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资讯 上市7年，美迪西累计助力近700件IND获批临床，年均助力约100件IND获批临床，平均约4天就有一款新药依托美迪西的平台赋能成功跨越IND，正式迈入临床阶段。
一边是创新药赛道争分夺秒的竞速压力，一边是全球监管日趋严苛的合规红线，提速与质控仿佛天然对立。美迪西究竟如何跳出“快则不稳、严则变慢”的行业困局，在效率与质量之间找到平衡，构筑起独有的研发优势？
01
打通一站式平台，压缩跨环节衔接等待损耗
传统模式下，药物化学、CMC、药效药理、药代动力学、安全性评价和IND申报常由多家服务商串行承接，技术转移、标准差异和信息不对称带来大量沟通与流转损耗，链条断点成为周期拖延的重要原因。
美迪西一站式服务平台的核心壁垒是将药物发现、药学研究、临床前研究、IND申报纳入统一项目管理与质量标准体系。项目启动时，项目科学家、技术负责人、质量与法规团队同步前置介入，共同锁定研发终点、全球监管要求和关键交付节点；各模块并行规划、协同推进，实现数据同源、标准统一、内部流转，消除跨供应商技术断层。并行推进不等于简化科学流程。实验方案、终点指标和质控标准在设计之初即对齐NMPA、FDA等全球监管逻辑；针对中美双报、多地区申报项目，从源头设计双轨合规路径，避免后期因监管冲突推倒重做，真正打通从分子发现到IND申报的全链路。
02
AI辅助药物发现，压缩源头研发迭代周期
药物发现是研发周期与失败风险高度集中的环节。传统模式依赖高通量湿实验试错，分子设计、合成筛选、成药性评估迭代慢，大量时间消耗于无效分子。
美迪西搭建AI药物研发综合技术平台（MAIDD），重点建设小分子、核酸、生物大分子、多肽四个AI研发子平台，运用AI构建“模型构建—虚拟筛选—分子设计（生成）—湿法验证—数据反馈优化”的干湿结合新药开发路径，提升研发效率与质量；并将AI技术应用到PROTAC、ADC、多肽/环肽、小核酸等多种新型分子形态平台，进行链接子或序列等模块构建与优化，增强平台实力与领先性。通过干湿数据闭环持续迭代模型，加快候选分子发现与先导化合物优化步伐。
03
前移风险识别，压缩后期失败成本
新药研发高失败属性明显，大量周期损耗来自方向错配、模型选择不当和成药性风险后置暴露。部分项目推进至GLP毒理阶段才暴露缺陷，前期投入全部沉没。
依托二十多年项目经验沉淀，美迪西搭建了1100+种药效模型，结合AI ADMET预测、类器官、NAMs新方法学等前沿评价技术，将风险识别节点大幅前移。在早期筛选阶段提前预判吸收、代谢、毒性及脱靶风险，提升候选分子成药性和临床转化成功率。针对ADC、CGT、PROTAC、大环肽、GLP-1、小核酸等前沿赛道，平台成熟杂质研究、制剂策略和生物分析方案可快速复用并按项目个性化适配。该模式压缩的是无意义重复实验，完整保留支撑IND申报所必需的严谨科学证据链。
04
国际化合规体系，压缩申报审评变数
IND阶段最昂贵的成本往往不是实验本身，而是数据不被受理、补充试验或因标准错位重做。美迪西是国内较早同时具备NMPA、OECD GLP资质并满足FDA GLP要求的企业，上海与波士顿研发中心均获AAALAC认证，方案设计阶段即可内置中美双报、中澳双报乃至多国申报要求，避免国内试验完成后再按海外标准重做。截至2026年6月底，参与研发支持的新药有77件实现中美双报、7件中澳美三报获批临床。
质量层面贯彻QbD理念，把质控嵌入全流程：质量团队深度参与方案评审，原始记录、样品流转、仪器校准、病理阅片全链路可追溯；依托Provantis、EMPOWER、Chromeleon、LIMS等数字化系统，配套SEND转换与eCTD申报能力，确保数据可核查、国际互认、可直接用于申报。
高效源于速度，更植根于严谨科学、严格合规。面对持续涌现的前沿疗法与不断迭代的全球监管科学，美迪西将持续夯实一站式临床前研发服务平台、国际化GLP合规体系与前沿创新技术，在质量与效率之间筑牢差异化研发壁垒，赋能更多创新分子快速从Target走向IND。
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#6
One IND Approval Every Four Days on Average: How Does Medicilon Balance R&D Speed and Quality?
In the seven years since its IPO, Medicilon has helped bring nearly 700 IND applications to clinical approval — around 100 a year, which works out to one new drug crossing the IND threshold and entering the clinic on Medicilon's platform every four days or so.
Racing timelines on one side, tightening global compliance on the other: speed and quality control look like natural adversaries. How does Medicilon step outside the industry trap of "fast means fragile, strict means slow" and build a distinctive R&D advantage?
01
One-stop collaboration: removing the waiting losses between stages
Traditionally, medicinal chemistry, CMC, pharmacology and efficacy, pharmacokinetics, safety evaluation, and IND filing are carried out serially by separate providers. Technology transfer, divergent standards, and information asymmetry generate heavy communication and workflow losses, and the breakpoints in that chain become a leading cause of delay.
Medicilon's one-stop platform instead brings drug discovery, CMC, preclinical studies, and IND filing under a single project-management and quality-standard system. At kick-off, scientists, technical leads, and the quality and regulatory teams all engage upfront and in parallel to lock down R&D endpoints, global regulatory requirements, and key delivery milestones. Modules are then planned and advanced in parallel, so data come from one source, standards stay unified, and work flows internally — with no technical gaps between vendors.
Running in parallel does not mean simplifying the science. Protocols, endpoints, and QC standards are aligned with NMPA and FDA regulatory logic from the design stage; for China–US dual filings and multi-region submissions, dual compliance tracks are built in from the outset, so nothing has to be torn down and rebuilt later over a regulatory conflict. The chain from molecular discovery to IND filing is connected end to end.
02
AI-assisted drug discovery: shortening iteration at the source
Drug discovery is where timelines and failure risk concentrate. The traditional route relies on high-throughput wet-lab trial and error, with slow iteration across molecular design, synthesis and screening, and developability assessment — and large amounts of time spent on molecules that were never viable.
Medicilon has built the MAIDD (Medicilon AI-Driven Drug Discovery) platform around four AI sub-platforms spanning small molecules, nucleic acids, biological macromolecules, and peptides. AI supports a dry-wet development loop — model building, virtual screening, molecular design (generation), wet-lab validation, and data feedback for optimization — raising both efficiency and quality. The same AI capabilities are applied to PROTAC, ADC, peptide/cyclic peptide, and small nucleic acid platforms for the construction and optimization of linkers, sequences, and other modules, strengthening the platform's capabilities and lead. The loop keeps feeding data back into the models, accelerating candidate discovery and lead optimization.
03
Identifying risk earlier: cutting the cost of late failure
Drug development fails often, and much of the lost time comes from pursuing the wrong direction, choosing the wrong model, or discovering a developability problem too late. Some projects only reveal their flaws at the GLP toxicology stage, when everything invested before is sunk.
Drawing on more than two decades of drug R&D experience, Medicilon has built a library of over 1,100 pharmacodynamic models and pairs it with frontier evaluation technologies — AI-based ADMET prediction, organoids, and NAMs (new approach methodologies) — to move risk identification substantially earlier. At the early screening stage, absorption, metabolism, toxicity, and off-target risks are anticipated in advance, improving candidate developability and the odds of clinical translation. For frontier modalities — the ones above plus CGT and GLP-1 — mature impurity studies, formulation strategies, and bioanalytical packages can be reused quickly and adapted to each project. What this compress is redundant experimentation; the rigorous evidence chain that supports an IND filing is kept intact.
04
An international compliance system: reducing variables in filing and review
At the IND stage, the most expensive item is rarely the experiment itself. It is data that are not accepted, repeat studies that are demanded, or work redone because standards were misaligned. Medicilon was among the earliest companies in China to hold both NMPA and OECD GLP accreditation while meeting FDA GLP requirements, and both its Shanghai and Boston R&D centers hold AAALAC accreditation. China–US, China–Australia, and even multi-country filing requirements can be designed into protocols from the start, so domestic studies do not have to be repeated against overseas standards. By the end of June 2026, the company had helped 77 China–US dual filings and 7 China–US–Australia triple filings reach clinical approval.
Quality follows the QbD principle, with control embedded across the whole process: the quality team takes part in protocol review, and raw records, sample transfers, instrument calibration, and pathology reads are traceable end to end. Digital systems — Provantis, EMPOWER, Chromeleon, and LIMS — together with SEND conversion and eCTD filing capability keep data verifiable, internationally recognized, and directly usable in a submission.
Efficiency comes from speed, and rests on rigor. As new therapeutic modalities keep emerging and global regulatory science keeps evolving, Medicilon will keep strengthening its one-stop preclinical R&D platform, its international GLP compliance system, and its frontier technologies — holding a differentiated position between quality and efficiency, and moving more innovative molecules 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.
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