Golidocitinib

药品营销避坑”试读： 药品导入期管理视频课（试听） 药品生命周期管理（案例） 药品立项需要注意什么（案例） 2026年4月8日国家药品监督管理局药品审评中心（CDE）网站信息显示，凌科药业泽普昔替尼胶囊的上市申请已获得CDE受理。预计本次申请的适应症为中重度活动性类风湿关节炎。 2026年1月凌科药业公布了泽普昔替尼治疗中重度活动性类风湿关节炎多中心、随机、双盲、安慰剂对照3期临床试验的研究结果。该研究共纳入430例生物制剂疾病改善抗风湿药物（bDMARD）应答不佳的中重度活动性类风湿关节炎患者。入组患者按1:1比例随机接受泽普昔替尼12mg每日两次或安慰剂治疗。泽普昔替尼组和安慰剂组至第12周达到ACR20（疾病体征和症状至少改善20%）的比例分别为74.0% 和29.9%（P < 0.0001），达到ACR50的比例分别为41.4%和9.3%（P < 0.0001），达到DAS28-CRP（28关节疾病活动度-C反应蛋白评分）≤3.2的比例分别为51.2%和15.0%（P<0.0001）。至第24周达到ACR20的比例分别为79.1%和39.7%（P < 0.0001），达到ACR50的比例分别为55.8%和22.0%（P < 0.0001），达到DAS28-CRP≤3.2的比例分别为67.0%和23.4%（P<0.0001）。在安全性方面，泽普昔替尼整体耐受性良好。治疗期间不良事件（TEAE）绝大多数为轻至中度（1–2级）。治疗组与安慰剂组的严重不良事件发生率相当（凌科药业., 2026）。 此外，2026年3月凌科药业公布了泽普昔替尼治疗中重度特应性皮炎（AD）多中心、随机、双盲、安慰剂对照3期临床试验的研究结果。该研究共纳入356例受试者，入组患者按1:1:1比例随机接受泽普昔替尼12 mg、24 mg或安慰剂，一天两次。至第16周，泽普昔替尼12 mg、24 mg组相对于安慰剂组达到湿疹面积和严重程度指数（EASI）评分较基线下降≥75%（EASI-75）的比例分别为38.1%和46.4%（p< 0.0001）。相对于安慰剂组，泽普昔替尼12 mg、24 mg组研究者AD整体评估验证量表（vIGA-AD）评分达到皮损完全清除（0分）或皮损基本清除（1分）的比例分别为30.3%和31.0%（p < 0.0001）。相对于安慰剂组，最严重瘙痒数字评分（WI-NRS）较基线降低≥4分（WI-NRS4）的比例分别为31.3% 和31.0%（p < 0.0001）。在EASI-50、EASI-90、SCORAD（特应性皮炎评分）、皮肤病生活质量指数（DLQI），以及患者湿疹自我检查评分量表（POEM）评分方面，泽普昔替尼组也显著优于安慰剂组。在安全性方面，泽普昔替尼整体耐受性良好。治疗期间不良事件（TEAE）绝大多数为1–2级（轻至中度）。严重不良事件、特别关注的不良事件（AESI）以及导致停药的不良事件发生率低，且与安慰剂组基本相当，未观察到新的安全性信号（凌科药业., 2026）。 泽普昔替尼（Zemprocitinib，LNK01001）为选择性JAK1抑制剂，属于第二代JAK抑制剂。通过抑制JAK1-STAT信号通路发挥抗炎作用。 推荐指数：★★ 推荐原因：JAK药物的用途广泛，市场潜力巨大。目前国内正处于第一代JAK向第二代JAK抑制剂过渡，以及第三代JAK进入市场阶段。目前已获批的第二代JAK包括乌帕替尼（Upadacitinib）、、阿布昔替尼（Abrocitinib）、戈利昔替尼（Golidocitinib）、艾玛昔替尼（Ivarmacitinib）。第三代JAK包括氘可来昔替尼（Deucravacitinib）和利特昔替尼（Ritlecitinib）。对于泽普昔替尼来说，还存在市场增长空间。泽普昔替尼一天需要给药二次，与其他第二代或第三代JAK相比，略有不便。 相关阅读： 明慧医药外用JAK抑制剂伊托法替布软膏申请上市 远力健药业第四代促胃动力药酒石酸西尼必利片首仿获批 首家，人福药业爆发性疼痛枸橼酸芬太尼口颊片获批 海和药物申请EZH1/2抑制剂艾普美妥司他上市 吉伦泰放射显影剂锝[99mTc]佩昔瑞特加肽注射液获批上市 润都制药心脏负荷试验药物盐酸去甲乌药碱注射液获批上市 反击奥氟格列隆，司美格鲁肽片25mg在间接比较研究中胜出 礼来奥氟格列隆，FDA批准首个减肥口服小分子GLP-1激动剂 优效，乳腺癌3期临床试验石药安尼妥单抗+白蛋白多西他赛 第2家申请上市，恒瑞镥[177Lu]氧奥曲肽注射液获CDE受理 3期临床甘李周胰岛素GZR4优于甘精U100和德谷胰岛素 恒瑞新一代梗阻性肥厚型心肌病药物HRS-1893二期研究发布 49.3%，3期临床试验诺华伊普可泮大幅减缓IgA肾病进展 相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。 如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

Insmed has given up on Brinsupri in the painful skin disorder hidradenitis suppurativa (HS) after a mid-stage trial failure. The company had ditched the pill in sinus inflammation at the end of last year. The study in HS, called CEDAR, was a comprehensive bust. Insmed revealed late on Tuesday that both doses of Brinsupri were outperformed by placebo on the primary endpoint. After four months’ treatment, patients with moderate-to-severe disease given 10 mg and 40 mg pills once daily had their total abscess and inflammatory nodule count reduced by 45.5% and 40.3%, respectively. The reduction in the placebo group was 57.1%. The DPP1 inhibitor failed on all the trial’s secondary efficacy endpoints, too. According to the study’s protocol on the federal clinical trials database, these included various measures of skin improvement, such as the proportion of subjects hitting a goal called HiSCR50, which represents a reduction of at least 50% in the number of abscesses and inflammatory nodules, with no increase in abscess or draining tunnel count. Insmed will end CEDAR without seeing through the year-long open-label part of its design. The company said the study reported no new safety signals, including in the 40 mg arm, which is the highest dose of Brinsupri it has yet tested. Serious treatment-emergent adverse events were seen in three patients given the 10 mg dose of Brinsupri and one patient each in the 40 mg and placebo arms. Insmed’s chief medical officer Martina Flammer said in a press release that as there are no established animal models in HS, clinical development is “particularly challenging.” This was similar to the defense she offered when Brinsupri failed in Phase 2 in chronic rhinosinusitis in December. In rhinosinusitis, the drug was also beaten by placebo, though not by as wide a margin as in the HS data. Insmed licensed the molecule from AstraZeneca a decade ago, paying $30 million upfront and promising a potential $120 million in biobucks. Brinsupri was approved last August for patients who have the lung disease bronchiectasis but don’t have cystic fibrosis. Analysts from Stifel wrote in a Tuesday note that HS was the final indication in which Insmed will test Brinsupri. Instead, the company plans to look at new, internally developed DPP1 inhibitors in new indications — ones for which animal models are available, hopefully increasing the chances of success in future proof-of-concept trials. In fairness to Insmed, HS is a difficult disease to treat. Incyte’s JAK1 inhibitor pill povorcitinib succeeded in two pivotal HS trials just over a year ago, but the data were regarded as disappointing compared with drugs that are already available for HS, like UCB’s Bimzelx. And last fall, MoonLake Immunotherapeutics’ IL-17A/F inhibitor sonelokimab hit in one of its pivotal HS trials but failed in the other, wiping vast amounts off the company’s market value. In defiance, the company has decided to press on with a BLA filing in September.