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资讯 10月18日，2026 SAPA-DC年会于马里兰州Gaithersburg Marriott圆满召开。本次大会主题为From Innovation to Global Product: Building FDA?Ready Biopharmaceutical Companies。美迪西创始人、董事长&CEO陈春麟博士受邀参与年会，发表主旨演讲并参与圆桌论坛，与FDA CDER NAMs高级顾问Nakissa Sadrieh博士、美国FDA前首席副局长Janet Woodcock博士、FDA/CDER产品质量评估办公室主任Lawrence Yu博士等围绕新药全球开发、法规现代化、AI与新型非临床技术等热点议题展开深度研讨。
本次论坛汇聚全球生物医药产学研投顶尖力量，邀请FDA、查尔斯河实验室、马里兰大学、约翰霍普金斯大学、乔治华盛顿大学、罗格斯大学，以及强生、阿斯利康、协和麒麟、Acadia、Spyre Tx、MCE、复宏汉霖、Corxel、Incyte、摩根士丹利、Ecphora Capital、Pickwick Capital Partners 等机构的专家担任演讲与讨论嘉宾，共同打造了一场多维度的行业思想盛宴。
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创新药出海浪潮下
怎样打通从Target到IND的全球化路径？
会上，陈博士发表题为《From R&D to IND Approval: Lessons and Insights from New Drug Development in China》专题报告，结合美迪西大量项目实践与产业数据，分享中国创新药走向全球的实战经验与思考。
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趋势洞察：出海授权持续升温，产业范式迭代升级
演讲开篇，陈博士解读中国创新药License-out出海新趋势：2025年国内创新药企达成31 笔对外授权，总额1356.6亿美元，同比增长161%，预计2026年交易额有望突破1500亿美元。跨国药企合作逻辑已从采购单一分子转向布局技术平台，打包交易渐成主流。GLP-1、新一代ADC等备受资本青睐，中国源头创新的价值持续获得国际市场认可。
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合规筑基：深耕双报能力，打通中美监管申报路径
中美双报的核心挑战在于NMPA与FDA两套监管体系的技术标准、申报规范差异显著。美迪西建成从Target到IND的一站式平台，具备AAALAC、NMPA、OECD GLP资质，符合FDA GLP要求，且通过PMDA、MFDS核查，支持多国同步申报。
陈博士重点解析了NMPA与FDA在毒理、病理阅片、质量研究、申报资料格式等方面的核心差异。依托完备资质与Provantis、Submit?专业工具，美迪西可完成SEND转换，输出符合NMPA、FDA标准的CTD/eCTD资料。截至2026年6月底，美迪西助力691件IND获批临床，其中77件中美双申报、7件中澳美三申报，26个创新药完成对外授权。
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平台赋能：布局前沿技术，夯实临床前研发实力
陈博士表示，美迪西坚持先于客户需求布局服务平台，紧扣全球新药研发需求，持续打造前沿技术平台，覆盖AI、ADC/DAC、大环肽、mRNA、体内CAR-T、光氧化还原催化、PROTAC、小核酸、AOC等方向。
依托平台能力，美迪西已助力36个ADC药物、51个抗体、22个GLP-1类药物、9个细胞治疗药物、13个蛋白/融合蛋白药物、8个PROTAC、3个小核酸药物、10个疫苗获批临床
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生态聚力：创新协作模式，适配药企研发需求
面对当下资本市场环境，陈博士介绍，美迪西以灵活商务模式与产业生态赋能创新药企，降低研发门槛、管控项目风险，构建三类合作模式：一是从Target到IND一站式服务，客户独享知识产权，支持里程碑付款；二是“IP+CRO+Pharm”协同开发，对接海内外IP资源，已有多个项目实现双报获批或权益转让；三是依托院士创新药熟化中心 GOI，联动政策与资本，为初创药企提供注册、融资、临床前研发一体化支撑。
目前美迪西GOI已入驻十余家生物医药初创企业，覆盖siRNA、CAR-T、PROTAC、AI药物研发、自身免疫疾病等前沿赛道，推动院士与高校科学家的源头科研成果快速推进至IND阶段，加速科研价值向产业价值跃迁。
圆
桌
论
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监管科学迭代下
新型疗法如何构建全球转化新范式？
随后的圆桌论坛由SAPA-DC会长卢传文博士主持。陈春麟博士与FDA CDER NAMs高级顾问Nakissa Sadrieh博士、美国FDA前首席副局长Janet Woodcock博士、阿斯利康全球医学事务副总裁Neelima Denduluri博士、Hogan Lovells Cadwalader合伙人Xin Tao博士同台，立足监管、产业、研发等不同视角，就创新疗法研发与监管等议题展开深度探讨。
圆桌论坛
从左至右依次为：阿斯利康全球医学事务副总裁Neelima Denduluri博士、FDA/CDER产品质量评估办公室主任Lawrence Yu博士、美国FDA前首席副局长Janet Woodcock博士、Hogan Lovells Cadwalader合伙人Xin Tao博士、FDA CDER NAMs高级顾问Nakissa Sadrieh博士、美迪西创始人、董事长&CEO陈春麟博士
陈博士结合美迪西丰富全球项目实践谈到，随着创新疗法快速迭代，药企需在药物发现与临床前早期阶段即树立全球化监管思维，筑牢中美双报体系下的数据完整性与申报合规根基。他表示，美迪西积极响应FDA推动NAMs新方法学的监管科学趋势，已布局AI、类器官等NAMs技术平台。同时他强调，新型疗法迭代快、路径独特，产业界与监管机构就NAMs数据证据权重与模型验证标准保持持续透明协作，是缩短全球新药开发周期的关键之一。
最后，与会嘉宾一致认为，全球新药创新需构建全周期全球化科学体系；监管方应持续完善NAMs评价框架，采用风险导向的弹性审评；产业端要打通跨境BD与全球临床布局能力，锚定未满足临床需求，加速创新药惠及全球患者。
放眼全球生物医药创新格局，中国源头创新正迎来走向世界的关键机遇。美迪西将持续发挥桥梁价值，以前瞻技术平台赋能海内外创新药企，以持续投入、高效协同与严苛质量管控，护航更多具有全球竞争力的创新药物从Target到IND，从中国走向全球！
关于美迪西
美迪西（股票代码：688202.SH）成立于 2004 年，专注于为全球制药企业、研究机构及科研工作者提供全方位的临床前新药研发服务。公司构建了覆盖药物发现、药学研究至临床前研究的一站式综合研发平台，并在 ADC/AOC、小核酸、多 (环)肽、TPD, RIPTAC等前沿领域搭建了服务平台。公司建立了符合国际规范的质量体系，已获得中国 NMPA、美国 FDA、欧盟 OECD 等 GLP 认证以及 AAALAC 国际认证。目前，公司在上海和Boston拥有约 9.2 万平方米研发实验室。至 2026 年 6 月末，公司已为全球超 2000 家客户提供药物研发服务，参与研发完成的新药项目已有 691 件 IND临床批件。美迪西将继续携手国内外合作伙伴共同推动药物创新，为人类健康贡献力量。欢迎访问公司官网 www.medicilon.com.cn 了解更多详情。
Medicilon’s Dr. Chunlin Chen Engages FDA Experts at SAPA-DC Annual Conference to Discuss Global IND Development and NAMs Technologies for Innovative Medicines
October 18, 2026 — The 2026 SAPA-DC Annual Conference concluded successfully at the Gaithersburg Marriott in Maryland. Centered on the theme “From Innovation to Global Product: Building FDA?Ready Biopharmaceutical Companies”, the event welcomed Dr. Chunlin Chen, Founder, Chairman and CEO of Medicilon. He delivered a keynote address and participated in a panel discussion alongside distinguished regulatory leaders including Dr. Nakissa Sadrieh, Senior Advisor for NAMs at FDA CDER; Dr. Janet Woodcock, Former Principal Deputy Commissioner of the U.S. FDA; and Dr. Lawrence Yu, Director of the Office of Product Quality Assessment at FDA/CDER. The group engaged in in-depth discussions on priority topics such as global new drug development, regulatory modernization, artificial intelligence, and advanced nonclinical technologies.
The conference brought together leading stakeholders across the global biopharma ecosystem — spanning academia, industry and investment. Speakers and panelists represented the FDA, Charles River Laboratories, University of Maryland, Johns Hopkins University, George Washington University, Rutgers University, plus industry and investment leaders including Johnson & Johnson, AstraZeneca, Kyowa Kirin, Acadia, Spyre Tx, MCE, Henlius, Corxel, Incyte, Morgan Stanley, Ecphora Capital and Pickwick Capital Partners. The program delivered a multi-faceted forum for cross-sector industry exchange.
Keynote Presentation
Navigating a Global Path from Target Identification to IND amid the Wave of Innovative Medicine Globalization
During his keynote, titled 《From R&D to IND Approval: Lessons and Insights from New Drug Development in China》, Dr. Chen drew on Medicilon’s extensive project track record and industry datasets to share hands-on experience and strategic perspectives for Chinese innovators advancing drugs to global markets.
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Trend Outlook: Rising Out-Licensing and Evolving Industry Models
Dr. Chen opened by outlining the accelerating out-licensing trend for Chinese novel drugs. In 2025, Chinese biotech firms closed 31 out-licensing deals with a total transaction value of USD 135.66 billion, marking a 161% year-over-year increase. Transaction volume is projected to exceed USD 150 billion in 2026.
Collaboration strategies of multinational pharma have shifted from acquiring single molecules toward strategic investments in technology platforms, with portfolio-based transactions becoming mainstream. Assets targeting GLP?1 and next-generation ADCs remain highly sought after by investors, and original innovation originating in China continues to gain recognition worldwide.
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Compliance Foundation: Building Capabilities for Concurrent NMPA and FDA Submissions
A core challenge for dual China?U.S. filings lies in substantial differences in technical standards and submission requirements between the NMPA and FDA regulatory frameworks. Medicilon operates an integrated platform covering the full continuum from target identification to IND-enabling studies. The facility holds AAALAC accreditation, NMPA and OECD GLP compliance, meets FDA GLP expectations, and has passed inspections by the PMDA and MFDS to support synchronized multi-jurisdictional submissions.
Dr. Chen highlighted key regulatory divergences between NMPA and FDA requirements for toxicology, histopathology review, quality studies, and submission dossier formatting. Leveraging full compliance credentials and validated tools including Provantis and Submit?, Medicilon supports SEND conversion and generates CTD/eCTD dossiers aligned with both NMPA and FDA specifications.
As of the end of June 2026, Medicilon has supported 691 IND approvals, including 77 dual China?U.S. filings, 7 tripartite China?Australia?U.S. filings, and 26 novel medicines that completed out-licensing transactions.
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Technology Platform Enablement: Advancing Cutting-Edge Capabilities for Preclinical Development
Dr. Chen noted that Medicilon proactively builds service platforms ahead of market demand to match global R&D needs. Its continuously expanding technology portfolio covers AI-enabled drug discovery, ADC/DAC, macrocyclic peptides, mRNA, in vivo CAR-T, photoredox catalysis, PROTACs, oligonucleotides and AOCs.
Backed by these platforms, Medicilon has supported clinical-stage progression for 36 ADC candidates, 51 antibody programs, 22 GLP?1 assets, 9 cell therapy candidates, 13 protein/fusion protein programs, 8 PROTACs, 3 oligonucleotide therapeutics and 10 vaccine candidates.
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Collaborative Ecosystem: Flexible Models Tailored to Global Biotech R&D Needs
Against the current capital market backdrop, Dr. Chen introduced Medicilon’s flexible partnership frameworks and ecosystem support designed to lower R&D barriers and mitigate project risks for innovators:
1. End-to-end target-to-IND service: Clients retain full IP ownership, with milestone-based payment structures available.
2. Integrated “IP + CRO + Pharma” co-development: Connecting global IP sources; multiple programs under this model have achieved dual-jurisdictional IND clearance or rights transfer.
3. GOI (Global Origin Innovation) Center for Academician-led Novel Drug Maturation: Bridging regulatory expertise and capital resources to provide early-stage biotechs with bundled support spanning regulatory strategy, financing and preclinical development.
The Medicilon GOI Center hosts more than ten biotech startups focused on frontier areas including siRNA, CAR-T, PROTACs, AI-driven drug discovery and autoimmune diseases. It accelerates the translation of discoveries from academicians and university researchers into IND programs, turning scientific breakthroughs into commercial value.
Panel Discussion
Forging New Global Translation Models for Advanced Therapies amid Evolving Regulatory Science
The subsequent panel session was moderated by Dr. Chuanwen Lu,SAPA-DC President. Joining Dr. Chen on stage were Dr. Nakissa Sadrieh (FDA CDER NAMs Senior Advisor), Dr. Janet Woodcock (Former Principal Deputy Commissioner, FDA), Dr. Neelima Denduluri (Vice President, Global Medical Affairs, AstraZeneca), and Dr. Xin Tao (Partner, Hogan Lovells Cadwalader). Panelists shared cross-perspective insights from regulators, sponsors and R&D organizations on the development and oversight of advanced therapies.
panel sessio
From left to right: Dr. Neelima Denduluri, Vice President of Global Medical Affairs at AstraZeneca; Dr. Chuanwen Lu,SAPA-DC President; Dr. Janet Woodcock, former Principal Deputy Commissioner of the FDA; Dr. Xin Tao, Partner at Hogan Lovells Cadwalader; Dr. Nakissa Sadrieh, Senior Advisor for New Approach Methodologies (NAMs) at FDA/CDER; and Dr. Chunlin Chen, Founder, Chairman and CEO of Medicilon.
Drawing on Medicilon’s global project portfolio, Dr. Chen emphasized that as advanced therapies evolve rapidly, sponsors must embed global regulatory strategy at the earliest stages of drug discovery and preclinical work to uphold data integrity and compliance for dual China?U.S. filings. Medicilon is actively aligning with FDA’s regulatory science priorities around NAMs and has established platforms for AI and organoid-based NAMs.
He stressed that the unique, fast-evolving development pathways of novel modalities depend on sustained, transparent dialogue between industry and regulators around the weight of evidence and validation standards for NAMs — a critical enabler for shortening global development timelines.
Panel participants reached consensus that global drug innovation requires a holistic, full-lifecycle regulatory framework. Regulators should continue refining NAMs assessment frameworks with risk-informed, flexible review approaches. Industry stakeholders need to strengthen cross-border business development and global clinical deployment to address unmet medical needs and bring breakthrough therapies to patients worldwide.
Within the global biotech landscape, original innovation from China stands at a pivotal moment for international expansion. Medicilon will continue to act as a bridge connecting East and West. With forward-looking technology platforms, rigorous quality systems and efficient collaboration, we empower innovators worldwide and shepherd more globally competitive drug candidates from target identification to IND.
About Medicilon
Founded in 2004, Medicilon (Stock Code: 688202.SH) is dedicated to delivering comprehensive preclinical drug R&D services to pharmaceutical enterprises, research institutions, and scientific investigators worldwide. The company has established a one-stop integrated R&D platform encompassing drug discovery, pharmaceutical research, and preclinical research, and has developed service platforms in cutting-edge fields including ADC/AOC, RNAi, peptides (including macrocyclic peptides), TPD, and RIPTAC. The company has instituted a quality system compliant with international standards and has secured GLP certifications from China's NMPA, the U.S. FDA, and the EU's OECD, along with AAALAC International accreditation. At present, the company operates approximately 92,000 square meters of R&D laboratory space across Shanghai and Boston. As of the end of June 2026, the company has provided drug R&D services to over 2,000 clients globally and has supported 691 IND approvals. For more information, visit www.medicilon.com.
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