链相关的单位或个人，在自愿的基础上，联合组成的行业性、非营利性社会团体，不受部门、地区和单位所有制的限制。其业务范围基本对应于国际标准组织外科植入物技术委员会ISO TC150的涵盖面，包括介入治疗产品等,和我国政府对医疗器械的管理分类一致。目前会员数300余家，其产品总量在国内市场的占有率约90%。爱尔兰投资发展局爱尔兰投资发展局暨爱尔兰驻上海总领事馆经济处，是爱尔兰政府吸引和促进海外投资的机构，通过专业咨询和增值服务促进外商直接投资爱尔兰，帮助投资者在爱尔兰建立或扩展业务，从而更好的拓展其欧洲市场的发展。目前，投资局在中国上海、深圳、北京三地设有办事处，旨在于帮助中国企业的海外发展，主要领域包含信息通讯与技术，生命科学以及国际金融服务。现已成功吸引华为、TikTok、中国工商银行、中国国家开发银行、中国银行、中国交通银行、中国航信、腾讯、药明生物、康哲药业、南京传奇等不同业务领域的中国投资者。IDA Ireland is an Irish Government funded organization whose main objective is to encourage investment into Ireland. Its objective is to create sustainable employment in Ireland by securing new investments from overseas and by encouraging existing overseas enterprises to expand their current Irish projects.In particular IDA Ireland focuses on business sectors that can operate competitively in global markets from a base in Ireland including international financial services, information technologies and life sciences. IDA Ireland works closely with client companies to help them assess opportunities in Europe and to support and assist them with establishing their operations in Ireland. To this end, IDA Ireland has opened three offices in Shanghai, Beijing and Shenzhen, successfully attracted Huawei, TikTok, ICBC, CDB, BOC, BOCOMM, TravelSky, Tencent, WuXi Biologics, CMS, Nanjing Legend Biotech, etc from difference industry to invest in Ireland. 雅法资本雅法资本成立于2013年，作为新型投资和投行咨询机构，致力于中国及海外生物医药项目的投资、融资服务、产品引进和资产孵化等。旗下雅法基金联合药企进行资产投资和并购，雅法全球医疗专注于医药产品跨境及国内授权交易。基于雅法在全球广泛的人脉与资源网络，在过去十年成功推进了大量的海外项目进入中国市场并协助多个中国产品完成海外授权。雅法拥有经验丰富的全球交易团队，覆盖美国、日本、欧洲等全球主要医药创新区域。核心合伙人均为华尔街资深投行人士或具有跨国药企经历，为客户交易提供强力支持。雅法总部位于上海，在伦敦、洛杉矶、东京、米兰、剑桥等地均设有分部。雅法在生物医药跨境授权及并购业务交易数量连续三年排名第一。Founded in 2013, YAFO Capital is a Shanghai based boutique investment and advisory firm, with professional team in our China, U.S., and London offices. Partnering with Pharmaceutical companies, YAFO Fund mainly invests in global assets. YAFO Life Sciences is a leading advisory boutique focused on asset transactions. YAFO has built a strong proven track record and closed dozens of in-licensing and out-licensing transactions with global pharma and biotech companies. YAFO has been ranked as the No. 1 advisor for China cross border licensing transactions in the past three years. For more information, please visit www.yafocapital.com（上下滑动查看详细内容）＋会场规模会场：血管植介入、骨科植入、医学影像、临床开发与注册、出海与合作规模预计：600+，其中展位20+，演讲嘉宾40+＋参会群体按企业：国内/国际医疗器械产品研发和生产企业；第三方服务机构；投资机构；产业园区；科研院所；政府及医院；创新材料；智慧医疗/人工智能/大数据；律师咨询；其他；媒体按职能：总裁/首席执行官/总经理/首席战略官/首席技术官/协会会长/创始人/合伙人/招商局局长；副总裁/总监(研发设计/临床转化/工艺生产/注册部/临床试验/药政监管/法规事务/市场/商务)；其他部分已确认发言嘉宾（持续更新中）虞奇峰上海纽脉医疗科技股份有限公司创始人、董事长上海纽脉医疗董事长、首席执行官，高级工程师，四川大学生物医学工程硕士，比利时联合商学院工商管理博士。至今拥有18年医疗器械产品研发和管理经验，熟悉行业发展趋势。2015年创立纽脉医疗，带领团队自主研发多款国内首创、国际领先介入瓣膜产品，有3款核心产品顺利通过国家药监局（NMPA）审批，进入创新医疗器械特别审查程序，即“绿色通道”。至今已申请了380余项具有自主知识产权的专利，主持或参与多个国家及上海市科技计划。2018年入选科技创新创业人才、第四批“万人计划”科技创新领军人才。个人担任中国生物材料学会理事、中国生物材料学会医用金属材料分会委员、中国生物材料学会生物材料表界面工程分会委员、中国医疗器械行业协会产品可靠性专业委员会常务委员。Qifeng Yu, chairman, CEO, Senior Engineer. Master of Biomedical Engineering, Sichuan University, Doctor of Business Administration, Associated Business Schools of Belgium. He has 18 years of experience in medical device product development and management, and is familiar with the development trend of this industry. In 2015, he founded NewMed Medical Co., Ltd.. He led the team to independently develop a number of domestic and international leading interventional valve products, and 3 core products successfully passed the approval of the NMPA and entered the special review procedure for innovative medical devices, that is, the "green path". He has applied for more than 380 patents, and hosted or participated in many national and Shanghai science and Technology programs. He was selected as the “Scientific and Technological Innovation and Entrepreneurship Talents” in 2018, the fourth batch of the "Ten Thousand Talent Program ", and the “Leading Talents in Scientific and Technological Innovation”. He is currently a member of the board of directors of the Chinese Society of Biomaterials, a committee member of the Medical Metal Materials Branch of the Chinese Society of Biomaterials, a committee member of the biomaterials surface and interface Engineering branch of the Chinese Society of Biomaterials, and a standing member of the Product Reliability Professional Committee of the China Medical Device Industry Association.解凤宝春立医疗执行董事、副总工程师解凤宝是北京市春立正达医疗器械股份有限公司副总工程师、执行董事。多年来一直从事骨科植入物产品设计研发工作，擅长髋、膝、肩和肘关节等设计。目前已发表授权发明专利30余项，实用新型专利40余项。主持多项国家级和省部级课题。Xie Fengbao is the deputy chief engineer and executive director of Beijing Chunlizhangda Medical Instrument Co., Ltd. For many years, he has been engaged in the design and development of orthopedic implant products, specializing in the design of hip, knee, shoulder and elbow joints etc. Currently, over 30 authorized invention patents and over 40 utility model patents have been published. Leading multiple national and provincial research project.马仁政启明医疗首席运营官兼首席技术官现为启明医疗首席运营官兼首席技术官，中国生物材料学会理事，杭州市滨江区政协委员曾任碧迪医疗大中华区创新和战略市场总监，亚太区研发总监。美敦力大中华区研发中心高级项目经理近20年医疗器械行业从业经历仪克晶沛嘉医疗研发副总裁沛嘉医疗（苏州）有限公司研发副总裁，全面负责结构事业部研发管理工作。在高风险器械行业拥有近二十年研发及生产管理经验：曾就职于上海微创医疗器械（集团）担任子公司总经理，后就职于美敦力中国研发中心担任脑脊液产品研发团队及运营管理负责人，拥有中国质量协会六西格玛黑带、PMP项目管理认证及美敦力DRM黑带的认证资质。康小然赛诺神畅医疗科技有限公司总裁康小然，赛诺神畅医疗科技有限公司CEO、法定代表人。毕业于同济大学材料科学与工程专业，副研究员职称，2007 年加入赛诺医疗先后担任研发项目经理、质量经理、注册经理、法规与临床事务总监、助理总裁、首席运营官。先后承担多项国家、省级科技项目，项目资金总额达1 亿多元人民币，其中BuMA 冠脉药物洗脱支架获“天津市科技进步一等奖”及“中法团队合作创新金奖”，NOVA 颅内药物洗脱支架获得中国国家药监局创新医疗器械审批，并入选中国医学科学院2021年度重要科学进展，临床结果在神经科学顶级期刊JAMA发表。组织开展首个获得美国FDA IDE 批准的国产冠脉药物支架产品的全球化、多中心、随机对照研究，产品已获欧盟及中国药监机构批准，2021 年进入申请美国上市前批准（PMA 申请）获FDA 受理。申请国内外专利十余项。Sean Kang, CEO and legal representative of Sinomed Neurovita Technology Inc.. He graduated from Tongji University majoring in Materials Science and Engineering with the title of associate researcher. In 2007, he joined Sinomed as Project Manager, Quality Manager, Registration Manager, Director of regulatory and clinical affairs, Assistant president and Chief Operating Officer. He has undertaken a number of national and provincial science and technology projects with a total fund of more than 100 million yuan, among which BuMA coronary drug-eluting stent won the "Tianjin Science and Technology Progress First Prize" and the "Sino-French Team Cooperation Innovation Gold Medal". NOVA intracranial drug-eluting stent won the approval of innovative medical devices by the China National Drug Administration. It was selected as an important scientific Progress in 2021 by the Chinese Academy of Medical Sciences, and its clinical results were published in JAMA, a top journal in neuroscience. He organized the first global, multi-center, randomized controlled study of domestic coronary stent products approved by the US FDA IDE, the product has been approved by the EMA and NMPA, and the application for premarket approval in the US in 2021 (PMA application) has been accepted by the FDA. He applied for more than 10 domestic and foreign patents.施小立核心医疗副总裁医疗器械高级工程师，生物医学工程博士ISO TC150，国家心血管植入器械标委会委员，深圳医疗器械行业协会副秘书长现深圳核心医疗科技股份有限公司副总裁，负责临床注册，市场营销等2019—2021，苏州沛嘉医疗科技有限公司副总裁，负责临床注册2009—2019，先健科技（深圳）有限公司副总裁，负责临床注册，研发管理，市场营销，测试中心，政府事务等2016—2019，深圳领先医疗，创始人CEO。主营医疗器械动物实验，理化生物测试，法规及体系，临床试验等。多类植介入心血管器械全球100多个国家上市准入经验。参与多个国际标准、国家行业标准及团体标准起草和制修订，包括心脏封堵器，可吸收支架，介入瓣膜，腔静脉滤器等。获得多项广东省及深圳市技术发明奖，科技进步奖等。马琛明南京圣德医疗科技有限公司总经理、董事长马琛明博士，本硕在北京大学医学部、博士在德国柏林夏洛特医学院完成临床医学学业，先后任职于国内外顶尖的心脏中心北京安贞医院、柏林心脏中心和慕尼黑德意志心脏中心，主刀过绝大部分复杂类型的心脏和大血管手术超千例，拥有20多年中欧一流心脏中心临床及研发经验，是心脏瓣膜、心脏移植及心血管介入疾病领域专家。马博士在德期间心系祖国医疗事业发展，在深刻认识到中国与欧美在心脏介入技术特别是瓣膜病治疗领域的差距后，于2019年4月辞去全部德国职位，全职回国创办南京圣德医疗科技有限公司，为国内数百万瓣膜病患者提供有针对性的临床解决方案，推动中国微创心血管手术的快速发展和普及下沉。回国创业后当选南京市浦口区第五届政协委员、南京江北新区归国华侨联合会副主席和副会长，入选2021年江苏省“双创人才计划”和2019年南京市紫金山英才计划的市级“高层次创业人才引进计划”。Dr. Chenming Ma completed his master's degree at Peking University Health Science Center (PKUHSC) and his doctorate at Charité – Universitätsmedizin Berlin. He served in top heart centers at home and abroad, such as Beijing Anzhen Hospital, German Heart Center Berlin, and German Heart Center Munich, where he has performed more than 1,000 complicated heart and great vessel surgeries. Having more than 20 years of experience in clinical, research and development of first-class heart centers in both China and Europe, Dr. Ma gradually became an expert in the field of cardiovascular interventions.During his stay in Germany, Dr. Ma was deeply concerned about the development of medical care in China. After recognizing the gap between Chinese and Western cardiac intervention technology, especially in the treatment of valvular disease, he resigned from all positions in Germany in April 2019 and established Nanjing Saint Medical Tech. Co. Ltd in Nanjing BPV. Nowadays, Dr. Ma is concentrating to promote the rapid development and popularization of minimally invasive cardiovascular surgery in China.蔡国峰上海英威思医疗科技有限公司CTO&联合创始人蔡国锋，先后就职于海微创医疗和恒瑞医疗器械，从事医疗器械12年。主导完成了多款导管、球囊、导丝、支架类产品的研发与取证。2020年7月，作为CTO&联合创始人，成立了上海英威思医疗科技有限公司。产品定位为神经和外周领域高值耗材，围绕进口替代，公司已初步完成导管，球囊，支架，导丝，涂层等技术平台的搭建。2024年1季度将完成6张三类医疗器械注册取证，相关支架类产品也将陆续开展临床前研究。姜智博微创心通医疗科技有限公司医学总监医学硕士、工商管理硕士，心内科主治医师，目前任心通医疗（港股上市公司）医学总监，负责心通医学相关工作，包括上市前产品动物实验，临床技术支持，上市后医学教育培训，上市后产品技术支持，上市后临床项目，医工合作，下游产品管理，公司兼并收购产品的技术评估等。肖嘉爱尔兰投资发展局中国区生命科学行业总监肖嘉先生本科毕业于上海大学电气自动化专业，同时拥有中国科学技术大学的MBA学位。目前担任爱尔兰投资发展局（IDA）的中国区生命科学行业总监。爱尔兰投资发展局是爱尔兰政府的投资促进机构。在过去的五十年里爱尔兰投资发展局成功将爱尔兰打造为全球领先的投资目的地之一，成功实现爱尔兰向“知识经济”的转型。爱尔兰投资发展局支持1800多家客户企业，以爱尔兰为基地开展面向国际市场的业务。在加入爱尔兰投资局前，肖嘉先生在朗客自动化以及泽尼斯自动化等多家跨国企业担任中国区销售负责人的职位。Mr. Chester Xiao is the Life Sciences Sales & Marketing Executive for IDA Ireland in China. IDA Ireland is the investment promotion agency of the Irish Government. Over the past 50 years, IDA Ireland has successfully established Ireland as one of the world's leading investment destinations and transformed Ireland into a 'knowledge economy'. Now IDA Ireland supports more than 1,800 client companies and operates internationally from its base in Ireland.Before joined IDA, Chester worked as China Sales Head for several international companies including Lanco Integrated and Zenith Technologies. Chester has a bachelor degree of electrical & automation of Shanghai University, as well he is a MBA holder of University of Science and Technology of China.顾磊敏元生创投合伙人复旦大学医学院医学学士，上海交大医学院医学硕士。20余年在跨国公司和国内公司进行医疗器械市场推广、生产、研发管理和销售的经验。曾任强生医疗器械中国总经理、飞利浦家庭医疗中国区总裁、Biosensor International全球高级副总裁，以及中国医学装备协会副理事长等职位。张启林辽宁开影医疗有限公司算法技术总监辽宁开影医疗算法技术总监，本溪市政协委员Algorithm Technical Director of Liaoning Campo Imaging Medical Co., Ltd Benxi CPPCC member媒体合作伙伴抢先报名限时免费扫描上方二维码并在第七条备注“BioBAY”进行报名（限园内医疗器械产品研发和生产企业/投资机构/科研院所）会议相关咨询请致电：BioBAY市场部隋先生0512-62956666-8005▌文章来源：士研生命科学责编：赵家帅审核：任旭推荐阅读会议活动丨BioBAY一站式服务中心“家门口的就业服务站”主题沙龙活动火热报名中！会议活动丨中国--丹麦生物经济与创新论坛成功举办会议活动丨BIOLIGN 2024苏州站开年盛会重磅来袭！