多款多肽迎来审批与临床突破，儿童肥胖、2型糖尿病国际指南更新
本期导读 / CONTENTS
01 产品获批：丽珠亮丙瑞林3个月剂型、韩国首个本土GLP-1药物efpeglenatide
02 临床进展：伊可白滞素（Icotrokinra）、索弗度肽（Survodutide）、奥格列龙（Orforglipron）
03 临床指南：WHO儿童肥胖指南、ADA/EASD共识
PRODUCT APPROVALS
产品获批
上海丽珠亮丙瑞林微球3个月剂型获NMPA批准上市
Shanghai Livzon’s 3-month leuprorelin microspheres approved by NMPA
健康元药业集团发布公告称，旗下上海丽珠生产的注射用醋酸亮丙瑞林微球11.25mg（3个月剂型）获国家药监局批准上市[1]。该产品是“全球首个按照美国FDA个药指南完成生物等效性研究获批的促性腺激素释放激素（GnRH）类制剂”，填补了国内3个月长效缓释微球制剂的技术空白。
EN
Joincare Pharmaceutical Group issued an announcement stating that Leuprorelin Acetate Microspheres for Injection, 11.25 mg (3-month formulation), manufactured by Shanghai Livzon, obtained marketing approval from the National Medical Products Administration (NMPA). As the world’s first GnRH formulation approved following bioequivalence studies conducted in accordance with FDA product-specific guidance, it fills China’s technical gap for 3-month sustained-release microsphere formulations.
韩国MFDS批准韩美药业efpeglenatide：韩国首款国产GLP-1减重药
Korea's MFDS approves Hanmi Pharmaceutical’s Efpeglenatide: Korea's first domestic GLP‑1 weight‑loss drug
韩国食品医药品安全处（MFDS）10月7日批准韩美药业长效GLP-1受体激动剂efpeglenatide（商品名Eppe），每周一次皮下注射，用于无糖尿病的成人肥胖患者，或伴体重相关合并症的超重成人的慢性体重管理[2]，为韩国第45个国产新药。其在韩国进行的Ⅲ期临床试验报告显示，40周内平均减重9.02%–9.75%（安慰剂0.89%）[3]。
EN
The Ministry of Food and Drug Safety (MFDS) approved Hanmi Pharmaceutical's long-acting GLP-1 receptor agonist efpeglenatide (brand name: Eppe) on 7 October. Administered via once-weekly subcutaneous injection, the product is indicated for chronic weight management in non-diabetic adults with obesity, or overweight adults with weight-related comorbidities. It marks the 45th domestically originated new drug in South Korea. According to Phase 3 clinical trial data conducted in South Korea, the mean body weight reduction of 9.02%–9.75% over 40 weeks, versus 0.89% in the placebo group.
CLINICAL PROGRESS
临床进展
强生口服多肽Icotyde两年维持数据：银屑病清除率维持至第112周
Johnson & Johnson oral peptide Icotyde two-year maintenance data: psoriasis clearance sustained through week 112
强生在欧洲皮肤病学年会（EADV）公布Ⅲ期ICONIC-TOTAL：311例难治部位斑块状银屑病患者中，口服多肽IL-23R阻断剂Icotyde组皮损完全清除或几乎清除比例从第16周57%升至第112周70%。ICONIC-LEAD两年数据显示，684例患者中至少70%自第64周至第112周维持清除状态，≥44%达PASI 100，停药复发后复治85%在24周内重获应答，无新安全信号[4]。
EN
Johnson & Johnson presented Phase 3 ICONIC-TOTAL data at the European Academy of Dermatology and Venereology (EADV) congress. Among 311 patients with plaque psoriasis involving difficult-to-treat areas, the proportion achieving complete or near-complete skin clearance in the oral peptide IL‑23 receptor antagonist Icotyde group increased from 57% at Week 16 to 70% at Week 112. Two-year findings from the ICONIC-LEAD trial showed that at least 70% of 684 patients maintained clearance from Week 64 through Week 112, with ≥44% achieving PASI 100. Following relapse after treatment discontinuation, 85% of patients regained response within 24 weeks upon retreatment, and no new safety signals were identified.
勃林格殷格翰survodutide Ⅲ期SYNCHRONIZE-2达到共同主要终点
The Phase 3 SYNCHRONIZE‑2 trial of Boehringer Ingelheim’s survodutide met its co-primary endpoints
Glucagon/GLP-1双受体激动剂survodutide的Ⅲ期SYNCHRONIZE-2试验结果于EASD公布并发表于NEJM：755名超重/肥胖合并2型糖尿病成人，第76周（疗效估计法）体重最多降13.1%（安慰剂组3.1%）；HbA1c自基线7.4%下降1.21%（安慰剂0.03%）。18%受试者因胃肠不良反应停药（安慰剂1.2%）[5]。
EN
Phase 3 SYNCHRONIZE‑2 results for survodutide, a dual glucagon/GLP‑1 receptor agonist, were presented at the EASD Annual Meeting and published in the New England Journal of Medicine (NEJM). Among 755 adults with overweight or obesity and type 2 diabetes, the maximum estimated mean body weight reduction at Week 76 was 13.1% (versus 3.1% in the placebo group). HbA1c decreased by 1.21% from a baseline of 7.4% (versus 0.03% in the placebo group). Treatment discontinuation due to gastrointestinal adverse reactions occurred in 18% of participants (1.2% in the placebo group).
礼来口服GLP-1 Foundayo Ⅲ期ACHIEVE-4达心血管非劣终点
The Phase 3 ACHIEVE‑4 trial of Lilly’s oral GLP‑1 receptor agonist Foundayo met the cardiovascular non‑inferiority endpoint
礼来Ⅲ期ACHIEVE-4试验结果在EASD发布并刊于《柳叶刀》：2749名伴有心血管风险的2型糖尿病超重/肥胖成人中，每日一次口服小分子GLP-1药物Foundayo对MACE-4相对甘精胰岛素达非劣效（HR 0.84，95%CI 0.59–1.20）。第52周HbA1c降1.6%，甘精胰岛素组1.0%、体重降8.8%，甘精胰岛素组增加1.7%[6]。
EN
Phase 3 ACHIEVE‑4 results for Lilly’s Foundayo were presented at EASD and published in The Lancet. Among 2,749 overweight or obese adults with type 2 diabetes and elevated cardiovascular risk, once‑daily oral small‑molecule GLP‑1 agonist Foundayo achieved non‑inferiority versus insulin glargine for MACE‑4 (HR 0.84, 95%CI 0.59–1.20). At Week 52, HbA1c was reduced by 1.6% versus 1.0% reduction in the insulin glargine group; body weight decreased by 8.8%, while the insulin glargine group saw a 1.7% weight gain.
CLINICAL GUIDELINES
临床指南
WHO发布首个儿童青少年肥胖管理指南
WHO released first guideline on the management of childhood and adolescent obesity
WHO于10月7日发布首个针对儿童与青少年肥胖的管理指南[7]。对9岁及以下儿童，基于低质量证据强烈不建议使用减重药物；对10–19岁，仅在出现肥胖相关并发症（如2型糖尿病或血压控制不佳）且经至少6个月有监督的饮食、运动与行为干预无效后，才在专科团队长期随访下有条件建议用药。WHO指出现有试验普遍偏短，且GLP-1使用者因不良反应停药较多。
EN
WHO released its first guideline on the management of obesity in children and adolescents on 7 October. For children aged 9 years and younger, the guideline makes a strong recommendation against weight loss pharmacotherapy based on low certainty evidence. For individuals aged 10–19 years, pharmacotherapy is conditionally recommended only in the presence of obesity‑related complications such as type 2 diabetes or poorly controlled hypertension, and only after at least six months of supervised dietary, physical activity and behavioural interventions have failed. Long-term follow-up by a specialist team is required during pharmacotherapy. WHO notes that available trials are generally short in duration, and GLP‑1 recipients experience higher rates of treatment discontinuation due to adverse events.
ADA与EASD联合发布2026年2型糖尿病管理共识：对于合并其他疾病的患者，应考虑更早地联合使用SGLT2抑制剂和GLP-1类药物
ADA and EASD jointly released the 2026 Consensus Report on the management of type 2 diabetes: earlier combination therapy with SGLT2 inhibitors and GLP-1–based therapies should be considered in patients with comorbidities
美国糖尿病协会（ADA）与EASD在Diabetes Care与Diabetologia同步发布2026版2型糖尿病管理共识报告[8]。共识主张更早启用降糖药物以预防并发症，并按个体心血管与肾脏风险，将SGLT2抑制剂及GLP-1类药物前移用于改善疾病进程；同时设定个体化体重管理目标，并加强对非酒精性脂肪性肝病（MASLD）等共存疾病的关注。
EN
The American Diabetes Association (ADA) and EASD simultaneously published Management of Type 2 Diabetes, 2026 in Diabetes Care and Diabetologia. The consensus advocates earlier initiation of glucose-lowering medications to prevent complications. Based on individual cardiovascular and renal risk profiles, SGLT2 inhibitors and GLP‑1‑based therapies are to be used earlier to modify disease progression. The consensus also sets individualized weight-management targets and strengthens attention to comorbid conditions such as MASLD.
参考文献 / REFERENCES
[1] 丽珠医药集团股份有限公司。关于获得《药品补充申请批准通知书》的公告[EB/OL]. (2026-09-29)[2026-10-15].
[2] Peptide News Digest. South Korea approves Hanmi's efpeglenatide, its first homegrown GLP-1 obesity drug[EB/OL]. (2026-10-11)[2026-10-13].
[3] HANMI PHARMACEUTICAL CO., LTD. Eppe (efpeglenatide) approval and phase 3 clinical data in obesity[EB/OL]. (2026-10-07)[2026-10-13].
[4] JOHNSON & JOHNSON. Johnson & Johnson announces new Icotyde (icotrokinra) data in difficult-to-treat plaque psoriasis with proven durability through 2 years[EB/OL]. (2026-10-02)[2026-10-13].
[5] ZEALAND PHARMA A/S. Zealand Pharma announces Boehringer Ingelheim's survodutide achieves up to 13.1% weight loss in new phase 3 trial[EB/OL]. (2026-10-01)[2026-10-13].
[6] ELI LILLY AND COMPANY. Lilly's oral GLP-1, Foundayo (orforglipron), demonstrated cardiovascular safety alongside sustained A1C reduction and weight loss in its largest and longest type 2 diabetes study[EB/OL]. (2026-10-01)[2026-10-13].
[7] World Health Organization. WHO guidelines on the management of obesity in children and adolescents[EB/OL]. (2026-10-07)[2026-10-13].
[8] AMERICAN DIABETES ASSOCIATION, EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES. Leading diabetes organizations publish joint consensus report on the management of type 2 diabetes[EB/OL]. (2026-10-02)[2026-10-13].