10月2日，Medicovestor, Inc. 的创新ADC药物MC001已获得美国食品药品监督管理局（FDA）临床试验批件，拟用于胰腺癌治疗。
美迪西助力
美迪西作为Medicovestor的临床前合作伙伴，为MC001提供了non-GLP和GLP的毒理试验，以专业、高效的研发服务，助力这款First-in-Class ADC成功获得FDA临床试验许可。
癌中之王・临床困境
胰腺癌恶性程度高
存在巨大未被满足的医疗需求
胰腺癌是恶性程度最高的实体瘤之一，起病隐匿、进展迅猛，患者总体五年生存率长期低位徘徊。对于晚期及转移性患者，现有治疗手段疗效有限、缓解短暂，存在重大未满足的临床需求。
ADC凭借“精准递送、定点杀伤”的优势，已在多个瘤种改写治疗格局，但在胰腺癌这类免疫“冷肿瘤”中，仍缺乏兼具疗效与安全的创新方案。Medicovestor MC001正是瞄准这一空白而开发，有望为胰腺癌及晚期实体瘤患者提供全新的治疗选择。
双效机制・化疗免疫
First-in-Class ADC MC001
兼具靶向杀伤与免疫激活
MC001是Medicovestor专有ADoBind™平台产出的首个临床候选药物。该平台融合传统细胞毒性载荷与二聚体IgG1抗体骨架，增强免疫细胞毒性效应，激活患者固有免疫应答。该差异化方案，既可对增殖活跃肿瘤细胞产生直接杀伤，还能通过免疫抗肿瘤机制作用于 G0/G1期等低增殖及静止状态肿瘤细胞。
ADoBind ADC Platform
临床前研究数据显示，在胰腺癌荷瘤SCID小鼠模型中，MC001在相当于单体ADC剂量20%的条件下，即表现出明显肿瘤生长抑制作用，抗肿瘤表现优于已获批产品索米妥昔单抗（Elahere）。在SD大鼠及食蟹猴研究中，12mg/kg剂量下主要观察到短暂性中性粒细胞减少，未发现其他明显器官毒性，总体耐受性良好。
这一兼具靶向杀伤与免疫激活的差异化设计，不仅为MC001的First-in-Class定位提供了有力支撑，也体现出Medicovestor在创新ADC研发领域深厚的技术积累与自主原研实力。
平台赋能・技术助力
从Target到IND
美迪西一站式助力ADC临床前研发
创新药海外IND申报，临床前毒理安全性评价是不可或缺的核心环节，也是创新药走向全球临床的关键门槛。美迪西拥有约2.9万平方米的GLP实验室，具备NMPA、OECD GLP资质，符合FDA GLP标准，并已通过AAALAC国际认证，可对细胞毒及靶向类小分子、单抗及双特异抗体等大分子药物、ADC/AOC、CAR-T/CAR-NK 细胞治疗抗肿瘤新药提供全面系统的评价。
在ADC药物研发领域，美迪西拥有多年实战经验与深厚技术积累，已搭建覆盖ADC Payloads合成、药物偶联、药效学、药代动力学及安全性评价的一站式临床前研发服务平台。目前，美迪西已成功助力36个ADC药物获批临床，其中5个ADC已达成对外授权，并有20多个ADC项目在研。
美迪西祝贺Medicovestor MC001获得美国FDA临床许可，期待该药在国际临床阶段进展顺利，早日为胰腺癌及晚期实体瘤患者带来全新的抗肿瘤治疗方案。未来，美迪西将持续精进一站式生物医药临床前研发服务平台，全力赋能全球创新药企，加速更多源头创新药物从Target到IND，助力全球抗肿瘤新药研发高质量发展！
关于Medicovestor
Medicovestor是一家总部位于美国纽约的生物技术公司，专注于开发用于肿瘤和自身免疫性疾病治疗的化疗免疫抗体偶联药物（ADC）。公司的两项专有平台技术——ADoBind（创新型二聚抗体结构）和ADoTope（双效载药靶向技术）旨在提升肿瘤选择性并降低系统性毒性，从而释放出超越传统ADC应用的新治疗潜力。
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。
Breaking the "King of Cancer": First-in-Class ADC MC001. Medicilon Supports Partner Medicovestor to Secure FDA IND Clearance
Recently, Medicovestor, Inc. has obtained IND clearance from the FDA for MC001, a novel ADC candidate developed for pancreatic cancer treatment.
Medicilon’s support
As Medicovestor’s preclinical CRO partner, Medicilon performed non-GLP and GLP toxicology studies for MC001. With professional and efficient R&D services, Medicilon supported this first-in-class ADC to successfully secure FDA IND approval.
The "King of Cancer": Unmet Clinical Needs
Pancreatic cancer ranks among the most aggressive solid tumors, characterized by insidious onset and rapid disease progression. Patients consistently face low five-year overall survival rates. For advanced and metastatic pancreatic cancer, available treatments yield limited, short-lived responses, creating a substantial unmet medical need.
ADCs have transformed treatment paradigms across multiple tumor types through targeted delivery and localized cytotoxic killing. However, pancreatic cancer, an immunologically "cold tumor", still lacks innovative options balancing efficacy and safety. Medicovestor’s MC001 was developed to fill this gap and may offer a new therapeutic option for patients with pancreatic cancer and other advanced solid tumors.
Dual-Action Mechanism: Targeted Cytotoxicity plus Immune Activation
MC001 is a first-in-class ADC with dual functions: targeted tumor killing and immune activation.
Medicovestor developed MC001 on its proprietary dimeric antibody platform, ADoBind™. Unlike conventional ADCs that rely on antibody targeting linked to cytotoxic payloads, MC001 uses a dimeric IgG1 antibody backbone. While its cytotoxic payload directly eliminates tumor cells, the molecule amplifies antibody-mediated immune effects and triggers the body’s innate immune responses. It can act on slow-proliferating and quiescent tumor cells, including those arrested in the G0/G1 phase.
ADoBind ADC Platform
Preclinical findings from pancreatic cancer xenograft models in SCID mice show MC001 achieves potent tumor growth inhibition at only 20% of the dose required for monomeric ADCs. Its anti-tumor activity surpassed that of the approved ADC, elahere (mirvetuximab soravtansine). In SD rat and cynomolgus monkey studies, the 12 mg/kg dose induced only transient neutropenia with no significant organ toxicity observed, demonstrating a favorable tolerability profile.
This differentiated dual-mechanism design validates MC001’s first-in-class positioning and reflects Medicovestor’s robust in-house capabilities and original innovation in ADC R&D.
Platform Empowerment: Enabling ADC Preclinical Development from Target to IND
Preclinical safety and toxicology assessment is an essential prerequisite for IND filings and a critical gateway for global clinical translation of novel drugs.
Medicilon operates approximately 29,000 m² of GLP laboratory space, holding NMPA and OECD GLP accreditation, complying with FDA GLP requirements and AAALAC international certification. Medicilon provide comprehensive safety evaluation for cytotoxic and targeted small molecules, mAbs, bispecific antibodies, ADC/AOC constructs, CAR-T and CAR-NK cell therapies for oncology.
With years of expertise in ADC R&D, Medicilon has built a one-stop preclinical service platform covering payload synthesis, drug conjugation, pharmacodynamics, pharmacokinetics and safety evaluation. To date, Medicilon has supported 36 ADC candidates to IND clearance. Five of these ADC assets have completed out-licensing, and more than 20 ADC programs are currently in progress.
Medicilon congratulates Medicovestor on obtaining FDA IND clearance for MC001. We look forward to smooth progress in global clinical development and hope this candidate will bring new anti-cancer therapies to patients with pancreatic cancer and advanced solid tumors. Moving forward, Medicilon will continue to refine our integrated preclinical R&D platform, empowering global biotech innovators to advance first-in-class assets from target identification to IND, and drive high-quality global oncology drug discovery.
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.
