本期导读 / CONTENTS
01 临床进展：安进AMG133、瑞他鲁肽（Retatrutide）、奥格列龙（Orforglipron）、伊可白滞素（Icotrokinra）
02 监管动态：司美格鲁肽CKD适应症获专利补偿；FDA要求GLP‑1类药物新增NAION风险警示
01
CLINICAL PROGRESS临床进展
安进每月一次减重药AMG133在中国启动Ⅲ期临床
Amgen initiates a Phase 3 clinical trial in China for its once‑monthly investigational weight‑loss agent AMG133
药物临床试验登记与信息公示平台显示，安进在中国登记了一项III期临床试验（登记号CTR20264119），评估其减重候选药物Maridebart Cafraglutide（AMG 133）在肥胖或超重、且伴有至少一种体重相关合并症的中国成人中的疗效、安全性和耐受性[1]。该研究为随机、双盲、安慰剂对照、平行组设计，将在国内35家医疗机构开展，拟入组300人，主要终点为治疗52周时体重较基线的变化百分比。
EN
According to the China Drug Trial Registration and Information Disclosure Platform, Amgen has registered a Phase 3 clinical trial (registration number: CTR20264119) in China to evaluate the efficacy, safety and tolerability of its weight-loss agent, Maridebart Cafraglutide (AMG 133), in obese or overweight Chinese adults with at least one weight-related comorbidity. This randomized, double-blind, placebo-controlled, parallel-group study will be conducted at 35 medical institutions across China, with a planned enrollment of 300 participants. The primary endpoint is the percentage change in body weight from baseline at week 52 of treatment.
礼来三靶点药物Retatrutide显著缓解肥胖合并膝骨关节炎疼痛
Lilly’s triple‑receptor agonist Retatrutide significantly relieves pain in obese patients with knee osteoarthritis
礼来于ACR Convergence2026公布三靶点药物retatrutide的III期TRIUMPH‑4研究数据[2]。在肥胖合并膝骨关节炎受试者中，经68周给药，12 mg组平均减重28.7%，WOMAC疼痛评分最高下降75.8%，约12.5%患者疼痛完全缓解，关节功能、僵硬情况及炎症指标同步改善。安慰剂组平均减重2.1%，WOMAC疼痛评分降幅40.3%，仅4.2%受试者疼痛完全缓解[3]。
EN
Lilly presented Phase 3 TRIUMPH‑4 data of its triple receptor agonist retatrutide at ACR Convergence 2026. Among participants with obesity and knee osteoarthritis, after 68 weeks of treatment, the 12 mg group achieved a mean weight loss of 28.7%, and the WOMAC pain score decreased by up to 75.8%. Approximately 12.5% of patients attained complete pain relief, with concurrent improvements in joint function, stiffness and inflammatory markers. The placebo group had a mean weight loss of 2.1% and a 40.3% reduction in WOMAC pain score, while only 4.2% of participants achieved complete pain relief.
礼来口服GLP-1药物Foundayo治疗中重度睡眠呼吸暂停Ⅲ期临床试验取得积极结果
Lilly’s oral GLP‑1 drug Foundayo achieved positive results in a Phase 3 clinical trial for moderate‑to‑severe obstructive sleep apnea
礼来公布其每日口服GLP-1受体激动剂Foundayo（orforglipron）治疗中重度阻塞性睡眠呼吸暂停（OSA）已达到主要终点[4]。在患有中重度OSA且肥胖或超重的成人中，Foundayo可使睡眠期间的呼吸中断平均减少高达44%，其中高达32%的参与者达到缓解或转为轻度OSA。此外，Foundayo还能将睡眠呼吸暂停特异性低氧负荷平均降低高达55.9%，从而改善睡眠期间的血氧水平。礼来计划于2026年底前向FDA提交Foundayo用于该适应症的监管申请。
EN
Lilly announced that Foundayo (orforglipron), its once‑daily oral GLP‑1 receptor agonist, had met the primary endpoint in the Phase 3 trial for moderate‑to‑severe obstructive sleep apnea (OSA). In adults with moderate-to-severe OSA and obesity or overweight, Foundayo reduced breathing interruptions during sleep by an average of up to 44%, with up to 32% of participants achieving remission or conversion to mild OSA. Foundayo also reduced sleep apnea-specific hypoxic burden by an average of up to 55.9%, improving oxygen levels during sleep. Lilly plans to submit the regulatory application of Foundayo to the U.S. FDA for this indication by the end of 2026.
强生口服IL-23R环肽抑制剂Icotrokinra Ⅲ期治疗银屑病关节炎达主要终点
Johnson & Johnson's oral IL-23R cyclic peptide inhibitor Icotrokinra achieved the primary endpoint in a Phase 3 trial for psoriatic arthritis
强生公布其每日口服一次的icotrokinra在ICONIC‑PsA1 Ⅲ期研究中达到主要终点，该试验受试者为既往未接受过生物制剂治疗的活动性银屑病关节炎成人患者[5]。数据结果显示，200mg给药组疗效随治疗时间持续提升。治疗16周，Icotrokinra组ACR20应答率58%，安慰剂组41%，ACR50为29%，安慰剂组16%，ACR70为13%，安慰剂组仅5%。16周时IGA 0/1（皮损清除或几乎清除）比例达到57%，安慰剂组仅14%。延长至24周，ACR20、ACR50、ACR70应答率分别提升至69%、40%、18%，IGA 0/1比例上升至64%。
EN
Johnson & Johnson announced that its once‑daily oral icotrokinra achieved the primary endpoint in the Phase 3 ICONIC‑PsA 1 trial. The study enrolled adult participants with active psoriatic arthritis who had not previously received biologic therapy. The data showed that efficacy in the 200 mg group continued to improve over the course of treatment. At week 16, the ACR20 response rate was 58% in the icotrokinra group versus 41% in the placebo group, the ACR50 rate was 29% versus 16%, and the ACR70 rate was 13% versus 5%. The proportion of patients achieving IGA 0/1 (clear or almost clear skin) reached 57%, versus 14% in the placebo group. At week 24 of the study extension, the response rates of ACR20, ACR50, and ACR70 increased to 69%, 40%, and 18% respectively, and the proportion of patients achieving IGA 0/1 increased to 64%.
02
REGULATORY DEVELOPMENTS监管动态
诺和诺德司美格鲁肽慢性肾脏病相关适应症获药品专利权期限补偿，专利保护期延至2031年
Novo Nordisk’s semaglutide for chronic kidney disease-related indications receives patent term extension, extending the patent protection period to 2031 in China
诺和诺德诺和泰®（司美格鲁肽注射液）慢性肾脏病（CKD）适应症相关发明专利的药品专利权期限补偿已获国家知识产权局（CNIPA）批准，补偿期限5年，该适应症相关专利保护期延长至2031年3月[6]。诺和泰®是中国首个且目前唯一获批慢性肾脏病适应症的GLP-1受体激动剂，可用于降低伴有慢性肾脏病2型糖尿病成人患者的估算肾小球滤过率（eGFR）持续下降、终末期肾病和心血管死亡的风险。
EN
Novo Nordisk has secured approval from the China National Intellectual Property Administration (CNIPA) for patent term extension on the invention patent related to the chronic kidney disease (CKD) indication of Ozempic® (semaglutide injection). The extension lasts five years, extending the patent protection term for this indication to March 2031. Ozempic® is the first and currently the only GLP‑1 receptor agonist approved in China for the CKD indication. It is indicated to lower the risk of sustained estimated glomerular filtration rate (eGFR) decline, end‑stage kidney disease and cardiovascular death in adult patients with type 2 diabetes and concomitant chronic kidney disease.
FDA要求全部GLP‑1受体激动剂说明书新增NAION罕见眼病风险警示
FDA requires a new warning for the rare NAION eye risk in the labeling of all GLP‑1 receptor agonists
FDA发布药物安全通讯，要求所有已上市GLP‑1受体激动剂在药品说明书警告与注意事项板块，增加非动脉炎性前部缺血性视神经病变（NAION）的潜在风险提示，本次为类别级标签变更，并非针对单一品种[7]。NAION俗称眼中风，典型表现为单眼突发、无痛性视力下降、视野缺损、色觉异常，严重时可造成永久性视力损伤，目前尚无公认有效的治疗手段[8]。监管机构强调该事件绝对风险偏低，目前尚未确立明确因果关系，仅为潜在风险信号。
EN
The FDA issued a drug safety communication requiring all marketed GLP‑1 receptor agonists to add a warning about non-arteritic anterior ischemic optic neuropathy (NAION) to the warnings and precautions section of their prescribing information. This is a class-wide labeling change and is not specific to any single product. NAION, commonly known as “eye stroke”, typically presents with sudden, painless monocular vision loss, visual field defects and dyschromatopsia, and may lead to permanent visual impairment in severe cases. There is no universally effective treatment at present. The regulator notes that while the absolute risk of this event is low and a definitive causal relationship has not yet been established, the warning reflects a potential risk signal.
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参考文献 / REFERENCES
[1] 安进生物技术咨询（上海）有限公司，Amgen Inc., Amgen Europe B.V. 一项在肥胖或超重且伴有体重相关合并症的中国成人参与者中评价Maridebart Cafraglutide的疗效、安全性和耐受性的随机、双盲、安慰剂对照、III期试验: CTR20264119 [EB/OL]. (2026-11-02)[2026-11-09].
[2] Eli Lilly and Company. Lilly to showcase new retatrutide, Taltz (ixekizumab) and Zepbound (tirzepatide) data at ACR Convergence 2026, advancing science at the intersection of rheumatologic conditions and obesity[EB/OL]. (2026‑11‑05)[2026‑11‑09].
[3] SCHNITZER T J, CONAGHAN P, et al. Retatrutide once weekly in adults with knee osteoarthritis pain and obesity[J]. New England Journal of Medicine, 2026. DOI:10.1056/NEJMoa2610676.
[4] Eli Lilly and Company. Lilly's Foundayo (orforglipron) significantly reduced obstructive sleep apnea severity, reinforcing its potential to improve health beyond weight loss[EB/OL]. (2026‑11‑09)[2026‑11‑10].
[5] Johnson & Johnson. Johnson & Johnson announces ICOTYDE® (icotrokinra) delivers significant improvement in psoriatic arthritis disease activity among biologic-naive patients with once-daily targeted oral peptide[EB/OL]. (2026-11-07)[2026-11-10].
[6] 诺和诺德中国. 诺和泰® 慢性肾脏病适应症获批专利权期限补偿，药品创新价值再获认可和保护[EB/OL]. (2026-11-10)[2026-11-12].
[7] U.S. Food and Drug Administration. FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition: Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)[EB/OL]. (2026-11-09)[2026-11-12].
[8] Hathaway J T, Shah M P, Hathaway D B, et al. Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide[J]. JAMA Ophthalmology, 2024, 142(8):732-739. DOI:10.1001/jamaophthalmol.2024.1564.
