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近日，西安新通药物研究股份有限公司宣布，其自主研发的1类化学创新药XTYW007片已正式获得国家药品监督管理局签发的《药物临床试验批准通知书》（编号：2026LP00363、2026LP00364、2026LP00365），为肝病创新药管线再添里程碑式进展。 美迪西助力 作为新通药物的战略合作伙伴，上海美迪西生物医药股份有限公司为XTYW007片的研发提供了临床前药代动力学和安全性评价研究服务，为该项目顺利获批临床奠定了坚实基础。 高选择性THR-β激动剂XTYW007片 引领MASH优效治疗新方向 新通药物XTYW007 片，拟用于治疗代谢相关脂肪性肝炎。临床前研究显示，在相同给药剂量下，本品相比已上市的同靶点药物Resmetirom，在小鼠模型中表现出更优的降低肝脏转氨酶、调节血脂、减少肝脂沉积及抑制肝纤维化的效果。作用机制研究进一步表明，XTYW007对甲状腺激素受体β亚型（THR-β）具有高选择性：在受体辅激活因子募集试验中，其THR-β/THR-α选择性高于10倍；在细胞激活试验中，该选择性超过40倍。目前，XTYW007片已完成临床试验前置伦理审查，计划于2026年3月直接启动I期临床试验。 作为新通药物肝靶向创新药物研发平台孵化的又一重要成果，XTYW007片也体现了其在肝病治疗领域的深厚积累。新通药物二十五年来专注重大肝病领域，已建立多个创新药研发管线。其中，全球首个基于HepDirect技术修饰的肝靶向乙肝新药新舒沐®（甲磺酸普雷福韦片）已获批上市并已纳入国家医保目录，展现出扎实的自主创新与商业化能力。 美迪西以国际化研发平台 加速创新药全球开发进程 对美迪西而言，每一次新药项目成功获批临床，都是对公司研发服务能力的有力印证。成立二十余年来，美迪西始终坚持国际化标准、构建一站式研发服务体系，已通过NMPA、FDA、OECD等国际GLP认证，建立了基于AI与体外模型的NAMs平台，并成功搭建覆盖ADC、核酸、多肽、CGT、PROTAC、抗体等前沿领域的多元化研发平台，能够全面支持各类创新药物的研发需求。 截至2025年末，美迪西已成功赋能610+件IND在全球获准开展临床研究，包括474项化学药（含194个抗肿瘤药物、77个炎症及免疫性疾病药物）、139项生物药（含32个ADC药物，16个多肽类药物，13个双抗药物，11个蛋白及融合蛋白药物，10个疫苗，8个细胞治疗类药物）及6个中药获IND批准，并成功助力宜联生物的HER3 ADC药物YL202、艾力斯医药的甲磺酸伏美替尼片、恒瑞医药的HRS-7535片、济煜医药的长效IgE抗体JYB1904等多款创新药物出海。 美迪西祝贺新通药物XTYW007片获批临床，期待其临床试验顺利推进，早日为代谢相关脂肪性肝炎患者带来更安全、有效的治疗新选择。未来，美迪西将继续依托一体化研发服务平台与全球化协作能力，持续赋能国内外药企加速创新药物研发。 关于新通药物 新通药物是一家专注药物研发超过二十年的高新技术企业，现聚焦于乙肝、代谢相关脂肪性肝炎及肝癌等重大肝病领域的药物开发，致力于研发具有自主知识产权、安全有效、以临床价值为导向的创新药物，力求填补肝病领域未被满足的临床需求，现已快速发展成为一家具备竞争力的肝病新药开发企业。 2024年10月全球首个经HepDirect技术平台修饰的肝靶向治疗乙肝的1类创新药产品新舒沐®（甲磺酸普雷福韦片）获批上市。公司做好已有获批产品生产和销售外，将继续推进多个肝病创新药的研发及产业化。 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，公司在国内外拥有近8万平方米研发实验室。至2025年末，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有610+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。 Recently, Xi’an Xintong Pharma announced that its independently developed innovative drug XTYW007 Tablets has officially obtained the Notice of Approval for Drug Clinical Trials issued by the National Medical Products Administration (NMPA) (Approval Nos.: 2026LP00363, 2026LP00364, 2026LP00365), marking another milestone in its liver disease innovative drug pipeline. As a strategic partner of Xintong Pharma, Medicilon providedpreclinical pharmacokinetics and safety evaluation services for XTYW007 Tablets, laying a solid foundation for the successful clinical approval of this program. XTYW007 Tablets, a Highly Selective THR‑β Agonist, Pioneers a New Direction for Effective MASH Treatment XTYW007 Tablets are intended for the treatment of metabolic dysfunction‑associated steatohepatitis (MASH). Preclinical studies have shown that, at the same dosage, this drug demonstrates superior efficacy in mouse models compared with the marketed same‑target drug Resmetirom, including greater reduction in liver transaminases, regulation of blood lipids, reduction of hepatic lipid deposition, and inhibition of liver fibrosis. Mechanism studies further indicate that XTYW007 exhibits high selectivity for the thyroid hormone receptor β subtype (THR‑β): Its THR‑β/THR‑α selectivity is more than 10‑fold in receptor coactivator recruitment assays; The selectivity exceeds 40‑fold in cell activation assays. XTYW007 Tablets have completed the pre‑clinical ethics review and are scheduled to directly initiate Phase I clinical trials in March 2026. As another important achievement incubated by Xintong Pharma’s liver‑targeted innovative drug R&D platform, XTYW007 Tablets reflect the company’s profound expertise in the field of liver disease treatment. For 25 years, Xintong Pharma has focused on major liver diseases and has built a number of innovative drug R&D pipelines. Among them, Xinshumu® (Preferovir Mesylate Tablets), the world’s first liver-targeted novel anti-HBV drug modified based on HepDirect® technology, has been approved for marketing and included in the National Reimbursement Drug List, reflecting the company’s solid capabilities in independent innovation and commercialization. Medicilon: Accelerating Global Innovative Drug Development with an International R&D Platform For Medicilon, every successful clinical approval of a new drug program strongly validates the company’s R&D service capabilities. For more than 20 years’ experience,  Medicilon has consistently adhered to international standards and built a one‑stop R&D service system.Medicilon has obtained international GLP certifications from NMPA, FDA, OECD and other authorities, established an AI and in vitro model‑based NAMs platform, and developed a diversified R&D platform covering cutting‑edge areas including ADC, nucleic acid, polypeptide, CGT, PROTAC, antibodies, etc., enabling comprehensive support for the R&D needs of various innovative drugs.  By the end of 2025, Medicilon had successfully supported more than 610 INDs approved globally for clinical studies, including: 474 small‑molecule drugs (including 194 anti‑tumor drugs and 77 inflammation & immune disease drugs); 139 biologics (including 32 ADCs, 16 peptides, 13 bispecific antibodies, 11 proteins & fusion proteins, 10 vaccines, 8 cell therapy products); 6 traditional medicines. Medicilon has also helped numerous innovative drugs go global, including YL202 (HER3 ADC) from MediLink Therapeutics, Furmonertinib Mesylate Tablets from Allist Pharma, HRS‑7535 Tablets from Hengrui Medicine, and long‑acting IgE antibody JYB1904 from Jeyou Pharma. Medicilon congratulates Xintong Pharma on the clinical approval of XTYW007 Tablets and wishes its clinical development smooth progress, aiming to bring safer and more effective new treatment options to patients with metabolic dysfunction‑associated steatohepatitis at an early date. In the future, Medicilon will continue to rely on its integrated R&D service platform and global collaboration capabilities to continuously empower pharmaceutical companies at home and abroad to accelerate innovative drug R&D. About Medicilon From its inception in 2004, Medicilon (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,and the EU OECD, as well as AAALAC accreditation. Currently, Medicilon has nearly 80,000 square meters of R&D laboratories.  By the end of 2025, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 610+ 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.