首款！FDA批准创新小分子药物Cycle Pharmaceuticals日前宣布，美国FDA批准小分子药物Harliku（nitisinone）片剂用于降低成人尿黑酸尿症（AKU）患者尿液中尿黑酸（HGA）水平。根据新闻稿，Harliku成为首款获得FDA批准用于治疗AKU的药物。AKU是一种极罕见的遗传代谢病，患者体内HGA堆积可引发骨关节炎、褐黄病（ochronosis），以及肾脏和心脏并发症等严重问题。Harliku这次的获批主要基于一项随机研究的结果，共纳入40例AKU患者。研究显示，经过三年治疗，Harliku显著改善了患者的疼痛感、精力和身体功能，评估工具为36项简明健康调查表（SF-36）。无进展生存期延长超3倍！罗氏双抗与ADC组合3期试验亮眼结果公布罗氏（Roche）日前公布其3期SUNMO研究的最新成果。分析显示，其CD20/CD3靶向双特异性抗体Lunsumio（mosunetuzumab）联合CD79b靶向抗体偶联药物（ADC）Polivy（polatuzumab vedotin），在治疗无法进行造血干细胞移植的复发或难治性大B细胞淋巴瘤（R/R LBCL）患者

近日，由三优生物提供抗体药研发CPO，明慧医药研发创新的B7-H3靶向抗体偶联药物MHB088C已正式在中国启动针对难治性小细胞肺癌（SCLC）的III期注册临床试验（CTR20250586）。同时，明慧医药与齐鲁制药就MHB088C达成总额13.45亿元人民币的独家授权合作，创下中国ADC领域又一里程碑！MHB088C是明慧基于自主研发的SuperTopoi™ ADC技术平台打造的创新型B7-H3靶向抗体偶联药物，兼具更强的肿瘤杀伤效力与更优的安全性，显著拓宽了治疗窗口。三优生物有幸通过CPO业务模式助力明慧医药达成这一重要里程碑，协同明慧医药完成了临床前B7-H3抗体药物发现的关键工作。（更多三优ADC研发服务信息请阅读《三优ADC药物研发系统解决方案》）。三优生物CEO郎国竣博士表示：“我们由衷祝贺明慧医药MHB088C实现从科学概念到III期临床的飞跃，并达成与齐鲁制药的战略合作！期待这款中国创新的重磅ADC药物早日上市，为全球患者点燃生命新希望！”关于明慧医药明慧医药是一家处于临床后期阶段的生物制药公司，专注于开发创新药物，以满足肿瘤和自身免疫性疾病领域的未满足医疗需求。依托

Breakthrough Studies Demonstrate Stem Cell-Based Technologies as a Potential Alternative Treatment for Type 1 Diabetes CHICAGO, June 20, 2025 /PRNewswire/ -- Findings from two studies reveal advancements in stem cell-derived treatment options to treat type 1 diabetes. Results from the FORWARD study, also simultaneously published in the New England Journal of Medicine (NEJM), evaluating the first and only allogeneic, stem-cell derived, islet cell therapy and a study of genetically modified stem c

Hybrid closed-loop technology effectively helped women stay in target glucose range for longer compared to standard of care CHICAGO, June 20, 2025 /PRNewswire/ -- A new study shows pregnant women with type 1 diabetes stayed in the target blood glucose (blood sugar) range for pregnancy more often with an automated insulin delivery (AID) system (Control-IQ Technology) that is currently available for use—but not approved in pregnancy—compared to standard insulin delivery with injections or open-lo

New Studies Highlight Machine Learning as Potential Early Risk Detection Strategy CHICAGO, June 20, 2025 /PRNewswire/ -- Developments from two studies highlighting the potential for machine learning leveraging artificial intelligence (AI) technology to improve early-stage identification of type 1 diabetes were presented as late-breaking poster sessions at the 85th Scientific Sessions of the American Diabetes Association® (ADA) in Chicago. Each year, around 64,000 Americans are diagnosed with typ

Data supports the potential of future indication expansion for the MiniMed™ 780G system. LENNY trial results published in Lancet Diabetes & Endocrinology. GALWAY, Ireland and CHICAGO, June 20, 2025 /PRNewswire/ -- Medtronic, a global leader in healthcare technology, will present data at the American Diabetes Association (ADA) 85th Scientific Sessions in Chicago, highlighting improved glycemic outcomes for individuals with insulin-intensive type 2 diabetes on the MiniMed™ 780G* system under inves

Both subcutaneous and oral formulations will advance straight to phase 3 development based on completed clinical studies and feedback received from regulatory authorities1,2 PLAINSBORO, N.J., June 20, 2025 /PRNewswire/ -- Today, results from two early-phase clinical trials evaluating Novo Nordisk's amycretin, an innovative investigational obesity treatment designed to target appetite regulation, were published in The Lancet.1 In a phase 1b/2a clinical trial of 125 adults with overweight or obesi

New Research Demonstrates Significant Benefits of Simple Dietary Switch for Blood Glucose Control and Long-Term Weight Management CHICAGO, June 20, 2025 /PRNewswire/ -- Consistently replacing diet beverages with water in women with type 2 diabetes may contribute to greater weight loss and increases the likelihood of long-term diabetes remission. The results were presented as a general poster at the 85th Scientific Sessions of the American Diabetes Association® (ADA) in Chicago. Everyday, approxi

Randomized, controlled clinical trial presented as a late-breaking poster at ADA's Scientific Sessions shows people participating in Abbott's Healthy Food Rx ate more vegetables and fruit, and reported significantly improved health status. Abbott's Healthy Food Rx community-focused "food is medicine" program provides home-delivered healthy food boxes and nutrition education in Stockton, Calif., where 60% of the population has diabetes or pre-diabetes. CHICAGO, June 20, 2025 /PRNewswire/ -- Late-

肿瘤标志物（tumor marker，TM）很多，但每个指标什么意义，适用于什么肿瘤？笔者对其进行了总结，希望对大家有所帮助。一、常见、通用的肿瘤血清 TM1、癌胚抗原（CEA）CEA升高常见于大肠癌、胰腺癌、胃癌、乳腺癌、甲状腺髓样癌、肝癌、肺癌、卵巢癌、泌尿系肿瘤等。但吸烟、妊娠期和心血管疾病、糖尿病、肠道憩室炎、直肠息肉、结肠炎、胰腺炎、肝硬化、肝炎、肺部疾病等，15%～53%的患者血清CEA也会升高，所以CEA不是恶性肿瘤的特异性标志，在诊断上只有辅助价值。大量临床实践证实，术前或治疗前CEA浓度能明确预示肿瘤的状态、存活期及有无手术指征等。术前CEA浓度越低，说明病期越早，肿瘤转移、复发的可能越小，其生存时间越长；反之，术前CEA浓度越高说明病期较晚，难于切除，预后差。CEA检测还可对经手术或其他方法治疗使CEA恢复正常的病人，进行长期随访，监测其复发和转移。通常采用以下方案：术后第六周一次；术后三年内，每月一次；3～5年每三月一次；5～7年每半年一次；7年后一年一次。若发现升高，两周后再测一次，两次都升高则提示复发和转移。正常参考值≤5ng/mL2、癌抗原125（CA125