中国苏州,2026年4月25日 —— 行业领先的新药临床前研究技术服务机构苏州华测生物技术有限公司(以下简称“苏州华测生物”),近日宣布与全球值得信赖的合同研究、开发和生产公司(CRDMO)保诺-桑迪亚达成战略合作。此次合作将充分发挥双方在临床前研发关键环节的专业优势,携手打造覆盖药物发现至IND申报的一体化研发平台,为全球创新药客户提供更高效、更灵活的研发支持。
此次合作中,保诺-桑迪亚将重点提供药物发现、开发及生产的端到端技术服务,包括药物化学、体内外生物学、药代动力学、药效学,以及原料药和制剂的研发与生产,并提供中美欧等多国申报支持;苏州华测生物将提供支持IND申报的GLP毒理研究及生物分析服务。通过双方优势互补与项目协同,将为客户提供高效、高质量的一站式研发解决方案,优化研发流程,降低沟通成本与管理风险,加速创新药项目推进至临床阶段。
保诺-桑迪亚CEO Armin Spura:
“IND的成功申报,依赖于早期开发各关键环节的稳健推进,而GLP毒理学研究正是至关重要的里程碑之一。通过此次战略合作,把保诺-桑迪亚的一体化发现与开发能力,与苏州华测生物在GLP毒理学及生物分析领域久经验证的专业优势深度融合,我们将进一步提升整体服务能力,助力客户以更高效率、更强确定性,加速创新药项目迈向临床。”
苏州华测生物总经理 刘涛:
“此次与保诺-桑迪亚达成战略合作,将进一步提升双方在临床前研发领域的协同服务能力,为全球客户提供更完整、更高效的一体化解决方案。我们期待双方团队紧密合作、持续创新,助力客户加快创新药研发进程,让更多创新疗法早日惠及全球患者。”
保诺-桑迪亚,安宏资本旗下投资企业,拥有30年的历史,是一家值得信赖的全球化合同研究、开发和生产公司(CRDMO)。公司总部位于美国加州尔湾,在全球设有多个研发生产中心,拥有超过2000名员工,在大小分子的药物发现、开发及生产领域具有深厚的专业积累。我们提供从化学、生物学到药代动力学(DMPK)的完整药物发现服务,并具备全面的支持新药临床试验申报(IND)的能力,涵盖原料药与制剂的开发。
关于苏州华测生物
苏州华测生物技术有限公司(以下简称:苏州华测生物)是一家致力于为国内外生物医药企业、科研机构等客户提供安全性评价、药代/毒代动力学、生物分析测试及药效学研究等“一站式”技术服务的高新企业,由华测检测认证集团股份有限公司(股票代码:300012)于2011年在苏州昆山投资成立。苏州华测生物于2016年2月获得NMPA(中国食品药品监督管理局)药物GLP认证;2017年11月通过国际AAALAC完全认证;2025年3月通过FDA(美国食品药品监督管理局)GLP检查;2026年4月通过OECD(经济合作与发展组织)GLP检查。截至目前,公司已帮助全球药企获得新药临床批件143项,其中19个项目获FDA批准开展临床试验。
BioDuro and CTI Biotechnology Enter Strategic Partnership to Accelerate Preclinical Drug Development
Suzhou, China, - April 25, 2026 — CTI Biotechnology (Suzhou) Co., Ltd. (“CTI Biotechnology”), a leading provider of preclinical research services for innovative drug development, today announced a strategic partnership with BioDuro, a trusted global Contract Research, Development and Manufacturing Organization (CRDMO). The collaboration will leverage the complementary strengths of both companies across critical stages of preclinical R&D to establish an integrated platform spanning from drug discovery to investigational new drug (IND) submission, providing global biotech and pharmaceutical clients with more efficient and flexible development solutions.
Under the partnership, BioDuro will provide integrated capabilities including discovery chemistry, biology, drug metabolism and pharmacokinetics (DMPK), and pharmacology, as well as API and drug product development and manufacturing, together with IND filing support across global markets. CTI Biotechnology will contribute GLP toxicology studies and bioanalytical services in readiness for successful IND submission.
By combining their complementary expertise and coordinating project execution, the two companies will deliver a high-quality, one-stop discovery and development solution that helps clients streamline workflow, reduce communication and management complexity, and more efficiently advance innovative therapies.
Armin Spura, CEO of BioDuro, said, “Successful IND submission depends on strong execution across every critical step of early development, and GLP toxicology is one of the most important milestones in that journey. By combining BioDuro’s integrated discovery and development capabilities with CTI’s proven expertise in GLP toxicology and bioanalytical services, we are strengthening our ability to help clients move innovative programs forward with greater speed, confidence, and efficiency.”
“Our strategic collaboration with BioDuro will further enhance our combined service capabilities in preclinical development and provide clients worldwide with a more complete and efficient integrated solution,” added Tony Liu, General Manager of CTI Biotechnology. “We look forward to working closely together to help accelerate our clients’ R&D programs and bring more innovative therapies to patients around the world.”
About BioDuro
BioDuro, an Advent portfolio company, is a CRDMO with a 30-year proven track record. Headquartered in Irvine, California, BioDuro employs more than 2,000 scientists with deep expertise in small- and large-molecule discovery, development, and manufacturing. We provide fully integrated drug discovery services spanning chemistry, biology, and pharmacokinetics (DMPK), along with comprehensive IND-enabling capabilities, including both drug substance and drug product development.
About CTI Biotechnology
CTI Biotechnology (Suzhou) Co., Ltd. is a high-tech enterprise committed to providing one-stop technical services including safety evaluation, pharmacokinetics/toxicokinetics (PK/TK), bioanalytical testing and pharmacodynamic research for biopharmaceutical enterprises, scientific research institutions and other domestic and international clients.
Founded in Kunshan, Suzhou in 2011 with investment by Centre Testing International Group Co., Ltd. (Stock Code: 300012), Up to now, CTI Biotechnology has assisted global pharmaceutical companies in obtaining 143 Investigational New Drug (IND) approvals, among which 19 projects have been approved for clinical trials by the U.S.FDA.
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华测医药市场部
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关于华测医药
华测医药是上市企业华测集团在医药及医学服务领域的重要布局,在医药领域,可提供从药物研发到商业化的全链条解决方案。包括临床前CMC研究、药代动力学研究、非临床GLP安全性评价研究、临床生物样本分析、药品检测及注册申报等服务。
非临床药代动力学
体外药代:代谢稳定性 (微粒体/S9/肝细胞/血浆/全血)、P450酶抑制 (包括TDI)、P450酶诱导、血浆蛋白结合率 (血浆/组织/微粒体)、红细胞/血浆分配比、Caco-2/MDCK渗透性、ABC和SLC转运体抑制试验、ABC和SLC转运体底物试验、P-gp/BCRP/OATs/OCTs/OATPs/MATEs/BSEP/MRPs、体外代谢产物鉴定
体内药代:大、小动物体内吸收试验、组织分布、排泄研究、体内代谢产物鉴定体内药物相互作用、血脑屏障通透性(体内部分)、荷瘤鼠PK/PD
GLP项目资质:单次给药毒性试验(啮齿类、非啮齿类)、多次给药毒性试验(啮齿类、非啮齿类)、生殖毒性试验(Ⅰ段,Ⅱ段,Ⅲ段)、遗传毒性试验(Ames/微核/染色体畸变)、局部毒性试验、免疫原性/免疫毒性试验、安全性药理试验、毒代动力学试验、致癌试验
药学CMC研究服务
合成研究
制剂研究
质量研究
临床研究
咨询及代持
药品检测服务
原辅料检测
元素杂质研究
微生物测试(无菌、微生物限度、内毒素、菌种鉴定、噬菌体、支原体)
相容性研究/可提取物与浸出物研究
大分子结构表征
大分子纯度与杂质研究
密封性研究
无菌过滤器验证
公用系统验证(洁净室验证、设备验证、水系统验证、消毒剂效力验证、软件验证)
体外技术研发服务
细胞库检定
干细胞质量检定
免疫细胞质量检定
外泌体质量检定
生物学活性检测
生物安全性检测
生物原辅料测试
生物分析服务
分子平台(PCR、NGS):药物基因检测、预测性生物标志物检测病理平台:常规病理、免疫组化、FISH、组织特染ELISA、MSD平台:抗体、融合蛋白、多肽、ADC等检测免疫分析平台:免疫原性、标志物分析生化分析平台:安全性生物标志物检测微生物平台:细菌、真菌等检测
质谱、色谱分析平台:PK/PD分析