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近年来，国产创新药加速走向全球同步开发、多国IND申报与License-out出海，但各国药监标准不一，GLP规范、动物伦理、数据格式差异显著，药企陷入两难：重复试验抬高成本、拉长周期，直接复用数据又易遭海外审评发补甚至驳回。 上市七载，美迪西已助力近700件IND通过中国NMPA、美国FDA、澳大利亚TGA及欧洲多国药监机构审评进入临床试验。面对出海合规难题，美迪西如何打造可全球互认的非临床研究体系，打通“一次试验、全球多报”？ 多国资质认证 打通全球IND申报入场券 历经多年打磨与多次核查，美迪西建成完善的多国合规资质矩阵，搭建起一套高质量数据可同步适配NMPA、FDA、OECD、TGA等多地审评要求的出海通道。 ✅ NMPA GLP资质：2011首次获证，历经10余次复查均顺利通过；GLP服务范围已扩至9项，建成约2.9万平方米标准化GLP实验室。 ✅ 达到FDA GLP标准：2012年通过美国FDA审查，此后经过多次审查，质量体系、原始数据溯源与试验执行全面匹配FDA要求。 ✅ OEC DGLP资质：2025年取得墨西哥和匈牙利OECD GLP认证，研究报告可被OECD成员国广泛采信。 ✅ AAALAC国际动物福利认证：美迪西普亚2009取得AAALAC国际完全认证； 2026年，美国波士顿研发中心通过AAALAC国际完全认证。 ✅ 日本PMDA项目核查认可：2025年通过日本PMDA现场项目核查，研究数据获得日本医药品医疗器械综合机构认可。 ✅ CNAS认可：2024年，美迪西分析测试中心获CNAS认可，检测数据具备国际互认效力，支持药理、毒理、DMPK等大量分析工作。 ✅ BSL‑2/ABSL‑2实验室备案：2025年，美迪西成为上海首家取得非人灵长类ABSL-2证书的实验室，也是同时拥有ABSL-2和BSL-2实验室的一站式生物医药临床前研发服务平台，可开展病毒、基因治疗类等高生物安全等级药物的非临床评价。 ✅ 数字化合规系统：部署Provantis GLP Tox、LIMS、EMPOWER、Chromeleon、WinNonlin等系统，具备SEND格式输出能力，可输出适配NMPA/FDA/OECD的CTD/eCTD资料，打通从原始数据到全球申报文档的完整链路。 紧跟全球监管变革 布局NAMs新评价技术 顺应FDA推动动物实验替代、NMPA启动“先锋计划”等全球药监对替代方法的政策转向，美迪西布局NAMs新方法学平台，搭建“人类细胞模型-AI预测-类器官”三位一体技术体系，融合类器官、器官芯片、PBPK建模以及AI-ADMET技术，有效提升药物人体相关性预测能力，降低研发对传统动物实验的依赖，为全球IND申报提供更充分、更前沿的科学证据。 前置方案设计 实现一套试验全球申报 资质仅是入场券，但真正实现“一次试验，全球多报”，考验的是项目端的落地能力。美迪西打破“先国内、后海外”的传统研发模式，立项之初即按多国药监同步要求设计方案，拒绝后期为海外申报临时“打补丁”。从种属选择、终点设置、样本采集、记录规范到原始数据留存，全面对齐NMPA、FDA、OECD、TGA指导原则，依靠同一套原始数据，输出多版合规报告与申报包，从源头规避数据不被海外采信的风险。 近700件IND获批临床 赋能多国申报与海外授权 这套模式已经经过大量项目的实战验证。美迪西已助力近700件新药项目通过NMPA、FDA、澳大利亚TGA、欧洲EMA获批进入临床试验；其中包含90件多国申报项目，77件中美双报项目。 具备全球互认的临床前研究数据，也成为国产创新药License-out对外授权谈判的硬核筹码。目前，美迪西已经助力27个中国创新药达成对外授权交易，包括宜联生物YL201靶向B7-H3的ADC药物授权罗氏，济煜医药JYB1904长效IgE抗体授权RAPT Therapeutics，恒瑞医药GLP-1受体游动剂HRS-7535授权Kailera Therapeutics等，覆盖ADC、单抗、多肽、小分子等药物，让中国原研成果获得全球资本与跨国药企的认可。 面向未来，美迪西将持续打磨全球合规综合能力，助力全球创新候选药物依托一套高质量临床前研究，高效递交多国 IND 申请，让更多前沿新药快速从Target走向IND，加速全球化布局。 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、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近700 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。 7th Anniversary Q&A #5: How to Break Global Regulatory Barriers and Achieve One Single Study for Multi‑Country IND Filings? Chinese innovative drugs are moving quickly toward globally synchronized development, multi-country IND filings, and out‑licensing. But regulatory standards diverge, GLP requirements, animal welfare rules, and data formats differ significantly across markets: leaving companies in a bind: repeat the studies and pay in cost and time, or reuse existing data and risk deficiency letters, or outright rejection, from overseas reviewers. Seven years after its IPO, Medicilon has supported nearly 700 INDs to secure clinical approvals from NMPA, FDA, Australia’s TGA, EMA and other European authorities. How has the company built a preclinical research system acceptable across jurisdictions — one that delivers "one study, multiple country submissions"? Multi-Country Credentials: The Foundation of Global IND Filings Years of refinement and repeated inspections have produced a multi-country compliance credential matrix, ensuring one set of high-quality data meets NMPA, FDA, OECD, and TGA requirements simultaneously. ✅ NMPA GLP: first certified in 2011; 10+ successful re-inspections; 9 service categories covered, supported by 29,000 m² of standardized GLP laboratories. ✅ FDA GLP: inspected by the FDA in 2012 and repeated audits confirm our quality system, raw data traceability and study execution fully meet FDA expectations. ✅ OECD GLP: certified in Mexico and Hungary in 2025, making study reports broadly acceptable across OECD member countries. ✅ AAALAC International Animal Welfare Certification: Medicilon Preclinical Research fully accredited in 2009; the Boston R&D Center fully accredited in 2026. ✅ Japan PMDA: passed an on-site project inspection in 2025, with data recognized by the Pharmaceuticals and Medical Devices Agency. ✅ CNAS Accreditation: Our analytical testing center obtained CNAS recognition in 2024, delivering internationally accepted test data for pharmacology, toxicology and DMPK studies. ✅ BSL-2/ABSL-2 Lab Registration: In 2025, Medicilon is the first laboratory in Shanghai to obtain an ABSL-2 certificate for non-human primate studies, and a one-stop preclinical platform holding both ABSL-2 and BSL-2 registrations — enabling evaluation of viral and gene therapies and other high-biosafety products. ✅Digital compliance: Provantis GLP Tox, LIMS, EMPOWER, Chromeleon, and WinNonlin, with SEND output and CTD/eCTD packages aligned with NMPA, FDA, and OECD — from raw data to global dossier. Embrace Global Regulatory Shifts Build NAMs Alternative Testing Platform Reflecting the global move toward alternative methods — the FDA's push to reduce animal testing, NMPA's "Pioneer Program" — Medicilon has built a New Approach Methodologies (NAMs) platform. Its "human cell models – AI prediction – organoids" system combines organoids, organ-on chip, PBPK modeling, and AI-ADMET to improve human-relevance prediction, reduce reliance on animal studies, and provide stronger scientific evidence for global filings. Upfront Design One Study to Support Worldwide Filings Execution is where this is delivered. Medicilon designs studies to multi-country requirements from the outset rather than retrofitting them at filing time. Species selection, endpoints, sample collection, documentation, and raw data retention are all aligned with NMPA, FDA, OECD, and TGA guidelines. From a single set of raw data, Medicilon generates multiple compliant reports and submission packages — removing the risk, at source, of data being rejected overseas. Proven Track Record Nearly 700 IND Approvals Powering Global Filings & Out‑Licensing This integrated compliance model has been validated across hundreds of projects. Medicilon has supported nearly 700 new drug candidates obtain clinical trial approvals from NMPA, FDA, TGA and EMA. The portfolio includes 90 multi‑country filing projects and 77 China‑U.S. dual filings. Globally recognized preclinical data has also become a strong negotiating asset in out-licensing. Medicilon has supported 27 Chinese innovative drugs in completing licensing deals, including YL201, a B7-H3-targeting ADC from MediLink Therapeutics licensed to Roche; JYB1904, a long-acting IgE antibody from Jeyou Pharma licensed to RAPT Therapeutics; and HRS-7535, a GLP-1 receptor agonist from Hengrui Pharma licensed to Kailera Therapeutics, spanning ADCs, monoclonal antibodies, peptides, and small molecules. Medicilon will continue to sharpen its global compliance capabilities so that candidates can rely on one set of high-quality preclinical studies to file INDs across multiple countries — and move faster from Target 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 nearly 700 IND approvals. For more information, visit www.medicilon.com.