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Micot SPF级动物房顺利换证过审
筑牢成药性评价核心基石
近日，陕西麦科奥特医药科技股份有限公司（以下简称 “麦科奥特”）SPF级动物房顺利完成资质换证审评工作，以高标准、规范化的设施条件与全流程质量管理体系，一次性通过陕西省科技厅动管办组织的审核，成功换发新证。此次换证成功，标志着公司自主成药性评价平台建设再上新台阶，为公司双 / 多功能多肽创新药全链条研发提供了更加坚实、可靠的核心支撑。
动物房是新药临床前研究的关键核心设施，更是麦科奥特四大技术平台之一 ——自主成药性评价平台的基石与载体。作为公司覆盖 “药物发现 — 分子设计 — 筛选优化 — 临床前评价” 全流程研发体系的关键一环，动物房承担着自研管线药理药效、早期药代动力学和安全性评价等核心研究任务，是验证候选药物成药性的 “生命实验室”。
麦科奥特动物房严格按照国际AAALAC规范标准建设，啮齿类动物全面采用 SPF 级屏障环境，配备高精度动态压差控制、恒温恒湿、智能监控与独立通风（IVC）等系统，可稳定开展大鼠、小鼠和兔等多物种动物实验。依托标准化设施与专业化团队，公司已自主构建200 余种疾病动物模型，覆盖心脑血管、代谢、肾病、抗炎镇痛等治疗领域，为MT1013等 7 款进入临床阶段的First in Class药物，及数十款临床前管线提供了精准、高效、可重复的临床前成药性评价数据，有力保障了公司研发管线科学、高效、合规和快速推进。
MICOT
此次换证审评中，评审专家组从设施环境、设备运维、动物质量、人员资质、实验操作、伦理管理、质量体系等全维度进行严格核查，对麦科奥特动物房的硬件条件、标准化流程、精细化管理及高质量研究成果给予高度认可。顺利换证不仅是对公司过往研发合规建设的充分肯定，更彰显了麦科奥特坚持高标准、严要求、重质量的研发理念，以及在多肽创新药临床前评价领域的专业实力与行业标杆地位。
作为专注于双/多功能多肽创新药研发的领军企业，麦科奥特自 2007 年成立以来，始终以 “创制新药，守护健康” 为使命，深耕多肽药物研发十余年，构建起全球领先的四大核心技术平台。公司研发项目两次入选国家 “重大新药创制” 专项，获多项国家级与省部级科研支持，目前已形成包含 30 余个创新药品种的丰富管线，7 款核心产品进入中美临床研究阶段，其中核心产品 MT1013 已进入 Ⅲ 期临床，有望成为肾病领域全球首创（First-in-Class）的双靶点多肽新药。
此次动物房换证成功，是公司研发平台能力建设的重要里程碑。未来，麦科奥特将以此为新起点，持续升级优化自主成药性评价平台与动物实验体系，深化标准化、智能化、国际化建设，以更严谨的科学态度、更规范的研究流程、更高效的技术支撑，加速推进公司自研管线从实验室走向临床、惠及全球患者，为攻克重大疾病、守护人类健康贡献更大力量。
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Micot Passes Re-Certification Review for SPF Animal Facility, Consolidating the Cornerstone of Its Drugability Evaluation Platform
Recently, the SPF animal facility of Shaanxi Micot Pharmaceutical Technology Co., Ltd. (“Micot”) has successfully completed its qualification re-certification review. Adhering to high-standard, standardized facilities and a comprehensive quality management system, the facility passed the inspection organized by Laboratory Animal Management Office of Shaanxi Provincial Department of Science and Technology in one go and was officially re-issued with the new certificate. This successful re-certification marks a new milestone in the development of the Company’s in house drugability evaluation platform, providing more solid and reliable core support for the entire R&D chain of Micot’s bi-/multi-functional peptide innovative drugs.
The animal facility is a critical core infrastructure for preclinical drug research, as well as the cornerstone and carrier of the in house drugability evaluation platform — one of Micot’s four major technology platforms. As a key link in the Company’s end-to-end R&D system covering drug discovery, molecular design, screening and optimization, and preclinical drugability evaluation, the animal facility undertakes core research tasks including pharmacology and efficacy, early pharmacokinetics and safety evaluation for the Company’s self-developed pipeline, serving as a “life science laboratory” for validating the drugability of drug candidates.
Built in strict international standards, Micot’s animal facility features a full SPF barrier environment for rodents, equipped with high-precision dynamic differential pressure control, constant temperature and humidity, intelligent monitoring, and independent ventilation cage (IVC) systems. It stably supports animal experiments in multiple species such as rats, mice, and rabbits. Relying on standardized facilities and a professional team, the Company has independently established more than 200 disease animal models covering therapeutic areas including cardiovascular and cerebrovascular diseases, metabolism, nephropathy, and anti-inflammatory analgesia. These capabilities have delivered accurate, efficient, and reproducible preclinical drugability evaluation data for seven first-in-class drug in clinical stages such as MT1013, as well as dozens of preclinical pipeline programs, strongly ensuring the scientific, efficient, compliant, and accelerated advancement of the Company’s R&D pipeline.
MICOT
During the re-certification review, the expert panel conducted a rigorous, full-dimensional inspection covering facility environment, equipment operation and maintenance, animal quality, personnel qualifications, experimental operations, ethical management, and quality systems. The panel highly recognized Micot’s animal facility for its hardware conditions, standardized procedures, refined management, and high-quality research outcomes. The successful re-certification not only fully affirms the Company’s past compliance in R&D construction but also demonstrates Micot’s R&D philosophy of upholding high standards, strict requirements, and quality focus, as well as its professional strength and industry benchmark status in preclinical evaluation of innovative drugs.
As a leading enterprise focused on the R&D of bi-/multi-functional peptide innovative drugs, Micot was founded in 2007 with the mission of “Developing Innovative Drugs, Safeguarding Health”. With over a decade of deep cultivation in peptide drug R&D, the Company has built four world-leading core technology platforms. Its R&D projects have been selected twice for the National Major New Drug Creation Program and received multiple national and provincial-level research grants. At present, Micot has built a rich pipeline of more than 30 innovative drug candidates, with seven core products in clinical trials in both China and U.S. Among them, the core product MT1013 is in Phase III clinical development and is expected to become the world’s first-in-class dual-target peptide drug for nephropathy.
The successful re-certification of the animal facility represents an important milestone in the capacity building of the Company’s R&D platform. Going forward, Micot will take this achievement as a new starting point to continuously upgrade and optimize its independent drugability evaluation platform and animal experiment system, deepen standardization, intelligentization, and internationalization. With a more rigorous scientific attitude, more standardized research procedures, and more efficient technical support, the Company will accelerate the translation of its self-developed pipeline from the laboratory to the clinic to benefit patients worldwide, and contribute greater efforts to conquering major diseases and protecting human health.
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