美迪西助力战略合作伙伴SAPU Sapu003在澳大利亚获得临床试验批准

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近日，由Sapu Bioscience, LLC.研发的创新药物Sapu003在澳大利亚正式获得临床试验批准。这是自今年2月美迪西与SAPU达成20个IND项目合作以来，首个成功获批的IND，其质量和速度是对美迪西服务品质的有力明证。

作为SAPU的战略合作伙伴，上海美迪西生物医药股份有限公司凭借一站式生物医药临床前研发服务平台，为Sapu003提供了CMC放行验证（正在进行中）、药代动力学、安全性评价以及IND申报等无缝衔接、高效联动的临床前研发服务，为其IND申报按下加速键。

美迪西与SAPU

协同攻克多重难关，一站式加速IND申报

美迪西助力

在Sapu003创新制剂的研发过程中，美迪西各团队与SAPU精诚合作，协同攻克多项技术难题：CMC团队通过采用CAD检测器建立了灵敏稳定的分析方法；药代动力学部门通过系统优化显著提升检测响应与重现性；毒理实验部及时响应ICH指南更新，优化实验方案确保合规性；生物分析团队通过改进内标选择、优化基质和溶液配制策略，有效提升了数据准确性与样品稳定性。

Sapu003与已上市口服药物相比采用了静脉注射的给药方式，大幅的提高了药物的生物利用度。本次临床试验批准的获得，不仅是SAPU创新研发实力的体现，也充分证明了美迪西在复杂制剂分析、跨部门协同与国际化注册申报方面的综合服务能力。

美迪西祝贺SAPU Sapu003在澳大利亚获得临床试验批准，期待Sapu003中美双报早日获批。美迪西将继续秉持“创新驱动，质量至上”的服务理念，深化与全球创新药企的合作，以更高质、更高效的一站式研发服务，为全球合作伙伴的创新药物研发保驾护航！

关于SAPU

Sapu Bioscience是一家免疫肿瘤学公司，致力于开发一流的RNA疗法以及针对癌症和传染病的小分子药物。OT-101是Sapu Bioscience的主要免疫肿瘤学候选药物，是一种首创的抗TGF-βRNA疗法，在临床试验环境中对复发/难治性癌症患者表现出单药活性。OT-101还具有针对SARS-CoV-2的活性。Sapu Bioscience正在寻求利用其在药物开发方面的深厚专业知识来改善癌症患者的治疗结果和生存率，并特别关注罕见的儿童癌症。Sapu Bioscience拥有罕见的DIPG（OT-101）儿科名称。

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、核酸、多肽、CGT、Protac、抗体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、日本PMDA等GLP认证以及AAALAC国际认证。目前，公司在国内外拥有近8万平方米研发实验室。至2025年6月底，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及仿制药项目已有588件IND获批临床，携手国内外合作伙伴共同推动药物创新突破。美迪西将继续立足全球，聚力创新，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。

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Recently, Sapu003, an innovative drug developed by SAPU Bioscience, has officially obtained clinical trial approval in Australia. This is the first successfully approved IND since Medicilon and SAPU entered into a strategic agreement for 20 IND projects in February this year. The quality and speed of this approval serve as a strong testament to the high standard of Medicilon 's services.

As a strategic partner of SAPU, Medicilon has leveraged its one-stop preclinical R&D service platform for pharmaceuticals to provide efficient preclinical R&D services for Sapu003, including CMC release validation (in progress), pharmacokinetics, safety evaluation, and IND submission filing. These services accelerated the IND application process for Sapu003.

Medicilon & SAPU:

Collaborating to Overcome Multiple Challenges, Accelerating IND Filing via One-Stop Services

Medicilon's support

During the R&D of Sapu003’s innovative formulation, various teams at Medicilon worked closely with SAPU to jointly overcome multiple technical hurdles: The CMC team established a sensitive and stable analytical method using a CAD. The pharmacokinetics department significantly improved detection response and reproducibility through systematic optimization. The toxicology testing department promptly adapted to updated ICH guidelines, optimizing experimental protocols to ensure compliance. The bioanalysis team effectively enhanced data accuracy and sample stability by improving internal standard selection and optimizing matrix and solution preparation strategies.

Compared to existing oral medications, Sapu003 employs intravenous administration, which dramatically increases the drug's bioavailability. The approval of this clinical trial is not only a testament to SAPU's innovative R&D capabilities but also a strong validation of Medicilon's comprehensive service capabilities in complex formulation analysis, cross-departmental collaboration, and international regulatory filing.

Medicilon congratulates SAPU on obtaining clinical trial approval for Sapu003 in Australia and looks forward to the early approval of Sapu003 in both China and the United States. Medicilon will continue to uphold the service philosophy of "Innovation Driven and Quality Focused," deepening its cooperation with global innovative pharmaceutical companies.

About Medicilon

From its inception in 2004, Shanghai Medicilon Inc. (stock code: 688202.SH) has been committed to providing comprehensive R&D services to pharmaceutical companies, research institutions, and any organizations working in the preclinical space. Medicilon has built an integrated one-stop R&D platform covering drug discovery, CMC and preclinical studies, and has established service platforms in cutting-edge fields such as ADC, nucleic acids, peptides, CGT, PROTAC, and antibodies. Medicilon has established a quality system in compliance with international standards and has obtained GLP certifications from China's NMPA, the US FDA, the EU OECD, and Japan's PMDA, as well as AAALAC accreditation. Currently, Medicilon has nearly 80,000 square meters of R&D laboratories.

By the end of June 2025, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 588 new drugs and generic drug projects that have been approved for clinical trials with IND applications. For more information, please visit the company's official website at www.medicilon.com.cn.