Dorzagliatin

2025年9月29日 中国，上海 香港卫生署受理多格列艾汀的新药上市许可申请（NDA），多格列艾汀是全球首个获批的葡萄糖激酶激活剂（GKA） 基于中国大陆的上市批准，以及强大的III期临床研究和真实世界临床结果，多格列艾汀显示出持久的血糖控制和安全性 香港将成为华领医药向东南亚及全球拓展的重要支点 华领医药（“公司”，香港联交所股份代号：2552）宣布，中国香港特别行政区卫生署已正式受理多格列艾汀（dorzagliatin）的新药上市许可申请（NDA）。多格列艾汀是世界上第一个获批准用于治疗2型糖尿病（T2D）的葡萄糖激酶激活剂（GKA）。  此次NDA被受理是华领医药拓展中国大陆以外市场战略的一个重要里程碑，有望将其创新的疾病疗法带给更多亚洲患者，并最终推向全球市场。  香港有超过50万人患有糖尿病，亚洲有近2.4亿人患有糖尿病，多格列艾汀的NDA是解决该地区最紧迫的健康挑战之一的重要一步。 一款具有全球潜力的首创疗法 多格列艾汀于2022年9月获得中国国家药品监督管理局（NMPA）的上市批准，获批两个适应症：1）单独用药治疗未经药物治疗的2型糖尿病患者，可以用于一线治疗；2）在单独使用盐酸二甲双胍血糖控制不佳时，与盐酸二甲双胍联合使用，改善成人2型糖尿病患者的血糖控制。与传统的降糖药物不同，多格列艾汀通过修复人体的葡萄糖传感器——葡萄糖激酶（GK）的功能，直击血糖调节异常的根源。通过恢复葡萄糖敏感性，多格列艾汀有助于维持血糖平衡，并支持疾病的长期管理。 在中国开展的两项III期注册临床研究结果显示，多格列艾汀能显著且持续地降低糖化血红蛋白（HbA1c）水平，改善胰岛β细胞功能，降低胰岛素抵抗，同时具有良好的安全性和耐受性。目前正在进行的真实世界研究进一步验证了这些发现，其中部分中期分析结果和数据已在2025年美国糖尿病协会（ADA）科学年会上公布。 通往新市场的战略门户 作为地区的医疗和金融枢纽，香港地区在糖尿病社区管理中已形成了一套较为完善且行之有效的体系。香港中文大学香港糖尿病及肥胖症研究所的研究成果显示，推行社区为本的公私营协作糖尿管理模式成效显著。香港地区的先进经验对提升糖尿病患者生活质量、控制病情发展及减轻医疗负担具有重要意义，待多格列艾汀在香港获批，也将为产品的糖尿病个性化管理提供更丰富的临床应用经验。 香港过去的新药审批制度规定，申请人须向管理局提供由两个或以上认可国家的药物监管机关发出的新药注册证明文件，以及其他规定的相关文件，才能支持该产品的审批上市。但在新设的“1+”机制下，在符合本地临床数据支持等要求，并经本地专家认可新药的适用范围后，只须提交一个（而非原来的两个）参考药物监管机构的许可，便可以在香港申请注册。该制度最早适用于治疗严重或罕见疾病的新药，2024年开始扩展至所有新药。在集团运营和大湾区发展部副总裁曹蓓莉女士的领导下，华领医药积极与香港当地临床专家和监管部门进行了充分且深入的沟通，成为这一政策的早期探路者。华领医药在7月底顺利完成多格列艾汀的新药递交申请，并于9月底正式受理。 华领医药创始人兼首席执行官 陈力博士表示： 多格列艾汀在香港的NDA获得受理，不仅是对多格列艾汀临床价值的认可，也是华领医药国际化进程中的重要一步。香港是地区医疗领域的引领者和金融枢纽，其独特的地位使其成为将多格列艾汀的影响力拓展至东南亚及其他地区的理想门户。我们会继续与香港本地医生及合作伙伴携手探索多格列艾汀在糖尿病前期、糖尿病早期治疗和预防等方面的潜力，让全球更多患者能从这一突破性疗法中获益。 多格列艾汀：一款变革性的 2 型糖尿病治疗药物 多格列艾汀于2022年9月在中国大陆获批，并被纳入2024年1月1日正式执行的国家医保药品目录。 多格列艾汀可作为新诊断患者的一线单药治疗药物，也可在二甲双胍单独用药血糖控制不佳时与二甲双胍联合使用，用于治疗成人2型糖尿病。与许多其它已获批的口服抗糖尿病药物不同，肾功能不全患者使用该药物无需调整剂量。其作用机制是修复人体的葡萄糖传感器——葡萄糖激酶，恢复葡萄糖敏感性和长期血糖平衡。多格列艾汀可以作用于多个关键器官：刺激胰腺分泌胰岛素、促进肠道分泌GLP-1、调节肝脏中的糖原。这种多靶点的作用方式可以直击2型糖尿病的根源，而非仅仅缓解其症状。 此次在香港地区的NDA申请基于两项在中国开展的多格列艾汀单药以及联合二甲双胍治疗 T2D 患者的 III 期注册临床研究结果。两项研究表明，针对新诊断未用药和二甲双胍足量治疗失效的两类2型糖尿病患者，通过修复GK的传感器功能缺陷，多格列艾汀能够持续、有效降低患者的HbA1c水平，显著降低餐后两小时血糖值（PPG），在无低血糖条件下血糖达标率高，具有良好的安全性和耐受性，并且能够持续改善β细胞功能和降低胰岛素抵抗。 前瞻性声明 本文包含有关华领医药以及产品未来预期、计划和前景的陈述。该等前瞻性陈述仅与本文作出该陈述当日的事件或资料有关，可能因未来发展而出现变动。除法律规定外，于作出前瞻性陈述当日之后，无论是否出现新资料、未来事件或其他情况，我们并无责任更新或公开修改任何前瞻性陈述及预料之外的事件。请仔细阅读本文并理解，由于各种风险、不确定性或其他法定要求我们的实际未来业绩或表现可能与预期有重大差异。 关于华领 华领医药（“本公司”）是一家总部位于中国上海的创新药物研发和商业化公司，在美国、中国香港设立了公司。华领医药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。公司核心产品华堂宁®（多格列艾汀片）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，改善患者血糖稳态失调。2022年9月30日，华堂宁®已获得中国国家药品监督管理局（NMPA）的上市批准，用于单独用药或者与二甲双胍联合用药，治疗成人2型糖尿病。对于肾功能不全患者，无需调整剂量，是一款可用于肾功能损伤的2型糖尿病患者的口服降糖药物。 详情垂询 华领医药 网址：www.huamedicine.com 投资者 电邮：ir@huamedicine.com 媒体 电邮：pr@huamedicine.com

Hua Medicine Announces that the Pharmaceutical Service of Hong Kong Department of Health of China has Officially Accepted the Application for Marketing Authorization of the New Drug Dorzagliatin Shanghai, China, September 29, 2025 Hong Kong Department of Health accepts NDA for dorzagliatin, the world's first approved glucokinase activator (GKA). Builds on  China approval and strong Phase III and real-world clinical results showing durable glucose control and safety. Positions Hong Kong as a strategic gateway for Hua Medicine’s global expansion into Southeast Asia and beyond. Hua Medicine ("the Company", HKEX: 2552) announced that the Department of Health of the Hong Kong Special Administrative Region of China accepted a New Drug Application (NDA) for dorzagliatin, the world’s first glucokinase activator (GKA) approved for the treatment of Type 2 diabetes (T2D).  The acceptance of the NDA marks an important milestone in Hua Medicine’s strategy to expand beyond China, bringing its innovative, disease-modifying treatment to more patients across Asia and ultimately to global markets. With more than half a million people living with diabetes in Hong Kong and nearly 240 million across Asia, the NDA represents a significant step toward addressing one of the region’s most urgent health challenges. A first-in-class therapy with global potential Dorzagliatin was approved for marketing by the China National Medical Products Administration (NMPA) in September 2022 for two indications, both to improve blood glucose control for T2D patients, 1) It can be used as mono-treatment for drug-naïve T2D patients, as first-line treatment, 2) When metformin hydrochloride alone has poor blood glucose control, it can be used in combination with metformin hydrochloride. Unlike conventional drugs that manage symptoms, dorzagliatin targets the root cause of blood sugar dysregulation by repairing the function of glucokinase (GK), the body’s glucose sensor. By restoring glucose sensitivity, dorzagliatin helps maintain blood sugar balance and supports long-term disease management. Results from two Phase III registration trials in China demonstrated that dorzagliatin significantly and sustainably lowered HbA1c levels, improved pancreatic β-cell function, and reduced insulin resistance, all while showing strong safety and tolerability.  Findings are being further validated in ongoing real-world studies, of which some interim analysis and data were presented at the 2025 American Diabetes Association (ADA) Scientific Sessions. Strategic gateway to new markets Hong Kong has established a comprehensive, community-based system for diabetes management and serves as a medical and financial hub for the region. Research findings from the Hong Kong Diabetes and Obesity Research Institute at The Chinese University of Hong Kong indicate that the implementation of a community-based public-private collaboration model for diabetes management provided significant benefits to the community. The advanced experience in Hong Kong is of great significance for improving the quality of life of diabetes patients, controlling the progression of the disease, and reducing the burden on the healthcare system. Once approved in Hong Kong, it will also provide clinical application of dorzagliation for the personalized management of diabetes. According to Hong Kong's former new drug approval mechanism, applicants were required to submit to the authority new drug registration certificates issued by the drug regulatory agencies of two or more recognized countries, as well as other specified relevant documents, in order to support the approval and marketing of the product. Under the newly established "1+" mechanism, after meeting requirements such as local clinical data support and having the applicable scope of the new drug endorsed by local experts, an applicant only needs to submit the approval from one (instead of the original two) reference drug regulatory authority to apply for registration of the new drug in Hong Kong. This mechanism initially applied to new drugs for the treatment of serious or rare diseases, and has been extended to all new drugs since 2024. Under the leadership of Ms. Beili Cao, Vice President of Department of Corporate Operation and Great Bay Development, Hua Medicine has conducted sufficient and in-depth communications with local clinical experts and regulatory authorities in Hong Kong, and became an early pioneer of this mechanism. The Company filed its application for registration of dorzagliatin in Hong Kong at the end of July, and the application was officially accepted by the end of September. Dr. Li Chen, Founder and Chief Executive Officer of Hua Medicine, said: Acceptance of dorzagliatin's NDA in Hong Kong is not only recognition of its clinical value but also a pivotal step in Hua Medicine’s international journey. Hong Kong’s unique position as a regional healthcare leader and financial hub makes it the ideal gateway for expanding dorzagliatin’s reach into Southeast Asia and beyond. We are committed to working with local doctors and partners in Hong Kong to explore dorzagliatin’s potential in both treatment and prevention of prediabetes and early-stage diabetes, ensuring more patients worldwide can benefit from this breakthrough therapy. Dorzagliatin: A transformative T2D treatment Dorzagliatin was approved in September 2022 in  China, and it was included in the country’s National Reimbursement Drug List (NRDL) as of January 1, 2024.  Dorzagliatin can be used alone as a first-line therapy for newly diagnosed patients, or together with metformin when blood sugar control is inadequate. Unlike many other approved oral antidiabetes drugs, no dose adjustment is required for patients with kidney impairment. It works by repairing the body’s glucose sensor, glucokinase (GK), restoring glucose sensitivity and long-term blood sugar balance. It acts across key organs—stimulating insulin secretion in the pancreas, boosting GLP-1 secretion in the gut, and regulating glycogen in the liver. This multi-target approach addresses the root cause of Type 2 diabetes, not just its symptoms. The NDA application in Hong Kong is based on the results of two Phase III registration clinical studies conducted in China evaluating the use of dorzagliatin monotherapy and in combination with metformin for the treatment of patients with Type 2 diabetes. Two studies have shown that for two categories of T2D patients—those newly diagnosed and not yet on medication, and those who have failed to respond adequately to metformin therapy— dorzagliatin can sustainably and effectively lower patients' HbA1c levels by repairing defects in the glucose sensor function of GK, significantly reduce postprandial two-hour blood glucose levels (2h-PPG), achieve high glycemic control rates without hypoglycemia, demonstrate good safety and tolerability, and continuously improve β-cell function and reduce insulin resistance.  Forward-Looking Statements This document contains statements regarding Hua Medicine’s future expectations, plans, and prospects for the Company and its products. These forward-looking statements pertain only to events or information as of the date they are made and may change due to future developments. Unless required by law, we are not obligated to update or publicly revise any forward-looking statements or unexpected events after the date of such statements, regardless of new information, future events, or other circumstances. Please read this document carefully and understand that our actual future performance or results may differ materially from expectations due to various risks, uncertainties, or other legal requirements. About Hua Medicine Hua Medicine (The "Company") is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine's cornerstone product HuaTangNing (dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin for adult T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with renal function impairment. For more information Hua Medicine Website: www.huamedicine.com Investors Email: ir@huamedicine.com Media Email: pr@huamedicine.com