GT-818

8月31日，标新生物（Gluetacs Therapeutics）宣布，其自主研发的全球首创1类新药GT818胶囊获得美国食品药品监督管理局（FDA）批准进入临床试验，用于晚期恶性肿瘤的治疗。此前，GT818已于2026年7月1日获得国家药品监督管理局（NMPA）临床试验默示许可，目前正在中国开展I期临床研究。GT818是全球首个靶向RSK的双功能降解剂，也是标新生物第三个在中美同时获批临床试验的产品管线，也是美迪西一站式生物医药临床前研发服务平台（包括化学合成、制剂开发、药效学研究、药代动力学、安全性评价）赋能其获得的第三款靶向蛋白降解药物批件。双方在TPD领域的合作再结硕果！深耕TPD前沿一站式赋能PROTAC/分子胶临床前研发在TPD领域，美迪西已构建覆盖PROTAC及分子胶药物临床前研发的服务平台，包括药物发现、药学研究和临床前研究：药物发现：具备靶蛋白/E3配体及Linker设计与合成能力，建立AI驱动的PROTAC降解剂智能设计与生物活性预测体系，提供Linker设计与活性预测服务。支持多种靶点的PROTAC药物开发，并支持分子胶等TPD药物关键中间体的合成优化与应用。持续推进靶向蛋白降解药物在多靶点、多适应症领域的研发。药学研究：设立技术服务平台，针对性攻克PROTAC分子的工艺开发、质量研究与增溶制剂难题。临床前研究：依托近1,100种药效模型（含800种肿瘤模型）、AI-ADMET预测平台及国际GLP资质，系统完成药效、药代和安全性评价，全面支持中美双报标准。截至2026年6月底，美迪西已成功助力8个PROTAC药物获批临床，另有超20个PROTAC项目在研，技术平台持续通过项目验证，积累深厚实战经验。国际化资质体系筑牢壁垒中美双报业务高速增长作为国内较早提供整套同时符合中国GLP和美国GLP标准的CRO公司，美迪西现拥有NMPA、OECD GLP资质及AAALAC国际权威认证，并达到美国FDA GLP标准。2026年公司国际化实力持续升级，通过NMPA GLP资质复查、完成波士顿海外中心AAALAC认证，海内外质控与运营体系全面接轨国际先进水平。依托2.9万平米标准化GLP实验室，结合AI、类器官等前沿技术，公司持续迭代升级全球药物研发评价服务能力。成熟的国际化布局与合规体系，支撑公司多国申报服务高速发展。美迪西已累计助力691件IND获批临床，包含90件多国申报项目（含77件中美双报获批）。仅2026年上半年，中美双报项目营收1.67亿元，同比增长93.46%，印证了市场对美迪西中美双报核心竞争力的高度认可。未来，美迪西将持续深耕TPD领域，聚焦PROTAC、分子胶等前沿创新技术领域，持续迭代优化一站式临床前服务平台，攻克源头性、关键性研发技术难题。公司将持续深化与全球创新药企的合作，以专业、高效、全球化的全链条研发服务，加速更多创新药物从Target到IND，赋能全球创新药研发产业高质量、高速化发展。

8月31日，标新生物（Gluetacs Therapeutics）宣布，其自主研发的全球首创1类新药GT818胶囊获得美国食品药品监督管理局（FDA）批准进入临床试验，用于晚期恶性肿瘤的治疗。此前，GT818已于2026年7月1日获得国家药品监督管理局（NMPA）临床试验默示许可，目前正在中国开展I期临床研究。 GT818是全球首个靶向RSK的双功能降解剂，也是标新生物第三个在中美同时获批临床试验的产品管线，也是美迪西一站式生物医药临床前研发服务平台（包括化学合成、制剂开发、药效学研究、药代动力学、安全性评价）赋能其获得的第三款靶向蛋白降解药物批件。双方在TPD领域的合作再结硕果！ 深耕TPD前沿 一站式赋能PROTAC/分子胶临床前研发 在TPD领域，美迪西已构建覆盖PROTAC及分子胶药物临床前研发的服务平台，包括药物发现、药学研究和临床前研究： 药物发现：具备靶蛋白/E3配体及Linker设计与合成能力，建立AI驱动的PROTAC降解剂智能设计与生物活性预测体系，提供Linker设计与活性预测服务。支持多种靶点的PROTAC药物开发，并支持分子胶等TPD药物关键中间体的合成优化与应用。持续推进靶向蛋白降解药物在多靶点、多适应症领域的研发。。 药学研究：设立技术服务平台，针对性攻克PROTAC分子的工艺开发、质量研究与增溶制剂难题。 临床前研究：依托近1,100种药效模型（含800种肿瘤模型）、AI-ADMET预测平台及国际GLP资质，系统完成药效、药代和安全性评价，全面支持中美双报标准。 截至2026年6月底，美迪西已成功助力8个PROTAC药物获批临床，另有超20个PROTAC项目在研，技术平台持续通过项目验证，积累深厚实战经验。 国际化资质体系筑牢壁垒 中美双报业务高速增长 作为国内较早提供整套同时符合中国GLP和美国GLP标准的CRO公司，美迪西现拥有NMPA、OECD GLP资质及AAALAC国际权威认证，并达到美国FDA GLP标准。2026年公司国际化实力持续升级，通过NMPA GLP资质复查、完成波士顿海外中心AAALAC认证，海内外质控与运营体系全面接轨国际先进水平。依托2.9万平米标准化GLP实验室，结合AI、类器官等前沿技术，公司持续迭代升级全球药物研发评价服务能力。 成熟的国际化布局与合规体系，支撑公司多国申报服务高速发展。美迪西已累计助力691件IND获批临床，包含90件多国申报项目（含77件中美双报获批）。仅2026年上半年，中美双报项目营收1.67亿元，同比增长93.46%，印证了市场对美迪西中美双报核心竞争力的高度认可。 未来，美迪西将持续深耕TPD领域，聚焦PROTAC、分子胶等前沿创新技术领域，持续迭代优化一站式临床前服务平台，攻克源头性、关键性研发技术难题。公司将持续深化与全球创新药企的合作，以专业、高效、全球化的全链条研发服务，加速更多创新药物从Target到IND，赋能全球创新药研发产业高质量、高速化发展。 关于标新生物 标新生物（Gluetacs Therapeutics）是一家专注于研发口服蛋白降解小分子药物的生物医药公司，为上海科技大学孵化的首家生物医药公司，2021年3月正式运营，由多名在蛋白降解领域深耕多年的科学家领衔创立。公司作为一家同时拥有自主知识产权的分子胶（GLUE）和双功能降解剂（GLUETAC）双平台创新型生物医药公司，在全球不同国家申请和授权该领域专利超百项，具备独具特色的差异化技术路线和发展战略。公司现已自主建立人工智能虚拟筛选平台、体外药效筛选平台、药代动力学平台、蛋白质组学平台、肿瘤动物药效模型平台、临床转化平台以及医学运营注册平台，实现了完备的全流程药物研发体系建设。自从正式运营以来，标新生物成功推动三个候选药物进入临床试验阶段，核心管线已进入临床二期。公司在适应症布局上覆盖血液瘤、实体瘤、自身免疫疾病及罕见病等多个领域，致力于造福病患的发展理念。 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等GLP认证以及AAALAC国际认证。目前，公司在国内外拥有约9.2万平方米研发实验室。至2026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项目已有691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。 TPD CN-US Dual Filing Milestone: Medicilon's One-Stop Platform Helps Gluetacs Secure Dual Approval for GT818, a First-in-Class RSK Degrader August 31, 2026 —Gluetacs Therapeutics announced that GT818 capsules, its self-developed first-in-class innovative drug, has been approved by the U.S. Food and Drug Administration (FDA) to enter clinical trials for the treatment of advanced malignant tumors. The candidate previously received an implied clinical trial approval from China's National Medical Products Administration (NMPA) on July 1, 2026, and a Phase I study is currently underway in China. GT818 is the world's first bifunctional degrader targeting RSK, and the third Gluetacs pipeline to obtain clinical trial approval in both China and the United States. It also marks the third targeted protein degradation (TPD) drug approval enabled by Medicilon's one-stop preclinical R&D service platform, which covers chemical synthesis, formulation development, pharmacology, pharmacokinetics, and safety evaluation. The two companies' partnership in the TPD field has once again delivered results. Advancing the frontiers of TPD: one-stop enablement of PROTAC and molecular glue preclinical R&D Medicilon has built a comprehensive service platform for the preclinical R&D of PROTAC and molecular glue drugs, spanning drug discovery, pharmaceutical research, and preclinical studies: Drug discovery: comprehensive services for PROTAC and molecular glue development. Our AI-driven platform facilitates the intelligent design, bioactivity prediction, and synthesis of of target proteins, E3 ligands, and linkers. We also support the synthesis, optimization, and application of key intermediates, advancing TPD drug R&D across various targets and indications. Pharmaceutical research: a dedicated technical platform tackling process development, quality research, and solubility-enhancing formulation challenges specific to PROTAC molecules. Preclinical studies: leveraging nearly 1,100 pharmacology models (including 800 tumor models), an AI-ADMET prediction platform, and international GLP accreditations to systematically complete efficacy, pharmacokinetic, and safety evaluations that fully support CN-US dual filing requirements. As of the end of June 2026, Medicilon has supported 8 PROTAC drugs to obtain clinical approval, with over 20 additional PROTAC programs in active development. A global compliance framework as a moat: rapid growth of CN-US dual filing services As one of the earliest CROs in China to provide a full suite of services compliant with both Chinese and U.S. GLP standards, Medicilon holds NMPA and OECD GLP accreditations and AAALAC International certification, and meets U.S. FDA GLP requirements. In 2026, the company further upgraded its international capabilities, passing the NMPA GLP re-inspection and completing AAALAC certification at its Boston overseas center, bringing its domestic and global quality control and operations systems in line with international best practices. Leveraging 29,000 m² of standardized GLP laboratories, together with frontier technologies such as AI and organoids, the company continues to enhance its global drug R&D evaluation services. This mature international footprint and compliance system underpins the rapid growth of the company's multi-country filing services. Medicilon has supported a cumulative total of 691 INDs to obtain clinical approval, including 90 multi-country filing projects, 77 of which achieved CN-US dual approval. In the first half of 2026 alone, revenue from CN-US dual filing projects reached RMB 167 million, up 93.46% year over year, underscoring strong market recognition of Medicilon's core competitiveness in this area. Looking ahead, Medicilon will continue to deepen its focus on TPD, concentrating on frontier technologies such as PROTAC and molecular glues while iteratively optimizing its one-stop preclinical service platform to overcome fundamental R&D challenges. The company will further strengthen collaborations with innovative drug developers worldwide, delivering professional, efficient, and globally integrated end-to-end R&D services to accelerate more innovative drugs from Target to IND. About Medicilon From its inception in 2004, Shanghai Medicilon Inc. (SHA: 688202)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,as well as AAALAC accreditation. Currently, Medicilon has nearly 92,000 square meters of R&D laboratories. By the end of June 2026, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 691 new drugs 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.