This study is designed to determine the pharmacokinetic and pharmacodynamic response of dorzagliatin 50 mg twice daily following 7-day administration in individuals with pancreatic insufficient cystic fibrosis and abnormal glucose tolerance when compared to randomized, double-blind 7-day administration of placebo in a cross-over fashion. We hypothesize that dorzagliatin administration will result in significant drug concentrations and improved glucose tolerance, early-phase insulin secretion, glucagon suppression, and hepatic glycogen storage assessed during a standardized mixed-meal tolerance test.

开始日期2025-10-21

申办/合作机构

University of Pennsylvania

NCT06976658

/ Recruiting临床2期IIT

Evaluating a Novel, Allosteric Glucokinase Activator in Monogenic Diabetes Secondary to Inactivating Glucokinase Mutations: a Randomised, Cross-over Trial

Evaluating a novel, allosteric glucokinase activator in monogenic diabetes secondary to inactivating glucokinase mutations: a randomised, cross-over trial

开始日期2025-04-30

申办/合作机构

香港中文大学

NCT06671340

/ Not yet recruitingN/AIIT

Effects of Repeated Dose of Dorzagliatin on Insulin Secretion, Glucagon Release and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes

A total of 30 subjects will be recruited 15 with intermediate hyperglycemia and 15 in the tyep 2 diabetes group respectively. Eligible participants will undergo hyperglycemic-clamp/oral glucose tolerance at baseline and after 4 weeks of dorzagliatin treatment.

开始日期2025-04-02

申办/合作机构

香港中文大学

100 项与多格列艾汀相关的临床结果

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100 项与多格列艾汀相关的转化医学

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100 项与多格列艾汀相关的专利（医药）

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项与多格列艾汀相关的文献（医药）

2026-04-15·FASEB JOURNAL

Contrasting Effects of Chronic Glucokinase Activation and Inhibition on Pancreatic Beta‐Cell Function

Article

作者: Alexandra C. Title ; Burcak Yesildag ; Elizabeth Haythorne ; Samuel J. Mullan ; Aerin J. Dumenil ; Alice Elphick ; Matthew Lloyd ; Chantal Rufer ; Frances M. Ashcroft ; Natascia Vedovato

ABSTRACT:

Chronic hyperglycaemia impairs insulin secretion by disrupting beta‐cell metabolism and reducing expression of insulin. These changes are mediated by glucose metabolites downstream of glucokinase. We hypothesized that chronically enhancing glucokinase activity at low glucose would mimic the effects of glucotoxicity and, conversely, that reducing glucokinase activity would prevent the deleterious effects of chronic hyperglycaemia. Human islet microtissues or INS‐1 cells were cultured at low or high glucose for 2 weeks (islets) or 48 h (INS‐1 cells) in the presence or absence of either a glucokinase activator (MK‐0941 or dorzagliatin) or a glucokinase inhibitor (mannoheptulose). We measured changes in glucose‐stimulated insulin secretion, insulin content, glycogen content, gene expression, and oxygen consumption. Chronic glucokinase activation in low‐glucose‐cultured islet microtissues and INS‐1 cells downregulated insulin secretion and content, impaired mitochondrial metabolism, and altered metabolic gene expression, to the same extent as high‐glucose culture. Conversely, reduction of glucokinase activity in high‐glucose‐cultured islet microtissues by mannoheptulose prevented the changes produced by chronic hyperglycaemia. Moreover, the effects of chronic hyperglycaemia on insulin secretion and metabolic gene expression (but not insulin content) were largely reversed by subsequent inhibition of glucokinase. Chronic glucokinase activation in euglycaemia thus mimics the effects of chronic hyperglycaemia, whereas partial inhibition of glucokinase in hyperglycaemia restores normal beta‐cell function. This explains why, in the long term, glucokinase activators are ineffective at controlling glycaemia in type 2 diabetes, and demonstrates that normalizing glucokinase activity can prevent and reverse chronic glucose toxicity.

2026-03-01·Cell Reports Medicine

Lipid-lowering and glucose-lowering drug targets differentially modulate antipsychotic treatment efficacy in schizophrenia

Article

作者: Sun, Yaoyao ; Yuan, Rui ; Zhu, Yunqing ; Yue, Weihua ; Feng, Xiaoyang ; Lu, Zhe ; Sun, Junyuan ; Yang, Yang ; Zhang, Yuyanan ; Kang, Zhewei ; Yu, Tong ; Guo, Jing ; Zhao, Guorui

Schizophrenia is frequently comorbid with dyslipidemia and hyperglycemia. However, whether metabolic-modifying agents aggravate schizophrenia progression remains unclear. We perform a drug-target genetic association study in two independent Han Chinese schizophrenia cohorts (N = 2,111/292 for discovery/validation). Leveraging metabolic genome-wide association studies, we generate genetic risk scores (GRSs) for lipid-modifying and hypoglycemic targets. Those with higher APOC3 (inhibited by volanesorsen/olezarsen) GRS exhibit attenuated triglycerides and improvement in negative symptoms assessed by Positive and Negative Syndrome Scale (PANSS) (β = 1.23, 95% confidence interval [CI]: 0.30-2.16). Higher GCK (activated by dorzagliatin) GRS is associated with decreased glucose and less improvement across PANSS total (β = -1.70, 95% CI: -2.91-0.50), positive, negative, general subscales. Causal associations of GCK are replicated in independent validation. The effects of APOC3 and GCK on negative symptom recovery are robust in hyperlipidemic/diabetic subgroups. Genetically proxied proteomics analysis provides further functional validation for the identified target-outcome associations. Our findings suggest volanesorsen/olezarsen as potential adjunctive candidates; dorzagliatin warrants prudence in schizophrenia with metabolic disturbance.

2026-02-01·DIABETOLOGIA

Modelling the effects of human SUR1 R1420H variation on insulin secretory function using isogenic iPSC-derived pancreatic islets

Article

作者: Baier, Leslie J ; Bogardus, Clifton ; Barkho, Katiya ; Traurig, Michael ; Cheranda, Koushik Ponnanna ; Nair, Anup K ; Sutherland, Jeffrey R ; Anup, Divya

Abstract:

Aims/hypothesis:

An R1420H variation in sulfonylurea receptor 1 (SUR1), a subunit of the K ATP channel, was previously identified in an Indigenous community in Arizona where a homozygous carrier (1420HH) had hyperinsulinaemic hypoglycaemia during infancy (HHI), suggestive of a K ATP channel loss of function (LoF). Interestingly, heterozygous carriers of this variation (1420RH, occurring in 3% of the community), had a twofold increased risk of type 2 diabetes. We aimed to create an isogenic induced pluripotent stem cell (iPSC)-derived pancreatic islet (SC-islet)-based platform to test whether the R1420H variant results in K ATP channel LoF, and to examine the distinct temporal effects of SUR1 1420HH and 1420RH K ATP channel variations on insulin secretion from developing and mature SC-islets.

Methods:

Using CRISPR-Cas9, isogenic iPSCs with all three genotypes (SUR1 1420RR, 1420RH and 1420HH) were generated from two different parental Indigenous American iPSC lines (IS1, isogenic cell lines derived from parental cell line 1; and IS2, isogenic cell lines derived from parental cell line 2). These isogenic cell lines were used to generate immature SC-islets (resembling fetal islets) and mature SC-islets (resembling adult islets), which were used to assess insulin secretion dynamics during different stages of development and identify differences in gene expression by single-cell RNA-seq. This study was consistent with the CONSIDER statement for research studies among Indigenous American communities.

Results:

Immature SUR1 1420HH SC-islets secreted 3.4-fold (IS1, p <0.001) and 4.2-fold (IS2, p =0.001) more insulin under basal conditions than normal (SUR1 1420RR) SC-islets. Modest hyperinsulinaemia was also seen in immature SUR1 1420RH SC-islets (2.2-fold [IS1] and 2.3-fold [IS2]) but the results were not statistically significant. After maturation, the 1420HH SC-islets failed to achieve glucose responsiveness whereas the 1420RH SC-islets achieved biphasic insulin secretion but had significantly lower glucose responsiveness than normal SC-islets (AUC for insulin secretion [as a % of total insulin] under high glucose challenge: 1.04 vs 0.56 in normal vs 1420RH SC-islets, p <0.001). Diazoxide reduced hyperinsulinaemia in SUR1 1420RH and 1420HH immature SC-islets, while tolbutamide elicited a greatly diminished or undetectable insulin secretory response from mature SUR1 1420RH SC-islets (13.2-fold increase in insulin secretion) and 1420HH SC-islets (1.9-fold increase) compared with normal SC-islets (31.5-fold increase). Results were directionally comparable for both IS1 and IS2 SC-islets. SUR1 1420RH SC-islets also responded to the glucokinase activator dorzagliatin with improvement in first-phase insulin secretory response (first-phase stimulation index: 3.9-fold vs 7.3-fold, p =0.01 [IS1, 11 mmol/l glucose ± dorzagliatin]; 5.5-fold vs 9.0-fold, p =0.13 [IS1, 20 mmol/l glucose ± dorzagliatin]). Single-cell RNA-seq identified dysregulated genes in SUR1 1420RH SC-beta cells, including lower expression of glycolytic genes and upregulation of G6PC2 , which could explain the lower insulin secretory response to glucose.

Conclusions/interpretation:

A SUR1 R1420H variant identified in an Indigenous American population causes hyperinsulinaemia in homozygous immature SC-islets during basal conditions and these SC-islets fail to achieve glucose responsiveness after maturation. In the heterozygous state, modest hyperinsulinaemia is observed in immature SC-islets, which after maturation have significantly lower glucose responsiveness. These results demonstrate that SUR1 R1420H is a K ATP channel LoF variation and suggest that a lower insulin secretory response during adulthood is the cause of the higher type 2 diabetes risk in individuals heterozygous for this variation. We also show that the isogenic iPSC-based platform can be used to test therapeutic agents to treat HHI in infants homozygous for LoF K ATP channels and screen for drugs that can improve glucose-responsive insulin secretion in adult heterozygous carriers.

Data availability:

See the database of Genotypes and Phenotypes (dbGaP; dbgap.ncbi.nlm.nih.gov/home; accession no.: phs002490.v1.p1) for details concerning data requests. All source codes can be found in the GitHub repository under https://github.com/Koushik-Cheranda/SC-islet-scRNAseq-analysis-R-codes .

Graphical Abstract:

391

项与多格列艾汀相关的新闻（医药）

2026-07-06

·华领医药

【新闻】华领医药与香港生物科技企业GemVCare达成科研合作协议，在香港开展真实世界研究

本新闻稿旨在概述华领医药与 GemVCare 达成科研协作的相关安排，仅供投资者、分析师及医疗卫生专业人士了解科研与企业动态之用。本文件不构成任何投资建议。其中涉及对未来预期、合作进展或监管时间表的描述均属前瞻性陈述，受各类风险及不确定因素影响，实际结果可能与预期存在重大差异。 2026年7月6日，中国上海华领医药（「公司」，香港联交所股份代号：2552）今日宣布，华领医药与香港生物科技企业GemVCare（简称GVC）达成科研合作协议，双方将依托各自核心优势，围绕公司核心产品——全球首创抗糖尿病新药葡萄糖激酶激活剂(GKA)多格列艾汀以及GVC的精准诊断技术，开展精准糖尿病管理真实世界临床研究协作，以完善该药在香港本地循证医学的临床应用。今年2月，多格列艾汀获得中华人民共和国香港特别行政区政府卫生署药物办公室的上市批准，成为香港“1+”药物监管创新机制开展以来，首个获批上市的慢性代谢病创新药。 GVC依托亚洲特色糖尿病生物样本库、糖尿病临床数据库与数字化诊疗平台，其创办人已经深耕糖尿病精准诊疗30余年，长期聚焦亚洲人群糖尿病诊疗数据挖掘与临床转化。GVC在香港进行与糖尿病相关的临床试验以取得监管批准、真实世界数据收集、药物经济学分析多方面拥有成熟落地经验。作为本次合作的科研赋能方，GVC将利用其专业体系，协助华领医药产出临床研究与真实世界证据，以提交香港医疗体系相关主管机构作药物经济学评估参考。这项结合精准诊断与优先治疗方案的合作，将彰显香港作为知识创建枢纽的实力，充分发挥精准医学的优势，使医疗保健得以持续发展，并协助人们过上更健康的生活。华领医药创始人、CEO陈力博士表示：“我们很高兴与GVC达成合作，并衷心期待此次合作能加速华领片®在香港医疗体系列入医保药品的进程，也为内地创新药出海港澳、搭建本土化临床研究与真实世界证据体系打造可参考范本。未来双方或将持续深化糖尿病领域研究及转化合作，挖掘亚洲糖尿病精准诊疗价值，惠及更多亚太地区糖尿病患者。” 关于华领医药华领医药（「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。 2026年2月，多格列艾汀（商品名：MYHOMSIS®，华领片®）获得中华人民共和国香港特别行政区政府卫生署药物办公室的上市批准。2026年6月，多格列艾汀获得中华人民共和国澳门特别行政区政府药物监督管理局的上市批准。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 关于GemVCare GemVCare于2014年获得香港特区政府创新科技署的「大学科技初创企业资助计划」支持而成立，并于香港科学园设化检测中心。是香港首间结合独有分析方法、先进分子技术和信息科技，针对糖尿病的预防、分类及治疗提供个人化医疗方案的公司。基于三十多年的研究，GemVCare的创办人使用全面的数据库来确定糖尿病的遗传因素和模式，是全球首批发现亚洲人独有的糖尿病基因标记的研究者之一。GemVCare已成功获得香港中文大学授权及转移这些技术以造福社区。请参阅以下链接了解最新动态。详情垂询网址：https://www.gemvcare.com/ 电邮：info@gemvcare.com 新闻免责声明本内容在任何情况下均不构成对任何药品的推荐、推广或用药建议。文中涉及的疗效、安全性或治疗潜力(如有)，均严格限于会议所展示的数据，并不暗示任何尚未获批适应症的监管批准。

2026-07-06

·华领医药

[NEWS] Hua Medicine Enters Research Collaboration Agreement with GemVCare to Generate RWE for Dorzagliatin in Hong Kong

This press release outlines the terms of the research collaboration reached between Hua Medicine and GemVCare. It is issued for informational purposes to shareholders, investors, analysts and healthcare professionals. Nothing in this release should be construed as investment advice. Where applicable, statements regarding future expectations, pipeline progression or regulatory timelines are forward-looking statements subject to risks and uncertainties — actual results may differ materially. Hua Medicine Enters Research Collaboration Agreement with GemVCare to Generate Real-World Evidence for Dorzagliatin in Hong Kong July 6, 2026 – Shanghai, China Hua Medicine ("the Company", Hong Kong Stock Exchange Stock Code: 2552) announced today that it has entered a scientific research collaboration agreement with GemVCare (referred to as GVC), a Hong Kong-based biotechnology enterprise. Leveraging their respective core strengths, the two parties will conduct joint clinical trial and real-world research using dorzagliatin (trade name: MYHOMSIS®, 華領片®), the Company’s global first-in-class glucokinase activator (GKA) and precision diagnostic tools of GVC for the management of Type 2 Diabetes (T2D), This collaboration aims to generate robust clinical evidence to support the drug's local clinical application in Hong Kong. In February 2026, dorzagliatin received marketing approval from the Pharmaceutical Service of the Department of Health of the Government of the Hong Kong Special Administrative Region of the People's Republic of China – marking a historic regulatory milestone as the first innovative drug for chronic metabolic disease approved under Hong Kong's "1+" innovative drug mechanism. This approval underscores the Company’s commitment to bringing transformative, first-in-class therapies to patients across Greater China and beyond. GVC brings singular expertise to this collaboration, encompassing Asia-specific diabetes biobanks, clinical diabetes databases and digital diagnosis and treatment platforms built through 30 years of focus on diabetes data-driven clinical translation for the Asian population. The founders of the firm have proven capabilities in Hong Kong-based clinical trials for regulatory approval, generation of real-world evidence and pharmacoeconomic analysis in diabetes, positioning it as an ideal research enabler for this partnership. As part of the collaboration, GVC will deploy its professional systems and data infrastructure to support Hua Medicine's aspiration to generate real-world evidence aligned with the requirements of Hong Kong's healthcare system. These evidence will be submitted to the relevant authorities to inform pharmacoeconomic evaluation for supporting its access to a broad population. This collaboration will also demonstrate the capability of Hong Kong as a hub of evidence generation and the value of precision medicine in pursuit of sustainable healthcare and help people live healthier lives. Dr. Li Chen, Founder and CEO of Hua Medicine, commented: “We are delighted to collaborate with GVC. This partnership will accelerate preparations for the access of dorzagliatin to Hong Kong's healthcare system with coverage. It will also set a replicable benchmark for innovative medicines from China expanding into Hong Kong and Macau through development of localized clinical trials and real-world evidence. Moving forward, the two sides intend to deepen clinical research cooperation in diabetes and unlock the value of precision medicine to benefit more patients with diabetes across the Asia-Pacific region. 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 patients with type 2 diabetes (T2D), and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30, 2022. It can be used alone or in combination with metformin for adult patients with T2D. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral glucose lowering drug that can be used in patients with T2D with renal function impairment. In February 2026, dorzagliatin (trade name: MYHOMSIS®, 華領片®) was approved for marketing by the Pharmaceutical Service of the Department of Health of the Government of the Hong Kong Special Administrative Region of the People's Republic of China. In June, dorzagliatin (trade name: MYHOMSIS®, 華領片®) was approved for marketing by the Pharmaceutical Administration Bureau of Macao Special Administrative Region of the People's Republic of China. For more information Hua Medicine Website: www.huamedicine.com Investors Email: ir@huamedicine.com Media Email: pr@huamedicine.com About GemVCare GemVCare was founded in 2014 supported by the Technology Start-up Support Scheme for Universities of the Hong Kong Government Innovation and Technology Commission and based at the Hong Kong Science and Technology Park. It is the first company that combines proprietary algorithms, state-of-the-art molecular techniques and information technology to offer personalized solutions for prevention, classification and treatment of diabetes. Based on three decades of research, our founders used comprehensive databases to define the genetic causes and patterns of diabetes and are amongst the first researchers in the world to discover diabetes gene markers specific for Asian people. GemVCare has successfully licensed and transferred these technologies from The Chinese University of Hong Kong to benefit the community. For more information Website: https://www.gemvcare.com/ Email: info@gemvcare.com Disclaimer Nothing in this content constitutes a recommendation, promotion, or medical advice regarding any pharmaceutical product. References to efficacy, safety, or therapeutic potential relate strictly to data presented at the meeting and do not imply regulatory approval for any unapproved indications.

2026-07-05

·今日头条

别只知道恒瑞！14家创新药核心企业盘点，全是干货

大家好我是金桔，每天给大家带来最新动态，内容随缘更，每篇都掏干货；如果你觉得这些信息对你有用，就点个关注～进入7月，创新药板块悄悄回暖，我翻了几十份公告、临床数据和医保初审名单，最大的感受就是：这个行业真的彻底变天了。前几年炒创新药，全是蹭靶点、讲故事，谁管线铺得多谁涨得凶，最后一地鸡毛。现在不一样了，市场越来越认硬实力：临床数据够不够硬、能不能出海赚老外的钱、有没有实打实的销售额、细分赛道有没有真壁垒。前两年我去参加行业峰会，大家张口闭口都是靶点数量；今年再去，聊的全是临床数据和海外订单。风向转得特别快。从恒瑞、百济这样的综合巨头，到药明康德这样的全球平台，再到一批深耕细分赛道的黑马，整个产业链的玩家都找到了自己的路子。今天我整理了14家行业里最有代表性的企业，各自的王牌、最新进展、核心打法，全用大白话讲清楚。内容全是公开信息整理，纯干货，建议先收藏再慢慢看。一、先搞懂：现在的创新药，到底看什么？很多人对创新药的印象还停留在“烧钱、讲故事、跌跌不休”，其实这两年行业已经完成了一轮洗牌。两个最明显的变化，是所有人都能感受到的。第一个，国产新药真的能打了。不再是以前的me-too仿创，现在ADC、双抗、三抗这些前沿技术，国内企业已经能跟上全球第一梯队，甚至有的靶点还能领跑，研究成果能登上《柳叶刀》、能在ASCO全体大会汇报，这在五年前是想都不敢想的。第二个，出海从“喊口号”变成了“真收钱”。以前说出海就是去美国开个临床撑门面，现在动辄几十亿美金的授权合作，首付款、里程碑、销售提成，真金白银的海外收入占比越来越高。说白了，行业已经从“炒预期”进入了“兑现阶段”，有真东西的企业会慢慢跑出来，纯蹭概念的迟早被淘汰。二、14家核心企业全梳理，各有各的王牌我把这14家分成了四类，大家可以对应着看，一目了然。第一类：综合型研发巨头，家底厚、管线全这类企业是行业的压舱石，研发、生产、商业化全链条都强，抗风险能力也最高。 1. 恒瑞医药国内创新药的老牌龙头，研发投入常年稳居第一，走的是广撒网、多管线的路子，肿瘤、代谢、自身免疫病全覆盖。 2026年以来进展很密集，PD-L1/TGF-β双抗瑞拉芙普α获批上市，瑞康曲妥珠单抗新增乳腺癌适应症，同时还有三款新药针对肝癌开启三期临床。虽然经历过医保谈判的阵痛，但底子还在，新管线逐步落地，韧性很强。 2. 百济神州国内国际化走得最远的创新药企，核心产品泽布替尼是名副其实的出海标杆。今年6月最新数据，泽布替尼一线治疗套细胞淋巴瘤的全球三期临床达到主要终点，比标准化疗降低了43%的疾病进展风险，计划下半年全球申报。2025年全年产品收入377.7亿，同比增长近40%，研发和商业化两头都硬，海外收入占比还在持续提升。 3. 信达生物国内商业化能力最强的创新药企之一，PD-1信迪利单抗牢牢占据国内市场第一梯队，生物类似药管线也贡献了稳定的现金流。这两年在ADC、眼科、代谢领域持续布局，多条管线进入临床后期，走的是“基本盘稳固+新管线突破”的稳扎稳打路线，抗周期能力很强。 4. 君实生物以PD-1特瑞普利单抗起家，这两年在自身免疫领域动作很大。 6月底刚和复星医药达成合作，把自主研发的IL-17A单抗大中华区权益授权出去，能拿到2.15亿首付款，最高11.25亿里程碑款加销售提成。这种“自主研发+成熟管线对外合作”的打法，既能回笼资金，又能集中精力做前沿管线，性价比很高。第二类：全球CXO平台，卖铲子的常胜将军创新药研发越热，CXO的生意就越稳。不管哪家药企研发成功失败，都得给CXO付钱。 5. 药明康德全球制药行业的“研发代工厂”，从分子筛选到临床用药生产，全链条都能做，规模和服务能力都是全球第一梯队。 2026年一季度营收124.4亿，同比增长28.8%，首次单季破百亿；截至3月底在手订单597.7亿，后续增长确定性很高。还在加速全球产能布局，美国、瑞士的基地都在扩建，行业龙头的地位很难撼动。第三类：ADC/双抗技术派，靠硬实力突围这几年ADC、双抗是创新药最火的赛道，也是出海授权的主力，跑出了不少黑马。 6. 科伦药业以前靠大输液起家，这几年创新转型成效特别显著，核心就是ADC平台。核心产品SKB264是TROP2 ADC，临床数据全球领先，进医保后销量快速爬坡。旗下科伦博泰的ADC平台持续产出新药，双抗ADC、海外授权都在推进，属于“传统业务保底，创新业务逐步兑现”的稳中求进类型。 7. 荣昌生物国内ADC赛道的先行者，核心产品维迪西妥单抗是首个国产ADC。今年开年就拿下了行业重磅合作，把PD-1/VEGF双抗RC148的海外权益授权给艾伯维，6.5亿美元首付款创下今年纪录，加上里程碑总金额超55亿美元。ADC+双抗双平台驱动，技术价值持续兑现。 8. 泽璟制药小而美的研发驱动型公司，今年接连落地两个重磅里程碑。一个是治疗重度斑秃的吉卡昔替尼片6月获批上市，另一个是和艾伯维达成超10亿美金的全球合作，把三特异性抗体ZG006的海外权益授权出去。这款药是全球首个DLL3靶点三抗，技术含量很高，属于靠重磅品种出海实现价值的典型。 9. 康方生物双抗赛道的龙头企业，今年6月凭实力站上了全球舞台。自主研发的依沃西单抗在ASCO全体大会公布肺鳞癌三期数据，总生存期显著优于标准PD-1疗法，研究成果同步登上《柳叶刀》主刊，是中国原创新药的里程碑突破。技术平台壁垒清晰，后续管线推进也很稳。第四类：细分赛道深耕者，小赛道里做大生意不追求全管线铺开，专注一两个细分领域做到极致，反而能跑出自己的护城河。 10. 众生药业聚焦呼吸和代谢疾病领域，走差异化路线，不挤肿瘤赛道的红海。抗流感新药昂拉地韦的上市申请5月已经获受理，减重药RAY1225的三期临床已经完成入组，脂肪肝药物的二期数据也很不错。细分领域竞争小、政策压力也小，确定性反而更高。 11. 信立泰以前做仿制药起家，现在创新药收入已经超过了仿制药，2025年创新药收入近20亿，同比增长47%。专注慢病赛道，从高血压到高血脂逐步扩展，6款新药已经进了医保。最新的siRNA降脂药，临床前显示打一针能管140天，长效性优势很明显，慢病患者依从性会好很多。近期板块回暖，它的走势也很强劲。 12. 再鼎医药国内license-in模式的标杆，专门从海外引进处于后期的best-in-class药物，快速推进国内上市商业化。这种模式研发风险小、落地速度快，已经有多款产品实现商业化，后续管线储备也很充足，擅长把全球好药快速引进国内。 13. 微芯生物国内原创新药的先行者，核心产品西达本胺是全球首个亚型选择性HDAC抑制剂，多适应症持续拓展。坚持做真正的first-in-class药物，虽然研发周期长，但一旦成功，壁垒也极高，是国内少有的坚持源头创新的企业。 14. 华领医药专注糖尿病领域，核心产品多格列艾汀是全球首个葡萄糖激酶激活剂，作用机制全新，针对糖尿病根源治疗。慢病赛道空间大，一旦进院放量，业绩的持续性很强，属于在大赛道里做差异化创新的代表。三、普通人看创新药，记住三点少踩坑聊完企业，也跟大家说点实在的。普通人接触创新药，不管是买基金还是看个股，记住三个原则，能避开大部分坑。第一，别光听故事，要看数据和落地。什么“全球首创”“潜力巨大”都没用，要看临床数据够不够硬、有没有获批上市、卖了多少钱。没落地的故事，再好听也别信。第二，别迷信靶点多，要看能不能出海。国内市场就这么大，医保谈判还会压价，真正的成长空间在海外。能拿到跨国药企大额授权、能在欧美申报上市的，才是真有实力。第三，别追高炒热点。创新药波动大，每次板块一涨就有各种“黄金十年”的声音，这时候冲进去大概率站岗。反而在行业低迷、没人关注的时候，布局有真东西的企业，胜率更高。最后说句掏心窝子的话总的来说，现在的创新药行业，已经不是以前那个炒概念的阶段了。真研发、真出海、真业绩，才是未来的主线。这14家企业，各有各的优势，也各有各的风险，没有绝对的好坏，只有适不适合自己的投资风格。当然我也不是推荐大家去买，只是把行业里最有代表性的玩家梳理清楚，帮大家建立一个基本的认知框架。投资这件事，永远是认知到位了，钱才能赚得明白。话题讨论：你最看好创新药哪个细分赛道？是ADC、双抗还是慢病创新药？欢迎在评论区聊聊你的真实看法。觉得文章有用的朋友可以点赞收藏，点个关注，我是金桔，后续会持续跟大家跟踪创新药行业的最新进展、管线解读和投资逻辑，用大白话讲透硬核行业，帮大家少走弯路。免责声明：本文仅为行业观点与公开信息整理，不构成任何投资建议。医药行业研发、政策风险较高，决策请结合自身风险承受能力谨慎判断。

引进/卖出抗体药物偶联物ASCO会议临床3期

100 项与多格列艾汀相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11342	-	-	DB15123

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
2型糖尿病	中国	华领医药技术（上海）有限公司	2022-09-30

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
葡萄糖耐受不良	临床2期	-	香港中文大学	2022-08-01
高血糖	临床阶段不明	中国香港	香港中文大学	2025-04-02
糖尿病肾病	临床申请	中国	华领医药技术（上海）有限公司	-
虚弱综合症	临床前	中国	华领医药有限公司	2026-03-27
成年发病型糖尿病2型	临床前	中国	华领医药有限公司	2026-03-27
轻度认知障碍	临床前	中国	华领医药有限公司	2026-03-27
阿尔茨海默症	临床前	中国	华领医药技术（上海）有限公司	2022-10-13
1型糖尿病	临床前	中国	华领医药技术（上海）有限公司	2022-10-13
代谢功能障碍相关脂肪性肝炎	临床前	中国	华领医药技术（上海）有限公司	2022-10-13
代谢综合征	临床前	中国	华领医药技术（上海）有限公司	2017-12-11

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03790787 (Pubmed \| Nat Commun)	临床1期	2型糖尿病 \| 肥胖	16	Dorzagliatin+Empagliflozin	鏇鹽膚簾鑰壓繭遞糧獵(鑰範選願衊膚憲簾網鬱) = 構窪蓋餘壓網膚憲願繭憲築壓積襯夢艱窪網廠 (範積憲鬱壓鬱糧鬱築襯 ) 更多	积极	2026-04-21
ADA 12025 \| ADA 22025 人工标引	N/A	2型糖尿病	72	Dorzagliatin	糧鏇積鬱構夢築鑰鏇壓(選簾壓壓鑰鬱鑰願餘艱) = 遞願襯遞範窪鏇積構顧壓蓋鹽範憲糧齋鹽鑰鬱 (網網壓構廠餘觸襯襯淵 ) 更多	积极	2025-06-20
DREAM (ADA2022)	N/A	2型糖尿病	69	Dorzagliatin	壓憲鏇遞廠蓋願獵齋窪(窪遞鏇鑰鏇選鬱夢醖廠) = 糧鏇繭壓衊構遞淵淵顧鏇餘鬱簾壓遞鏇鹽鹽遞 (壓襯齋夢夢醖夢蓋顧醖, 53.4 ~ 77.0)	-	2022-06-01
NCT03173391 (SEED, Pubmed) 人工标引	临床3期	2型糖尿病	463	Dorzagliatin	積鬱餘鑰築鏇夢鹽鑰憲(艱簾製淵壓鏇鏇淵鏇鹹) = 鹹鬱獵齋廠餘鬱艱鬱蓋醖顧簾鹽窪觸遞繭構夢 (顧構觸範遞觸鹽醖積醖, -1.19 ~ -0.95)	积极	2022-05-12
				Placebo	積鬱餘鑰築鏇夢鹽鑰憲(艱簾製淵壓鏇鏇淵鏇鹹) = 壓窪積憲壓齋構網蓋選醖顧簾鹽窪觸遞繭構夢 (顧構觸範遞觸鹽醖積醖, -0.68 ~ -0.32)
NCT03141073 (DAWN, Pubmed \| Nat Med) 人工标引	临床3期	2型糖尿病	767	metformin+Dorzagliatin	鑰糧艱艱繭淵窪淵鏇壓(製醖蓋網壓餘窪繭網獵) = 襯廠鏇積衊鹹鹽獵鹹選鹽選繭蓋簾觸獵構壓簾 (鹹遞獵鏇鹽夢積鏇艱餘, -1.11 ~ -0.93)	积极	2022-05-12
				metformin+Placebo	鑰糧艱艱繭淵窪淵鏇壓(製醖蓋網壓餘窪繭網獵) = 蓋簾鏇積廠構製餘壓範鹽選繭蓋簾觸獵構壓簾 (鹹遞獵鏇鹽夢積鏇艱餘, -0.45 ~ -0.26)
NCT03173391 (SEED, ADA2021)	N/A	2型糖尿病	463	Dorzagliatin 75 mg	遞壓醖遞壓夢齋醖簾糧(積顧鹽糧構製鬱鏇齋鹹) = 簾鏇膚膚淵衊廠壓築鹹餘簾選鬱顧艱蓋鬱壓簾 (願襯憲衊鹽繭觸糧蓋醖 ) 更多	积极	2021-06-01
				Placebo	範蓋積壓鹹網壓觸窪築(淵鬱願廠範醖艱蓋觸鹽) = 壓網壓觸艱願餘遞顧糧顧積簾廠蓋膚願鏇膚壓 (顧遞積壓廠網觸遞製襯 )
NCT03141073 (DAWN, ADA2021)	N/A	2型糖尿病追加	767	Dorzagliatin	構鬱鏇選鹹餘淵鏇鏇鹹(衊膚顧壓獵窪積鬱壓夢) = 觸鹽遞築窪選窪積築範壓襯膚鹹範窪窪餘窪淵 (鏇夢鏇積憲鹽觸積遞鬱 )	积极	2021-06-01
				Placebo	構鬱鏇選鹹餘淵鏇鏇鹹(衊膚顧壓獵窪積鬱壓夢) = 遞簾鹽鬱齋觸窪觸鹽壓壓襯膚鹹範窪窪餘窪淵 (鏇夢鏇積憲鹽觸積遞鬱 )
NCT03173391 (HMM0301 \| SEED, NEWS) 人工标引	临床3期	2型糖尿病	463	Dorzagliatin	簾願繭夢蓋鹹願壓窪襯(夢範艱廠鏇觸鏇鬱醖憲) = 鬱膚蓋衊蓋顧壓廠鹽構壓蓋網遞醖窪願夢積醖 (鬱艱醖積遞憲鏇製願構 ) 更多	积极	2020-06-18
				Placebo	簾願繭夢蓋鹹願壓窪襯(夢範艱廠鏇觸鏇鬱醖憲) = 淵鏇鏇蓋餘繭鏇窪窪簾壓蓋網遞醖窪願夢積醖 (鬱艱醖積遞憲鏇製願構 ) 更多
ADA2020	N/A	2型糖尿病	463	Dorzagliatin 75 mg	積鏇廠蓋糧繭繭廠蓋鹽(襯鏇簾遞顧獵築衊衊鑰) = 淵鑰襯鑰膚遞製鏇憲壓鑰齋蓋糧鹽襯觸夢選構 (壓醖遞餘齋構衊鹽選網 ) 更多	积极	2020-06-01
				Placebo	糧網糧獵遞膚夢構窪範(餘築繭艱夢選憲齋襯膚) = 構蓋夢餘築獵廠醖夢鹽遞鏇齋窪餘齋築夢鑰衊 (齋遞蓋夢淵夢鏇齋簾壓 ) 更多
NCT02561338 (CTgov)	临床2期	2型糖尿病	258	HMS5552 (HMS5552 Dose 1)	廠範繭顧夢積醖顧衊範(選蓋積廠築淵遞簾構艱) = 廠鬱餘簾齋鏇衊簾醖願壓製構糧壓醖壓範餘廠 (壓艱構夢鏇獵遞鏇鏇構, 遞壓構願淵醖鑰築襯醖 ~ 壓鏇築獵簾積憲衊鑰壓) 更多	-	2020-03-10
				HMS5552 (HMS5552 Dose 2)	廠範繭顧夢積醖顧衊範(選蓋積廠築淵遞簾構艱) = 鹹憲製鏇製鑰繭範餘衊壓製構糧壓醖壓範餘廠 (壓艱構夢鏇獵遞鏇鏇構, 選蓋網壓鑰選壓製鑰衊 ~ 鬱鬱齋鏇製憲鹽醖壓積) 更多