Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026

来源：European Medicine Agency | 发布时间：2026-10-30

摘要：欧盟10月批药结果出炉：6款新药获推荐，辉瑞和阿斯利康各撤回一项申请。礼来口服减肥药、百济神州的胰腺癌新药等上榜；5款老药扩了新用途。辉瑞的哌柏西利因数据不足撤审，Omeros的罕见病药Yartemlea再次被拒。

Six new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended six medicines for approval at its October 2026 meeting.

Rasonque (daraxonrasib) received a positive opinion from the CHMP for the treatment of adults with metastatic pancreatic adenocarcinoma (pancreatic cancer that has spread) who have received at least one previous treatment. This recommendation follows a phased review of data on Rasonque, which was identified as a high-priority medicine under EMA’s Cancer Medicines Pathfinder project, given its potential to address this unmet medical need. See more details in the news announcement in the grid below.

The committee recommended granting a marketing authorisation for Foundayo (orforglipron), an oral GLP-1 receptor agonist for weight management and treatment of type 2 diabetes in adults. Foundayo will be available as a tablet taken once daily, providing an alternative to injectable and other oral GLP-1 receptor agonists. See more details in the news announcement in the grid below.

The CHMP recommended granting a marketing authorisation for Yuviwel (navepegritide), for the treatment of achondroplasia in children. Achondroplasia is an inherited disease caused by a mutation in a gene called fibroblast growth-factor receptor 3. The mutation affects growth of almost all bones in the body including the skull, spine, arms and legs, resulting in very short stature with a characteristic appearance.

The committee adopted positive opinions for two biosimilar medicines:

Fovlussea (ranibizumab), for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularisation.
Neuzafy (filgrastim), for the treatment of neutropenia in adults and children.

The committee recommended granting a marketing authorisation for Kizfizo (temozolomide), for the treatment of adults with glioblastoma multiforme (an aggressive type of brain tumour) and children with malignant glioma (brain tumours). This medicine was submitted in a hybrid application, which relies in part on the results of pre-clinical tests and clinical trials of an already-authorised reference product, and in part on new data.

Recommendations on extensions of therapeutic indication for five medicines

The committee recommended extensions of indication for five medicines that are already authorised in the European Union (EU): Pandemic influenza vaccine H5N1 AstraZeneca, Kyinsu, Talvey, Tryngolza, and Tukysa.

Outcome of re-examination

Following a re-examination of its initial opinion, the committee has confirmed its recommendation to refuse marketing authorisation for the medicine Yartemlea (narsoplimab). The medicine was intended for the treatment of adults and children from two years of age with haematopoietic stem cell transplant (HSCT)-associated thrombotic microangiopathy. Thrombotic microangiopathy is a serious and potentially life-threatening complication following HSCT, a procedure where the patient’s bone marrow is replaced by stem cells from a donor to form new bone marrow that produces healthy cells.

For more information, see the question-and-answer document in the grid below.

Withdrawal of applications

Applications to extend the use of two medicines were withdrawn:

Ibrance (palbociclib), a cancer medicine used to treat breast cancer when the cancer is locally advanced or metastatic. The company withdrew its application to extend its use to the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer.
Truqap (capivasertib), a cancer medicine used to treat breast cancer that is locally advanced or metastatic when the cancer has come back or worsened after hormonal treatment. The company withdrew its application for its use in the treatment of metastatic prostate cancer that responds to hormone treatment when the cancer cells lack a protein called PTEN.

Question-and-answer documents on the withdrawal of these two applications are available in the grid below.

Other updates

The CHMP has finalised its assessment of an application to extend the use of Mylotarg (gemtuzumab ozogamicin) to include the treatment of children aged one to less than 18 years with newly diagnosed acute myeloid leukaemia (AML). Although the committee did not recommend this use, it agreed that relevant data from the study submitted with the application be included in the medicine’s product information so that healthcare professionals have access to-up-to date data on the effects of Mylotarg in these patients. For more information, see the question-and-answer document in the grid below.

The committee recommended changing the legal status of Nyxoid (naloxone) to make it available without a medical prescription. Nyxoid is a nasal spray used for emergency treatment in case of known or suspected overdose of opioid drugs, such as heroin or morphine.

Agenda and minutes

The agenda of the October 2026 CHMP meeting is published on EMA’s website. Minutes of the meeting will be published in the coming weeks.

CHMP statistics

Key figures from the October 2026 CHMP meeting are represented in the graphic below.

阿斯利康、辉瑞双双撤申请, 欧盟2026年10月药物批准简述

10月16日（当地时间），欧盟药品管理局（EMA）发布2026年10月
人用药品委员会（CHMP）会议结果。

10月份会议中，6款新药上市许可申请获推荐，包括礼来口服GLP-1R激动剂Orforgliprion、百济神州拥有亚洲权益的明星胰腺癌新药Daraxonrasib。

5款已上市药品适应症变更或新适应症获推荐意见，同时有2款药物撤回上市申请。

一、推荐上市新药

1、礼来口服GLP-1R激动剂OrforglipronOrforglipron（奥氟格列隆，CAS：2212020-52-3）是每日一次口服小分子（非肽类）胰高血糖素样肽 – 1受体激动剂（GLP-1RA），可全天任何时间服用，对饮食或饮水不加以限制。

该药物由日本药企中外制药（Chugai Pharmaceutical ）开发，2018年授权给礼来。https://wxa.wxs.qq.com/tmpl/qe/base_tmpl.html今年4月份，FDA提前300天加速批准上市，商品名：Foundayo，适应症：联合低卡饮食和增加锻炼用于降低至少一个肥胖合并症的肥胖患者过度体重并维持长期体重维持。

今年1月份，中国NMPA受理奥氟格列隆片12项上市申请。

2、明星胰腺癌创新药DaraxonrasibDaraxonrasib（RMC-6236，CAS：2765081-21-6）是口服、可靶向突变和野生型RAS在GTP结合（ON）状态下的多选择性抑制剂，其通过与伴侣蛋白CypA（亲环素A）结合，形成的 “药物-CypA” 复合物再结合活性态RAS（GTP结合的RAS (ON)），阻断RAS与下游效应蛋白（如 BRAF）的结合，全面抑制RAS驱动的致癌信号（包括MAPK/ERK通路）。其可抑制所有常见RAS突变（G12C/D/V、G13、Q61）+野生型RAS，还有望克服传统KRAS G12C 抑制剂的突变谱局限与耐药。今年8月份， FDA批准上市，商品名相同，适应症为既往至少一种系统治疗或不适合多药系统治疗的转移胰腺导管癌成人患者。中国方面，百济神州8月初和Revolution Medicines达成合作协议。百济神州获得Revolution Medicines包括Daraxonrasib在内药物在日本和韩国之外亚洲市场的独家开发及商业化权益。9月和10月，百济神州递交的7项临床试验申请获中国CDE受理。

3、Ascendis制药A/S（中国子公司维昇药业）长效儿童软骨发育不全新药那韦培肽（TransCon C-型利钠肽) 是一款在研基于TransCon平台开发长效产品，旨在以安全和方便的每周一次给药，持续抑制过度激活的FGFR3受体通路，恢复软骨细胞的正常分化和增生以及全身骨骼的生长发育，同时改善和预防软骨发育不全的并发症。今年2月份，FDA批准上市，商品名：Yuviwel，用于年龄≥2岁开放性骨骺体软骨发育不全儿童患者的线性生长。3月份，中国国家药品监督管理局药品审评中心（CDE）将其纳入优先审评名单，适应症：2岁及以上骨骺未闭合软骨发育不全儿童患者。

二、撤回上市申请药物

1、辉瑞CDK4/6抑制剂Palbociclib（哌柏西利，商品名：Ibrance/爱博信）哌柏西利（Palbociclib，CAS：571190-30-2）是一种口服细胞周期素依赖性激酶(CDKs) 4和6抑制剂， CDKs 4和6是细胞周期的关键调节因素，其能够触发细胞周期进展。

2015年2月，美国FDA批准胶囊剂型上市，商品名：Ibrance，2019年11月批准片剂上市，适应症为治疗HR+、HER2-晚期或转移性乳腺癌成人患者：联合芳香化酶抑制剂作为内分泌疗法起始治疗，或氟位司群用于内分泌疗法后进展的患者。2018年7月中国获批上市，商品名：爱博新（胶囊剂型），用于HR阳性、HER2阴性的局部晚期或转移性乳腺癌，应与芳香化酶抑制剂联合使用作为绝经后女性患者的初始内分泌治疗。2022年7月，片剂中国获批。2016年，欧盟批准上市。本次撤审的9月份递交的新适应症：作为HR阳性、HER2阳性局部晚期或转移性乳腺癌的维持治疗。支持该适应症的数据来518例HR阳性、HER2阳性局部晚期或转移性乳腺癌患者3期临床研究结果。

对于该研究，CHMP认为现有数据无法提供充分证据：开放标签设计，患者和研究者均知晓治疗分组，研究者评估疗效结果和独立第三方评估结果的差异引发偏向研究药物的担忧，且独立评估结果未确认明显改善，其他疗效指标未能提供足够的支持性证据。基于以上原因，辉瑞称需要更多时间搜集数据和分析结果，故撤回本次申请。

2、阿斯利康口服泛AKT激酶抑制剂Capivasertib（卡匹色替）Capivasertib（卡匹色替，商品名：Truqap/荃科得，CAS：1143532-39-1）是新型、高效、选择性ATP竞争性泛Akt激酶抑制剂，在三种亚型AKT1、AKT2和 AKT3中具有相似的活性。抑制AKT磷酸化，阻断下游mTOR、GSK3β等信号，抑制肿瘤增殖、促进凋亡、逆转内分泌耐药。

2023年11月，其以1类新化学实体的注册分类优先审评资格获得FDA批准联合氟维司群用于成年乳腺癌患者的治疗，商品名：Truqap。2024年3月，日本批准上市。2024年4月，EMA CHMP推荐上市，用于治疗ER阳性、HER2阴性局部晚期或转移性乳腺癌，这些患者在接受内分泌治疗期间或之后出现复发或进展，且存在一个或多个PIK3CA、AKT1或PTEN改变。2025年4月，中国NMPA批准上市，商品名：荃科得，适应症：联合氟维司群用于转移性阶段至少接受过一种内分泌治疗后疾病进展，或在辅助治疗期间或完成辅助治疗后12个月内复发的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性且伴有一种或多种PIK3CA/AKT1/PTEN改变的局部晚期或转移性乳腺癌成人患者。

本次CHMP撤回申请的信息尚未公布。

三、负面意见药物-无

四、新适应症/变更

五、再审药物-MASP-2单抗Narsoplimab（商品名：Yartemlea）结论：拒绝Narsoplimab（纳索普利单抗，商品名：Yartemlea，研发代号：OMS721）是美国Omeros开发的全球首款选择性MASP-2（甘露聚糖结合凝集素相关丝氨酸蛋白酶2）单抗，其精准阻断补体凝集素途径异常激活，抑制血管内皮损伤、微血管内血栓形成，减少肾脏、神经等多器官损伤；不影响补体经典途径、替代途径，保留机体抗感染免疫能力，相比广谱补体抑制剂感染风险更低。2025年12月，FDA批准上市，商品名：Yartemlea，用于年龄≥2岁儿科和成人造血干细胞移植（HSCT）相关血栓性微血管病（TA-TMA)。

今年6月份CHMP会议中拒绝批准，理由：1）主研究未与安慰剂或其他治疗方案比较，同时患者还接受其他治疗，无法判定疗效与Narsoplimab相关性；2）研究期间疗效评估方法和剂量选择变更导致很难解释试验结果，无法确认疗效；3）文献中披露的其他治疗手段可提供与Narsoplimab相似的疗效；4）儿童人群无充足的数据评估安全性或疗效，成人数据因未体现出获益，所以也无法外推至儿童患者中。10月份会议中，CHMP评估企业补充递交的数据和信息，并咨询对应适应症领域专家意见后，认为6月会议中拒绝批准的理由仍存在，不能得出获益大于风险的结论，故不推荐批准。