华领医药是一家立足中国，针对全球糖尿病患者尚未满足的临床需求，研发全球原创新药的生物技术公司，其全球首创新药葡萄糖激酶激活剂多格列艾汀（dorzagliatin）已获得中国国家药品监督管理局（NMPA）的新药上市申请受理。研发进展方面，一项名为DREAM的临床试验显示，参与播种研究（SEED，多格列艾汀单药治疗III期注册临床研究）的部分患者血糖达标后（经多格列艾汀治疗后血糖达标），他们在不服用任何降糖药物的情况下，52周糖尿病缓解率为65.2%，对于探索口服用药在糖尿病缓解中的可能性，拓展2型糖尿病的治疗方案具有重要意义。 合全药业是华领医药在合作研究开发生产（CDMO）领域的最早、最长期的合作伙伴，在多格列艾汀的研发过程中，双方在原料药和固体分散体的工艺开发、生产、分析等方面通力合作。2021年，合全药业外高桥基地及常州基地顺利通过了NMPA对多格列艾汀的上市批准前检查（PAI，Pre-Approval Inspection），为该款全球首创2型糖尿病新药早日在中国获批上市打下了坚实基础。根据合作协议，双方将继续在原料药和固体分散体研发及商业化生产等多方面加强合作。 此外，为了感谢合全-多格列艾汀项目团队对华领医药长期以来的支持，签约仪式上，华领医药还向合全药业授予了“最有价值合作伙伴”奖杯。 华领医药CEO陈力博士表示：“合全药业是华领医药重要的合作伙伴，双方合作已有10年，我们非常期待在即将到来的商业化生产供应中，能够更加紧密地合作，优质高效地完成多格列艾汀上市后的生产，提高临床急需药品的可及性，更好地服务中国2型糖尿病患者，并实现全球糖尿病的控制和转归。” 药明康德联席首席执行官、合全药业首席执行官陈民章博士表示：“华领医药与合全药业在多格列艾汀项目上的合作卓有成效，很高兴双方能进一步深化合作，通过合全药业一体化CMC平台、充足的原料药和固体分散体产能以及符合国际标准的质量体系，加速多格列艾汀的商业化进程，造福广大糖尿病患者。” 关于合全药业合全药业是药明康德子公司，在全球多地设有研发及生产基地。合全药业服务于生命科学行业，拥有卓越的化学创新药研发和生产的能力和技术平台。作为全球新药合作研究开发生产领域（CDMO）的领军企业，合全药业致力于为全球合作伙伴提供高效、灵活、高质量的一站式解决方案，以支持包括小分子、寡核苷酸、多肽及各种复杂化学偶联药物的研发与生产。更多信息，请访问公司网站：www.stapharma.com.cn。 关于华领医药华领医药是一家创立于中国的创新药物研发公司，专注于未被满足的医疗需求，为全球患者开发全新疗法。华领医药汇聚全球医药行业高素质人才，融合全球创新技术，依托全球优势资源，研究开发突破性的技术和产品，引领全球糖尿病医疗创新。其核心产品多格列艾汀以葡萄糖传感器葡萄糖激酶为靶点，提升2型糖尿病患者的葡萄糖敏感性，已经在中国完成播种研究（SEED）和黎明研究（DAWN）两项III期注册试验，并已向中国药品监督管理局递交了新药上市申请。这款全球首创的葡萄糖激酶激活剂在临床研究中展示了糖尿病缓解的潜力，以帮助全球数亿糖尿病患者。更多信息，请访问公司网站：www.huamedicine.com。 WuXi STA and Hua Medicine Sign Supply Agreement for Dorzagliatin SHANGHAI, CHINA, WuXi STA – a subsidiary of WuXi AppTec– and Hua Medicine (SEHK stock code: 2552.HK) today announced signing a supply agreement for the commercial manufacturing of dorzagliatin, a first-in-class oral therapy for type 2 diabetes (T2D). This commercial supply agreement between Hua Medicine and WuXi STA will further enhance their current collaboration. As the long-time trusted partner of Hua Medicine, WuXi STA will provide the commercial supply of dorzagliatin, helping millions of people with diabetes in China. Hua Medicine is a leading innovative biotechnology company in China focusing on novel therapy development for diseases with unmet medical needs. It was announced in April last year that the New Drug Application (NDA) of dorzagliatin, a first-in-class glucokinase activator (GKA), was accepted by China National Medical Products Administration (NMPA). The phase III clinical study of dorzagliatin monotherapy showed 65.2% diabetes remission rate without the intervention of any glucose-lowering medication in 52 weeks, after the patients reached the normal glucose level with dorzagliatin treatment. With this positive result, dorzagliatin provides a new option of oral treatment for T2D patients. WuXi STA was the 1st CDMO that Hua Medicine ever worked with and remains a preferred partner. For dorzagliatin, the two companies worked closely for API and solid dispersion process development and manufacturing, accelerating the first-in-class oral antidiabetic therapy to market. Last year, dorzagliatin has successfully passed the Pre-approval Inspection (PAI) by NMPA at the Shanghai Waigaoqiao site and Changzhou site of WuXi STA. With the agreement signed, Hua Medicine and WuXi STA will continue their close collaboration for API and solid dispersion RD and commercial manufacturing. Additionally, WuXi STA received the “Most Valuable Partner” award by Hua Medicine in recognition of its long-term contribution to the dorzagliatin project. Dr. Li Chen, CEO of Hua Medicine, said, “WuXi STA proved to be an important partner for us during our 10-year collaboration. Going forward, we expect a closer relationship with WuXi STA in the commercial manufacturing of dorzagliatin to reach more T2D patients in China, thus addressing this major public health issue.” Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, “We are pleased to enhance our partnership with Hua Medicine for dorzagliatin. We look forward to leveraging our proven integrated CMC platform, global standard quality system, and vast API and solid dispersion commercial manufacturing capacity to accelerate the commercialization of dorzagliatin for diabetic patients.” About WuXi STAWuXi STA (stapharma.com), a subsidiary of WuXi AppTec (wuxiapptec.com), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier contract development and manufacturing organization (CDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate.For more information, please visit: http://www.STApharma.com About Hua MedicineHua Medicine is an innovative drug development company in China focused on developing novel therapies for patients worldwide with unmet medical needs. Hua Medicine teams up with global high caliber people and integrates ultimate global resources to explore breakthrough technologies and products, and accelerate global innovation in diabetes care. Targeted on glucose sensor glucokinase, dorzagliatin, a novel oral diabetes drug, restoring glucose sensitivity in T2D patients, has completed SEED and DAWN registration trials and filed NDA in China. This global first-in-class glucokinase activator (GKA) has demonstrated its potential of achieving diabetes remission to help millions of diabetic patients around world. 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。