FUTURE Platform Trial - A Phase II Platform Trial of Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities

The FUTURE trial is a prospective, multicentre, exploratory, open-label phase II platform trial. Its goal is to evaluate the efficacy, feasibility and safety of futibatinib combined with immunotherapeutic, targeted or chemotherapeutic agents in colorectal and other solid tumors and to additionally identify biomarkers that correlate with clinical outcome.

开始日期2025-06-01

申办/合作机构-

NCT06263153

/ Recruiting临床2期IIT

A Phase II Trial of Futibatinib in Combination With Durvalumab (MEDI4736) Administered to Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer Before Cystectomy

This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy.

开始日期2024-12-30

申办/合作机构

Ohio State University Comprehensive Cancer Center

[+1]

CTIS2024-512217-40-00

/ Recruiting临床2/3期

An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study - TAS-120-404

开始日期2024-10-21

申办/合作机构

Taiho Oncology, Inc.

100 项与福巴替尼相关的临床结果

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100 项与福巴替尼相关的转化医学

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100 项与福巴替尼相关的专利（医药）

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147

项与福巴替尼相关的文献（医药）

2025-09-01·JOURNAL OF PHOTOCHEMISTRY AND PHOTOBIOLOGY A-CHEMISTRY

Adopted green spectrophotometric determination of futibatinib based on diazo coupling with 1-naphthol and assisted computational calculations

作者: Abdelazim, Ahmed H. ; Alaqel, Saleh l. ; Abduljabbar, Maram H. ; Alnemari, Reem M. ; Almalki, Atiah H. ; Alqahtani, Arwa S.

Futibatinib, a potent fibroblast growth factor receptor inhibitor, received US approval on Sept. 30, 2022, for treating breast, esophageal, and lung cancers by reducing cell viability.A new spectrophotometric method has been developed to accurately quantify this drug with the use of computational tools and matching environmentally friendly (green) principles. 1-Naphthol was found to be the best reagent for diazo-coupling of futibatinib based on the d. functional theory calculationsThe exptl. process involves diazo coupling futibatinib with sodium nitrite to produce a diazonium ion, which then interacts with 1-Naphthol to develop a red-colored chromogen complex.At 514 nm, the resultant complex displays defined measurable quant. absorption peaks.A number of elements that affect the diazotization were researched in order to optimize the process.The method exhibited excellent linearity within the range of 1-12 μg/mL (r2 = 0.9996), with limits of detection and quantification at 0.10 μg/mL and 0.30 μg/mL, resp.It also demonstrated high accuracy (99.32 %) and precision (%RSD < 1).The proposed method has a greener profile, scoring 0.69 compared to 0.48 for previously reported UPLC-MS/MS methods, offering reduced waste, shorter anal. times, and lower energy consumption.Addnl., it is more cost-effective and environmentally sustainable, making it a viable choice for both pure and pharmaceutical applications.

2025-07-01·PHARMACOLOGICAL RESEARCH

Orally effective FDA-approved protein kinase targeted covalent inhibitors (TCIs): A 2025 update

Review

作者: Roskoski, Robert

Because aberrations of protein kinase activity play causal roles in several human diseases, this family of enzymes is one of the most important drug targets of the 21st century. Of the 88 protein kinase antagonists that are approved by the FDA, eleven of them form irreversible covalent complexes with their target enzymes. The clinical efficacy of ibrutinib, a Bruton tyrosine kinase blocker, in the treatment of mantle cell lymphoma following its 2013 approval helped to overcome a general bias against the development of irreversible drug inhibitors. Other approved targeted covalent inhibitors include acalabrutinib and zanubrutinib, which also block Bruton tyrosine kinase. Afatinib, dacomitinib, lazertinib, mobocertinib, and osimertinib inhibit members of the epidermal growth factor receptor family (ErbB1/2/3/4) and are used in the treatment of non-small cell lung cancers. Neratinib inhibits ErbB2 and is used in the management of ErbB2/HER2-positive breast cancer. Futibatinib blocks the fibroblast growth factor receptor family and is prescribed for the treatment of cholangiocarcinoma while ritlecitinib, which inhibits JAK3, is used in the management of alopecia areata. The eleven drugs considered in this review have a common mechanism of action involving the addition of a protein cysteine thiolate anion (proteinS:) to an acrylamide or an acrylamide-like derivative producing a thioether. The development of targeted covalent inhibitors is gaining acceptance as a valuable component of the medicinal chemist's toolbox and has made a significant impact on the development of protein kinase antagonists and receptor modulators.

2025-04-01·MOLECULAR DIVERSITY

Targeting AFP-RARβ complex formation: a potential strategy for treating AFP-positive hepatocellular carcinoma

Article

作者: Dev, Radul R ; Soman, Sowmya ; Banjan, Bhavya ; Raju, Rajesh ; Vishwakarma, Riya ; Kalath, Haritha ; Rehman, Niyas ; Revikumar, Amjesh ; Kumar, Pankaj ; Abhinand, Chandran S ; Ramakrishnan, Krishnapriya

Alpha-fetoprotein (AFP) is a glycoprotein primarily expressed during embryogenesis, with declining levels postnatally. Elevated AFP levels correlate with pathological conditions such as liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). Recent investigations underscore AFP's intracellular role in HCC progression, wherein it forms complexes with proteins like Phosphatase and tensin homolog (PTEN), Caspase 3 (CASP3), and Retinoic acid receptors and Retinoid X receptors (RAR/RXR). RAR and RXR regulate gene expression linked to cell death and tumorigenesis in normal physiology. AFP impedes RAR/RXR dimerization, nuclear translocation, and function, promoting gene expression favoring cancer progression in HCC that provoked us to target AFP as a drug candidate. Despite extensive studies, inhibitors targeting AFP to disrupt complex formation and activities remain scarce. In this study, employing protein-protein docking, amino acid residues involved in AFP-RARβ interaction were identified, guiding the definition of AFP's active site for potential inhibitor screening. Currently, kinase inhibitors play a significant role in cancer treatment and, the present study explores the potential of repurposing FDA-approved protein kinase inhibitors to target AFP. Molecular docking with kinase inhibitors revealed Lapatinib as a candidate drug of the AFP-RARβ complex. Molecular dynamics simulations and binding energy calculations, employing Mechanic/Poisson-Boltzmann Surface Area (MM-PBSA), confirmed Lapatinib's stability with AFP. The study suggests Lapatinib's potential in disrupting the AFP-RARβ complex, providing a promising avenue for treating molecularly stratified AFP-positive HCC or its early stages.

项与福巴替尼相关的新闻（医药）

2025-07-01

·Biotech前瞻

FGFR靶点丨安进/再鼎单抗胃癌一线成功，小分子抑制剂、ADC加速拓展其他瘤种

点击蓝字关注我们本期看点近期有多篇文章围绕高度异质性的胃癌领域的最新药物进展，如安斯泰来的CLDN18.2单抗，近日，安进也宣布FGFR单抗胃癌一线获得成功。胃癌的精准靶向治疗手段日渐丰富。统计显示：FGFR1基因扩增见于约20%的肺鳞癌；乳腺癌中FGFR1/2扩增占7–23%；尿路上皮癌中FGFR3突变占10–60%、融合占约6%；肝内胆管癌约10–20%存在FGFR2融合；子宫内膜癌12%存在FGFR2突变。本文聚焦FGFR靶点各种药物形式在胃癌、胆管癌、尿路上皮癌、肺癌等领域的最新进展。本期内容01安进/再鼎丨FGFR单抗丨胃癌02FGFR靶向治疗的癌种拓展03新一代FGFR2b ADC与生物药研发04总结与展望【01 安进/再鼎丨FGFR单抗丨胃癌】2025年6月30日，安进（Amgen）宣布其与再鼎共同开发的FGFR2b抗体贝马利珠单抗（bemarituzumab）联合化疗在FORTITUDE‑101三期试验中提前达到一线胃癌总生存（OS）主要终点。这一消息再次凸显FGFR2b作为胃癌等肿瘤的关键驱动因素。FGFR2b是一种成纤维细胞生长因子受体IIb亚型，过表达时可异常激活下游信号通路，促进肿瘤增殖。FGFR靶点及bemarituzumab作用机制FGFR2b在晚期胃癌或胃食管结合部癌（G/GEJ）中的过表达率约为38%，其中约16%患者肿瘤细胞≥10%呈现2+/3+阳性。值得注意的是，Fortitude‑101和早期阶段试验均观察到贝马利珠单抗组中眼部不良事件（如角膜炎、干眼等）频发，与其强效阻断FGF10配体有关。未来全试验数据发布后，将更清晰评估其风险/获益比，但这一积极结果已经为FGFR2b靶点在胃癌领域奠定了临床地位。截止到目前为止，仅贝玛妥珠单抗进入针对FGFR2b过表达胃癌一线治疗III期研究阶段，包括联合化疗与联合免疫治疗和化疗两项，以研究其与化疗（FORTITUDE-101）以及与nivolumab和化疗联合使用（FORTITUDE-102）的疗效。胃癌的现有及新兴治疗靶点与疗法由此可见，相比于安斯泰来的CLDN18.2单抗只联合化疗对比化疗（安斯泰来CLDN18.2单抗正式销售；竞品单抗重开棋局，联合PD-1聚焦中低表达胃癌人群），贝玛妥珠单抗则提前于目前胃癌一线标准治疗方案（免疫+化疗）进行了类比，更加巩固自己的一线地位。02 FGFR靶向治疗的癌种拓展虽然胃癌治疗的最新进展吸引关注，但FGFR基因改变在多种实体瘤中均有分布。约7%的未分选肿瘤携带FGFR改变。本章节就各个瘤种的FGFR药物最新进展进行汇总。胆管癌：FGFR2融合引领靶向时代FGFR2融合是肝内胆管癌（iCCA）最常见的驱动突变之一（约10–20%）。全球范围内，胆管癌靶向治疗因FGFR2而开启新篇章：2020年4月，Incyte的FGFR1–3抑制剂佩米替尼（商品名Pemazyre）成为全球首个获批治疗携带FGFR2融合晚期胆管癌的靶向药；紧随其后，futibatinib也于2022年10月获FDA加速批准，用于既往治疗过、携带FGFR2重排（含融合）的转移性胆管癌患者。佩米替尼在中国同样进展迅速：2018年，信达生物与Incyte达成合作，获得其在中国的开发和商业化权利；2022年3月，中国NMPA批准佩米替尼（达伯坦®）用于经治、检测到FGFR2融合或重排的晚期胆管癌患者。此外，infigratinib曾于2021年获FDA加速批准用于胆管癌，但因后续III期试验招募等问题，2024年主动撤销了适应症。但毋庸置疑的是，FGFR靶向药物深刻改变了胆管癌的治疗格局，进入到精准治疗时代。尿路上皮癌：泛FGFR抑制剂进程尿路上皮癌（尤其膀胱癌）中FGFR3突变比例很高，已经成为重要靶点。首款上市的FGFR抑制剂厄达替尼（Balversa）即获FDA批准用于携带FGFR3/2突变的复发转移性膀胱癌。该药在美国上市后表现出显著的总缓解率提升，也因此被称为膀胱癌首个靶向疗法。目前国内相关进展也在加速推进：2023年底，国家药监局受理了强生公司提交的厄达替尼上市申请，用于治疗晚期尿路上皮癌（FGFR3/2突变），业内普遍预计获批将为国内癌症患者带来新希望。其他肿瘤类型中的FGFR靶向策略除上述两种主打适应症外，FGFR靶点在多种肿瘤中均有探索潜力。例如，约20%的肺鳞癌患者存在FGFR1扩增，已有研究表明FGFR抑制剂可使这部分患者的肿瘤显著缩小；部分子宫内膜癌患者携带FGFR2突变，也被认为是未来可尝试的靶点。此外，成纤维细胞生长因子19（FGF19）–FGFR4通路在部分肝细胞癌中异常激活，新一代FGFR4抑制剂（如BLU-554等）正在全球临床评估。虽然目前尚无其他肿瘤类型的FGFR靶向疗法获得临床批准，但随着对FGFR生物学理解加深，预计未来将有更多II/III期临床研究结果公布。03 新一代FGFR2b ADC与生物药研发随着贝马利珠单抗在胃癌中的进展，业界对FGFR2b靶向疗法的兴趣进一步升温，ADC已成为热门方向。国内外多家公司加紧布局下一代FGFR2b ADC，以期兼顾疗效和安全性：如百济神州研发的BG-C137为一款FGFR2b ADC，payload为TOPOI抑制剂，DAR值为8，采用稳定连接子，有望避免角膜毒性，已经推进到临床I期阶段。2025年6月25日，中美华东在研的FGFR2b ADC HDM2020 获批开展晚期实体瘤适应症的临床研究。此外，还有一些早期在研FGFR ADC产品，不再一一赘述。这些新药在设计上往往优化了抗体表位和链接子，以降低阻断FGF10所致的眼部毒性，并借助先进载药平台扩大治疗窗口。期望能够在临床试验中得到验证。04 总结与展望FGFR靶点治疗正从胃癌治疗走向更广阔的领域。与此同时，FGFR2b方向的ADC和新一代抑制剂有望突破眼部毒性瓶颈，赋能胃癌以外的多种实体瘤患者。对于医药从业者而言，紧跟FGFR靶点的药物研发动态、理解各种FGFR变异的生物学意义，已成为当前精准肿瘤治疗领域的一大重点。 ★

临床3期抗体药物偶联物临床结果临床2期

2025-06-27

·PRNewswire

TransThera Publishes Translational Studies of Tinengotinib (TT-00420) against Cholangiocarcinoma on Annals of Oncology

NANJING, China and GAITHERSBURG, Md., June 27, 2025 /PRNewswire/ -- TransThera Sciences Inc. ("TransThera") announced that the translational studies of tinengotinib in CCA with acquired resistance to FGFR inhibitors were published in Annals of Oncology (IF 56.7). Dr. Peng Peng, Vice President at TransThera, serves as the co-first author. CCA is an aggressive bile duct cancer often driven by FGFR2 fusion and rearrangement, which are targetable with inhibitors like pemigatinib and futibatinib. However, resistance frequently develops due to acquired FGFR2 mutations. In this paper, multimodal analyses led to a model characterizing the biology of acquired resistance, informing the rational design of next-generation FGFR inhibitors. Novel FGFR inhibitors should be small, high-affinity, and capable of binding to active form of FGFR. The article discloses for the first time the co-crystal structure of tinengotinib with the FGFR2 kinase domain of its unique binding mode, in addition to kinetic studies to illustrate its higher affinity compared to first-generation FGFR inhibitors, in vitro and in vivo activities against clinically acquired FGFR2 resistance mutations, as well as a case report to demonstrate its clinical efficacy. These data demonstrated that tinengotinib is a second-generation FGFR inhibitor meeting all the aforementioned criteria. Dr. Lipika Goyal, the Director of Gastrointestinal Oncology at the Stanford Cancer Center, who is the principal investigator of the study and correspondence author of the paper, stated, "The study represents a comprehensive analysis of acquired resistance to FGFR inhibitors using circulating tumor DNA, biopsy, rapid autopsy, pharmacokinetic, and in vitro and in vivo data, It represents the largest collection of primary patient data on acquired FGFR resistance, with analysis of nearly 500 clinical samples. Research in rare cancers like CCA relies on the collective efforts of numerous teams working together, and we highly appreciated the translational studies of tinengotinib by TransThera, which validated the principles of developing next-generation FGFR inhibitors highlighted in this publication. We believe this study will be a substantial contribution to the field that will advance our understanding of acquired resistance to FGFR inhibitors." "We are delighted that TransThera's discovery be part of the fundamental research in the field of overcoming FGFR refractory. Currently tinengotnib is undergoing a pivotal phase 3 study globally and we hope to bring novel treatment option to CCA patients", commented by Dr. Peng from TransThera. About Tinengotinib Tinengotinib is an internally discovered, global phase III multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs and VEGFRs, mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation(ODD) and Fast Track Designation(FTD) by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by NMPA in China, the Orphan Drug Designation(ODD) for the treatment of biliary tract cancer by EMA. About TransThera TransThera is a clinical demand-oriented, registrational clinical-stage biopharmaceutical company focusing on discovering and developing innovative small molecule therapies for oncology, inflammatory and cardiometabolic diseases. Further aided by in-depth study of translational medicine and drug design, TransThera aims to develop first-in-class or best-in-class drug candidates strategically positioned to meet urgent clinical needs on a global scale. For more information, please visit Forward-looking statements This news contains forward-looking statements that involve risks, uncertainties, and assumptions. If risks or uncertainties ever materialize or the assumptions prove incorrect, our actual results may differ from those expressed or implied by such forward-looking statements. All statements other than statements of historical facts could be deemed forward-looking, including, but not limited to, any statement of the plans, strategies, and objectives of management for future operations, including but not limited to our clinical development and commercialization plans; any projections of financial information; any statements about historical results that may suggest trends for our business; any statements of expectation or belief regarding future events, potential markets or market size, technology developments, our product pipeline, clinical data, results or practices or the implications thereof, enforceability of our intellectual property rights, competitive strengths or our position within the industry; and any statements of assumptions underlying any of the items mentioned. SOURCE TransThera Sciences (Nanjing) Inc. 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孤儿药快速通道临床3期突破性疗法

2025-06-26

·汇聚南药

药捷安康，药界南哥

“苏超”联赛正如火如荼地进行着，人们津津乐道地讨论着谁才是真正的“南哥”，谁会成为“十三妹”。在今年的另一个赛场上，港股18A的IPO也是不逞多让，截至今年6月份，已有6家生物科技公司通过18A的规则登陆港股，打破了去年全年4家的数量。而在这6家生物科技公司里，全球总部位于南京的药捷安康，以IPO当天高达78.71%的涨幅，成为小分子企业里涨幅最高的企业，是当之无愧的“南哥”。 “南哥”药捷安康取得如此佳绩，靠的是遍布全球的开发足迹、扎实的理论基础、全球性的创新能力以及具有非凡潜力的市场空间。1. 遍布全球2. 扎实创新3. 潜力非凡4. 结语遍布全球作为药捷安康首款进入到关键性临床和注册性临床的候选药物，多靶点激酶抑制剂Tinengotinib/TT-00420的3期国际多中心临床试验地点遍布亚太和欧美地区，包括美国、韩国、英国、欧盟八国及台湾。只有对自身产品竞争力具有很强烈的信心，才会去美国那边开展3期临床试验。而美国高额的支付能力也让药企具有丰厚的回报。同样在美国那边开展3期临床试验的中国小分子企业，如百济神州、和黄医药、亚盛医药、和誉医药等，他们后续通过自建商业化团队或BD的方式，将自身产品的商业价值最大化，同时也给公司的股价带来不错的回馈。除此之外，拥有出色自研能力的药捷安康，也受到来自亚太地区其他药企的青睐。2020年8月，药捷安康将处于临床前阶段VAP-1抑制剂TT-01025的全球权益（除大中华区和日本）license out给韩国LG Chem公司；2020年10月，与日本的帝人公司就苗头/先导化合物进行合作开发，全球权益共同承担（除大中华区和日本）；2023年7月，与日本EA Pharma公司就炎症和代谢疾病领域的新靶点进行合作开发。扎实创新硬核的产品竞争力和备受同行青睐的研发能力，离不开药捷安康新颖的基础研究、扎实的临床研究和全球领先的开发能力。Tinengotinib是药捷安康基于内部识别出的一种新型分子骨架而开发出来的药物，这种全新药物没有任何可供参考的开发路径，与FGFR具有独特的结合模式和高亲和力，能够克服多重抗药突变。新颖的机制。Tinengotinib结构中不含infigratinib、futibatinib和pemigatinib共有的庞大的二甲氧基苯基部分。FGFR2的共晶体结构证实其不会延伸至后口袋。Tinengotinib与FGFR2的铰链区产生3个氢键（上一代FGFR抑制剂则产生1-2个），从而促成与FGFR的更高亲和力。相较于infigratinib，Tinengotinib表现出快速结合和非常缓慢解离的结合动力学，与靶点的结合强度较上一代FGFR抑制剂高近两个数量级。Tinengotinib的作用机制（来源：药捷安康招股书）扎实的临床研究。截止2023年9月26日，共有350名实体瘤患者接受Tinengotinib单药治疗，包括295名美国患者及55名中国患者。大量的早期临床积累的患者数据让Tinengotinib开展3期注册性临床试验时会更加从容，并且还有大量的美国患者，更加真实地反映美国地区情况，降低在美国开展3期临床的风险。最为关键的是，如此扎实的临床研究，在对外BD谈判的时候会掌握更多的话语权，杜绝了买方对China-only药物数据的担忧。全球领先的开发能力。Tinengotinib在胆管癌领域，是世界首个且唯一已进入注册临床阶段治疗FGFR抑制剂复发或难治性胆管癌患者的研究药物；在mCRPC（转移性去势抵抗性前列腺癌）领域，Tinengotinib是全球首个和唯一一个可能同时抑制FGFR/JAK通路，且针对mCRPC有临床疗效证据的研究药物。其他管线的差异化竞争优势，如AXL/FLT3抑制剂TT-00973、非共价可逆BTK抑制剂TT-01488、S1P1调节剂TT-01688、PDE9抑制剂TT-00920和VPA-1抑制剂TT-01025等，归纳总结在下面这张表格里。药捷安康管线布局（丰硕创投整理）潜力非凡Tinengotinib——进度领先，BD价值上限高2024年12月，Relay Therapeutics公司以5亿美元的总价格把FGFR2抑制剂Lirafugratinib的全球权益卖给了Elevar Therapeutics，Lirafugratinib最领先的适应症是FGFR2驱动的胆管癌。2023年，Leerink Partners曾预测Lirafugratinib非胆管癌的销售峰值约为11亿美元。从这两则消息看出，在胆管癌和mCRPC适应症上都具有领先性的Tinengotinib，它未来的BD价值和商业化价值已经具备一定可预见性了，相信随着临床工作的进一步推进，离兑现那一天也不远了。而且在mCRPC适应症上，Tinengotinib与目前已获批的用于治疗mCRPC的小分子靶向疗法，如雄激素受体拮抗剂、雄激素受体抑制剂或PARP抑制剂都不一样，Tinengotinib通过抑制FGFR/JAK通路，破坏并逆转前列腺癌的谱系可塑过程，阻断谱系可塑性已成为mCRPC治疗的焦点，使得药捷安康成为“谱系重塑第一股”。最后必须重点提出来的是，Tinengotinib联合康方生物的卡度尼利/依沃西治疗晚期肝癌，是有望让Tinengotinib实现弯道超车，拿下并成为潜在最佳的肝细胞癌一线疗法。在晚期肝细胞癌系统治疗中，靶向+免疫联合治疗逐渐成为主流，且多靶点联合是突破靶向+免疫联合治疗瓶颈的重要思路。此前探索性研究中，卡度尼利和依沃西相关疗法治疗肝细胞癌均展现了优于PD-1/PD-L1单抗疗法的研究数据。药捷安康与康方生物的这项联合疗法合作始于2025年3月份，并且这一轮IPO的基石投资者里有康方生物，反映了康方生物对这项合作，对药捷安康的长期看好。TT-01488——高选择性低毒性，市场空间巨大对于非共价可逆BTK抑制剂TT-01488，同类进度最快的竞品Pirtobrutinib于2023年获得美国FDA批准上市，上市后第二年2024年的销售达到了3.37亿美元，最新的2025年第一季度的销售为0.92美元，同比增长85%，处于高速增长阶段，GlobalData团队在2024年预测其在白血病领域的销售峰值或可达到30亿美元，市场空间巨大。TT-01488最新的初步临床数据显示，在7名MCL/WM/MZL的患者中，ORR为100%（7/7），以及其对EGFR和Tec家族蛋白的高选择性所带来的潜在更好的耐受性，相信其在未来如此大的市场空间里，能够占据不小的份额。TT-01688——高活性高选择性低毒性，潜在国内10亿品种作为国内首款潜在用于治疗炎症性肠病的伊曲莫德，中国药监局于2024年12月受理了上市申请，云顶新耀公司估计其销售峰值为20亿人民币。而拥有更高活性、更高选择性、更低毒性、低药物相互作用且进度排在国内第二梯队的TT-01688，在国内市场空间超过20亿元的前提下，是有可能成为10亿元品种的。TT-01688的选择性（来源：药捷安康招股书）结语成立于2014年的药捷安康，在当时正处于中国创新药黄金发展的1.0阶段，每隔1到2年就能完成一轮融资，平均每年有2个推进到IND阶段的管线，更是在2021年7月份完成了D轮融资，融资额达到了6.43亿人民币，投后估值去到了43.29亿人民币。然而中国创新药的行情在2021年下半年开始急转直下，进入了漫长的4年熊市阶段，药捷安康也开启了4年4次申报IPO之旅。分别于2021年8月申报港交所，2022年10月筹备科创板，2024年6月申报港交所以及这次在2024年12月成功申报港交所。这次药捷安康成功登陆港交所，并在IPO首日拿下不错的涨幅，港股IPO行情逐渐有起色是一个原因，但更大的驱动因素还在于药捷安康在过去4年资金紧张的熊市期间，狠修“内功”，Tinengotinib于2023年7月获得了中国药监局的突破性疗法认定，接着陆陆续续在全球各地获批开展3期临床试验，包括台湾、韩国、欧洲以及美国。无人扶我青云志，我自踏雪至山巅。试问一下，有几家港股18A生物科技公司，在IPO的时候，就已经独立在美国开展3期临床试验了？而且Tinengotinib的全球权益仍在药捷安康的手上，具有十分强烈的BD催化剂，在目前投资者翻遍全网去寻找潜在创新药BD漏网之鱼的时候，恰巧药捷安康是其中一条大鱼。喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~免责声明“汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。信息来源：丰硕创投往期推荐本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。

IPO引进/卖出临床3期

100 项与福巴替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11725	-	-	DB15149

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
FGFR2融合或重排的胆管癌	日本	Taiho Pharmaceutical Co., Ltd.	2023-06-26
肝内胆管癌	美国	Taiho Oncology, Inc.	2022-09-30

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
胆道癌	申请上市	日本	Taiho Pharmaceutical Co., Ltd.	2022-01-30
肿瘤转移	临床3期	美国	Taiho Oncology, Inc.	2024-10-01
肿瘤转移	临床3期	法国	Taiho Oncology, Inc.	2024-10-01
肿瘤转移	临床3期	韩国	Taiho Oncology, Inc.	2024-10-01
肿瘤转移	临床3期	西班牙	Taiho Oncology, Inc.	2024-10-01
肿瘤转移	临床3期	英国	Taiho Oncology, Inc.	2024-10-01
食管腺癌	临床2期	美国	Taiho Oncology, Inc.	2023-07-13
食管腺癌	临床2期	法国	Taiho Oncology, Inc.	2023-07-13
食管腺癌	临床2期	德国	Taiho Oncology, Inc.	2023-07-13
食管腺癌	临床2期	西班牙	Taiho Oncology, Inc.	2023-07-13

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临床结果

适应症

分期

评价

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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


NCT04093362 (FOENIX-CCA3, CTgov)	临床3期	FGFR2融合或重排的胆管癌	10	Futibatinib	艱糧醖繭鑰顧糧鏇觸觸 = 襯範選鑰糧遞壓淵廠繭遞餘鏇鹽蓋繭鹽壓鏇鹽 (糧網襯壓鹹壓簾壓鬱築, 醖壓鹽觸憲憲簾蓋顧壓 ~ 構憲遞壓築鹽築醖膚餘) 更多	-	2025-02-07
NCT04999761 (ASCO_GI2025) 人工标引	临床1期	转移性食管癌一线	43	Zimberelimab + Futibatinib + cisplatin + fluorouracil	鬱餘顧膚願蓋夢範鬱膚(鹽糧選齋膚衊製構夢糧) = DLTs were evaluated in the first three pts, and none were reported. 製觸選蓋範鹽積夢繭鹽 (簾鹹鬱選壓醖齋蓋簾鏇 )	积极	2025-01-23
Phase 1b study of futibatinib plus pembrolizumab (ASCO_GI2025)	临床1期	食管癌 CD3+ \| CD4 \| CD8+ ... 更多	18	Futibatinib + Pembrolizumab	廠積簾夢積艱醖鹽夢觸(鑰衊夢繭觸窪憲顧壓積) = 22.2% 構淵壓廠構鏇築襯築憲 (鹽窪鬱衊觸糧壓壓鏇繭 ) 更多	积极	2025-01-23
NCT04601857 (ESMO2024) 人工标引	临床2期	尿路上皮癌一线 FGFR alteration	43	Futibatinib 20 mg PO QD Pembrolizumabzumab 200 mg IV Q3W	夢蓋膚獵願鹹衊夢簾鑰(壓窪淵廠衊獵積築網壓) = 鹹壓獵餘壓膚襯鏇顧夢獵鬱獵構範衊衊鏇繭製 (顧齋構膚衊鏇艱繭憲醖, 23 ~ 72) 更多	积极	2024-09-15
NCT04601857 (ESMO2024) 人工标引	临床2期	尿路上皮癌一线 FGFR alteration	43	Futibatinib 20 mg PO QD+PembrolizumabPembrolizumab 200 mg IV Q3W (without FGFR3 mutations or FGFR1–4 fusion/rearrangements)	夢蓋膚獵願鹹衊夢簾鑰(壓窪淵廠衊獵積築網壓) = 鑰淵獵顧獵選窪餘簾繭獵鬱獵構範衊衊鏇繭製 (顧齋構膚衊鏇艱繭憲醖, 14 ~ 52) 更多	积极	2024-09-15
NCT02052778 (FOENIX-CCA2, Pubmed \| Future Oncol) 人工标引	临床2期	晚期胆管癌 FGFR2 Fusion	-	Futibatinib	夢顧鹹選壓遞壓積廠觸(糧餘製齋積餘築淵衊艱) = 醖範鏇鏇簾醖簾顧窪窪鬱鏇顧遞鏇觸觸蓋觸憲 (顧壓淵網夢廠廠鬱觸鹽 ) 更多	积极	2024-06-17
JPRN-jRCT2080224975 (ASCO2024) 人工标引	临床1期	食管癌	-	Futibatinib 2Pembrolizumabembrolizumab 200mg/q3w with chemotherapy	獵窪繭繭淵觸糧襯範艱(選壓窪齋壓夢願願夢糧) = 願製獵襯壓廠艱顧獵鹹蓋壓鏇壓糧廠繭襯夢艱 (蓋簾顧膚願繭簾齋簾夢, 43.4 ~ 87.4) 更多	积极	2024-05-24
JPRN-jRCT2080224975 (ASCO2024) 人工标引	临床1期	食管癌	-	Futibatinib 20Pembrolizumabmbrolizumab 200mg/q3w without chemotherapy	獵窪繭繭淵觸糧襯範艱(選壓窪齋壓夢願願夢糧) = 顧網醖醖製醖膚遞鹽製蓋壓鏇壓糧廠繭襯夢艱 (蓋簾顧膚願繭簾齋簾夢, 26.3 ~ 60.6) 更多	积极	2024-05-24
JPRN-jRCT2080224975 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	食管癌	92	Futibatinib + pembrolizumab (ICI naïve)	壓糧繭壓獵顧觸遞窪鏇(鏇窪願製鬱廠壓齋夢獵) = 鑰壓鏇廠製壓鬱窪淵膚構艱憲獵願願糧積憲糧 (艱範鹽製夢夢鹽願觸齋 ) 更多	积极	2023-10-23
JPRN-jRCT2080224975 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	食管癌	92	Futibatinib + pembrolizumab (ICI refractory)	壓糧繭壓獵顧觸遞窪鏇(鏇窪願製鬱廠壓齋夢獵) = 壓願淵觸餘網襯憲醖壓構艱憲獵願願糧積憲糧 (艱範鹽製夢夢鹽願觸齋 ) 更多	积极	2023-10-23
TAS-120-101 (EMA) 人工标引	N/A	FGFR2融合或重排的胆管癌	103	futibatinib	窪餘製範鹹壓窪鹽觸簾(廠遞壓糧蓋鬱獵鹹鏇膚) = 壓鹽製繭壓鏇觸範糧鬱鏇網窪鹹獵膚簾築獵願 (選積構築願範壓簾繭觸, 32 ~ 52) 更多	积极	2023-07-18
NCT04189445 (SO-10, ESMO_GI2023)	临床2期	FGFR2阳性胃食管交界处腺癌 FGFR2 amplification	28	Futibatinib 20 mg	襯襯膚醖壓範鬱製選齋(窪鬱鹹壓餘襯廠艱網艱) = 觸夢鏇願網廠選顧醖鹽積顧構窪淵選鹽獵醖積 (遞簾膚艱鹹夢鏇艱鹽夢, 6.1 ~ 36.9) 更多	积极	2023-07-01
NCT02052778 (FOENIX-CCA2, ESMO_GI2023)	临床2期	FGFR2阳性肝内胆管癌 FGFR2	103	Futibatinib	憲憲獵製鹹壓糧簾壓顧(憲製膚構齋襯憲蓋艱鬱) = 範鑰遞鬱願夢觸蓋鏇鏇餘遞夢築獵選願糧繭選 (鏇鬱積願簾願獵襯獵窪 ) 更多	积极	2023-07-01