预约演示

更新于：2026-06-18

Binimetinib

贝美替尼

更新于：2026-06-18

概要

基本信息

药物类型

小分子化药

别名

Balimek、Binimetinib (JAN/USAN)、比美替尼

+ [10]

靶点

MEK1 x MEK2

作用方式

抑制剂

作用机制

MEK1抑制剂(双特异性丝裂原活化蛋白激酶激酶1抑制剂)、MEK2抑制剂(双特异性丝裂原活化蛋白激酶激酶2抑制剂)

治疗领域

肿瘤内分泌与代谢疾病呼吸系统疾病+ [4]

在研适应症

非小细胞肺癌BRAF突变的甲状腺未分化癌BRAF突变甲状腺癌+ [16]

非在研适应症

急性髓性白血病肺腺癌晚期胆管癌+ [48]

原研机构

Array BioPharma, Inc.

在研机构

Pfizer Inc.Pierre Fabre Medicament Information

Array BioPharma, Inc.

+ [9]

非在研机构

Deciphera Pharmaceuticals, Inc.

Novartis Pharmaceuticals Corp.

Plexxikon, Inc.

权益机构

Strata Oncology, Inc.

Medison Pharma Ltd.

OnKure, Inc.

+ [7]

最高研发阶段批准上市

首次获批日期

美国 (2018-06-27),

BRAF V600 突变阳性黑色素瘤

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)

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结构/序列

分子式C17H15BrF2N4O3

InChIKeyACWZRVQXLIRSDF-UHFFFAOYSA-N

CAS号606143-89-9

关联

153

项与贝美替尼相关的临床试验

JPRN-jRCT1031260160

/ RecruitingN/AIIT

Encorafenib and Binimetinib in BRAF-mutated Thyroid Cancer : a Real-world data Utilization Multi-center study (EMBLAZE study)

开始日期2026-05-28

申办/合作机构

National Cancer Center Hospital East

NCT07022457

/ Active, not recruitingN/A

UK ENcorafenib and BInimetinib Real-world Study in Melanoma (UK-EnBiRiM): A Prospective Observational Real-world App-based Study to Explore HRQoL Outcomes, of Adults With Metastatic Cutaneous BRAF V600 Mutation-positive Melanoma, Initiated on Combination Encorafenib and Binimetinib Therapy in the UK

This is a prospective longitudinal multi-centre observational study conducted in the United Kingdom, in patients with metastatic cutaneous BRAF V600 mutation-positive melanoma assigned to receive encorafenib and binimetinib. The aim of this study is to learn about how encorafenib and binimetinib perform, patients' experiences of using them, and how they might affect patient's quality of life, in the real world, when these treatments are prescribed by doctors instead of in a clinical trial. Participants will complete electronic data entry via questionnaires over a 24-month period. Site research teams will also complete electronic data entry using participants' medical records over a 24-month period.

开始日期2025-07-31

申办/合作机构

Pierre Fabre Ltd.

[+1]

NCT06887088

/ Recruiting临床2期IIT

Phase II, Single Arm, Multicentre Clinical Trial to Evaluate the Activity of Encorafenib Plus Binimetinib Followed by Cemiplimab And Fianlimab in Patients With BRAF Mutated Melanoma and Symptomatic Brain Metastases

Brain metastases in patients with advanced and metastatic melanoma are a frequent complication and a significant cause of morbidity and mortality in this patient population. As the incidence of brain metastases continues to increase in patients with metastatic melanoma, it is urgent that the investigators identify effective therapies.
ENCEFALO is a Phase II, single arm, multicentre clinical trial designed to evaluate the activity of encorafenib plus binimetinib followed by cemiplimab and fianlimab in patients with BRAF mutated melanoma and symptomatic brain metastases, following the simon design Two-stage minimax.
The objective main is to evaluate the 6 month intracranial progression-free survival (icPFS) proportion of Encorafenib plus Binimetinib followed by Cemiplimab plus Fianlimab in patients with BRAF-mutated melanoma and symptomatic brain metastases according RECIST criteria
The trial hypothesis is: For patients with BRAF-mutated melanoma and symptomatic brain metastases, an induction treatment with encorafenib and binimetinib (EB) for about two months (i.e. 8 weeks) followed by cemiplimab plus fianlimab (CF) would allow a 6 month icPFS rate of 40% in comparison to historical control of 20% based on CM204 symptomatic arm (Tawbi et al 2021).

开始日期2025-05-29

申办/合作机构

Mfar Constructions Pvt Ltd.

[+2]

100 项与贝美替尼相关的临床结果

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100 项与贝美替尼相关的转化医学

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100 项与贝美替尼相关的专利（医药）

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689

项与贝美替尼相关的文献（医药）

2026-07-01·CLINICAL PHARMACOLOGY & THERAPEUTICS

Cutaneous Adverse Drug Reactions Associated With BRAF and MEK Inhibitors: A Real‐World Analysis of WHO Pharmacovigilance Data

Article

作者: Giedziun, Piotr ; Calik, Jacek ; Sauer, Natalia ; Wiela‐Hojeńska, Anna

BRAF inhibitors and MEK inhibitors (MEKi) have reshaped the treatment of BRAF V600 ‐mutant malignancies; however, cutaneous adverse drug reactions (ADRs) remain a frequent and clinically impactful toxicity. Although clinical trials provide insight into their safety profiles, real‐world data on dermatologic ADRs are limited. We conducted a retrospective pharmacovigilance analysis of the WHO VigiAccess database, examining individual case safety reports (ICSRs) for seven BRAF and MEKi up to May 2025. Disproportionality analyses (reporting odds ratio (ROR), proportional reporting ratio (PRR), with 95% confidence intervals (CIs)) were performed for high‐frequency dermatologic ADRs. Shannon entropy was used to assess the diversity of toxicity profiles across agents. Among 72,720 ICSRs, skin‐related ADRs accounted for 39.78% of reports with vemurafenib, 16.49% with dabrafenib, and 14.62% with encorafenib. Among MEKi, the proportion of skin‐related ADRs was highest for selumetinib (40.03%) and cobimetinib (34.31%). Rash was the predominant ADR across agents, but selumetinib demonstrated a significant disproportionality for dermatitis acneiform (ROR = 6.46, 95% CI [5.10, 8.18]). Photosensitivity reactions were most frequently reported with vemurafenib (11.31%) and cobimetinib (12.02%). Shannon entropy analysis identified two groups with differing ADR profile diversity: a higher‐diversity group (cobimetinib, H = 3.66; dabrafenib, H = 3.60) and a lower‐diversity group (trametinib, H = 3.51; binimetinib, H = 3.47); all cross‐group comparisons were statistically significant after Holm‐Bonferroni correction ( p < 0.05). Chi‐squared tests confirmed significant differences in skin ADR frequencies among agents (BRAF inhibitors: χ2 (2) = 1393.21, p < 0.001, Cramér's V = 0.255; MEKi: χ2 (3) = 1129.77, p < 0.001, Cramér's V = 0.175), with effect sizes indicating clinical relevance. Cutaneous ADRs are a defining toxicity of MAPK pathway inhibitors, with substantial interagent variability in frequency and phenotype. Real‐world pharmacovigilance data underscore the necessity for agent‐specific dermatologic monitoring strategies. Clinical pharmacists play a pivotal role in early ADR detection and management, enhancing adherence and optimizing therapeutic outcomes.

2026-06-20·BRITISH JOURNAL OF CANCER

Safety and efficacy of lapatinib, binimetinib, and vinorelbine for RAS mutant metastatic colorectal cancer: results of the RASTRIC Phase I/II trial

Article

作者: Braat, Manon N G J A ; Guven Mese, Sermin M ; Klein Wolterink, Helena M ; Huismans, Maarten A ; Gort, Eelke H ; Snippert, Hugo J G ; Roodhart, Jeanine M L ; Koopman, Miriam ; de Vos, Filip Y F L ; Huitema, Alwin D R ; Devriese, Lot A ; van der Heijden, Lisa T ; Verheul, Henk M W ; Crommelin, Heleen A ; Elias, Sjoerd G ; Nienhuis, Hilde H ; Opdam, Frans L

BACKGROUND:

Treatment options for RAS-mutant metastatic colorectal cancer (mCRC) remain limited. Based on preclinical work with patient-derived organoids, we investigated a triple therapy of binimetinib, lapatinib, and vinorelbine in a Phase I/II trial.

METHODS:

Forty patients with RAS-mutant mCRC received escalating doses of binimetinib and lapatinib with vinorelbine 17.5 mg/m² in three-weekly schedules. Phase I aimed to determine the Recommended Phase II Regimen (RP2R), while Phase II evaluated Overall Response Rate using Simon's two-stage design. Pharmacokinetic analyses were performed on cycle 1 day 3.

RESULTS:

The Maximum Tolerated Dose was established at lapatinib 750 mg QD and binimetinib 30 mg BID (both 5 days on/2 days off), with vinorelbine 17.5 mg/m² on days 3 and 10 every 21 days. Toxicities included diarrhoea (75%), rash (65%), and increased CPK (57%). Among 33 evaluable patients, no objective responses occurred, with 9 (27%) achieving stable disease, lasting beyond 3 months (maximum: 297 days) in three patients. Pharmacokinetics showed dose-proportional exposure for binimetinib but not lapatinib. Binimetinib absorption may be affected by colostomy and loperamide-induced constipation.

CONCLUSIONS:

The triple combination showed moderate tolerability and termination occurred after the first stage of Phase II due to insufficient efficacy. Our findings highlight challenges in translating organoid-derived drug combinations to clinical practice.

CLINICAL TRIAL REGISTRATION:

EUDRACT: 2019-004987-23.

2026-05-26·Blood Advances

Long-term MAPK inhibition of childhood refractory-Langerhans cell histiocytosis: an observational study of 288 patients

Article

作者: von Bahr Greenwood, Tatiana ; Lacaille, Florence ; Berard, Perinne Marec ; Nguyen, Trung ; Gaspari, Stefania ; Bishop, Hugh ; Beutel, Karin ; Bomken, Simon ; Chevallier, Aurore ; Barkaoui, Mohamed ; Slater, Olga ; Le Louet, Solenne ; Hélias-Rodzewicz, Zofia ; Ben Fraj, Ilhem ; Héritier, Sébastien ; Karaoli, Eva ; Holzhauer, Suzanne ; Osipova, Daria ; Elitzur, Sarah ; Munthe-Kaas, Monica Cheng ; Henter, Jan Inge ; Lyudovskikh, Evelina ; Astigarraga, Itziar ; Bronin, Gleb ; Evseev, Dmitry ; Felizzia, Guido ; Saultier, Paul ; Escherich, Gabriele ; Ben Arush, Myriam ; Dvir, Rina ; Novosad, Olga ; Schneider, Pascale ; Penn, Anthony ; Garcia-Obregon, Susana ; Boudiaf, Houda ; Alvarez, Jean-Claude ; Chalard, François ; Hutter, Caroline ; Braier, Jorge ; De Fusco, Carmela ; Pagnier, Anne ; Maschan, Michael ; Aladjidi, Nathalie ; Krenova, Zdenka ; Kabbara, Nabil ; Salmon, Alexandra ; Lehrnbecher, Thomas ; Levy, Gabriel ; Papadakis, Vassilios ; Larabi, Islam Amine ; Bernard, Fanette ; Collin, Matthew ; Efremova, Viktoria ; Corti, Paola ; Chiaravalli, Stefano ; Svojgr, Karel ; Valero-Arrese, Lorena ; Emile, Jean-François ; Sieni, Elena ; Adam, Cecile ; Blanc, Laurence ; Malas, Zofia ; Moreno, Mara Andrés ; Hessissen, Laila ; Golan, Michal ; Haenicke, Henriette ; Burcev, Evgueni ; Ahlmann, Martina ; Minkov, Milen ; McLin, Valérie ; Costa, Vitor ; Donadieu, Jean ; Idbaih, Ahmed ; Luz, Ines ; Habes, Dalila ; Olivier, Laura ; Lustig, Dana Ashkenazi ; van den Bos, Cor ; Trambusti, Irene ; Todesco, Alessandra ; Diallo, Safiatou ; Kristensen, Ines Ackerl ; Dahl, Christine ; Renard, Cecile ; Naeije, Leonie ; Ruano, David ; Simonin, Mathieu ; Kolenova, Alexandra ; Pegoraro, Francesco ; Raciborska, Anna ; Bellouard, Marie ; Gandemer, Virginie ; Milne, Paul ; Thalhammer, Julian

Abstract:

We evaluated long-term outcomes of 288 children with refractory-Langerhans cell histiocytosis (R-LCH) from 26 countries, who were prescribed off-label MAPK inhibitors (MAPKis) according to clinical indications. MAPKi indications included 148 R-risk-organ–positive (R-RO+), 67 R-risk-organ–negative (R-RO–), 13 lung destruction (lung), 9 sclerosing cholangitis (SC), 49 neurodegeneration (ND), and 2 diabetes insipidus (DI) cases. Median ages at diagnosis and MAPKi onset were 1.3 and 2.3 years, respectively, with median follow-up of 3.7 years (1166 person-years). Agents mostly prescribed as monotherapies were 184 prescriptions of vemurafenib, 115 of dabrafenib, 3 of encorafenib, 42 of cobimetinib, 45 of trametinib, and/or 1 prescription of binimetinib; followed 51 times by various chemotherapies or hematopoietic stem-cell transplantation, or 28 times by combined anti-BRAF–anti-MEK. Short-term responses (<8 weeks) ranged from 98% (R-RO+ and R-RO–), to 30% (lung) to none (ND, DI, and SC); although long-term lung and ND responses could be observed. Skin rash was the most frequent adverse event (∼55%), and 7 others included 1 case of cardiomyopathy and 6 of retinitis. Five developed MAPKi-unrelated tumors and 9 patients died. Five-year survival was 98%. After 113 patients with R-LCH discontinued MAPKi, 69 experienced disease reactivation. None of the various empirical maintenance therapies were able to prevent secondary reactivation. Among the 143 assessable patients without ND-LCH at MAPKi onset, 60 developed ND (45%, 5-year risk). MAPKis appeared to be safe and effective in children with R-RO+/RO–LCH, whereas other indications’ responses were less frequent or occurred later. Further studies are needed to find effective maintenance-therapy approaches, particularly to prevent frequently observed secondary ND.

300

项与贝美替尼相关的新闻（医药）

2026-06-18

·皮尔法伯医疗科技

皮尔法伯集团毕太维®（恩考芬尼）和美妥维®（贝美替尼）联合疗法在华获批，精准靶向BRAFV600E突变型转移性非小细胞肺癌

法国卡斯特尔，2026年6月15日——皮尔法伯集团今日宣布，毕太维®（恩考芬尼）和美妥维®（贝美替尼）的联合疗法已获得中国国家药品监督管理局(NMPA)正式批准，用于治疗BRAFV600E突变型转移性非小细胞肺癌(NSCLC)成人患者。肺癌是中国癌症相关死亡的首要原因，也是国家的重大公共卫生负担。中国每年肺癌死亡病例近73.33万，年新发病例超106.05万例。1本次在华获批，主要基于全球关键性II期PHAROS研究（这一研究促成了该药在欧盟和美国获批）2以及在中国开展的本土II期OCEAN II研究3的数据。两项研究均证实，该联合疗法具有显著临床获益，且在全球患者与中国患者中疗效一致。 PHAROS试验结果显示，在主要分析时点（截止日期：2022年9月22日），经独立放射学审查(IRR)确定的主要终点——客观缓解率(ORR)达到预设目标。在初治患者(n=59)中，客观缓解率(ORR)为75%(95% CI: 62-85)；而在既往接受过治疗的患者(n=39)中，ORR为46%(95% CI: 30-63)。1 中国的注册关键研究OCEAN II显示与PHAROS同样趋势的有效性和安全性的研究结果。医疗与患者消费事业部负责人Núria Perez-Cullell表示：“这一新联合疗法能够惠及更多患者群体，进一步彰显了皮尔法伯集团对肺癌等未满足医疗需求领域的持续承诺。目前，BRAFV600E突变型非小细胞肺癌(NSCLC)的靶向治疗选择仍然有限。该亚型约占中国所有非小细胞肺癌病例的2.7%。4如今能够获得一种已证实具有临床意义且疗效持久的全新治疗方案，是一项重大进步。” 皮尔法伯制药首席执行官高雅睿(Marie-Andrée GAMACHE)补充道：“毕太维®和美妥维®联合疗法在中国获批上市，是一个重要里程碑。我们距离将这一治疗选择带给中国BRAFV600E突变型转移性非小细胞肺癌患者又更近了一步。我们正与中国监管机构及医疗专业人员紧密合作，帮助符合条件的患者尽快用上这一疗法。” “在与卫生监管部门紧密合作的基础上，我们正将这一治疗方案带给中国有需要的患者。这体现了我们始终如一的承诺——通过在尚未得到充分满足的领域提供具有临床意义价值的治疗方案，不断改善中国患者的生活质量。”皮尔法伯制药中国区总裁黄田伟表示。关于PHAROS PHAROS(NCT03915951)是一项全球性、开放标签、多中心、非随机的II期研究，旨在评估毕太维®（恩考芬尼）联合美妥维®（贝美替尼）治疗98名携带BRAFV600E突变的晚期非小细胞肺癌(NSCLC)患者的疗效和安全性。突变通过患者当地实验室进行下一代测序或聚合酶链反应检测来确定。主要终点为根据RECIST v1.1标准、通过独立放射学审查(IRR)确认的ORR；次要目标包括缓解持续时间(DoR)、PFS和OS等其他疗效终点以及安全性。该试验在意大利、荷兰、韩国、西班牙和美国的143个研究机构进行。 PHAROS试验由辉瑞公司申办，并在皮尔法伯的支持下进行。关于OCEAN II OCEAN II(NCT05195632)是一项在中国开展的II期、多中心、单臂研究，包含安全性导入期与扩展期，旨在评估毕太维®（恩考芬尼）联合美妥维®（贝美替尼）治疗患有不可切除IV期BRAFV600E突变型非小细胞肺癌的中国成人受试者的疗效、安全性与药代动力学。入组受试者为未接受过BRAF和MEK抑制剂治疗、转移性阶段未接受过治疗或仅接受过一线治疗的患者。主要终点为首个28天周期(SLI)内的剂量限制性毒性(DLT)，以及经独立中心评估(ICR)的确认客观缓解率(cORR)。次要终点包括疾病控制率(DCR)、缓解持续时间(DoR)、无进展生存期(PFS)、总生存期(OS)及安全性。皮尔法伯集团是本研究的唯一申办方。关于BRAFV600E突变型转移性非小细胞肺癌(NSCLC) 肺癌是癌症相关死亡的主要原因，每年导致全球超180万人死亡。5在全球范围内，肺癌占所有癌症的12.4%，每年新发病例超过240万。非小细胞肺癌(NSCLC)约占所有肺癌病例的85%。6 精准医疗显著推动了携带基因变异（如BRAFV600E突变）的非小细胞肺癌患者的治疗进展。这些基因变化可通过生物标志物检测发现。7,8 在中国，在超过17.5万例非小细胞肺癌(NSCLC)患者中，BRAF（B-Raf原癌基因）突变的检出率为3.6%，其中BRAFV600E突变的检出患病率为 0.9%。9 目前，据估计，多达69%的晚期NSCLC患者在多个基因中存在可供药物靶向的突变。10 BRAFV600E突变型约占非小细胞肺癌的1%–2%。11该突变通过异常激活MAP激酶(MAPK)信号通路驱动肿瘤细胞生长增殖。研究显示，与单用BRAF抑制剂相比，同时抑制BRAF与下游MEK通路，可显著提升患者缓解率。12 近年来，靶向治疗的进步与生物标志物检测的普及，已显著降低了非小细胞肺癌人群的死亡率。13 关于毕太维®（恩考芬尼）和美妥维®（贝美替尼）毕太维®（恩考芬尼）是一种强效且具有高度选择性的BRAF抑制剂，其药理特征与其他BRAF抑制剂不同；美妥维®（贝美替尼）是一种强效且具有选择性的MEK抑制剂。这两种药物通过抑制MAPK通路中的激酶来发挥作用，从而产生具有临床意义的抗肿瘤活性。而MAPK通路在BRAFV600E突变的非小细胞肺癌(NSCLC)中会被持续性地激活。已有研究证明，许多癌症都出现了该通路激活不受控制的现象，包括黑色素瘤、结直肠癌(CRC)和NSCLC。1,14 2018年，欧盟委员会批准毕太维®+美妥维®用于治疗BRAFV600突变型不可切除或转移性黑色素瘤成年患者。该获批是基于随机、主动对照、开放标签、多中心III期COLUMBUS试验的结果。 2020年，毕太维®获得欧盟批准，与西妥昔单抗联合用于接受过系统治疗、携带BRAFV600E突变的转移性结直肠癌成人患者。该获批是基于随机、主动对照、开放标签、多中心III期BEACON CRC试验的结果。 2024年，毕太维®获得欧盟批准，与美妥维®联合用于治疗携带BRAFV600E突变的晚期非小细胞肺癌成人患者。该获批是基于开放标签、多中心II期PHAROS试验的结果。辉瑞拥有毕太维®和美妥维®在美国、加拿大以及拉丁美洲、非洲和中东地区所有国家（伊朗和叙利亚除外）的独家商业化权利。小野制药有限公司拥有这两种产品在日本和韩国的独家商业权，Medison拥有以色列的独家商业权，皮尔法伯拥有这两种产品在所有其他国家（包括欧洲和亚太地区）的独家商业权。欲了解更多信息请访问www.pierre-fabre.co @Laboratoires Pierre Fabre @Pierre Fabre Oncology 参考文献 [1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Observatory: Cancer Today (GLOBOCAN 2022). Lyon (France): International Agency for Research on Cancer; 2022. [2] Riely GJ, Smit EF, Ahn MJ. Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non–Small-Cell Lung Cancer. Journal of Clinical Oncology. 2023;41:21,3700-3711. [3] H. Zhou et al. Results from OCEAN II: A phase II study of encorafenib + binimetinib combination in Chinese patients with BRAFV600E mutated metastatic non-small cell lung cancer. Abstract presented at the American Society of Clinical Oncology (ASCO) Congress, Chicago, June 2026. [4] IPSOS Research Data, 2025 [5] Cancer Today. Lung Factsheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Last accessed: May 2026. [6] American Cancer Society. What is lung cancer? Available at: https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Last accessed: May 2026. [7] Planchard D, Popat S, Kerr K, et al. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2018;29(Suppl. 4), iv192-iv237. Doi:10.1093/annonc/mdy275. [8] König D, Savic Prince S, Rothschild SI. Targeted therapy in advanced and metastatic non-small cell lung cancer. An update on treatment of the most important actionable oncogenic driver alterations. Cancers. 2021;13(4), 804. doi:10.3390/cancers13040804. [9] B. Jia, S. Wang, F. Zhang, et al. Prevalence, genetic variations and clinical outcomes of BRAF-V600 mutated advanced NSCLC in China: a retrospective real-world multi-centre study. EBioMedicine. 114 (2025) 105652. [10] Fois S. S et al. Molecular Epidemiology of the Main Druggable Genetic Alterations in Non-Small Cell Lung Cancer Int. J. Mol. Sci. 2021, 22, 612. [11] Planchard, D., Sanborn, R.E., Negrao, M.V. et al. BRAFV600E-mutant metastatic NSCLC: disease overview and treatment landscape. npj Precis. Onc. 8, 90 (2024). [12] Yan N, Guo S, Zhang H, et al. BRAF-Mutated Non-Small Cell Lung Cancer: Current Treatment Status and Future Perspective. Front Oncol. 2022;12:863043. doi: 10.3389/fonc.2022.863043. [13] Howlader N, Forjaz G, Mooradian MJ, et al. The effect of advances in lung-cancer treatment on population mortality. N Engl J Med. 2020;383(7), 640–649. doi:10.1056/NEJMoa1916623. [14] Delord J-P, et al. Phase I Dose-Escalation and -Expansion Study of the BRAF Inhibitor Encorafenib (LGX818) in Metastatic BRAF-Mutant Melanoma. Clin Cancer Res. 2017;23(18):5339-5348. 免责声明 1. 本新闻公告旨在发布公司动态、产品研发注册进展、科学教育信息或市场资讯，非广告用途。 2. 本新闻不对任何药品、治疗方案和/或适应症作推荐，不对任何产品疗效或安全性作承诺或宣传。 3. 本新闻公告中涉及的信息仅供参考，不构成任何形式的医疗或健康建议。如有任何健康问题或用药需求，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。 4. 本新闻公告如包含关于皮尔法伯产品的前瞻性陈述，仅反映本公司截至发布之日的当前预期，并不构成对未来表现的任何保证。皮尔法伯公司无义务就由于新信息、未来事件或其他原因产生的任何变化对本新闻公告相关信息进行更新。 5. 对于因使用、转发、依赖本新闻公告中所载的任何信息或因信息遗漏而直接或间接产生的任何损失，皮尔法伯公司在无故意及重大过失的前提下，不承担任何法律责任。识别二维码关注 “皮尔法伯医疗科技”

2026-06-17

·医药观澜

治疗肺癌，口服小分子联合疗法在中国获批上市丨产业新闻

6月16日，皮尔法伯（Pierre Fabre）宣布，恩考芬尼和贝美替尼的联合疗法已获得中国国家药品监督管理局（NMPA）正式批准，用于治疗BRAF V600E突变型转移性非小细胞肺癌（NSCLC）成人患者。恩考芬尼是一种强效且具有高度选择性的BRAF抑制剂，其药理特征与其他BRAF抑制剂不同；贝美替尼是一种强效且具有选择性的MEK抑制剂。这两种药物通过抑制MAPK通路中的激酶来发挥作用，从而产生具有临床意义的抗肿瘤活性。而MAPK通路在BRAF V600E突变的非小细胞肺癌（NSCLC）中会被持续性地激活。已有研究证明，许多癌症都出现了该通路激活不受控制的现象，包括黑色素瘤、结直肠癌（CRC）和NSCLC。 BRAF V600E突变型约占非小细胞肺癌的1%–2%。该突变通过异常激活MAP激酶（MAPK）信号通路驱动肿瘤细胞生长增殖。研究显示，与单用BRAF抑制剂相比，同时抑制BRAF与下游MEK通路，可显著提升患者缓解率。本次该联合疗法在华获批，主要基于全球关键性2期PHAROS研究（这一研究促成了该药在欧盟和美国获批）以及在中国开展的2期OCEAN II研究的数据。两项研究均证实，该联合疗法具有显著临床获益，且在全球患者与中国患者中疗效一致。 PHAROS试验结果显示，在主要分析时点（截止日期：2022年9月22日），经独立放射学审查（IRR）确定的主要终点 —— 客观缓解率（ORR）达到预设目标。在初治患者（n=59）中，客观缓解率（ORR）为75%；而在既往接受过治疗的患者（n=39）中，ORR为46%。中国的注册关键研究OCEAN II显示与PHAROS同样趋势的有效性和安全性的研究结果。参考资料：[1]毕太维®联合美妥维®在华获批精准靶向BRAFV600E突变NSCLC. From https://www.prnasia.com/story/537430-1.shtml免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

2026-06-17

·药研苑

男性延时喷雾，复星万邦利多卡因丙胺卡因气雾剂获批上市

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6月16日香港励晶太平洋集团宣布，利多卡因丙胺卡因气雾剂（Senstend）已获得国家药品监督管理局批准，用于早泄治疗。 Senstend（欧洲商品名Fortacin，研发代号：PSD502 ）由香港励晶太平洋集团下属英国企业Plethora Solutions开发。2018年复星万邦（原江苏万邦）获得在中国大陆的商业化权利。利多卡因丙胺卡因气雾剂是由利多卡因和丙胺卡因组成的外用复方制剂，利多卡因和丙胺卡因都属于局麻药物，通过阻断神经传导降低龟头的敏感性延长射精潜伏时间。一项纳入300名早泄患者多中心、双盲、安慰剂对照3期临床试验显示，在性生活前5分钟使用PSD502局部3喷使用完全覆盖龟头治疗3个月，PSD502组和安慰剂组平均射精潜伏时间由基线的0.6分钟，分别延长至3.8分钟和1.1分钟。PSD502组早泄指数量表（控制）射精控制评分和性满意度评分与基线相比分别增加 7.0分和5.9分（P均< 0.001）。66%的患者认为PSD502的疗效达到满意和很满意。在安全性方面，受试者和其性伴侣局部不良事件的发生率分别为2.6%和3.1%（W Wallace Dinsmore., 2009）。推荐指数：★★ 推荐原因：早泄治疗药物在零售市场表现晚好于医院市场，目前获批治疗早泄的药物较少，该品种未来市场表现，主要取决于企业在零售市场的商业化能力。个人观点，仅限参考。相关阅读：石药集团速溶白蛋白结合型紫杉醇获批上市复星医药芦沃美替尼LCH适用年龄拓展至2岁及以上皮尔法伯恩考芬尼+贝美替尼获批用于BRAF V600E非小细胞肺癌翰森拟钙剂HS-10568申请上市用于继发性甲状旁腺功能亢进优于普通片，恒瑞医药非布司他缓释片HR091506三期试验数据默沙东呼吸道合胞病毒单抗疫苗克莱罗韦单抗获批上市诺华达拉非尼+曲美替尼联合疗法获批治疗晚期甲状腺癌朗来科技兰诺可泮获批治疗的阵发性睡眠性血红蛋白尿症首药控股ALK抑制剂康特替尼获批用于晚期非小细胞肺癌康方生物抗IL-17A单抗古莫奇单抗获批治疗中重度银屑病博瑞制药GLP-1/GIP双受体激动剂BGM0504申请上市用于减重首仿，知原药业抗灰指甲药物环吡酮搽剂申请上市天广实奥妥珠单抗β获批治疗原发性膜性肾病中国药科大学深圳校友会关于加强医药企业合规经营、促进行业健康发展的倡议书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。

100 项与贝美替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10604	贝美替尼	L01XE41	DB11967

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
非小细胞肺癌	澳大利亚	Pierre Fabre SA	2025-11-28
BRAF突变的甲状腺未分化癌	日本	Ono Pharmaceutical Co., Ltd.	2024-05-17
BRAF突变甲状腺癌	日本	Ono Pharmaceutical Co., Ltd.	2024-05-17
BRAF V600E突变非小细胞肺癌	美国	Array BioPharma, Inc.	2023-10-11
BRAF 突变结直肠癌	日本	Ono Pharmaceutical Co., Ltd.	2020-11-27
BRAF突变阳性黑色素瘤	日本	Ono Pharmaceutical Co., Ltd.	2019-01-08
黑色素瘤	澳大利亚	Pierre Fabre SA	2019-01-03
BRAF V600 突变阳性黑色素瘤	美国	Array BioPharma, Inc.	2018-06-27

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
皮肤黑色素瘤	临床3期	阿根廷	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	澳大利亚	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	奥地利	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	比利时	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	巴西	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	加拿大	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	捷克	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	法国	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	德国	Pierre Fabre Medicament Information	2022-05-02
皮肤黑色素瘤	临床3期	希腊	Pierre Fabre Medicament Information	2022-05-02

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适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


BEETS (ASCO2026)	N/A	BRAF V600E突变结直肠癌二线 \| 三线 BRAF V600E	162	Encorafenib+Cetuximab	顧齋鹹夢網鬱願製衊顧(淵夢餘簾壓廠衊鏇顧蓋) = 窪餘顧糧鏇積夢壓艱憲築範鏇憲築壓鑰糧鬱廠 (繭鬱顧膚壓範夢簾獵醖 ) 更多	积极	2026-05-29
				Encorafenib+Cetuximab+Binimetinib	顧齋鹹夢網鬱願製衊顧(淵夢餘簾壓廠衊鏇顧蓋) = 範積蓋憲簾膚壓鏇築觸築範鏇憲築壓鑰糧鬱廠 (繭鬱顧膚壓範夢簾獵醖 ) 更多
JPRN-jRCTs051210152 (TRESBIEN, ASCO2026)	临床2期	BRAF V600E突变结直肠癌 BRAF V600E-mutated	25	Cetuximab 400 mg/m² (day1) then 250 mg/m² weeklyEncorafenib 300 mg once daily + Cetuximab 400 mg/m² (day1) then 250 mg/m² weeklyEncorafenib 300 mg once daily + Cetuximab 400 mg/m² (day1) then 250 mg/m² weeklyEncorafenib 300 mg once dailyen 250 mg/m² weekly (BRAF V600E-mutated colorectal cancer)	觸顧蓋鏇鹹鹹顧窪獵醖(鬱醖範願簾鑰醖鑰齋鑰) = 襯鏇遞蓋鹹鏇鬱壓築願鏇製餘壓餘觸鬱膚衊齋 (鑰廠淵製蓋齋艱廠築製, 40.6 ~ 81.2) 更多	积极	2026-05-29
ASCO2026	N/A	BRAF V600E阳性黑色素瘤一线 BRAF-mutant	790	Dabrafenib + trametinib (D+T)	選醖鏇廠衊獵鹹網築廠(艱積遞觸淵築糧淵選襯) = 鹹鹹襯壓簾壓網糧遞繭餘鹽願膚襯鹽醖膚壓構 (齋醖壓選積鏇鹽範窪遞, 7.33 ~ 9.33) 更多	积极	2026-05-29
				encorafenib + binimetinib (E+B)	選醖鏇廠衊獵鹹網築廠(艱積遞觸淵築糧淵選襯) = 淵襯襯鑰簾範範窪襯衊餘鹽願膚襯鹽醖膚壓構 (齋醖壓選積鏇鹽範窪遞, 7.95 ~ 12.42) 更多
ASCO2026	临床2期	胰腺癌二线 BRAF V600E	6	Encorafenib + Binimetinib	艱廠廠選膚築蓋淵遞廠(鬱蓋網願積簾獵膚繭壓) = 簾積簾窪鹹衊鏇衊餘餘窪鹽遞鬱獵繭網繭夢顧 (衊製製壓壓願衊齋遞構 ) 更多	积极	2026-05-29
NCT03543969 (ASCO2026)	临床2期	BRAF V600E阳性黑色素瘤 BRAF V600E	10	continuous encorafenib+binimetinib+nivolumab	艱遞艱範繭蓋築簾鏇憲(顧範範鏇鑰願網齋積鏇) = only 6 grade 3 AEs in Arm B, 16 treatment-related grade 3 adverse events in Arm A 餘鹽範獵鬱顧鏇築鹹積 (襯構簾窪顧窪繭選鬱醖 )	积极	2026-05-29
				patient-specific adaptively dosed encorafenib+binimetinib+nivolumab
JPRN-jRCTs031210510 (BAYONET, ASCO2026)	临床2期	BRAF V600突变结直肠癌 BRAF V600E-mutant \| RAS wild-type	30	Encorafenib + Binimetinib + Cetuximab	獵衊憲醖積糧鬱醖構鑰(繭餘網衊遞鏇憲窪鹽淵) = 窪顧廠糧選壓鏇鹹壓構鑰簾繭觸積蓋窪鹽製糧 (憲網衊鑰觸簾鑰蓋鏇憲, 21.8 ~ 46.6) 更多	积极	2026-05-29
AACR2026	N/A	BRAF V600E突变结直肠癌二线 BRAF-V600E mutation \| WEE1 expression	15	Encorafenib plus cetuximab with or without binimetinib (high-WEE1)	遞遞鏇襯範網願選顧憲(選艱獵願顧淵網窪選顧) = 窪遞蓋艱鹽夢膚網鑰鏇製遞遞衊觸製淵鹹鹹糧 (齋繭艱顧積願願齋鑰網 )	积极	2026-04-22
				Encorafenib plus cetuximab with or without binimetinib (low-WEE1)	遞遞鏇襯範網願選顧憲(選艱獵願顧淵網窪選顧) = 鹽繭鑰願構醖鬱鹽憲願製遞遞衊觸製淵鹹鹹糧 (齋繭艱顧積願願齋鑰網 )
ESMO_ELCC2026	N/A	BRAF突变非小细胞肺癌 EGFR exon 19 del \| acquired tier I/II BRAF alterations	5	Encorafenib+binimetinib+osimertinib	網積鹽夢遞襯糧鹹網膚(鹹繭製餘選範憲範繭築) = Two patients required dose interruption/discontinuation due to gastrointestinal (GI) toxicity (grade 2 diarrhea and grade 3 colitis). No pyrexia was observed. 構衊窪選廠積網築淵齋 (鬱膚構鹹鹽齋獵艱壓窪 ) 更多	积极	2026-03-25
NCT05554354 (CTgov)	临床2期	HR阳性乳腺癌 \| HR阳性乳腺腺癌 \| 转移性乳腺癌 ... 更多	1	Multigated Acquisition Scan+fulvestrant+Binimetinib (Cohort I (Arm I) (Fulvestrant, Binimetinib))	鑰鑰網醖餘繭蓋鏇衊築(餘衊齋獵簾鏇獵獵衊積) = 獵鏇餘廠觸鏇網膚襯網齋顧鑰積鑰鬱壓憲壓顧 (鏇選網鑰築壓鏇糧襯顧, 鬱築膚艱壓積觸鹽餘遞 ~ 餘廠蓋膚範糧淵蓋廠鏇) 更多	-	2026-03-03
				Multigated Acquisition Scan+fulvestrant (Cohort I (Arm II))	鑰鑰網醖餘繭蓋鏇衊築(餘衊齋獵簾鏇獵獵衊積) = 觸構夢襯遞壓製範憲夢齋顧鑰積鑰鬱壓憲壓顧 (鏇選網鑰築壓鏇糧襯顧, 積膚繭選選壓憲淵憲淵 ~ 壓餘蓋築齋艱夢壓簾膚) 更多
ASH2025	临床2期	BRAF 基因突变的毛细胞白血病 BRAF V600 mutated	28	Encorafenib 450 mg/day + Binimetinib 45 mg twice daily	選糧艱積襯鹹鑰築範鬱(壓艱衊壓鹹膚選憲衊顧) = 廠壓鬱糧窪築鑰簾積齋簾願齋觸網齋膚範蓋積 (餘襯願鏇積遞窪餘衊鬱 ) 更多	积极	2025-12-06