1月15日，Axcynsis Therapeutics Pte Ltd（以下简称“Axcynsis”或“泰诚思生物”）宣布，其自主研发的针对CLDN-6阳性实体瘤患者的治疗药物AT03-65的新药临床研究申请（IND）已获得美国食品药品监督管理局（FDA）的批准，并计划于2025年第一季度在美国启动一项I期多中心临床试验。 qy千亿官网（以下简称“QY千亿国际”）对AT03-65项目的快速、成功获批表示热烈祝贺，期盼项目即将在美国启动的临床研究顺利推进！

泰诚思生物是2022年注册成立的、专门从事创新抗体偶联药物（ADC）设计、研发的Biotech公司。AT03-65作为泰诚思生物的首发项目，承载了公司的极高重视与深切期望。AT03-65是具有差异化特性的ADC，能够高亲和力地选择性结合CLDN6，通过采用AxcynDOT™这一专有载荷设计平台，结合了已批准上市的一种具有独特作用机制和广泛抗肿瘤活性的肿瘤治疗药物的衍生物，并与一种可裂解的亲水性专有连接子相结合，开发前景优异。

QY千亿国际在ADC药物评价方面进行了前瞻性、国际化的战略布局， 在团队建设、硬件设施、方案设计、高效执行以及质量保证等多个方面，持续保持着非临床系统评价和注册申报技术支持领域的领先地位。针对AT03-65项目所独有的新靶点、新抗体、新链接、新Payload特点，QY千亿国际与泰诚思生物团队进行了充分且深入的技术交流、探讨，设计出支持中国、美国新药临床申报的全面性、针对性解决方案，获得了泰诚思生物团队的高度认可，成功成为该项目的非临床评价业务服务商。QY千亿国际高度重视此项目的执行进度，集结了一支由高层技术专家领衔、汇聚各专业项目执行部门、项目管理部门、质量保证部门的强悍团队，与泰诚思生物携手并进、精诚合作，高质、高效地完成了AT03-65项目的非临床药代动力学和安全性评价研究，以科学、标准、规范的非临床研究数据支持该项目顺利获得了FDA临床试验许可。

作为创新药科研型CRO领创者，QY千亿国际始终恪守全球最高质量监管标准，支持中国和国际新药申报，能够为全球药物研发企业提供专业的研究技术支持。据不完全统计，QY千亿国际参与研究的新药项目已有约50项通过中国NMPA、美国FDA、澳洲TGA等地区的临床申请，赋能客户产品赢得中国和国际市场，快速、成功开发事业。

泰诚思生物创始人兼首席执行官邹斌博士表示：

“This is a transformational event for Axcynsis and a significant milestone for our proprietary ADC platform using AxcynDOT™,” said Dr. Zou Bin, CEO of Axcynsis. “We are pleased that FDA has cleared AT03-65 which leverages our AxcynDOT™ technology for this first-in-human study.  We are very excited with the potential of offering a transformative therapeutic option for patients with CLDN6-positive tumors as well as advancing our pipeline with  differentiated  and effective ADCs using AxcynDOT™ to improve the lives of cancer patients worldwide”.

The upcoming Phase 1 multicentre clinical trial in the United States will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AT03-65 in patients with advanced CLDN6-positive solid tumors.

关于AT03-65

AT03-65 is a recombinant anti-CLDN6 monoclonal antibody conjugated to AxcynDOT™, a proprietary payload developed by Axcynsis with a differentiated mechanism of action and broad anti-cancer activities.  AT03-65 is designed to target advanced, recurrent, or metastatic CLDN6+ solid tumors in patients who have progressed on or after standard systemic treatment or for whom no standard therapies are available.

The antibody of AT03-65 is rationally engineered for high affinity and specificity to CLDN6.  Upon binding to CLDN6-expressing tumor cells, the ADC is internalized into lysosomes, where it releases its payload to inhibit tumor growth effectively. Preclinical studies demonstrate that AT03-65 not only directly kill CLDN6-positive tumor cells but also exhibits bystander killing effect, targeting neighboring CLDN6-negative tumor cells to enhance its anti-tumor efficacy. AT03-65 has demonstrated promising anti-tumor activities in multiple tumor mouse models and a favorable safety profile in non-human primates.

关于泰诚思生物

Axcynsis Therapeutics is a pioneering biotechnology company headquartered in Singapore with operations in the United States and China. The company has developed AxcynDOT™, a proprietary linker payload platform to advance a pipeline of differentiated ADC candidates aimed at addressing key unmet medical needs. The company is committed to advance effective and targeted oncology therapeutics with breakthrough potential to improve the lives of cancer patients worldwide.