A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of TT-00420 (Tinengotinib) Tablets Combined With Fulvestrant Injection in Patients With Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2 (HER-2) Negative or Low-Expressing Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment

The goal of this clinical trial is to learn if tinengotinib combined with fulvestrant works to treat patients with HR-Positive and HER-2-Negative or low-expressing advanced breast cancer. It will also learn about the safety of combination therapy. The main questions it aims to answer are:
1. Does tinengotinib combined with fulvestrant reduce the tumor burden in participants?
2. What medical problems do participants have when taking the combination therapy?
Participants will:
Take tinengotinib and fulvestrant to find the optimal dose of tinengotinib for the combination therapy in Part A.
In Part B, will take tinengotinib at the optimal dose with fulvestrant or tinengotinib alone to see if the combination therapy works better than tinengotinib monotherapy.

开始日期2026-03-17

申办/合作机构

药捷安康（南京）科技股份有限公司

NCT07328919

/ Not yet recruiting临床3期

A Phase III, Randomized Controlled, Open-Label, Multicenter Clinical Study Evaluating the Efficacy and Safety of TT-00420 Tablets Versus Chemotherapy in Patients With Surgically Unresectable Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations, Who Have Progressed or Relapsed After Prior First-Line Systemic Therapy

This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions/rearrangements or mutations, who have experienced recurrence or progression after prior first-line systemic chemotherapy.

开始日期2026-01-01

申办/合作机构

药捷安康（南京）科技股份有限公司

100 项与替恩戈替尼相关的临床结果

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100 项与替恩戈替尼相关的转化医学

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100 项与替恩戈替尼相关的专利（医药）

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项与替恩戈替尼相关的文献（医药）

2026-02-01·The Lancet Gastroenterology & Hepatology

Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial

Article

作者: Sahai, Vaibhav ; Richards, Donald ; Peng, Peng ; Cohn, Allen ; Javle, Milind ; Ni, Shumao ; Sun, Caixia ; Fountzilas, Christos ; Fonkoua, Lionel Kankeu ; Pelster, Meredith ; Wang, Hui ; Li, Daneng ; Kingsley, Edwin ; Fan, Jean ; Liao, Chih-Yi ; Deming, Dustin ; Mahipal, Amit ; Hennessy, Katie ; Wu, Frank ; Mantry, Parvez

BACKGROUND:

Cholangiocarcinoma is a rare, aggressive cancer often driven by FGFR2 fusions, which are targetable with inhibitors such as pemigatinib and futibatinib. However, resistance frequently develops due to acquired FGFR2 mutations. In this study, we aimed to evaluate the efficacy and safety of tinengotinib in previously treated patients with advanced cholangiocarcinoma.

METHODS:

This open-label, multicentre, phase 2 trial was done at 32 medical centres in the USA. Eligible patients were aged 18 years or older with advanced or metastatic cholangiocarcinoma, who had previous systemic chemotherapy, and an Eastern Cooperative Oncology Group score of 0-1. Patients were assigned to one of four cohorts on the basis of FGFR status: cohort A1, FGFR2 fusions with primary FGFR inhibitor resistance; cohort A2, FGFR2 fusions with acquired FGFR inhibitor resistance; cohort B, other FGFR alterations; or cohort C, FGFR wild-type. Patints orally self-administered tinengotinib 10 mg daily in 28-day cycles in 28-day treatment cycles until documented disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was objective response rate as per investigator assessment, defined as the proportion of patients with confirmed tumour response (complete response or partial response) that was redocumented 4 weeks or after initial assessment based on RECIST (version 1.1), as assessed by the investigator. The primary endpoint was assessed in the in the efficacy evaluable population, which included all patients who received at least one dose of tinengotinib, had measurable disease at baseline, and had at least one post-baseline tumour assessment. Safety assessed in all patients who received at least one dose of tinengotinib. This trial is registered with ClinicalTrials.gov, NCT04919642, and enrolment is complete.

FINDINGS:

Between Nov 19, 2021, and March 5, 2024, 55 patients were enrolled and assigned to one of four cohorts (cohort A1 [n=18], cohort A2 [n=11], cohort B [n=13], and cohort C [n=13]); all received tinengotinib. Patients had a median age of 61 years (IQR 56-68); 31 (56%) patients were female. All patients had received at least one previous systemic therapy. Median follow-up was 11·3 months (IQR 6·5-17·3). Among 51 patients included in the efficacy evaluable set, the objective response rate was 6·3% (95% CI 0·2-30·2; one confirmed partial response) in cohort A1, 30·0% (6·7-65·3; three confirmed partial responses) in cohort A2, 23·1% (5·0-53·8; three confirmed partial responses) in cohort B, and 0% in cohort C. Grade 3 treatment-related adverse events included hypertension in 17 (31%) of 55 patients, palmar-plantar erythrodysesthesia syndrome in seven (13%) patients, and stomatitis in six (11%) patients. Grade 4 treatment-related adverse events occurred in two (4%) of 55 patients (increased lipase [n=1] and posterior reversible encephalopathy syndrome [n=1]); no grade 5 treatment-related adverse events were reported.

INTERPRETATION:

These findings suggest that tinengotinib might have activity in patients with cholangiocarcinoma with FGFR2 fusions that progressed following FGFR inhibitor therapy. Anti-tumour activity was also observed in patients with other FGFR alterations. The data from this phase 2 study supported the initiation of a phase 3 registration trial.

FUNDING:

TransThera Sciences.

2025-04-01·CANCER SCIENCE

Multiple Kinase Small Molecule Inhibitor Tinengotinib (TT‐00420) Alone or With Chemotherapy Inhibit the Growth of SCLC

Article

作者: Yuanhua Lu ; Peng Peng ; Rui Zhong ; Chenchen Tang ; Ying Cheng ; Hui Li ; Shaowei Lan ; Xiaoyan Qiang ; Yan Liu ; Chunjiao Wu ; Peiyan Zhao ; Ying Liu ; Frank Wu ; Rixin Li

ABSTRACT:

There is an urgent need to develop new targeted treatment agents for small cell lung cancer (SCLC). Tinengotinib (TT‐00420) is a novel, multi‐targeted, and spectrally selective small‐molecule kinase inhibitor that has shown significant inhibitory effects on certain solid tumors in preclinical studies. However, its role and mechanism of action in SCLC remain unclear. In this study, we demonstrated that tinengotinib effectively inhibited SCLC cell proliferation, especially highly expressing NeuroD1 (SCLC‐N), in the SCLC cell line‐derived xenograft (CDX) model and the malignant pleural effusion cell model of patients with SCLC. When combined with etoposide/cisplatin, it synergistically inhibited SCLC growth. Tinengotinib regulates proliferation, apoptosis, migration, cell cycle and angiogenesis in SCLC cells. Mechanistic studies revealed that c‐Myc expression may be a key factor influencing the effect of tinengotinib in SCLC‐N. This study provides reliable preclinical data and a new direction for tinengotinib as a promising therapy for SCLC, either alone or in combination with chemotherapy.

2025-04-01·ANNALS OF ONCOLOGY

A model for decoding resistance in precision oncology: acquired resistance to FGFR inhibitors in cholangiocarcinoma

Article

作者: Qiang, X ; Borad, M ; Kambadakone, A R ; Danysh, B P ; Shroff, R T ; Flaherty, K T ; Leshchiner, I ; Martin, E E ; DiToro, D ; Lennerz, J K ; Saha, S K ; Lin, B ; Chen, C T ; Javle, M ; Iyer, R ; Sun, C ; Friboulet, L ; Harris, T ; Wang, H ; Li, L ; Reyes, S ; Cleary, J M ; Stone, J R ; Fan, J ; Gordan, J D ; Karasic, T ; Bensen, D C ; Iyer, S ; Kelley, R K ; Hoffman, I D ; Berchuck, J E ; Sootome, H ; Maurer, J ; Damjanov, N ; Baiev, I ; Goyal, L ; Peng, P ; Uboha, N V ; Wehrenberg-Klee, E ; Mody, K ; Parida, L ; Getz, G ; Walmsley, C ; Hollebecque, A ; Juric, D ; Harris, W ; Nelson, K J ; Majeed, U ; Zhang, K ; Zhu, A X ; Wu, F ; Facchinetti, F ; Vasseur, D ; Hirai, H ; Pinto, C

BACKGROUND:

Fibroblast growth factor receptor (FGFR) inhibitors have significantly improved outcomes for patients with FGFR-altered cholangiocarcinoma, leading to their regulatory approval in multiple countries. As with many targeted therapies, however, acquired resistance limits their efficacy. A comprehensive, multimodal approach is crucial to characterizing resistance patterns to FGFR inhibitors.

PATIENTS AND METHODS:

This study integrated data from six investigative strategies: cell-free DNA, tissue biopsy, rapid autopsy, statistical genomics, in vitro and in vivo studies, and pharmacology. We characterized the diversity, clonality, frequency, and mechanisms of acquired resistance to FGFR inhibitors in patients with FGFR-altered cholangiocarcinoma. Clinical samples were analyzed longitudinally as part of routine care across 10 institutions.

RESULTS:

Among 138 patients evaluated, 77 met eligibility, yielding a total of 486 clinical samples. Patients with clinical benefit exhibited a significantly higher rate of FGFR2 kinase domain mutations compared with those without clinical benefit (65% versus 10%, P < 0.0001). We identified 26 distinct FGFR2 kinase domain mutations, with 63% of patients harboring multiple. While IC50 assessments indicated strong potency of pan-FGFR inhibitors against common resistance mutations, pharmacokinetic studies revealed that low clinically achievable drug concentrations may underly polyclonal resistance. Molecular brake and gatekeeper mutations predominated, with 94% of patients with FGFR2 mutations exhibiting one or both, whereas mutations at the cysteine residue targeted by covalent inhibitors were rare. Statistical genomics and functional studies demonstrated that mutation frequencies were driven by their combined effects on drug binding and kinase activity rather than intrinsic mutational processes.

CONCLUSION:

Our multimodal analysis led to a model characterizing the biology of acquired resistance, informing the rational design of next-generation FGFR inhibitors. FGFR inhibitors should be small, high-affinity, and selective for specific FGFR family members. Tinengotinib, a novel small molecule inhibitor with these characteristics, exhibited preclinical and clinical activity against key resistance mutations. This integrated approach offers a blueprint for advancing drug resistance research across cancer types.

549

项与替恩戈替尼相关的新闻（医药）

2026-09-08

·i Hope医学

9月8日肿瘤临床研究进展日报

今日要闻NMPA 批准恩沙替尼用于 ALK 阳性非小细胞肺癌术后辅助治疗，为国产首款英文原文：China NMPA approves ensartinib (Ensacove) as adjuvant therapy for ALK-positive NSCLC, first domestic ALK inhibitor in this indication 进展要点：贝达药业 9 月 3 日获 NMPA 注册证书，II-IIIB 期患者 2 年 DFS 86.4% vs 安慰剂 53.5%，复发风险降低 80%；2026 版 CSCO 指南已纳入 IB 期术后辅助唯一推荐。NMPA 附条件批准甲磺酸氘申艾替尼片（卡达沙）一线治疗伴 CNS 转移的 EGFR 突变 NSCLC 英文原文：China NMPA conditionally approves deuterated aumolertinib mesylate (Kadasa) as first-line for EGFR-mutant NSCLC with CNS metastases 进展要点：8 月 31 日浙江同源康医药获批，针对 19DEL/L858R 突变伴中枢神经系统转移的局部晚期或转移性 NSCLC，颅内 ORR 达 95.5%。FDA 加速批准 camizestrant（Etcamah）联合 CDK4/6 抑制剂治疗 ESR1 突变 HR+/HER2- 晚期乳腺癌英文原文：FDA grants accelerated approval to camizestrant with CDK4/6 inhibitor for ESR1-mutated HR+/HER2- advanced breast cancer 进展要点：9 月 4 日获批，基于 SERENA-6 III 期研究；中位 PFS 16 个月 vs 9.2 个月，HR 0.44；AstraZeneca 同步拿下 Guardant360 CDx 伴随诊断。和黄医药与GSK 就 KRAS-EGFR 抗体靶向治疗偶联物 HMPL-A830 达成 12.95 亿美元海外授权英文原文：HUTCHMED and GSK sign $1.295B licensing deal for KRAS-EGFR antibody-targeted therapy conjugate HMPL-A830 进展要点：首付款 1.1 亿美元 + 11.85 亿美元里程碑款；适应症聚焦结直肠癌、胰腺导管腺癌、肺腺癌（KRAS 突变率 44% / 89% / 34%）；HUTCHMED 保留大中华区权益。EMERALD-3 III 期：STRIDE 方案联合仑伐替尼 + TACE 治疗不可切除 HCC，PFS 风险降低 30% 英文原文：EMERALD-3 Phase 3: STRIDE regimen + lenvatinib + TACE cuts progression risk by 30% in unresectable HCC 进展要点：AstraZeneca EMERALD-3 报告，度伐利尤单抗+曲麦利尤单抗+仑伐替尼+TACE vs TACE：中位 PFS 13.0 vs 9.8 个月，HR 0.70；OS 呈现阳性趋势（HR 0.84）。新注册/ 更新临床试验（ClinicalTrials.gov）NCT07416552 — A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) 中文标题：CEA-PRIT 2.0 在转移性结直肠癌（mCRC）患者中的研究分期/ 状态：PHASE1 · RECRUITING 瘤种/ 干预：Metastatic Colorectal Cancer 申办方/ 更新日期：Hoffmann-La Roche · 2026-09-04 链接：https://clinicaltrials.gov/study/NCT07416552NCT07252297 — The Role of Universal Cancer Only Marker SIX6 in Diagnosing Non-Muscle Invasive Bladder Cancer 中文标题：通用肿瘤标志物 SIX6 在诊断非肌层浸润性膀胱癌中的作用分期/ 状态：NA · ACTIVE_NOT_RECRUITING 瘤种/ 干预：Non-muscle Invasive Bladder Cancer 申办方/ 更新日期：Xijing Hospital · 2026-09-04 链接：https://clinicaltrials.gov/study/NCT07252297NCT01972919 — MR Guided Phase II Radiotherapy Dose Escalation in Unresectable Non-Metastatic Pancreatic Cancer 中文标题：MR 引导下 II 期放疗剂量递增治疗不可切除非转移性胰腺癌分期/ 状态：PHASE2 · COMPLETED 瘤种/ 干预：Unresectable Pancreatic Cancer 申办方/ 更新日期：Medical College of Wisconsin · 2026-09-04 链接：https://clinicaltrials.gov/study/NCT01972919NCT07361562 — A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors 中文标题：选择性 ERBB2 抑制剂 CGT4255 在晚期实体瘤患者中的研究分期/ 状态：PHASE1 · RECRUITING 瘤种/ 干预：Advanced Solid Tumor, Adult, ERBB2 Altered Breast Cancer, ERBB2 Gene Amplification, HER2 Overexpression, Non-Small Cell Lung Cancer, HER2 申办方/ 更新日期：Cogent Biosciences, Inc. · 2026-09-04 链接：https://clinicaltrials.gov/study/NCT07361562NCT06062498 — Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer 中文标题：Elacestrant 单药 vs 联合 CDK4/6 抑制剂治疗 ER+/HER2- 晚期或转移性乳腺癌分期/ 状态：PHASE2 · RECRUITING 瘤种/ 干预：Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer 申办方/ 更新日期：Northwestern University · 2026-09-04 链接：https://clinicaltrials.gov/study/NCT06062498NCT06364410 — Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors 中文标题：德曲妥珠单抗（DS-8201a）联合 Azenosertib（ZN-c3）治疗胃癌或其他实体瘤的临床研究分期/ 状态：PHASE1 · RECRUITING 瘤种/ 干预：Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Locally Advanced Gastric Carcinoma, Locally Advanced Gastroesophageal Junction Adenocarcinoma, Locally Advanced Malignant Solid Neoplasm, Metastatic Gastric Carcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Metastatic Malignant Solid Neoplasm, Unresectable Gastric Carcinoma, Unresectable Gastroesophageal Junction Adenocarcinoma, Unresectable Malignant Solid Neoplasm 申办方/ 更新日期：National Cancer Institute (NCI) · 2026-09-04 链接：https://clinicaltrials.gov/study/NCT06364410顶刊论文The Lancet Oncology ·An integrated lifestyle intervention for mitigation of adverse effects associated with androgen deprivation therapy for prostate cancer (STAMINA): a multicentre, randomised trial. — 综合生活方式干预缓解前列腺癌雄激素剥夺治疗相关不良反应的STAMINA 多中心随机试验（PMID 42697217，2026 Sep 4）。 ·Exercise oncology: from trials and guidelines to routine clinical care. — 运动肿瘤学：从临床试验与指南走向常规临床实践（PMID 42697216，2026 Sep 4）。 ·Delays in cancer referrals and care lead to harm and missed diagnoses in England. — 英格兰地区癌症转诊与诊疗延误导致伤害与漏诊（PMID 42660162，2026 Aug 27）。Journal of Clinical Oncology ·Breast Cancer Risk Assessment Has a Data Integration Problem: Can Artificial Intelligence Solve It? — 乳腺癌风险评估面临数据整合难题：人工智能能否破解？（PMID 42696695，2026 Sep 4）。 ·International Breast Cancer Trials and Optimal Sequence of Treatment. — 国际乳腺癌临床试验与最佳治疗顺序（PMID 42696689，2026 Sep 4）。 ·Daraxonrasib in Pancreatic Cancer: From Second-Line Breakthrough to First-Line Evidence. — Daraxonrasib 治疗胰腺癌：从二线突破到一线循证（PMID 42691452，2026 Sep 3）。 ·Molecularly Guided Therapy Versus Continued Chemotherapy in Unfavorable Cancer of Unknown Primary: Updated Efficacy and Safety From the Randomized, Phase II CUPISCO Study. — 分子指导治疗vs 继续化疗治疗不良预后原发不明癌：随机 II 期 CUPISCO 研究最新疗效与安全性更新（PMID 42691436，2026 Sep 3）。 ·Bridging the Gap: Mounting Evidence for Metastasis-Directed Therapy in Oligometastatic Disease. — 弥合差距：寡转移性疾病转移定向治疗证据日益充实（PMID 42685304，2026 Sep 2）。JAMA Oncology ·Neoadjuvant Anbenitamab and HB1801 in ERBB2-Positive Breast Cancer: A Phase 3 Randomized Clinical Trial. — 新辅助Anbenitamab 联合 HB1801 治疗 ERBB2 阳性乳腺癌：III 期随机临床试验（PMID 42690668，2026 Sep 3）。 ·Incidental SDHA Variant Diagnosis-A Cancer Geneticist's Viewpoint as a Patient. — Incidental SDHA Variant Diagnosis-A Cancer Geneticist's Viewpoint as a Patient.（PMID 42690657，2026 Sep 3）。会议摘要（ASCO 2026 重磅 LBA） ·LIBRETTO-432: Adjuvant selpercatinib in IB-IIIA RET fusion-positive NSCLC, EFS HR 0.172 in stage II-IIIA — LIBRETTO-432：selpercatinib 辅助治疗 IB-IIIA 期 RET 融合 NSCLC，II-IIIA 期 EFS HR 0.172（LBA3, ASCO 2026）。 ·PROTEUS: Perioperative apalutamide + ADT in high-risk localized prostate cancer, dual primary endpoints met — PROTEUS：高危局限性前列腺癌围手术期 apalutamide + ADT，pCR/MFS 双终点阳性（LBA1, ASCO 2026）。 ·SARC041: Abemaciclib vs placebo in dedifferentiated liposarcoma, PFS 9.67 vs 1.52 months — SARC041：abemaciclib vs 安慰剂治疗去分化脂肪肉瘤，PFS 9.67 vs 1.52 个月（LBA2, ASCO 2026）。 ·HARMONi-6: Ivonescimab + chemo vs tislelizumab + chemo in untreated advanced squamous NSCLC, OS 27.9 vs 23.7 months — HARMONi-6：ivonescimab + 化疗 vs tislelizumab + 化疗治疗初治晚期鳞状 NSCLC，OS 27.9 vs 23.7 个月（LBA4, ASCO 2026）。 ·RASolute 302: Daraxonrasib vs chemo in previously treated mPDAC, primary and final analysis positive — RASolute 302：daraxonrasib vs 化疗治疗既往治疗 mPDAC，主要终点阳性（LBA5, ASCO 2026）。 ·EMERALD-3: STRIDE ± lenvatinib + TACE in unresectable embolization-eligible HCC — EMERALD-3：STRIDE 方案 ± lenvatinib + TACE 治疗可栓塞不可切除 HCC（LBA4000, ASCO 2026）。 ·SERENA-6: First-line camizestrant + CDK4/6i for emergent ESR1 mutation in aBC, final PFS2 results — SERENA-6：camizestrant + CDK4/6 抑制剂在 ESR1 突变 aBC 一线治疗的最终 PFS2 数据（LBA1007, ASCO 2026）。 ·VIKTORIA-1: Gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- PIK3CA-mutant aBC — VIKTORIA-1：gedatolisib + fulvestrant ± palbociclib vs SOC 治疗 HR+/HER2- PIK3CA 突变 aBC（LBA1008, ASCO 2026）。PubMed 最新实体瘤文献 ·Engineered Natural Killer Cell Derived-Extracellular Vesicles: An Acellular Immunotherapy with Cytotoxic Effects in SNU-1079 Human Cholangiocarcinoma Cells. — 工程化自然杀伤细胞来源细胞外囊泡：一种对SNU-1079 人胆管癌细胞具细胞毒性的非细胞免疫疗法（Molecular pharmaceutics，PMID 42704135，2026 Sep 7）。 ·Organ-specific response to atezolizumab + bevacizumab combination therapy for unresectable hepatocellular carcinoma with extrahepatic metastases: a retrospective cohort study. — 阿替利珠单抗+ 贝伐珠单抗联合治疗伴肝外转移的不可切除肝细胞癌的器官特异性反应：回顾性队列研究（Journal of gastrointestinal oncology，PMID 42703494，2026 Aug 31）。 ·Tumor border delineation in basal cell carcinoma using Fourier analysis. — Tumor border delineation in basal cell carcinoma using Fourier analysis.（Lasers in medical science，PMID 42702677，2026 Sep 7）。 ·CRISPR-Engineered CAR-T Cell Therapy for Epstein-Barr Virus-Associated Nasopharyngeal Carcinoma: A Review of Emerging Therapeutic Prospects. — CRISPR 工程化 CAR-T 细胞疗法治疗 EB 病毒相关鼻咽癌：新兴治疗前景综述（Reviews in medical virology，PMID 42700448，2026 Sep）。 ·PET Imaging of Tumor-Associated Macrophage Dynamics and Response to Clinical Treatment for Potential Translation. — 肿瘤相关巨噬细胞动态及临床治疗反应的PET 显像：转化潜力评估（Journal of nuclear medicine : official publication, Society of Nuclear Medicine，PMID 42692828，2026 Sep 3）。 ·Brain metastasis: Opportunities for novel therapies. — 脑转移瘤：新疗法的探索机遇（Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics，PMID 42691591，2026 Sep 3）。监管动态（FDA / NMPA）FDA 批件：FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors 中文：FDA 正式批准 selpercatinib 用于既往治疗后进展的局部晚期或转移性 RET 融合阳性实体瘤药物/ 日期：RETEVMO (Selpercatinib) · 2026-07-14 链接：https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret 批件：FDA approves zanidatamab-hrii + tislelizumab-jsgr for first-line HER2-positive gastric/GJ/esophageal adenocarcinoma 中文：FDA 批准 zanidatamab-hrii 联合 tislelizumab-jsgr 用于 HER2 阳性晚期胃/胃食管交界/食管腺癌一线治疗药物/ 日期：ZIIHERA (Zanidatamab-hrii) · 2026-08-25 链接：https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric 批件：FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma 中文：FDA 批准 daraxonrasib 用于既往治疗后或不适合多药系统治疗的转移性胰腺导管腺癌药物/ 日期：RASONQUE (Daraxonrasib) · 2026-08-26 链接：https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma 批件：FDA grants accelerated approval to camizestrant + CDK4/6 inhibitor for ESR1-mutated HR+/HER2- breast cancer 中文：FDA 加速批准 camizestrant 联合 CDK4/6 抑制剂治疗 ESR1 突变 HR+/HER2- 晚期乳腺癌药物/ 日期：ETCAMAH (Camizestrant) · 2026-09-04 链接：https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negativeNMPA（中国国家药监局）批件：China NMPA conditionally approves van-deglafenib (爱领达, Hutchmed) for FGFR2 fusion/rearrangement intrahepatic cholangiocarcinoma 中文：NMPA 附条件批准和记黄埔医药凡瑞格拉替尼片（爱领达）用于 FGFR2 融合/重排的晚期肝内胆管癌日期：2026-08-31 链接：https://www.toutiao.com/article/7680386024190591523 批件：China NMPA approves Hengrui raylolizumab trastuzumab (Rui Kang, Aiweida®) for HER2-positive colorectal cancer 中文：NMPA 批准恒瑞 HER2 ADC 瑞康曲妥珠单抗（艾维达®）用于经奥沙利铂/氟尿嘧啶/伊立替康失败的 HER2 阳性结直肠癌，国内首个 HER2 CRC 适应症日期：2026-08-中旬链接：https://www.cnfin.com/announ/detail/index.html?id=839366390666 批件：China NMPA approves bevacizumab + anlotinib sequential chemo for first-line locally advanced or metastatic squamous NSCLC 中文：NMPA 批准中国生物制药贝莫苏拜单抗联合安罗替尼序贯化疗一线治疗局部晚期或转移性鳞状 NSCLC 日期：2026-08-07 链接：https://www.zyzhan.com/news/detail/100024.html 批件：China NMPA approves tasurgratinib (替恩戈替尼, Transcenta) for pretreated FGFR2 fusion cholangiocarcinoma 中文：NMPA 批准药捷安康捷恩泰®（替恩戈替尼）用于 FGFR 抑制剂治疗失败且 FGFR2 融合/重排的晚期胆管癌日期：2026-08-06 链接：https://www.zyzhan.com/news/detail/100024.html 批件：China NMPA approves ensartinib (Ensacove, Betta) for adjuvant therapy in ALK-positive stage IB-IIIB NSCLC 中文：NMPA 批准贝达药业恩沙替尼（贝美纳）用于 ALK 阳性 IB-IIIB 期 NSCLC 术后辅助治疗，国产首款 ALK 辅助适应症日期：2026-09-03 链接：https://news.qq.com/rain/a/20260903A08TIF00药企公告（实体瘤方向） ·Evotec and Plectonic enter research collaboration on next-generation T-cell-engaging therapies for solid tumors — Evotec 与 Plectonic 达成新一代 T 细胞接合器实体瘤免疫疗法研究合作（来源：药企新闻稿）。链接：https://www.gurufocus.com/news/9063524/evotec-and-plectonic-enter-research-collaboration-to-explore-new-generation-of-tcellengaging-approaches-for-solid-tumors ·GSK licenses HUTCHMED's solid-tumor conjugate HMPL-A830 in up to $1.3B deal — GSK 引进和黄医药 KRAS-EGFR 抗体靶向治疗偶联物（HMPL-A830），总金额高达 12.95 亿美元（来源：药企新闻稿）。链接：https://www.pharmaceutical-technology.com/news/gsk-licenses-hutchmeds-solid-tumour-conjugate-in-up-to-1-3bn-deal/ ·Styx Biotechnologies signs strategic agreement with ZoeNCure Therapeutics to advance ADC pipeline to clinic — Styx Biotechnologies 与 ZoeNCure Therapeutics 达成战略合作，加速 ADC 管线进入首次人体临床研究（来源：药企新闻稿）。链接：https://www.morningstar.com/news/business-wire/20260901406609/styx-biotechnologies-announces-strategic-agreement-with-zoencure-therapeutics-to-accelerate-next-generation-adc-pipeline-to-clinic

2026-09-08

·赤象咨询

【医药月报】2026年09月中国医药行业深度分析月报

本月报的价值与意义【赤象咨询】医药月报：不仅是对过去一个月市场表现的简单总结，更是一套深度解读行业动态、前瞻预判未来走向的决策参考体系, 为您定位自身在快速变化的医药生态中的位置。我们与您共同思考，在医药行业的伟大时代中，如何更聪明地发现价值、把握机遇。我们诚挚地建议您持续关注本系列月报。报告摘要本报告将从政策、资本、临床、商业化及组织架构五个维度，梳理当月关键动态，并进行深度分析与趋势研判。 2026年8月，中国生物医药行业在政策法治化、创新兑现、资本分化与人才重构四大维度同步深化，从“框架搭建”全面进入“细则深耕+法治化运营”新阶段。政策端，十四届全国人大常委会8月28日通过首部《医疗保障法》，2027年1月1日起施行，标志着医保制度升级为长期法治框架。北京CGT促进措施征求意见稿从5维度提出9项支持举措；国家医保局发布《全民医疗保障“十五五”规划》；第三批鼓励研发儿童药品清单与罕见病用药保障政策双线发力，政策向差异化创新精准倾斜。临床端，8月共14款1类新药获NMPA批准上市。替恩戈替尼与凡瑞格拉替尼填补国产FGFR2空白；富马酸立康可泮成为国内首款PNH口服药；纬利妥米单抗（BCMA×CD3双抗）打破进口垄断；依沃西拿下肺鳞癌一线第3个适应症。IND、优先审评、突破性治疗密集落地，同质化管线加速出清。资本端，一级市场融资回暖，2026上半年创新药融资418亿元（+79.1%）；二级市场医药板块8月上涨2.81%，医疗服务以13.37%领涨。IPO窗口未全面放开，但港交所迎来A股药企集中申报H股热潮。BD出海持续放量——映恩生物×罗氏（4500万美元首付+10亿美元里程碑）、石药巨石×阿斯利康（3000万美元首付）、复宏汉霖×Sandoz（首批3款至多3.14亿美元）、甘李药业×Menarini（6200万欧元首付+6.64亿欧元里程碑），跨国药企采购逻辑从“买单品”转向“买平台+管线组合”。组织与人才端，8月至少17家药企高管变动，跨国药企全球精简与中国本土化加码并行，内资药企密集引入国际化背景人才。合规监管持续深化，于文明受贿案一审宣判15年，《医药代表管理办法》施行后首例违规案例落地。整体而言，8月行业在法治化、创新兑现、资本分化、合规深化中向高质量发展纵深推进。统计口径：2026.8.1-2026.8.31 目录展示：（关注公众号，回复：09，即可获取）获取完整报告关注“赤象咨询”公众号⬇ 回复关键词：09 郑重说明：本报告著作权归【赤象咨询】研究团队所有，仅供行业交流和职业参考。未经事先书面授权，任何机构和个人均不得以任何方式对本报告的任何部分制作任何形式的修改、仿制、刊发，或以任何侵犯本公司版权的其他方式使用。经过书面授权的引用、刊发，需在文章开始注明出处为“赤象咨询”，且不得对本报告进行任何有悖原意的删节和修改。我们欢迎大家以正确的方式转发和分享，拒绝盗版和恶意引流。如果觉得本文有价值，记得点个关注和分享哦！我们垂直于医药行业内容分享，也欢迎转发给身边的医药朋友~ End. 2026年中秋福利方案，超大优惠提前预订！企业采购服务说明： 1.支持批量采购，价格梯度合理 2.可开对公发票，签订正式采购合同 3.礼盒/礼券均可定制企业专属元素 4.下单后统一配送至公司或员工个人地址（大闸蟹礼券支持单独预约配送）欢迎各企业行政、HR部门垂询，我们将根据预算与需求，提供一对一的定制方案。咨询方式：扫码添加企业采购顾问，备注“中秋福利”，获取详细产品手册与报价。

2026-09-07

·微信

NMPA：五个新药获批上市

来源：国家药监局编辑：无名摘要：2026年08月31日，国家药监局批准了五款新药上市，分别为珠海市丽珠单抗生物技术有限公司申报的莱康奇塔单抗注射液、重庆智翔金泰生物制药股份有限公司申报的纬利妥米单抗注射液、和记黄埔医药（上海）有限公司申报的1类创新药酒石酸凡瑞格拉替尼片、Janssen-Cilag International NV申报的1类创新药盐酸伊可白滞素片、浙江同源康医药股份有限公司申报的1类创新药甲磺酸氘申艾替尼片；截至2026年8月，NMPA已批准了超过20款1类创新药，主要包括： 2026年01月批准了杭州先为达生物科技股份有限公司申报的埃诺格鲁肽注射液上市、宜昌东阳光长江药业股份有限公司申报的奥洛格列净胶囊上市、以岭万洲国际制药有限公司申报的苯胺洛芬注射液上市、恒瑞医药申报的瑞拉芙普α注射液上市、维亚臻（Arrowhead）申报的普乐司兰钠注射液上市、华辉安健申报的立贝韦塔单抗注射液上市、泽璟制药申报的注射用人促甲状腺素β等。 2026年02月，批准了三生国健药业（上海）股份有限公司申报的安沐奇塔单抗注射液上市、云顶新耀申报的维适平上市、正大天晴申报的罗伐昔替尼片上市、浙江杭煜制药申报的硫酸索西美雷塞片上市、天广实生物申报的奥妥珠单抗β注射液上市、礼来申报的米吉珠单抗注射液上市等。 2026年03月，批准了先为达生物申报的埃诺格鲁肽注射液（新增减重适应症）上市、三生制药申报的罗赛促红素α注射液上市、迈威生物申报的德莫奇单抗注射液上市、科伦药业申报的布瑞哌唑口溶膜上市、石药集团申报的阿瑞匹坦注射液等。 2026年04月，批准了珠海润都制药股份有限公司申报的盐酸去甲乌药碱注射液上市、新华制药申报的布美他尼注射液上市、誉衡药业申报的甲氨蝶呤注射液上市、信达生物申报的伏欣奇拜单抗注射液上市、鞍石药业申报的苯甲酸安达艾替尼胶囊上市、杭州邦顺制药申报的贝泽昔替尼片上市及佛山瑞迪奥医药申报的锝[99mTc]佩昔瑞特加肽注射液等。 2026年05月，批准了福建盛迪医药有限公司申报的ω-3甘油三酯注射液上市、勃林格殷格翰申报的宗艾替尼片上市等。 2026年06月，国家药监局批准9款新药上市，包括1类创新药法赞雷生片和尼卡利单抗注射液等。 2026年07月，国家药监局批准8款新药上市，分别为1类创新药阿更葡糖钠注射液、1类创新药琥珀酸安维吖啶片、1类创新药奥普雷顿片、1类创新药琥珀酸思普可泮片、1类创新药盐酸伊司特韦片、中药1.1类创新药椒七止痛凝胶贴膏、瑞西奇拜单抗注射液和舒地胰岛素注射液； 2026年08月，国家药监局批准3款新药上市，分别为1类创新药替恩戈替尼片、中药1.1类创新药小儿通便颗粒； 01 莱康奇塔单抗注射液近日，国家药品监督管理局通过优先审评审批程序批准珠海市丽珠单抗生物技术有限公司申报的莱康奇塔单抗注射液（皮下注射）（商品名：丽倍坦）上市，用于适合接受系统治疗或光疗的中重度斑块状银屑病的成人患者。该品种的上市为相关患者提供了新的治疗选择。 02 纬利妥米单抗注射液近日，国家药品监督管理局通过优先审评审批程序附条件批准重庆智翔金泰生物制药股份有限公司申报的纬利妥米单抗注射液（商品名：维可妥）上市，适用于既往至少接受过三线治疗（包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗 CD38 单克隆抗体）的复发或难治性多发性骨髓瘤成人患者。该品种的上市为相关患者提供了新的治疗选择。 03 酒石酸凡瑞格拉替尼片近日，国家药品监督管理局通过优先审评审批程序，附条件批准和记黄埔医药（上海）有限公司申报的1类创新药酒石酸凡瑞格拉替尼片（商品名称：爱领达）上市，该药用于既往接受过系统性治疗，且具有成纤维细胞生长因子受体（FGFR）2融合或重排的晚期、转移性或不可手术切除的肝内胆管癌成人患者的治疗。该药品上市为患者提供了新的治疗选择。 04 盐酸伊可白滞素片近日，国家药品监督管理局通过优先审评审批程序，批准Janssen-Cilag International NV申报的1类创新药盐酸伊可白滞素片上市，该药用于适合系统治疗或光疗的中重度斑块状银屑病成人患者和12岁及以上且体重40公斤及以上的儿童患者。该药品上市为患者提供了新的治疗选择。 05 甲磺酸氘申艾替尼片近日，国家药品监督管理局通过优先审评审批程序，附条件批准浙江同源康医药股份有限公司申报的1类创新药甲磺酸氘申艾替尼片（商品名称：卡达沙）上市，该药用于具有表皮生长因子受体（EGFR）外显子19缺失（19DEL）或外显子21（L858R）置换突变，并伴有中枢神经系统（CNS）转移的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗。该药品上市为患者提供了新的治疗选择。

上市批准

100 项与替恩戈替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12545	-	-	-

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
晚期胆管癌	中国	药捷安康（南京）科技股份有限公司	2026-08-04
不能切除的胆管癌	中国	药捷安康（南京）科技股份有限公司	2026-08-04
FGFR2融合或重排的胆管癌	中国	药捷安康（南京）科技股份有限公司	2026-08-04
转移性胆管癌	中国	药捷安康（南京）科技股份有限公司	2026-08-04

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
不可切除的肝内胆管癌	临床3期	中国	药捷安康（南京）科技股份有限公司	2026-01-01
FGFR阳性胆管癌	临床3期	美国	药捷安康（南京）科技股份有限公司	2023-12-20
FGFR阳性胆管癌	临床3期	奥地利	药捷安康（南京）科技股份有限公司	2023-12-20
FGFR阳性胆管癌	临床3期	比利时	药捷安康（南京）科技股份有限公司	2023-12-20
FGFR阳性胆管癌	临床3期	法国	药捷安康（南京）科技股份有限公司	2023-12-20
FGFR阳性胆管癌	临床3期	德国	药捷安康（南京）科技股份有限公司	2023-12-20
FGFR阳性胆管癌	临床3期	意大利	药捷安康（南京）科技股份有限公司	2023-12-20
FGFR阳性胆管癌	临床3期	荷兰	药捷安康（南京）科技股份有限公司	2023-12-20
FGFR阳性胆管癌	临床3期	波兰	药捷安康（南京）科技股份有限公司	2023-12-20
FGFR阳性胆管癌	临床3期	葡萄牙	药捷安康（南京）科技股份有限公司	2023-12-20

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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


NCT04919642 (Pubmed \| Lancet Gastroenterol Hepatol)	临床2期	转移性胆管癌	55	Tinengotinib (FGFR2 fusions with acquired FGFR inhibitor resistance)	窪襯淵網鹹製廠廠願蓋(鹽糧選鹽鏇廠觸鏇鬱窪) = Grade 3 treatment-related adverse events included hypertension in 17 (31%) of 55 patients, palmar-plantar erythrodysesthesia syndrome in seven (13%) patients, and stomatitis in six (11%) patients. 構廠襯構網網憲艱醖蓋 (壓醖蓋淵範顧觸窪蓋鹽 ) 更多	积极	2025-12-01
NCT03654547 (ESMO2025)	临床1/2期	晚期胆管癌 FGFR2-altered	109	Tinengotinib	獵願衊鹽製繭鏇廠醖窪(顧鑰醖衊獵遞襯廠獵夢) = 廠觸願膚鹹積築獵鹽艱襯選繭膚蓋簾觸衊遞窪 (範糧淵遞鏇廠鹽餘衊願 ) 更多	积极	2025-10-17
				Tinengotinib (FGFR2-altered)	夢窪蓋夢鬱範夢糧願壓(簾選顧淵鏇齋願憲蓋築) = 夢膚觸遞觸衊夢糧鹹獵淵選窪艱夢簾積衊鏇鏇 (繭鬱艱壓蓋衊願廠夢構, 9.43 ~ 19.48) 更多
NEWS 人工标引	N/A	胆管癌	43	Tinengotinib	築憲膚蓋衊遞製觸製壓(構齋膚網齋獵壓遞鬱齋) = 衊範選壓繭獵選艱壓壓餘夢淵廠範製憲夢夢遞 (夢網構鏇夢製醖鏇網顧 ) 更多	积极	2025-07-13
NCT04919642 (TransThera's phase 2, ASCO2025)	临床2期	胆管癌 FGFR2 fusion \| FGFR alterations \| FGFR wild type	37	Tinengotinib	淵淵網窪構構鬱衊艱選(願醖餘願窪夢鹹鏇構範) = 繭鹽壓鬱遞廠蓋窪製製觸願膚鏇願網膚鹹糧鹹 (襯襯遞淵獵糧構醖窪鏇 ) 更多	积极	2025-05-30
NCT04742959 (AACR2025)	临床1/2期	晚期恶性实体瘤 Aurora kinases A/B \| Janus kinases (JAK) \| receptor tyrosine kinases (FGFRs and VEGFRs)	197	Tinengotinib 4mg BID	顧淵鏇鹹獵構製淵艱蓋(淵艱糧遞壓鬱醖鹹簾壓) = No notable difference in AUC was observed in QD vs. BID schedules 襯網廠憲築網廠選築艱 (觸顧選糧壓願窪製簾遞 ) 更多	-	2025-04-29
				Tinengotinib 6mg BID
NCT04742959 (AACR2025)	临床1/2期	转移性胆管癌 FGFR fusions \| FGFR2 KD mutations	2	Tinengotinib 12mg once daily	鏇積壓艱鏇願醖積顧積(襯範願繭網艱願築鹽鑰) = suspected grade 3 TSH increase 範衊簾範艱窪衊築願鑰 (廠醖膚遞衊艱範廠夢顧 ) 更多	积极	2025-04-27
				Chemotherapy
NCT04919642 (ASCO_GI2025) 人工标引	临床2期	转移性胆管癌 MED12 mutation \| ARID1A mutation	55	Tinengotinib 10 mg QD (A1: FGFR2 fusion(s) with primary progression on previous FGFR inhibitor (FGFRi))	壓廠艱糧鬱鬱鏇網遞網(繭構衊齋糧鬱範積簾鏇) = 觸觸願醖範獵淵網鏇糧構憲鑰簾築衊遞壓襯鏇 (製憲齋築積構艱顧遞壓, 7.5 ~ 19.5)	积极	2025-01-23
				Tinengotinib 10 mg QDTinengotinib 10 mg QD (A2: FGFR2 fusion(s) with progression after prior response to FGFRi)	壓廠艱糧鬱鬱鏇網遞網(繭構衊齋糧鬱範積簾鏇) = 願築鹽衊憲顧衊繭積鹽構憲鑰簾築衊遞壓襯鏇 (製憲齋築積構艱顧遞壓, 9.6 ~ NR)
NCT05253053 (TT-00420, ESMO_ASIA2024) 人工标引	临床1/2期	胆道癌	31	Tinengotinib + Atezolizumab	醖醖糧獵簾醖鑰餘襯艱(窪糧襯衊廠網鏇鏇齋願) = 淵鹹鏇蓋繭觸選積鏇壓繭糧鑰艱夢夢鏇鑰艱鬱 (廠積淵艱壓窪艱窪蓋膚 ) 更多	积极	2024-12-07
				Tinengotinib + Atezolizumab (cholangiocarcinoma)	醖醖糧獵簾醖鑰餘襯艱(窪糧襯衊廠網鏇鏇齋願) = 齋積繭膚鬱鹽鹹糧膚糧繭糧鑰艱夢夢鏇鑰艱鬱 (廠積淵艱壓窪艱窪蓋膚 ) 更多
NCT05253053 \| NCT04742959 \| NCT03654547 \| NCT04919642 (AACR2024) 人工标引	临床1/2期	实体瘤 FGFR1 Mutation \| FGFR2 Mutation \| FGFR3 Mutation	53	Tinengotinib 5-12mg	鹽積獵鬱鹽繭網鑰憲壓(積鏇蓋願網淵餘製範鏇) = 餘壓餘蓋蓋憲觸鏇範願鑰艱簾醖醖憲衊製繭餘 (壓築窪窪構廠淵選艱鑰 ) 更多	积极	2024-04-05
				Tinengotinib 5-12mg (prior FGFR inhibitor)	鹽積獵鬱鹽繭網鑰憲壓(積鏇蓋願網淵餘製範鏇) = 製膚鹽齋鏇夢製淵餘衊鑰艱簾醖醖憲衊製繭餘 (壓築窪窪構廠淵選艱鑰 ) 更多
NCT05253053 \| NCT04742959 \| NCT03654547 (ASCO_GU2024) 人工标引	临床1/2期	转移性去势抵抗性前列腺癌	30	Tinengotinib	壓窪範憲蓋觸簾衊顧範(鏇製獵簾鹽餘鬱艱遞餘) = 鹽艱獵顧顧鹽簾淵遞襯鑰鬱網鬱蓋觸觸淵構夢 (構夢壓選壓鏇廠蓋鑰壓 ) 更多	-	2024-01-25