FGFRs antagonists(Fibroblast growth factor receptors antagonists), PDGFR antagonists(Platelet-derived growth factor receptor antagonists), Tyrosine kinase inhibitors

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseRespiratory Diseases+ [8]

Active Indication

Metastatic Renal Cell CarcinomaUnresectable Renal Cell CarcinomaEndometrial Carcinoma+ [51]

Inactive Indication

adenocarcinoma of biliary tractAdvanced Bile Duct CarcinomaAdvanced biliary tract cancer+ [54]

Originator Organization

Advenchen Laboratories LLC

Active Organization

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Advenchen Laboratories LLCShanghai Zhengda Tianqing Pharmaceutical Co., Ltd.

Inactive Organization

Peking University People's Hospital

Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (08 May 2018),

Locally Advanced Lung Non-Small Cell Carcinomametastatic non-small cell lung cancer

RegulationOrphan Drug (United States), Priority Review (China), Special Review Project (China), Conditional marketing approval (China)

Structure/Sequence

Molecular FormulaC23H23ClFN3O3

InChIKeyGTAUHBAHFJIAQT-UHFFFAOYSA-N

CAS Registry1360460-82-7

715

Clinical Trials associated with Anlotinib Dihydrochloride

NCT07137884

/ Not yet recruitingPhase 2IIT

A Phase II, Multicenter, Randomized, Controlled Clinical Study of Anlotinib Hydrochloride Capsules as Maintenance Therapy for Intermediate-High Risk Rhabdomyosarcoma in Children

This is a randomized controlled phase II clinical study aimed at evaluating the efficacy and safety of anlotinib hydrochloride in children with Intermediate-High -risk rhabdomyosarcoma. The study enrolled children with rhabdomyosarcoma confirmed by histopathology, with a clinical risk classification of high or Intermediate-risk accompanied by high-risk factors (high-risk factors are defined as age > 10 years，Poor prognosis molecular characteristics or those who cannot undergo surgery/radiotherapy);One year of maintenance treatment with anlotinib can increase the duration of response and long-term survival.

Start Date01 Oct 2025

Sponsor / Collaborator

Sun Yat-Sen University

NCT07165951

/ Not yet recruitingPhase 3

A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules to Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

This study adopts a randomized, open label, placebo-controlled, multicenter trial design. OS was the primary endpoint, and eligible subjects were randomly divided into 1:1 groups and received TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy, compared to placebo combined with chemotherapy.

Start Date01 Oct 2025

Sponsor / Collaborator

Shanghai Zhengda Tianqing Pharmaceutical Co., Ltd.

NCT07156643

/ Not yet recruitingPhase 2IIT

A Prospective, Single-arm, Multicenter Exploratory Clinical Study of Anlotinib Combined With Bempegaldesleukin and Conventional Chemoradiotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Soft Tissue Sarcoma.

This study employs a multicenter, single-arm trial design. Participants will receive a treatment regimen consisting of "anlotinib plus bempegaldesleukin concurrent with radiotherapy," followed by a maintenance therapy phase of "anlotinib plus bempegaldesleukin concurrent with chemotherapy." The study aims to evaluate the clinical efficacy and safety of anlotinib in combination with bempegaldesleukin and conventional chemoradiotherapy for the treatment of unresectable locally advanced or metastatic soft tissue sarcoma.

Start Date01 Oct 2025

Sponsor / Collaborator

Third Affiliated Hospital of Nanjing Medical University

[+1]

100 Clinical Results associated with Anlotinib Dihydrochloride

100 Translational Medicine associated with Anlotinib Dihydrochloride

100 Patents (Medical) associated with Anlotinib Dihydrochloride

1,225

Literatures (Medical) associated with Anlotinib Dihydrochloride

31 Dec 2025·Future Science OA

Real-world efficacy and safety of anlotinib combined with chemotherapy for advanced pancreatic cancer: a retrospective study

Article

Author: Gan, Hexia ; Zhang, Xiuping ; Wang, Zhiming ; Cheng, Lisha ; Li, Zhiyong ; Shen, Feng

BACKGROUND:

Pancreatic cancer (PC) is often diagnosed at advanced stages, limiting surgical options. There is no standardized treatment for second-line or beyond therapies, necessitating alternative treatments. This study evaluates the efficacy and safety of anlotinib combined with chemotherapy in advanced PC patients receiving second-line or subsequent treatments.

METHODS:

A retrospective analysis of 68 advanced PC patients was conducted. Twenty-six patients treated with anlotinib and chemotherapy were compared to 42 controls who received chemotherapy only. Demographic data, efficacy, survival, and adverse reactions were analyzed.

RESULTS:

In the anlotinib group, the therapeutic responses were as follows: Complete Response: 0, Partial Response: 2 (7.7%), Stable Disease: 13 (50.0%), and Progressive Disease: 11 (42.3%), the Objective Remission Rate was 7.7%, and the Disease Control Rate was 57.7%. The median Progression-Free Survival was 4.5 months. The Overall Survival was significantly longer in the anlotinib group compared to controls. Common adverse reactions included fatigue, bone marrow suppression, and hypertension, mostly grade 1-3. The potential toxicity and cumulative toxicity of long-term use is hand-foot syndrome, hypothyroidism and hypertension.

CONCLUSION:

The data generated suggest that anlotinib combined with chemotherapy may be an effective and tolerable option for second-line and subsequent treatment of advanced PC.

31 Dec 2025·ANNALS OF MEDICINE

The efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed on prior immune checkpoint inhibitors (ICIs): a retrospective real-world study (NCT 04984096)

Article

Author: Zhang, Ming ; Yu, Wen ; Ma, Xiumei ; Liu, Jun ; Li, Zhigang ; Zhu, Xueru ; Cheng, Yan ; Zhao, Lei ; Fu, Xiaolong ; Li, Hongxuan ; Feng, Wen ; Wu, Jianguo

BACKGROUND:

Several studies have shown that combining immune checkpoint inhibitors (ICIs) with antiangiogenic tyrosine kinase inhibitors is effective for solid tumors, including esophageal squamous cell carcinoma (ESCC). However, most of these studies were focused on immunotherapy-naive patients. This retrospective real-world study offers insights into the efficacy and safety of combining anlotinib with ICIs in locally advanced/metastatic ESCC patients who progressed on prior ICI.

METHODS:

We retrospectively analyzed the efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic ESCC patients who had progressed on PD-1 inhibitor. Efficacy was assessed according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The primary endpoints were the objective response rate (ORR) and disease control rate (DCR), while secondary endpoints were safety, overall survival (OS) and progression-free survival (PFS). Baseline characteristics and adverse events (AEs) were documented throughout the study.

RESULTS:

Between July 2020 and March 2022, 29 eligible patients were included in the final analysis, with 23 (79.3%) having previously undergone resection for ESCC. Of these 29 patients, 8 (27.6%) received first-line systemic therapy, 20 (69.0%) received second-line therapy, and 1 patient (3%) received third-line therapy. At the data cutoff, the ORR was 31.0%, and the DCR was 86.2%, with 9 patients achieving partial response (PR), 16 patients with stable disease (SD) and 4 patients with disease progression (PD). The median PFS was 5.33 months (95% CI: 4.28-6.38), and the median OS was 10.37 months (95% CI: 6.26-14.46). All patients experienced treatment-related adverse events (TRAEs), with anemia and lymphopenia being the most common. Only 2 patients (6.9%) experiencing grade 3-4 lymphopenia. All AEs were managed with symptomatic treatment and no treatment-related deaths occurred.

CONCLUSION:

The combination of anlotinib and a PD-1 inhibitor demonstrated promising antitumor efficacy and manageable toxicity in patients with locally advanced/metastatic ESCC who progressed on prior ICI. This regimen represents a feasible and well-tolerated treatment option for this patient population.

TRIAL REGISTRATION NUMBER:

NCT04984096.

01 Dec 2025·COLLOIDS AND SURFACES B-BIOINTERFACES

Biomimetic anlotinib-loaded FePc-silicate nanoparticles for sonodynamic and immunotherapy in non-small cell lung cancer via dual PD-L1 modulation

Article

Author: Xie, Cheng ; Liu, Yahui ; Cai, Hongqiao ; Li, Hongru ; Jiao, Yan ; Liu, Yunpeng ; Zhang, Ting

Non-small cell lung cancer (NSCLC) accounts for approximately 85 % of all lung cancer cases, in urgent need for multimodal therapeutic strategies. Sonodynamic therapy (SDT) has recently emerged as a promising non-invasive strategy. Programmed death-ligand 1 (PD-L1) antibody represented immunotherapy has shown limited efficacy due to inadequate tumor accumulation and persistent intracellular PD-L1 signaling. To address these challenges, we developed a multifunctional biomimetic nanodrug (APSNM), composed of iron phthalocyanine (FePc)-silicate nanoparticle (NP) and encapsulated Anlotinib, with PD-L1 coated macrophage membrane onto the surface. This design enables dual checkpoint inhibition by concurrently downregulating intracellular PD-L1 via p-VEGFR2/p-JAK2/p-STAT3 pathway suppression and blocking extracellular PD-L1 through antibody-mediated surface binding. Upon ultrasound activation, APSNM generates reactive oxygen species (ROS) and enhances antitumor immunity. Orthotopic lung tumor mouse model demonstrates that APSNM exhibits excellent tumor-targeting capability and enhanced antitumor efficacy compared to non-functionalized or non-ultrasound-treated controls. Notably, APSNM + US treatment led to the greatest tumor regression, increased CD4⁺ and CD8^⁺ T cell infiltration, and elevated IFN-γ expression. These findings highlight APSNM as a promising nanoplatform for precise, multimodal NSCLC therapy via the integration of antiangiogenesis, sonodynamic therapy, and immune checkpoint modulation.

News (Medical) associated with Anlotinib Dihydrochloride

09 Sep 2025

·www.prnewswire.com

Dizal Showcases Robust Portfolio of Lung Cancer Studies at 2025 WCLC

SHANGHAI, Sept. 9, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced the presentation of new findings on its leading assets, ZEGFROVY® (sunvozertinib) and golidocitinib, in non-small cell lung cancer (NSCLC) at the 2025 World Conference on Lung Cancer (WCLC), held September 6–9 in Barcelona, Spain. ZEGFROVY: Targeting EGFR exon20ins and a wide spectrum of EGFR mutations The latest data from the multinational pivotal WU-KONG1 Part B (WU-KONG1B) study for ZEGFROVY were presented in an oral session at the conference and simultaneously published in the Journal of Clinical Oncology. Based on results from WU-KONG1B, ZEGFROVY received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2025 as the only targeted oral therapy for NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). ZEGFROVY demonstrated a favorable benefit/risk profile in patients with platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The study showed robust and durable antitumor activity with a manageable safety profile. (#MA08.01). In addition to the oral presentation, multiple studies of ZEGFROVY were presented at the WCLC, highlighting its potential across a broad range of NSCLC patients, including those with EGFR exon20ins across all lines of therapy, uncommon EGFR and HER2 mutations, EGFR-sensitive mutation and co-mutations, and EGFR mutations resistant to EGFR TKIs. Both monotherapy and combination regimens were evaluated. In EGFR exon20ins NSCLC, ZEGFROVY demonstrated promising antitumor efficacy and a tolerable safety profile across first- and second- line, as well as adjuvant and neoadjuvant treatment settings. ZEGFROVY combined with anlotinib achieved an objective response rate (ORR) of over 80% and a disease control rate (DCR) of 100% in treatment-naïve EGFR exon20ins NSCLC (#P3.12.43). In previously treated patients, ZEGFROVY combined with bevacizumab achieved a DCR of 100%, with target tumor lesion shrinkage observed in 85.7% of patients. With a median follow-up of 15.2 months, the median duration of response (DoR) was 19.1 months, and three patients (3/14) remained in response at the data cut-off (#P2.10.13). Real-world cases supported the potential of ZEGFROVY in early- and advanced- stage NSCLC patients with EGFR exon20ins. As a neoadjuvant therapy, ZEGFROVY showed encouraging clinical benefit, with all 3 patients achieving an obvious partial response (PR) before surgery. (#EP.07.49). In the adjuvant setting, ZEGFROVY showed sustained efficacy and tolerable safety profiles, helping patients successfully pass the 1-year after surgery, a peak period for disease recurrence (#EP.07.55). In the first-line maintenance setting, ZEGFROVY showed sustained efficacy and safety in lung adenocarcinoma patients who were intolerant to immunotherapy and chemotherapy (#EP.12.47). In NSCLC patients harboring uncommon EGFR mutations, ZEGFROVY combined with anlotinib demonstrated promising efficacy, including one patient who achieved complete remission of intracranial lesions (#P3.12.43). In a separate real-world case series, ZEGFROVY exhibited clinical efficacy in advanced NSCLC with HER2 exon20ins, with tumor shrinkage obviously observed post-prior treatment failures (#EP.12.46). In treatment-naïve NSCLC patients with EGFR-sensitive mutation and co-mutations, ZEGFROVY in combination with anlotinib achieved an ORR of 77.8% and a DCR of 100% (#P3.12.22). In NSCLC patients with EGFR mutations who failed prior EGFR-TKI therapies, ZEGFROVY, both as monotherapy (#EP.12.43) and in combination with chemotherapy (#P3.12.47), was well tolerated and demonstrated encouraging antitumor activity. Golidocitinib: Janus kinase 1 (JAK1) only inhibitor Plus Anti-PD-1 in Anti-PD-1 Treated Advanced NSCLC Resistance to first-line immune checkpoint inhibitors (ICIs) in non-small cell lung cancer (NSCLC) leads to limited treatment options and poor prognosis. Preclinical and early clinical data have shown synergistic effects between JAK inhibitors and anti-PD-1, suggesting a promising therapeutic strategy in this population. Golidocitinib in combination with anti-PD-1 was being evaluated in immune-resistant NSCLC patients. The study showed a well-tolerated profile, with no DLTs observed in the dose-escalation phase. Ongoing enrollment and data collection will provide deeper insights into clinical utility of golidocitinib (#P1.11.74). Dr. Xiaolin Zhang, CEO of Dizal, remarked, "Dizal is advancing therapies for patients with NSCLC across EGFR exon 20 insertion, uncommon and EGFR-sensitizing mutations to address significant unmet medical needs. Through scientific innovation, we aim to deliver safe, effective and transformative treatments to patients worldwide." - End - About ZEGFROVY®(sunvozertinib) ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The China approval is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication. In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. WU-KONG28, a phase III, multinational, randomized study assessing ZEGFROVY as a first-line treatment for patients with EGFR exon20ins NSCLC, has completed enrollment across 16 countries and regions. Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology. About golidocitinib (DZD4205) Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4). About Dizal Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with multiple assets in global pivotal studies and two leading assets: ZEGFROVY, approved in both the U.S. and China, and golidocitinib, approved in China. To learn more about Dizal, please visit , or follow us on Linkedin or X. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions. Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect. Contacts Investor Relations: [email protected] Business Development: [email protected] Media Contact: [email protected] SOURCE Dizal Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3ImmunotherapyDrug ApprovalPriority Review

05 Sep 2025

·www.globenewswire.com

HUTCHMED Highlights Clinical Data to be Presented at the 2025 World Conference of Lung Cancer and the CSCO Annual Meeting 2025

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 05, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the 2025 World Conference on Lung Cancer (“WCLC”) taking place on September 6-9, 2025 in Barcelona, Spain, and the Chinese Society of Clinical Oncology (“CSCO”) Annual Meeting 2025, taking place on September 10-14, 2025 in Jinan, China. Updated analysis from savolitinib’s SACHI, SAVANNAH and a Phase IIIb confirmatory study in non-small cell lung cancer (“NSCLC”) patients will be presented at WCLC 2025. Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. Details of the WCLC 2025 presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIES SAVANNAH: Biomarker Concordance and Acquired Resistance in Patients with EGFRm MET-OverExp and / or Amp NSCLCChristina Baik, University of Washington and Fred Hutchinson Cancer Center, Seattle, USAMA03.03Mini Oral: New Advances in Circulating BiomarkersRoom 06Sunday, September 7, 20253:15 - 4:30PM CESTEfficacy and Safety of Savolitinib in Advanced or Metastatic METex14 NSCLC Patients With or Without Prior ImmunotherapyYongfeng Yu, Shanghai Chest Hospital, Shanghai, ChinaP3.12.48Poster: Metastatic NSCLC – Targeted TherapyTuesday, September 9, 2025Frontline Treatment Duration in MET-Amplified NSCLC After Third-Generation EGFR-TKI Failure: SACHI Study InsightsLijuan Chen, Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, ChinaP3.12.64Poster: Metastatic NSCLC – Targeted TherapyTuesday, September 9, 2025Osimertinib + Savolitinib in EGFRm Advanced NSCLC With MET Overexp And/Or Amp Post-Progression on Osimertinib: SAVANNAH PROsSilvia Novello, University of Turin, San Luigi Hospital, Turin, ItalyPT2.12.04ePoster: Metastatic NSCLC – Targeted TherapyMonday, September 8, 2025INVESTIGATOR-INITIATED STUDIESEfficacy and Safety of Surufatinib, Durvalumab in Combined with Chemotherapy as First-line Treatment of Extensive-stage Small-cell Lung CancerHui Zhang/ Ying Hu, Beijing Chest Hospital, Beijing, ChinaP3.13.22Poster: Small Cell Lung Cancer and Neuroendocrine TumorsTuesday, September 9, 2025 Clinical data of HMPL-653, a novel, selective and potent CSF-1R inhibitor, from a first-in-human Phase I study in patients with tenosynovial giant cell tumor in China will be presented for the first time at the CSCO Annual Meeting 2025. Details of the CSCO Annual Meeting 2025 presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIES A first-in-human phase I study of HMPL-653, a CSF-1R inhibitor, in patients with tenosynovial giant cell tumorXiaohui Niu25297Oral SessionFriday, September 12, 202515:00 - 15:12PM HKTINVESTIGATOR-INITIATED STUDIES Fruquintinib Plus Serplulimab as First-Line Therapy in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (nccRCC): Updated Efficacy and Safety from a Multicenter, Single-Arm TrialJiwei Huang/ Wei Xue23258Oral SessionThursday, September 11, 202516:50 - 17:15PM HKTFruquintinib plus camrelizumab combined with paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): updated data from a single-arm, phase II clinical trialTianzhu Qiu/ Yanhong Gu23766Oral SessionFriday, September 12, 202511:20 - 12:00 noon HKTFruquintinib plus chemotherapy as second-line therapy in metastatic colorectal cancer: a multicenter, open-label, phase II clinical trialYongshun Chen22084Poster SessionEfficacy and Safety of Neoadjuvant Fruquintinib plus Toripalimab and Short-Course Radiotherapy (SCRT) for Locally Advanced Rectal Cancer: Updated Results from a Phase II Clinical TrialZhiping Li21915AbstractFruquintinib combined with chemotherapy as first-line treatment for advanced metastatic colorectal cancer: a propensity score-matched comparison of efficacy between a prospective single-arm cohort and a retrospective observational cohortFuxiang Zhou23550AbstractEfficacy and safety of fruquintinib combined with PD-1 inhibitor and chidamide in MSS mCRC: a comparison with real-world bevacizumab plus anti-pd-1 and chidamide armMiaomiao Gou23591AbstractPhase ll Clinical Study of Surufatinib Combined with Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract CancerMiaomiao Gou23610Oral SessionFriday, September 12, 202516:53 - 16:59PM HKTA single-arm, Phase Ib/II trial of surufatinib plus KN046 and gemcitabine and nab-paclitaxel as first-line treatment for unresectable advanced pancreatic cancerWenquan Wang/ Liang Liu23783Oral SessionThursday, September 11, 202516:20 - 16:35PM HKTUpdated results of surufatinib plus transarterial embolization versus surufatinib monotherapy in neuroendocrine tumor with liver metastasis: a prospective, randomized, controlled trialDan Cao22652Poster SessionSurufatinib in patients with soft tissue myeloma who have failed first-line standard chemotherapy or anlotinib: a multicenter, prospective, two-cohort, phase II clinical studyYuhong Zhou/ Xi GuoP80Poster SessionEfficacy and Mechanistic Study of the NASCA Regimen (Surufatinib Combined with Camrelizumab, Nab-Paclitaxel, and S-1) in Advanced Pancreatic Cancer Patients with Liver MetastasisGuanghai Dai/ Ru Jia22309AbstractA Phase II, Single-Arm Study of Surufatinib Combined with Zimberelimab and Nab-Paclitaxel in Patients with Advanced Triple-Negative Breast Cancer: Data UpdateCaixia Wang23679AbstractEfficacy and safety of surufatinib combined with gemcitabine, cisplatin and immune checkpoint inhibitor for the treatment of unresectable locally advanced or metastatic intrahepatic cholangiocarcinomaXuetao Shi/ Jingtao Zhong24133AbstractEfficacy and Safety of Surufatinib in Patients with Neuroendocrine Neoplasms: A Multicenter Retrospective StudyJiang Long24294Abstract About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, surufatinib, savolitinib and HMPL-653, the further clinical development for fruquintinib, surufatinib, savolitinib and HMPL-653, its expectations as to whether any studies on fruquintinib, surufatinib, savolitinib and HMPL-653 would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, surufatinib, savolitinib and HMPL-653, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, surufatinib, savolitinib and HMPL-653 for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting –+44 20 3727 1030 / HUTCHMED@fticonsulting.comBen Atwell / Alex Shaw+44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerFreddie Barnfield / Jeffrey Wong / Duncan Monteith+44 20 7260 1000

Phase 2ImmunotherapyClinical ResultPhase 1Drug Approval

20 Mar 2025

·www.prnewswire.com

Dizal's Golidocitinib in Combination with Anti-PD-1 Shows Promise in IO Resistant Non-Small Cell Lung Cancer

Golidocitinib is a JAK1 only inhibitor approved for the treatment of relapsed or refractory PTCL The combination of golidocitinib and PD-1 antibody showed synergistic anti-tumor effects in anti-PD-1-resistant NSCLC SHANGHAI, March 20, 2025 /PRNewswire/ -- Dizal (SSE: 688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, today announced new findings on golidocitinib, a first-in-class Janus kinase 1 (JAK1) only inhibitor, in combination with PD-1 antibodies for patients who have progressed on anti-PD-1 therapy. The details of the trial design and clinical results will be presented at the 2025 European Lung Cancer Congress (ELCC 2025) in Paris, March 26-29. Recent studies showed that the dysregulated activation of the JAK/STAT pathway, which leads to the prolonged release of IFN-γ, is a significant contributor to the resistance to immune checkpoint inhibitors in cancer immunotherapy. Preclinical and clinical studies have demonstrated that the combination of JAK inhibitors with PD-1 immunotherapy can reverse or delay onset of immunotherapy resistance by modulating the JAK/STAT pathway in Hodgkin's lymphoma and NSCLC. Golidocitinib has shown excellent clinical benefits by effectively inhibiting the JAK/STAT pathway, leading to its approval for the treatment of relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) in China. Preclinical studies also show that the combination of Golidocitinib and PD-1 antibody has synergistic potentials for anti-tumor effects. Building on these findings, an exploratory phase Ib clinical study combining golidocitinib with PD-1 antibodies was designed to explore the synergistic effects of this combined regimen in NSCLC patients who have failed from anti-PD-1 containing regimens. This study will enroll 30 locally advanced or metastatic NSCLC patients who have previously received anti-PD-1 monotherapy or anti-PD-1 therapy with platinum-containing chemotherapy regimens. "Immunotherapy alone or with chemotherapy is commonly used as front line treatment for NSCLC patients without driver mutations. Unfortunately, resistance is inevitable and once the disease progresses, the prognosis is poor and treatment option is limited." said Xiaolin Zhang, PhD, CEO of Dizal. "The findings we are presenting at ELCC 2025 highlight the potential for Golidocitinib-based combination regimen to delay or overcome the resistance. The preliminary results are very promising and justify further clinical validation." In addition to the golidocitinib-based combination therapy, positive results from a Phase II study of sunvozertinib in combination with Anlotinib will also be presented. Sunvozertinib combined with anlotinib was well tolerated and demonstrated encouraging antitumor activity in NSCLC patients with EGFR mutations who had failed prior EGFR-TKI therapies. As of December 25, 2024, the objective response rate (ORR) and the disease control rate (DCR) were 33.3% and 100%, respectively, in this heavily pre-treated patient population. Enrollment is ongoing and detailed results will be updated at the congress. Dizal presentation details during ELCC 2025 About golidocitinib (DZD4205) Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, mDoR reached 20.7 months. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) was published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) was published in The Lancet Oncology (Impact Factor: 54.4). About sunvozertinib (DZD9008) Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins. Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine. About Dizal Dizal is a biopharmaceutical company, dedicated to the discovery, development, and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two approved drugs and multiple assets in global pivotal studies. To learn more about Dizal, please visit , or follow us on Linkedin or Twitter. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions. Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect. Contacts Investor Relations: [email protected] Business Development: [email protected] Media Contact: [email protected] SOURCE Dizal Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyPhase 1Fast TrackDrug Approval

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Renal Cell Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	13 May 2025
Unresectable Renal Cell Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	13 May 2025
Endometrial Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	22 Nov 2024
Extensive stage Small Cell Lung Cancer	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 May 2024
Differentiated Thyroid Gland Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 Apr 2022
Thyroid Cancer, Medullary	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	30 Jan 2021
Small Cell Lung Cancer	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Sep 2019
Soft Tissue Sarcoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Jul 2019
Non-Small Cell Lung Cancer	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	14 May 2018
Locally Advanced Lung Non-Small Cell Carcinoma	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 May 2018
metastatic non-small cell lung cancer	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 May 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alveolar Soft Part Sarcoma	NDA/BLA	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	23 Aug 2025
Advanced Lung Non-Small Cell Squamous Carcinoma	NDA/BLA	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	23 Apr 2025
Non-small cell lung cancer stage III	NDA/BLA	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	23 Apr 2025
Hepatocellular Carcinoma	NDA/BLA	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	21 Nov 2024
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 3	China	Shanghai Zhengda Tianqing Pharmaceutical Co., Ltd.	01 Oct 2025
Small cell lung cancer limited stage	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Sep 2024
Primary peritoneal carcinoma	Phase 3	United States	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	United States	Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	06 Apr 2022
Primary peritoneal carcinoma	Phase 3	China	Nanjing Edcheng Ningxin Pharmaceutical Research and Development Co., Ltd.	06 Apr 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05778149 (WCLC2025)	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line EGFR sensitive mutation (Ex19del, L858R),TP53 mutation	15	Anlotinib(12mgAnlotinib(12mg+orally QD+day 1 to 14 of a 21-day cycle)+Aumolertinib(110mg+orally QD)Aumolertinib(110mg+orally QD) (EGFR-positive NSCLC pts with TP53 co-mutation)	pitevwtzhr(ytlxtrvztq) = avevdsxuth pnnnyzgssd (kwqlkmwymv, 11.0 - NA) View more	Positive	09 Sep 2025
NCT05778149 (WCLC2025)	Phase 2		15	Anlotinib(12mgAnlotinib(12mg+orally QD+day 1 to 14 of a 21-day cycle)+Aumolertinib(110mg+orally QD)Aumolertinib(110mg+orally QD) (19del group)	gagyfyogke(frbszaqzyw) = ilchwmoadm rprmegncux (evvamljazz )	Positive	09 Sep 2025
NCT06348927 (WUKONG32, WCLC2025)	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line EGFR sensitive mutation (Ex19del, L858R)	16	Sunvozertinib+Anlotinib	erczvlkxga(uogakuwsnq) = fskitwxcqk xnemtfvpcn (grxmlypplr ) View more	Positive	09 Sep 2025
NCT06456138 (ATTRAS001, WCLC2025)	Phase 1	Advanced Lung Non-Small Cell Carcinoma Third line \| Second line KRAS mutation	12	trametinib+Anlotinib+Tislelizumab	zoeiblqvyx(ukvsbiyzvr) = ykxhltetvu amgrggetnz (uinrexhdzx ) View more	Positive	08 Sep 2025
NCT04691388 (Pubmed \| Cancer Med)	Phase 2	metastatic non-small cell lung cancer Second line	29	Sintilimab plus Anlotinib	dutajreslb(topfihqref) = sizejohras fklfinxgyg (myfxknjfwm ) View more	Positive	01 Sep 2025
ESMO_GI2025	Not Applicable	Hepatocellular Carcinoma ICIs	210	Anlotinib	ntexqwdtau(qsxkpgcnql) = ewgtllzhxz zrphaeosdd (adarbrrkhq ) View more	Positive	03 Jul 2025
ESMO_GI2025	Not Applicable	Hepatocellular Carcinoma ICIs	210	Anlotinib (Other treatment methods not including anti-angiogenic TKIs)	ntexqwdtau(qsxkpgcnql) = ccspfjltzz zrphaeosdd (adarbrrkhq ) View more	Positive	03 Jul 2025
ESMO_GI2025	Not Applicable	Gastrointestinal Neoplasms RGC32 \| TGFβ1 pathway	256	Anlotinib monotherapy or combination group	hltphcihvd(xlqnsthbwj) = mjjvstetjw ekcoppozce (jvnvvkngah, 2.4 - 8.1)	Positive	03 Jul 2025
ESMO_GI2025	Not Applicable	Gastrointestinal Neoplasms RGC32 \| TGFβ1 pathway	256	Other treatments without anti-angiogenic TKIs group	hltphcihvd(xlqnsthbwj) = rzxtxymidi ekcoppozce (jvnvvkngah, 2.8 - 4.8)	Positive	03 Jul 2025
NCT04376073 (ANNIE, Pubmed \| Ther Clin Risk Manag)	Phase 2	Platinum-Resistant Ovarian Carcinoma	40	Anlotinib 10 mg (12 mg after amendment)Niraparib 200 mg or 300 mg + Anlotinib 10 mg (12 mg after amendment)Niraparib 200 mg(12 mg after amendment)	qqajxazmdx(awwagwrtag) = dnevayrobg iikdnvdsjl (ylbifphbos, 12.1 - NE)	Positive	01 Jul 2025
Pubmed \| Sci Rep	Not Applicable	Advanced Esophageal Squamous Cell Carcinoma	-	Anlotinib + Camrelizumab + Chemotherapy (TCAC group)	jorjrqmfws(plggiidrzp) = wqjxfcqdld kancgpjlta (ejodaemjrr ) View more	-	01 Jul 2025
Pubmed \| Sci Rep	Not Applicable	Advanced Esophageal Squamous Cell Carcinoma	-	Camrelizumab + Chemotherapy (TCC group)	jorjrqmfws(plggiidrzp) = fqhlmbrpyi kancgpjlta (ejodaemjrr ) View more	-	01 Jul 2025
NCT04877821 (NeoSACT, Pubmed \| Cell Rep Med)	Phase 2	Triple Negative Breast Cancer Neoadjuvant programmed death-ligand 1 (PD-L1)-negative	29	Anlotinib	ljmacoqotf(grsbuuqqzb) = jrowtmwrvg dcrurbovwn (qnlcmhgynr, 49.0% - 85.0)	Positive	01 Jul 2025
NCT04757779 (Pubmed \| Lung Cancer)	Phase 2	Extensive stage Small Cell Lung Cancer Second line	37	Anlotinib 12 mg + Irinotecan 65 mg/m2	qmznpbbmag(svfhqmfpot) = cguehefwal wmdkldfopg (qqvayustdo ) View more	Positive	01 Jul 2025

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