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

+ [4]

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseRespiratory Diseases+ [9]

Active Indication

Extensive stage Small Cell Lung CancerDifferentiated Thyroid Gland CarcinomaThyroid Cancer, Medullary+ [50]

Inactive Indication

Acral Lentiginous Malignant Melanomaadenocarcinoma of biliary tractAdvanced Bile Duct Carcinoma+ [27]

Originator Organization

Advenchen Laboratories LLC

Active Organization

Advenchen Laboratories LLC

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Inactive Organization

Peking University People's Hospital

Drug Highest PhaseApproved

First Approval Date

CN (08 May 2018),

Non-Small Cell Lung Cancer

RegulationConditional marketing approval (CN), Special Review Project (CN), Orphan Drug (US), Priority Review (CN)

Structure

Molecular FormulaC23H23ClFN3O3

InChIKeyGTAUHBAHFJIAQT-UHFFFAOYSA-N

CAS Registry1360460-82-7

View All Structures (2)

615

Clinical Trials associated with Anlotinib Dihydrochloride

NCT06634667 / Not yet recruitingPhase 2IIT

Efficacy and Safety of Third-generation EGFR-TKI Combined With Anlotinib as Maintenance Therapy Following 4-6 Cycles of Chemotherapy and Immunotherapy in NSCLC With Small Cell Transformation After EGFR-TKI Resistance: a Single-arm Prospective Phase II Study

This study aimed to evaluate the efficacy and safety of third-generation EGFR-TKI plus anlotinib as maintenance after chemotherapy plus immunotherapy in advanced NSCLC with small cell transformation after EGFR-TKI resistance.

Start Date30 Nov 2024

Sponsor / Collaborator

Hunan Cancer Hospital

NCT06662877 / Not yet recruitingPhase 2/3IIT

Anlotinib Plus Nab-Paclitaxels and S-1 Versus FOLFOX for Patients with Advanced Biliary Tract Cancer As Second-Line Treatment: a Phase 2/3, Multi-centric Double-stage Randomized Controlled Trial

Biliary tract cancer (BTC) presents with a 5-year survival rate less than 5%. The goal of this clinical trial is to evaluate if Anlotinib plus Nab-Paclitaxels and S-1 as second-line regimen can improve the treatment efficacy in advanced biliary tract cancer (BTC) after progression upon first-line standard treatment, in comparison with standard second-line FOLFOX regimen.

Start Date25 Nov 2024

Sponsor / Collaborator

Sun Yat-Sen University

ChiCTR2400091770 / RecruitingPhase 2IIT

A single-arm, open-label clinical study on the safety and efficacy of combined treatment with Anlotinib, Capecitabine, and Toripalimab plus local radiotherapy in patients with metastatic triple-negative breast cancer.

Start Date04 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Anlotinib Dihydrochloride

100 Translational Medicine associated with Anlotinib Dihydrochloride

100 Patents (Medical) associated with Anlotinib Dihydrochloride

910

Literatures (Medical) associated with Anlotinib Dihydrochloride

31 Dec 2024·Future Science OA

Surgical resection due to poor outcome of the immunotherapy of a relapsed mediastinal liposarcoma: a case report

Author: Xie, Dong ; Wang, Ming-Ji ; Li, Zhi-Xin ; Xu, Shu-Quan ; Wu, Lei-Lei

The feasibility of surgery after immunotherapy for mediastinal liposarcoma remains uncertain. Besides, the case of immunotherapy for liposarcoma is still lacking. We report a case of recurrence after resection of a left mediastinal liposarcoma. After recurrence, one course of pembrolizumab plus anlotinib hydrochloride showed no tumor shrinkage, and genetic testing showed CDK4 amplification and PD-L1 TPS <1%; therefore, the plan was changed to one course of pembrolizumab plus palbociclib, but the tumor still did not shrink. Thus, second tumor resection was performed. In addition, the postoperative pathology was still well-differentiated liposarcoma. The significance of immunotherapy in liposarcoma still needs to be further explored. In the absence of surgical contraindications, secondary surgery might be feasible.

31 Dec 2024·Annals of Medicine

A phase II study of anlotinib plus whole brain radiation therapy for patients with NSCLC with multiple brain metastases

Article

Author: Zhu, Jun ; Yu, Hongliang ; Tao, Hua ; Qian, Pudong ; Xu, Jianhua ; Jiang, Ming ; Zhu, Xiangzhi ; Ding, Naixin ; Gu, Dayong

BACKGROUNDWhole brain radiotherapy (WBRT) is the mainstay of treatment for patients with non-small cell lung cancer (NSCLC) with multiple brain metastases (BMs); however, the BRAIN study showed that the efficacy of WBRT is unsatisfactory. This prospective phase II study aimed to evaluate the efficacy and safety of WBRT combined with anlotinib, a novel anti-angiogenic multi-target tyrosine kinase inhibitor (TKI), in patients with multiple BMs (>3) from advanced NSCLC.METHODSPatients with advanced NSCLC with multiple BMs who had received two or more lines of treatment were eligible for enrolment into this study. All patients were treated with anlotinib (8-12 mg, QD, on days 1-14 of a 21-day cycle) combined with WBRT (DT 30 Gy/12 F), followed by maintenance therapy with anlotinib until disease progression or treatment intolerance. The primary endpoint of this study was the intracranial progression-free survival (iPFS). The secondary endpoints were intracranial objective response rate (iORR), intracranial disease control rate (iDCR), overall survival (OS) and treatment safety.RESULTSBetween May 2019 and January 2021, 28 patients were enrolled, all of whom were evaluable for efficacy and safety. The median age was 57.7 years, and 46.4% were male. Twenty-five patients had adenocarcinoma (89.3%), six had EGFR mutations (21.4%) and two had ALK mutations (7.1%). The median iPFS was 11.1 months (95% confidence interval (CI): 5.4-16.8 months) and the median OS was 13.4 months (95% CI: 5.2-21.6 months). The iORR was 71.4% (six complete responses + 14 partial responses). The most frequently observed adverse events (AEs) were hypertension (71.4%), fatigue (64.3%), anorexia (46.4%), and foot and hand skin reactions (25.0%). No patients developed ≥ grade 4 AEs. No intracranial haemorrhages occurred during treatment. Dose adjustment due to AEs occurred in 17.9% of patients.CONCLUSIONSAnlotinib combined with WBRT is effective and well-tolerated in patients with NSCLC with multiple BMs.

31 Dec 2024·Cell Adhesion & Migration

Galectin-1 overexpression induces normal fibroblasts translate into cancer-associated fibroblasts and attenuates the sensitivity of anlotinib in lung cancer

Article

Author: Chen, Wenbang ; Li, Xiaojun ; Wang, Gengming ; Zhu, Xiao ; Zhang, Lei ; Xing, Fubao

We aimed to investigate galectin-1 overexpression induces normal fibroblasts (NFs) translates into cancer-associated fibroblasts (CAFs). Galectin-1 overexpression was conducted in Human embryonic lung fibroblasts (HFL1) cell. The motilities of H1299 and A549 cells were measured. Human umbilical vein endothelial cell (HUVEC) proliferation and tube formation ability were assessed. Tumor volume and tumor weight was recorded. Cells motilities were increased, while apoptosis rates were decreased after CMs co-cultured. B-cell lymphoma-2 (Bcl-2) expression level was increased, while Bcl2-associatedX (Bax) and cleaved-caspase3 decreased. CMs treatment enhanced HUVEC proliferation and tube formation. Tumor volume and weight in CMs treated mice were increased, and the sensitivity of anlotinib in co-cultured cells was decreased. Our results revealed that galectin-1 overexpression induced NFs translated into CAFs.

News (Medical) associated with Anlotinib Dihydrochloride

09 Sep 2024

·www.globenewswire.com

HUTCHMED Highlights Clinical Data to be Presented at ESMO Congress 2024 and the 2024 World Conference of Lung Cancer

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 09, 2024 (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 2024 World Conference on Lung Cancer (“WCLC24”) in San Diego, USA, and the European Society for Medical Oncology (“ESMO”) Congress 2024, taking place in Barcelona, Spain. Results from the FLOWERS study, a prospective, two-arm, randomized, multicenter Phase II clinical trial of osimertinib with or without savolitinib as first-line treatment in EGFRm, MET-aberrant advanced non-small cell lung cancer (“NSCLC”) patients, will be presented at WCLC24. As of May 28, 2024, the median follow-up was 8.2 months. Patients treated with osimertinib plus savolitinib (Cohort 2, N=21) showed deeper and more durable response over osimertinib monotherapy (Cohort 1, N=23) along the study follow-up. The confirmed objective response rate (ORR) in Cohort 1 and Cohort 2 were 60.9% and 90.5%, respectively, with disease control rate (DCR) of 87% and 95.2%, respectively. Immature progression-free survival (“PFS”) data also showed a positive trend in favor of the combination therapy, with median PFS of 9.3 months and 19.6 months in the cohort 1 and cohort 2 with maturity of 34.8% and 23.8%, respectively. Safety profiles of osimertinib monotherapy and osimertinib plus savolitinib were as expected, tolerable and manageable. Abstract titlePresenter / Lead authorPresentation detailsWCLC24 - INVESTIGATOR-INITIATED STUDIES Osimertinib with or without savolitinib as 1L in de novo MET aberrant, EGFRm advanced NSCLC (CTONG 2008): A Phase II trialJinji Yang, Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, Southern Medical University, Guangzhou, ChinaPL04.10Plenary Session PL04 Presidential Symposium 2, Plenary HallMonday, September 9, 2024 at 8:30 AM PDTStudy of Surufatinib Combined with Low Dose Topotecan in Second or Third-Line Multiple Distant Organ Metastatic ES-SCLCYingying Du, The First Affiliated Hospital of Anhui Medical University, Hefei, China; Hesheng Qian, Fuyang Cancer Hospital, Fuyang, ChinaEP.13A.04AePosterSaturday, September 7, 2024Surufatinib Plus Docetaxel in Patients with Relapsed Advanced Driver-Negative Non-Squamous NSCLC: A Phase Ib/II Study Qitao Yu, Wei Jiang, Guangxi Medical University Cancer Hospital, Nanning, ChinaP3.12C.08PosterMonday, September 9, 2024 at 8:30 AM PDT Further analysis of fruquintinib’s FRESCO-2 study in metastatic colorectal cancer and FRUTIGA study in gastric cancer, a biomarker study of savolitinib in gastric cancer as well as investigator-initiated studies of fruquintinib and surufatinib will be presented at the ESMO Congress 2024. Details of the presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsESMO 2024 - SPONSORED STUDIESEfficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer with and without liver metastasis: A subgroup analysis of the phase 3 FRESCO-2 trialRocio Garcia-Carbonero,Hospital Universitario 12 de Octubre, lmas12, UCM, Madrid, Spain520P Poster Session – Colorectal cancerMonday, 16 September 2024Efficacy and safety of fruquintinib in refractory metastatic colorectal cancer: A FRESCO-2 subgroup analysis by ageMaria Elena Elez Fernandez,Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain526PPoster Session – Colorectal cancerMonday, 16 September 2024Efficacy of fruquintinib plus paclitaxel (F+PTX) in patients (pts) with prior immunotherapy (prior-IO): subgroup analysis from FRUTIGA studyLin Shen,Peking University Cancer Hospital & Institute, Beijing, China1410PPoster Session – Oesophagogastric cancerMonday, 16 September 2024Impact of subsequent anti-tumor therapies in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma receiving fruquintinib (F) plus paclitaxel (PTX) or placebo plus PTX in FRUTIGA studyRuihua Xu,Sun Yat-sen University Cancer Center, Guangzhou, China1434PPoster Session – Oesophagogastric cancerMonday, 16 September 2024Association between Fruquintinib-induced Hypertension and Clinical Outcomes from FRUTIGA, a Phase 3 Study of Fruquintinib plus Paclitaxel in Previously Treated Advanced Gastric or Gastroesophageal Junction (G/GEJ) AdenocarcinomaShukui Qin,Chinese People's Liberation Army Cancer Center of Nanjing Bayi Hospital, Nanjing, China1443PPoster Session – Oesophagogastric cancerMonday, 16 September 2024Analysis of MET gene alterations in cfDNA samples from a phase II study of savolitinib in patients (pts) with MET-amplified gastroesophageal junction adenocarcinomas or gastric cancer (GEJ/GC)Zhi Peng,Peking University Cancer Hospital & Institute, Beijing, China1461PPoster Session – Oesophagogastric cancerMonday, 16 September 2024 ESMO 2024 - INVESTIGATOR-INITIATED STUDIES A phase II clinical study of fruquintinib (Fru) combined with toripalimab (Tor) and short-course radiotherapy (SCRT) as neoadjuvant therapy for locally advanced rectal cancer (LARC)Zhiping Li, Ye Chen,West China Hospital of Sichuan University, Chengdu, China570PPoster Session – Colorectal cancerMonday, 16 September 2024Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: Updated findings from a single-arm, prospective phase II trial (RIFLE)Zhen Zhang, Yajie Chen, Fudan University Shanghai Cancer Center, Shanghai, China537P Poster Session – Colorectal cancerMonday, 16 September 2024Fruquintinib combined with sintilimab and chemotherapy as the first-line treatment in advanced naïve EGFR- and ALK-negative non-squamous non-small cell lung cancer (nsq-NSCLC): Updated resultsYongqian Shu, Pei Ma,Jiangsu Province Hospital/The First Affiliated Hospital of Nanjing Medical University, Nanjing, China1329P Poster Session – NSCLC, metastaticSaturday, 14 September 2024Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced G/GEJ cancer: A phase 1b/2 clinical trial (FUNCTION)Xiaobing Chen, Beibei Chen,Henan Cancer Hospital/ Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China1475TiPPoster Session – Oesophagogastric cancerMonday, 16 September 2024Fruquintinib combined with nab-paclitaxel and gemcitabine (AG) as the first-line treatment for pancreatic ductal adenocarcinoma (PDAC) with liver metastases: An open-label, single-arm, single-center phase II clinical studyXianjun Yu, Miaoyan Wei,Fudan University Shanghai Cancer Center, Shanghai, China1529P Poster Session – Pancreatic cancerMonday, 16 September 2024A phase II study of Fruquintinib in the 1L or 2L treatment of unresectable metastatic soft tissue sarcomaZhiguo Luo, Xiaowei Zhang,Fudan University Shanghai Cancer Center, Shanghai, China1743PPoster Session – SarcomaSaturday, 14 September 2024Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II studyFuxiang Zhou,Zhongnan Hospital, Wuhan University, Wuhan, China974PPoster Session – Hepatocellular carcinoma (HCC)Monday, 16 September 2024Updated results of Surufatinib plus transarterial embolization versus surufatinib monotherapy in neuroendocrine tumor with liver metastasis: a prospective, randomized, controlled trialDan Cao, West China Hospital, Sichuan University, Chengdu, China1155PPoster Session – Neuroendocrine tumoursMonday, 16 September 2024Surufatinib plus toripalimab combined with pemetrexed (A), and platinum (P) in patients (pts) with advanced non-squamous non-small cell lung cancer (nsq-NSCLC): Updated results of a single-center, phase II trialLi Zhang, Wenfeng Fang,Sun Yat-Sen University Cancer Center, Guangzhou, China1345PPoster Session – NSCLC, metastaticSaturday, 14 September 2024Surufatinib combined with gemcitabine in soft tissue sarcoma (STS) patients failed with anthracyclines chemotherapy or monotherapy post-anlotinib progression: a multi-center, phase II trialXiaohui Niu, Yuhong Zhou,Zhongshan Hospital, Fudan University, Shanghai, China1740PPoster Session – SarcomaSaturday, 14 September 2024 About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer 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 marketed in the US and Europe. 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 U.S. 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, savolitinib and surufatinib, the further clinical development for fruquintinib, savolitinib and surufatinib, its expectations as to whether any studies on fruquintinib, savolitinib and surufatinib, 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, savolitinib and surufatinib, 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, savolitinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of CAPEOX, docetaxel, gemcitabine, nab-paclitaxel, paclitaxel, pemetrexed, platinum, sintilimab, topotecan, tislelizumab or toripalimab 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 U.S. 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 Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley /Rupert Dearden, Panmure Liberum+44 (20) 7886 2500

Phase 2Clinical ResultImmunotherapy

06 Sep 2024

·www.prnewswire.com

Akeso to Present Data from 13 Clinical Studies at ESMO 2024, Featuring its Internally Developed Cadonilimab, Ivonescimab, Ligufalimab, and other I/O Antibodies

HONG KONG, Sept. 5, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) will showcase promising results from 13 clinical studies on its internally developed PD-1/CTLA-4 bispecific antibody cadonilimab, PD-1/VEGF bispecific antibody ivonescimab, next-generation CD47 monoclonal antibody ligufalimab, and commercially available PD-1 monoclonal antibody penpulimab at the ESMO Congress 2024 from September 13th to 17th (CEST). These studies span advanced colorectal cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, hepatocellular carcinoma, nasopharyngeal carcinoma, gynecological malignancies, gastric cancer, esophageal squamous cell carcinoma, and biliary tract malignancies. Notably, ivonescimab's clinical results in combination with ligufalimab will be presented for the first time. Data on ivonescimab ± ligufalimab plus chemotherapy for mCRC and ivonescimab combined with chemotherapy for TNBC will be featured in the Mini Oral Session. Additionally, the Phase III study of anlotinib combined with penpulimab versus sorafenib for HCC will be presented as a late-breaking abstract in the Proffered Paper Session. Stay tuned for additional updates! Details of the Presentations: Colorectal Cancer Abstract Title: The efficacy and safety of ivonescimab with or without ligufalimab in combination with FOLFOXIRI as first-line (1L) treatment for metastatic colorectal cancer (mCRC) Key Study Findings: For first-line treatment of MSS-type mCRC, previous immunotherapies have shown limited benefits. Ivonescimab has achieved meaningfully significant ORR, DCR, and PFS (although data is immature) in these mCRC patients. When combined with ligufalimab (CD47), the clinical outcome improved further, surpassing current standard treatments. These findings highlight the promising potential of ivonescimab, both alone and in combination with ligufalimab, for treating MSS-type mCRC. Session Type: Mini Oral Session Number: 514MO Presentation Presentation Time: Saturday, 14 September 15:50-15:55 (CEST) Speaker: Yanhong Deng, Sun Yat-sen University Sixth Affiliated Hospital Triple-Negative Breast Cancer Abstract Title: The safety and efficacy of ivonescimab in combination with chemotherapy as first-line (1L) treatment for triple-negative breast cancer (TNBC) Key Study Findings : Most patients were PD-L1 negative (53.3%). The proportion of patients who had previously received taxane-based neoadjuvant therapy (60%) was higher than in similar targeted drug studies. Ivonescimab demonstrated robust ORR and DCR. PFS results were meaningfully significant, even in patients with limited follow-up time and immature data. The safety profile of ivonescimab aligns with results from prior studies. Session Type: Mini Oral Session Number: 347MO Presentation Time: Monday, 16 September 08:30-08:35 (CEST) Speaker: Xiaojia Wang, Zhejiang Provincial Cancer Hospital Head And Neck Squamous Cell Carcinoma Abstract Title: Evaluation of the safety and efficacy of ivonescimab in combination with ligufalimab as first-line treatment for PD-L1 positive recurrent/metastasis head and neck squamous cell carcinoma (R/M HNSCC) Key Study Findings: PD-1 is the standard first-line treatment for CPS≥1 R/M HNSCC but has limited efficacy. Preliminary data from this study suggest that ivonescimab improves ORR and PFS for patients needing rapid tumor shrinkage. Ivonescimab combined with ligufalimab (CD47) further extends both ORR and PFS. Ivonescimab, both as monotherapy and in combination with ligufalimab, has yielded preliminary results that significantly outperform currently approved PD-1 treatments. A Phase III head-to-head trial against Keytruda is scheduled to initiate patient enrollment in the fourth quarter of 2024. Session Type: Poster Session Number: 876P Presentation Time: Saturday, 14 September 2024 (CEST) Abstract Title: Neoadjuvant and Adjuvant AK104 in patients with recurrent, resectable squamous cell carcinoma of the head and neck: A phase II study Session Type: Poster Session Number: 866P Presentation Time: Saturday, 14 September 2024 (CEST) Hepatocellular Carcinoma Abstract Title: Primary results from the phase III ALTN-AK105-III-02 study: Anlotinib plus penpulimab versus sorafenib as first-line (1L) therapy for advanced hepatocellular carcinoma (aHCC) Session Type: Proffered Paper Session Number: LBA40 Presentation Time: Friday,13 September 16:55-17:05 (CEST) Gynecological Oncology Abstract Title: A phase II study of cadonilimab plus chemotherapy in persistent recurrent/ metastatic cervical cancer patients who failed previous immuno/chemotherapy Session Type: Poster Session Number: 732P Presentation Time: Saturday, 14 September 2024 (CEST) Abstract Title: Real-world efficacy and safety of cadonilimab in recurrent or metastatic cervical cancer: a multicenter retrospective analysis in China Session Type: Poster Session Number: 727P Presentation Time: Saturday, 14 September 2024 (CEST) Abstract Title: Cadonilimab with neoadjuvant chemotherapy in advanced ovarian cancer patients : an open, prospective, single arm, phase II trial Session Type: Poster Session Number: 760P Presentation Time: Saturday, 14 September 2024(CEST) Nasopharyngeal Carcinoma Abstract Title: Combination of cadonilimab (anti-PD-1 and CTLA-4 bispecific antibody) with chemotherapy in anti-PD-1 resistant recurrent or metastatic nasopharyngeal carcinoma: an open-label, single-arm, phase II clinical trial Session Type: Poster Session Number: 893P Presentation Time: Saturday, 14 September 2024(CEST) Biliary Tract Cancer Abstract Title: Cadonilimab in combined with gemcitabine and cisplatin in advanced biliary tract cancer (BicureX): A Phase II, single-arm clinical trial Session Type: Poster Session Number: 52P Presentation Time: Monday, 16 September 2024 (CEST) Gastric Cancer Abstract Title: Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastroesophageal junction cancer: A prospective, single-arm, phase II clinical trial Session Type: Poster Session Number: 1455P Presentation Time: Monday, 16 September 2024(CEST) Abstract Title: Neoadjuvant SOX combined with cadonilimab (AK104) for PD-L1 negative upper GC/GEJC patients Session Type: Poster Session Number: 1473TiP Presentation Time: Monday, 16 September 2024 (CEST) Esophageal Squamous Cell Carcinoma Abstract Title: Efficacy and safety of cadonilimab combined albumin-paclitaxel, cisplatin and fluorouracil (APF) in neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma (LAESCC): results from the CAPITAL trial Session Type: Poster Session Number: 1446P Presentation Time: Monday, 16 September 2024 (CEST) SOURCE Akeso, Inc.

Clinical ResultPhase 3Phase 2Immunotherapy

29 Aug 2024

·www.prnewswire.com

Innovent to Present Clinical Data of Multiple Novel Molecules at WCLC and ESMO 2024

SAN FRANCISCO and SUZHOU, China, Aug. 28, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that nearly 20 accepted clinical data of its novel oncology molecules, including six oral presentations, will be released at World Conference on Lung Cancer (WCLC) from Sept 7-10, 2024, in San Diego, U.S., and the European Society of Medical Oncology (ESMO) from Sept 13-17, 2024, in Barcelona, Spain. Key data showcase includes: an oral presentation of updated Phase 1 result of its first-in-class PD-1/IL-2 α -bias (IBI363) in NSCLC (up to 3mg/kg dosage) at WCLC, updated Phase 1 results of IBI363 (PD-1/IL-2 α -bias ) combination therapy in colorectal cancer at ESMO, an oral presentation of updated pivotal Phase 2 results of Dupert® (fulzerasib, KRAS G12C inhibitor) in NSCLC at WCLC, an oral presentation of Phase 1 results of IBI354 (HER2 ADC) in HER2+ solid tumors at ESMO, and multiple clinical results of TYVYT® (sintilimab injection). Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are very pleased to present a robust set of clinical data for our next-generation innovative bispecific antibodies and ADC molecules across renowned medical conferences of 2024 including ASCO, ESMO Plenary and ESMO GI in June, and WCLC and ESMO in September. We observed the preliminary efficacy and safety signals for those innovative candidates, underscoring their potential for further development and clinical value. As one of the few biopharmaceutical companies with both the technology platforms and robust pipeline in "IO+ADC" areas, Innovent remains dedicated to advancing cancer treatment and is committed to offering doctors and patients more innovative, effective, and safe therapeutic options." Details on the abstracts are listed below: WCLC: Oral Sessions Abstract Title: First-in-Class PD-1/IL-2 Bispecific Antibody IBI363 In Patients with Advanced Non-Small Cell Lung Cancer in a Phase 1 Study Abstract No: MA11.04 Session Type and Title: WCLC 2024-MA11. Building on the Foundations of Current Immunotherapies Presentation Time: Tuesday, September 10, 2024, 13:37-13:42 PDT Presenter: Jianya Zhou,The First Affiliated Hospital of Zhejiang University School of Medicine Abstract Title: KRAS G12C Inhibitor IBI351 In Patients (pts) with Advanced Non-Small Cell Lung Cancer (NSCLC): Updated Results from a Pivotal Phase 2 Study Abstract No: OA14.05 Session Type and Title: WCLC 2024-OA14. New Horizons in Targeting KRAS G12C Presentation Time: Monday, September 9, 2024, 15:52-16:02 PDT Presenter: Qing Zhou, Guangdong People's Hospital Abstract Title: Neoadjuvant Sintilimab plus Chemotherapy in EGFR-mutant NSCLC Followed by adjuvant Osimertinib or Observation: A Phase 2 CTONG2104 Trial Abstract No: MA15.11 Session Type and Title: Mini Oral Presentation Time: Tuesday, September 10, 2024 at 3:48-3:53 PM PDT Presenter: Guangdong Lung Cancer Institute, C. Zhang Abstract Title: First-Line Treatment of Locally Advanced or Metastatic Pulmonary Lymphoepithelioma-like carcinoma: A Multicenter, Single-Arm, Phase 2 Trial Abstract No: MA11.03 Session Type and Title: Mini Oral Presentation Time: Tuesday, September 10, 2024 at 1:32-1:37 PM PDT Presenter: The First Affiliated Hospital of Medical University, C. Zhou ESMO: Oral Sessions Abstract Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with advanced solid tumors and breast cancer (BC): results from a Phase 1 study Abstract No: 345MO Session Type and Title: ESMO 2024-Mini oral session 1: Breast cancer, metastatic Presentation Time: Sunday, September 15, 2024, 9:15-9:20 AM CEST Presenter: Christina Teng, Scientia Clinical Research, Australia Abstract Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with advanced gynecological cancers (Gynecol C): results from a phase 1 study Abstract No: 720MO Session Type and Title: ESMO 2024-Mini oral session 2: Gynecological cancers Presentation Time: Sunday, September 15, 2024, 15:45-15:50 CEST Presenter: Jin Shu, Chongqing University Affiliated Cancer Hospital WCLC: Posters Abstract Title: Neoadjuvant Chemoimmunotherapy for Potentially Resectable IIIA/IIIB NSCLC: Survival Updates and Predictive Effect of MRD Abstract No: EP.08D.01 Session Type and Title: E-Poster Presentation Time: Saturday, September 7, 2024 at 11:58-11:59 AM PDT Presenter: First Hospital of Jilin University, K. Ma Abstract Title: Safety and Efficacy of Sintilimab Combined with Anlotinib in Patients with KRAS-Mutant Advanced Non-Small Cell Lung Cancer Abstract No.: P4.11E.10 Session Type and Title: E-Poster Presentation Time: Monday, September 9, 2024 at 6:30 PM PDT Presenter: Peking University Shenzhen Hospital, F. Wang ESMO: Posters Abstract Title: First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 + bevacizumab (beva) in patients (pts) with advanced colorectal cancer (CRC): A phase I study Abstract No: 574P Session Type and Title: ESMO 2024-Poster Presentation Time: Monday, September 16, 2024 CEST Presenter: Zhen Yu Lin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Abstract Title: Safety and efficacy of IBI354 (anti-HER2 ADC) in patients (pts) with advanced gastrointestinal (GI) cancers: results from a Phase 1 study Abstract No: 576P Session Type and Title: ESMO 2024-Poster Presentation Time: Monday, September 16, 2024 CEST Presenter: Jifang Gong, Peking University Cancer Hospital Abstract Title: Hepatic Artery Infusion Chemotherapy (HAIC) Plus Sintilimab and Bevacizumab Biosimilar (IBI305) for Initial Unresectable Hepatocellular Carcinoma (HCC) in Patients with Child-Pugh B Liver Function: A prospective study Abstract No.: 980P Session Type and Title: Hepatocellular carcinoma (HCC) - Poster Presentation Time: Monday, September 16, 2024 Presenter: Tianjin Medical University Cancer Institute & Hospital, Huikai Li Abstract Title: Hepatic arterial infusion chemotherapy combined with Sintilimab and regorafenib as adjuvant therapy for colorectal liver metastasis patients with high risk of recurrent: a single-arm, Phase 2 study Abstract No.: 539P Session Type and Title: Colorectal cancer - Poster Presentation Time: Monday, September 16, 2024 Presenter: Fudan University Shanghai Cancer Center, Lu Wang Abstract Title: Fruquintinib combined with sintilimab and chemotherapy as the first-line treatment in advanced naïve EGFR- and ALK-negative non-squamous non-small cell lung cancer (nsq-NSCLC): Updated results Abstract No: 1329P Session Type and Title: NSCLC, metastatic - Poster Presentation Time: Saturday, September 14, 2024 Presenter: Jiangsu Province Hospital, Pei Ma Abstract Title: Sintilimab plus anlotinib in patients with advanced sarcomas (SINANLOSARC): a single-center, single-arm, Phase 2 trial Abstract No.: 1735P Session Type and Title: Sarcoma - Poster Presentation Time: Saturday, September 14, 2024 Presenter: Shandong Cancer Institute, Shandong Cancer Hospital, Zengjun Liu Abstract Title: Efficacy and safety of sintilimab in combination with anlotinib plus metronomic chemotherapy in advanced triple negative breast cancer (SPACE): preliminary results of a single-arm, multicenter Phase 2 trial Abstract No.: 389P Session Type and Title: Breast cancer, metastatic - Poster Presentation Time: Monday, September 16, 2024 Presenter: Shandong Cancer Institute, Shandong Cancer Hospital, Huihui Li Trial in Progress Abstract Title: Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced G/GEJ cancer: A phase 1b/2 clinical trial (FUNCTION) Abstract No.: 1475TiP Session Type and Title: Oesophagogastric cancer, Poster Presentation Time: Monday, September 16, 2024 Presenter: Henan Cancer Hospital, Bei-Bei Chen About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 11 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-looking statement 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", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. SOURCE Innovent Biologics

Phase 1Phase 2Clinical ResultASCO

100 Deals associated with Anlotinib Dihydrochloride

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KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB11885

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 May 2024
Differentiated Thyroid Gland Carcinoma	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	08 Apr 2022
Thyroid Cancer, Medullary	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	30 Jan 2021
Soft Tissue Sarcoma	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Jul 2019
Non-Small Cell Lung Cancer	CN	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
Metastatic Renal Cell Carcinoma	NDA/BLA	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Aug 2024
Unresectable Renal Cell Carcinoma	NDA/BLA	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Aug 2024
Endometrial Carcinoma	Phase 3	IT	Advenchen Laboratories LLC	01 Dec 2015
Endometrial Carcinoma	Phase 3	CN	Advenchen Laboratories LLC	01 Dec 2015
Endometrial Carcinoma	Phase 3	ES	Advenchen Laboratories LLC	01 Dec 2015
Refractory Thyroid Gland Carcinoma	Discovery	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Jul 2015
Ichthyosis, X-Linked	Discovery	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	12 May 2015
Metastatic colon cancer	Discovery	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Dec 2014
Advanced Lung Non-Small Cell Carcinoma	Discovery	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Dec 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ALTER-UC-007 (NEWS) Manual	Phase 2	Bladder Cancer	6	吉西他滨+顺铂 or 派安普利单+安罗替尼	(yjjxuhnaut) = vzexswlmvh njpskqgnzc (wnkbvocwlk )	Positive	30 Oct 2024
ALTER-UC-007 (NEWS) Manual	Phase 2	Bladder Cancer	6	吉西他滨+顺铂 or 派安普利单+安罗替尼 (受手术的患者)	(ehogrejlcq) = cigyifzuxt huzxuftcbx (plfhvttiau )	Positive	30 Oct 2024
NCT04203719 (Pubmed) Manual	Phase 2	Small Cell Lung Cancer Second line	21	Anlotinib 10/12 mg QD + Penpulimab 200 mg IV (Cohort 4)	(wmhmrkxuav) = lhauzgcqri xmhfpvjgbc (jfcewepifp, 17.7 - 66.6) View more	Positive	01 Oct 2024
NCT04959500 (Phase II Trial, ASTRO)	Phase 2	Glioblastoma	153	STUPP regimen + Anlotinib	ktackptwym(foeqcbpdqj) = rcclpxysgp ujdqadtefp (ssnoniqkli, 67.06 - 81.98) View more	Positive	01 Oct 2024
NCT04959500 (Phase II Trial, ASTRO)	Phase 2	Glioblastoma	153	STUPP regimen + Placebo	(ubjtrlbhtt) = ocxoffcbdl mwnwiueeon (ndzjhrhqdf )	Positive	01 Oct 2024
NEWS Manual	Not Applicable	Sarcoma	17	安罗替尼+特瑞普利单抗	(aunsrvehua) = nusrqttiwa gbxwlvuwhf (kywpajmfnp ) View more	Positive	30 Sep 2024
NCT03823118 (SALTER TRIAL, Pubmed \| BMC Cancer) Manual	Phase 2	Small Cell Lung Cancer	52	Anlotinib +S-1	(tvpfxnvamh) = cnerxmqpcy duxusmrubw (wesvbyavqf ) View more	Positive	27 Sep 2024
ChiCTR2100044725 (SPACE, ESMO2024) Manual	Phase 2	Advanced Triple-Negative Breast Carcinoma Second line \| Third line	43	Sintilimab+anlotinib+metronomic chemotherapy	(mfnjvgsymp) = cqzvcfvvxp mshvidovmi (gagrxdgucf, 0.12 - 0.39) View more	Positive	16 Sep 2024
NCT05244993 (ESMO2024) Manual	Phase 2	Advanced Triple-Negative Breast Carcinoma First line	33	AK105, anlotinib, nab-P	(avtxxmtcxd) = ibbmfvscjz gsibegvhqy (bjazfnavsl, 60.65 - 93.45) View more	Positive	16 Sep 2024
NCT05111366 (ALTER-H006, ESMO2024) Manual	Phase 2	Hepatocellular Carcinoma Adjuvant	38	Anlotinib+TQB2450	(jyhmfhuhev) = crjphsmnwt eqlzzgddcv (vylolgtxji, 28.61 - 72.50) View more	Positive	16 Sep 2024
ESMO2024	Not Applicable	Metastatic HER2-Negative Breast Carcinoma Second line HER-2 negative	106	Anlotinib plus chemotherapy	(lbhhntwbfx) = hrbgpnrhzw sjguuwltln (ofvszxvolz ) View more	Positive	16 Sep 2024
ESMO2024	Not Applicable		106	Bevacizumab plus chemotherapy	(lbhhntwbfx) = bbcyjbfjdz sjguuwltln (ofvszxvolz ) View more	Positive	16 Sep 2024
ChiCTR2000039175 (ESMO2024) Manual	Phase 2	Recurrent Glioblastoma	54	Toripalimab in combination with Anlotinib	(fhiqbqwdko) = chsiitjasa ijedrldnrk (wuafaisdty ) View more	Positive	15 Sep 2024

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