2026.09.20
《大国新药》国际版02期｜ADC商业化时代：从卓越的CMC到构建全球竞争力
抗体药物偶联物（ADC）作为生物医药领域的王牌赛道，凭借精准靶向、高效抗肿瘤的核心优势，已迈入规模化商业化落地的关键新阶段。ADC药物从临床突破走向商业化放量，CMC已不再只是后端的执行环节，而是决定产品出海、国际合规以及在激烈竞争中建立壁垒的隐形裁判。全球ADC赛道竞争日趋白热化，靶点同质化、工艺迭代加速、全球监管标准趋严、供应链稳定性不足等问题，成为制约国内ADC企业从“临床突破”迈向“全球化商业化”的核心瓶颈。 2026年，全球ADC赛道进入关键转折期：一方面是临床管线持续增长，另一方面是商业化生产、跨国监管、供应链布局的复杂挑战日益凸显。在ADC商业化下半场，创新不再局限于分子结构与药物设计，CMC工艺能力、商业化制造体系、全球合规布局、供应链战略已成为决定企业核心竞争力的关键底色，更是国内药企出海突围、对标国际顶尖企业的重要支点。 如何在CMC环节实现卓越，并以此为支点构建全球竞争力，正成为每一家ADC Biotech、CDMO与投资机构必须回答的核心命题。9月23日19:30，《大国新药·国际版》第二期节目将聚焦“ADC商业化时代：从CMC卓越到构建全球竞争力”，集结四位国内外行业重磅嘉宾，涵盖Biotech、CMC、CDMO以及资本的多元视角，深度拆解ADC商业化全链路核心难题。 中方嘉宾： 冯 辉 | 安领科生物 创始人、CEO 李铁军 | 凯莱英生物 CMC负责人 国际嘉宾： George Procopiou | Valink Therapeutics ADC化学与工程副总裁 Ray Sison | SCxCMC Solutions 管理合伙人&联合创始人 主持人： 戚飞 | 君联资本 执行董事 本场对话将围绕ADC商业化时代的五大关键议题展开： 1. CMC——ADC商业化的隐形裁判从分子结构设计到偶联工艺，CMC决定ADC产品的质量、稳定性与可放大性。 2. CMC和制造策略的十字路口——构建高效的商业化供应体系 临床阶段与商业化阶段的制造策略有何本质不同？如何平衡速度、成本与质量？ 3. 从工艺突破到全球供应链的布局ADC生产涉及高活、抗体DS、偶联等多个复杂环节，全球化供应链如何布局才能确保韧性与合规？ 4. 全球化CMC合规——跨越监管鸿沟 中美欧监管要求差异，如何建立被全球主流市场接受的CMC数据与申报策略？ 5. 未来展望——CMC如何定义下一代ADC领导者 当行业进入差异化竞争阶段，CMC如何重塑ADC企业的估值逻辑与市场地位？嘉宾简介向上滑动查看Hui Feng Founder & CEO Allink BiotherapeuticsDr. Hui Feng graduated from Tsinghua University in 1997 with a degree in Biological Sciences and Biotechnology. He subsequently earned a Ph.D. in Molecular Pharmacology from Albert Einstein College of Medicine at Yeshiva University in 2003. With nearly two decades of experience in innovative drug discovery and development, Dr. Feng has held a number of senior leadership and scientific positions, including ADPE Scientist at MedImmune, the U.S. biologics division of AstraZeneca; Chief Operating Officer of TopAlliance Biosciences in the United States; and Chief Operating Officer of Shanghai Junshi Biosciences. In 2023, he founded Allink Biotherapeutics, where he serves as Chief Executive Officer, focusing on the global development of highly differentiated bispecific antibodies and bispecific antibody-drug conjugates (ADCs).Dr. Feng brings extensive expertise in innovative drug development, global strategic planning, and the coordination and submission of IND and BLA applications in China and international markets. He is the inventor of more than 30 patents and has led the development of nearly 20 first-in-class antibody therapeutics. Among these, toripalimab became the first domestically developed PD-1 antibody to receive marketing approval from both China’s NMPA and the U.S. FDA, helping usher in a new era of cancer immunotherapy. In collaboration with the Institute of Microbiology of the Chinese Academy of Sciences and Eli Lilly, Dr. Feng also led the development and advancement of etesevimab, a neutralizing antibody targeting COVID-19. Etesevimab received emergency use authorization in 17 countries with exceeding one million doses distributed worldwide.George Procopiou Vice President of ADC Chemistry and Engineering, Valink TherapeuticsGeorge Procopiou is Vice President of ADC Chemistry and Engineering at Valink Therapeutics, leveraging over a decade of experience in the ADC oncology space.Prior to Valink, he served as Director of Chemistry at Pheon Therapeutics (formerly ‘Femtogenix’), where he supported multiple clinical programmes and the raising of $200M in Series A and B financing. He played a critical role in defining company-wide chemistry strategy, with end-to-end responsibilities spanning early pipeline discovery through IND-enabling activities.He has led numerous preclinical R&D initiatives, with particular expertise in the development of novel linker–payload platforms. His work has encompassed: molecular and synthetic route design and optimisation, laboratory build-out and operations, procurement and outsourcing, bioconjugation, in vitro and in vivo profiling, pharmacology, and high-potency H&S. Under the CMC remit, he facilitated delivery of all CTM, including process development and regulatory submissions, as well as GMP resupplies of mAb, LP, DS and DP.Femtogenix was spun out following his Postdoctoral studies in Prof. David Thurston’s group at King’s College London (KCL). Previously, he has also completed placements at GlaxoSmithKline (GSK), Peakdale Molecular, and the University of Crete, along with his first Postdoc at the University of Nottingham – amassing 15 years’ overall experience as a bench scientist.George obtained his PhD also from the University of Nottingham, and his undergraduate degree from University College London (UCL). He has filed 14 patents, published 19 papers and review articles, and has presented regularly at international conferences (e.g., the AACR).Tiejun Li Head of CMC , AsymBioDr. Tiejun Li leads the CMC and Project Management functions at AsymBio and is responsible for advancing the CMC strategy, driving technical innovation, and supporting cross-functional project execution. He received his Ph.D. in Chemistry from UCLA and his B.S. in Applied Chemistry from Peking University. With nearly 20 years of experience in the biopharmaceutical industry, Dr. Li brings extensive expertise in biologics development, including antibodies, ADCs, and fusion proteins. He has contributed to more than 20 IND and NDA/BLA submissions across global markets, with experience spanning technology transfer, process scale-up, cGMP manufacturing, and regulatory submissions to major agencies including the FDA, EMA, and NMPA. As a strategic technical leader, he supports AsymBio’s end-to-end CMC capabilities and high-quality project delivery across the portfolio.Ray Sison Managing Partner & Co-founder, SCxCMC SolutionsRay Sison, Managing Partner at SCxCMC Solutions, Founder and Executive Director of SOPPhC (Society of Professional Pharmaceutical Consultants), and Editor at Large at CDMO World. With over 30 years of experience in CMC strategy, tech transfer, and pharmaceutical manufacturing, Ray specializes in helping biotech companies scale from clinical to commercial supply. He has directed or advised on over $250 million in outsourced manufacturing and packaging contracts, and supported successful launches of products including Orgovyx®, Xhance®, Nuzyra®, and Onzetra Xsail®. Ray brings deep cross-project expertise in CDMO selection, supply chain optimization, commercial tech transfer, contract negotiation, and global manufacturing footprint strategy across North America, Europe, and Asia主持人：Qi Fei Executive Director, Legend CapitalDr. QI Fei Joined Legend Capital in 2014. Now he is an Executive Director of Legend Capital focusing on investments in innovative biotechnology, digital health and cross border.Dr. Qi led or participated in investments including Ribolia (HK:06938)，Baheal Pharmaceutical (SZ:301015), SIPAI HEALTH (HK:0314), UBC Medical (IDX:LABS)、Diastika Bio (IDX:CHEK), Navi Therapeutics, BeYang Therapeutics, DeliNova，LncTAC, Accuedit, Nuwacell，CR Therapeutics，BioMap, ETANA, Exegenesis, Innostellar, Genskey，Oncologynews, VCBeat etc.Dr. Qi holds a Ph. D. degree in cell biology and a bachelor degree in biotechnology from Peking University. Prior to joining Legend Capital, Dr. Qi worked as a visiting scholar at University of California, Los Angeles (UCLA).
