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+ [8]

Active Indication

Endometrial CarcinomaExtensive stage Small Cell Lung CancerDifferentiated Thyroid Gland Carcinoma+ [58]

Inactive Indication

Acral Lentiginous Malignant Melanomaadenocarcinoma of biliary tractAdvanced Bile Duct Carcinoma+ [31]

Originator Organization

Advenchen Laboratories LLC

Active Organization

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Advenchen Laboratories LLC

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/Sequence

Molecular FormulaC23H23ClFN3O3

InChIKeyGTAUHBAHFJIAQT-UHFFFAOYSA-N

CAS Registry1360460-82-7

View All Structures (2)

637

Clinical Trials associated with Anlotinib Dihydrochloride

NCT06761417

/ Not yet recruitingPhase 2IIT

A Prospective, Single-arm Clinical Study of Liposomal Mitoxantrone Combination Regimen in the Treatment of Relapsed and Refractory Solid Tumors in Children, Adolescents and Young Adults

The aim of this clinical study is to determine the efficacy and safety of the liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors among children, adolescents, and young adults. The key questions it intends to address are:
Can the liposomal mitoxantrone combination regimen improve the objective response rate (ORR) compared to historical data? What are the adverse events associated with this combination regimen? Researchers will administer the liposomal mitoxantrone combination regimen (including capecitabine and anlotinib with specific dosing regimens) to the participants and closely monitor their conditions.
Participants will:
Receive the treatment regimen for 4 - 6 cycles, with each cycle lasting 21 days Undergo regular checkups and tests during the treatment period and follow-up period as per the protocol.
Have their tumor status, blood parameters, and other relevant indicators measured to evaluate the treatment effect and safety.

Start Date01 Feb 2025

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

ChiCTR2400094970

/ SuspendedPhase 2IIT

Efficacy and safety of anlotinib hydrochloride as postoperative adjuvant therapy in patients with localized high-risk primary soft tissue sarcoma of the trunk and extremities

Start Date05 Jan 2025

Sponsor / Collaborator-

ChiCTR2400093534

/ SuspendedPhase 2IIT

The efficacy and safety of ifosfamide/etoposide ± anlotinib in the treatment of advanced undifferentiated small round cell sarcoma patients with progression or recurrence after anthracycline-based chemotherapy: a non-comparative randomised trial

Start Date01 Jan 2025

Sponsor / Collaborator

West China Hospital

100 Clinical Results associated with Anlotinib Dihydrochloride

100 Translational Medicine associated with Anlotinib Dihydrochloride

100 Patents (Medical) associated with Anlotinib Dihydrochloride

976

Literatures (Medical) associated with Anlotinib Dihydrochloride

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

BACKGROUNDSeveral 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.METHODSWe 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.RESULTSBetween 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.CONCLUSIONThe 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 NUMBERNCT04984096.

01 Feb 2025·Leukemia Research

Anlotinib enhances the pro-apoptotic effect of APG-115 on acute myeloid leukemia cell lines by inhibiting the P13K/AKT signaling pathway

Article

Author: Cheng, Cheng ; Guo, Xiaoli ; Hu, Chenxi ; Cui, Yu ; Li, Dongbei ; Wei, Xudong ; He, Rongheng ; Zhao, Rui

BACKGROUNDAPG-115 is a novel small-molecule selective inhibitor that destabilizes the p53-MDM2 complex and activates p53-mediated apoptosis in tumor cells. Anlotinib inhibits tumor angiogenesis and promotes apoptosis. In this study, we investigated the apoptotic effect and potential mechanism of APG-115 and anlotinib combination on AML cell lines with different p53 backgrounds.MATERIAL AND METHODSThe IC50 values of APG-115 and anlotinib were detected by CCK-8 assay. The apoptosis rate of AML cells was evaluated by Annexin-V and PI double staining. Transcriptome sequencing was performed on the MOLM16 cell line treated with APG-115 and anlotinib, and differential analysis and enrichment analysis were performed. Real-time quantitative PCR and Western blot were used to detect the changes in cell cycle and pathway-related genes and proteins in AML cell lines after drug treatment. In vivo experiments, the anti-leukemia effects of APG-115 and anlotinib on AML xenograft mouse models were evaluated.RESULTSAPG-115 and anlotinib could independently promote AML cell apoptosis, and the combination of the two drugs could produce a synergistic effect. Transcriptome sequencing showed that compared with the APG-115 monotherapy group, the differentially expressed genes were mainly enriched in the MDM2-p53 and PI3K/AKT pathways. In vivo experiments showed that compared with AML xenograft mice treated with either drug alone, AML progression was slowed in AML xenograft mice treated with APG-115 and anlotinib.CONCLUSIONIn vivo and in vitro experimental have shown that APG-115 combined with anlotinib can promote AML cells apoptosis and inhibit the progression of disease is independent of the p53 status.

01 Feb 2025·Endocrine-Related Cancer

ERRATUM: Autophagic blockade potentiates anlotinib-mediated ferroptosis in anaplastic thyroid cancer

Author: Liu, Ruiqi ; Liang, Juyong ; Qiu, Weihua ; Tan, Zhuo ; Wang, Jiafeng ; Jiang, Liehao ; Ma, Wenli ; Lv, Tian ; Wu, Jiajun ; Liu, Qing ; Ge, Minghua ; Pan, Yan ; Fu, Kangyin

News (Medical) associated with Anlotinib Dihydrochloride

04 Dec 2024

·www.prnewswire.com

Akeso's Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) Combination Therapy for PD-(L)1 Resistant NSCLC Showcased in Oral Presentation at 2024 Asian Conference on Lung Cancer

HONG KONG, Dec. 4, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced the results from a prospective, open-label, single-arm, multi-center phase Ib/II clinical study (AK104-IIT-018) of cadonilimab (PD-1/CTLA-4 bispecific antibody) in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who had progressed after prior PD-(L)1 inhibitor treatment, were presented at the 2024 Asian Conference on Lung Cancer (ACLC). Professor Han Baohui from Shanghai Chest Hospital presented the initial positive results of the cadonilimab combination therapy for immune-resistant NSCLC at the conference. The treatment demonstrated a 6-month progression-free survival (PFS) rate of 56.9%, a median PFS of 6.5 months, a disease control rate (DCR) of 94.0%, and a median duration of response (DoR) of 5.0 months. Nearly all patients showed long-lasting tumor control, highlighting cadonilimab as a promising and effective second-line treatment for advanced immune-resistant NSCLC. The AK104-IIT-018 study is a prospective, open-label, single-arm, multicenter Phase Ib/II clinical trial (NCT05816499) conducted across four centers in China. The study was initated in February 2023, and this report presented the preliminary data analysis. The study enrolled patients with unresectable, incurable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC), who tested negative for driver mutations and had previously received PD-1/L1 inhibitors along with platinum-based doublet chemotherapy (either in combination or sequentially, regardless of sequence), with disease progression. Patients were treated with a combination regimen of cadonilimab (10 mg/kg every 3 weeks), anlotinib, and docetaxel (60 mg/m²). The primary endpoint of the study is the 6-month progression-free survival (PFS) rate. As of May 31, 2024, 46 patients had been enrolled in the study. Among these, 41.3% had non-squamous NSCLC and 58.7% had squamous NSCLC. Regarding PD-L1 expression, 10.9% of patients had levels <1%, 28.3% between 1-49%, and 15.2% had PD-L1 expression≥50%. Reflective of the real-world NSCLC patient population, 10.9% of patients had brain metastasis, 6.5% of the patients had liver metastasis, and 23.9% of the patients had bone metastasis. Progression-Free Survival (PFS): As of May 31, 2024, the maturity of PFS was 30.4%, with a 6-month PFS rate of 56.9% (compared to 30% for docetaxel monotherapy). The median PFS was 6.5 months (versus 4 months for docetaxel monotherapy). Tumor Response: Out of 33 patients, 10 achieved partial response (PR), and 21 had stable disease (SD). The overall objective response rate (ORR) was 30.3%, which is significantly higher than the 14% ORR observed in previous studies of docetaxel alone. Among the 10 patients with partial response, the median duration of response (DoR) was 5.0 months. Disease Control Rate (DCR): The DCR reached 94.0%, with nearly all patients experiencing effective tumor control. Safety: The combination of cadonilimab, anlotinib, and docetaxel for treating advanced, driver gene-negative, immune-resistant NSCLC was well-tolerated. The adverse events were manageable and controllable, and the safety profile was favorable. For patients with advanced, driver gene-negative NSCLC who progress after first-line immunotherapy combined with chemotherapy, treatment options are limited. The standard treatment recommended by the NCCN guidelines is single-agent chemotherapy, but its efficacy is limited, with an objective response rate (ORR) of 14%–17%, a 6-month progression-free survival (PFS) rate of approximately 30%, PFS of 4.0–5.4 months, and overall survival (OS) of 10.5–12 months. The cadonilimab regimen holds potential as a new treatment option for immune-resistant NSCLC. Cadonilimab is a bispecific antibody that targets both PD-1 and CTLA-4, and is independently developed by Akeso. It is a humanized immunoglobulin G1 (IgG1) bispecific antibody (BsAb). Cadonilimab promotes "immune normalization" in the tumor microenvironment through multiple mechanisms. Its unique tetravalent symmetric structure design and Fc modifications enable enhanced accumulation in tumor tissues. As a result of this study, cadonilimab demonstrated the potential to improve the efficacy of tumor immunotherapy while reducing adverse reactions. Akeso has conducted several clinical trials to evaluate cadonilimab in the treatment of immune-resistant or poorly responsive tumors. These include the registrational phase III trial (AK109-301) of cadonilimab combined with its VEGFR-2 monoclonal antibody for advanced gastric cancer progressing after PD-1/L1 inhibitors plus chemotherapy, and the phase III trial (AK104-307) comparing cadonilimab plus chemotherapy to tislelizumab plus chemotherapy as first-line treatment for PD-L1-negative NSCLC. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin, and X (formerly Twitter). SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Immunotherapy

25 Nov 2024

·www.prnewswire.com

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

SAN FRANCISCO and SUZHOU, China, Nov. 24, 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 10 accepted clinical data of its novel oncology molecules, including an oral presentation of updated Phase 1 result of its novel TOPO1i CLDN18.2 ADC (IBI343) in previously-treated pancreatic cancer, will be released at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2024 from Dec 06-08, 2024, in Singapore. Details on the abstracts are listed below: Mini Oral Abstract Title: Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients with advanced pancreatic ductal adenocarcinoma (PDAC): updated results from a Phase 1 study Abstract No: 132MO Session Type and Title: Mini Oral session: Gastrointestinal tumors Presentation Time: 2024-12-07, 09:50-09:55 Presenter: Jian Zhang, Fudan University Shanghai Cancer Center, CN Abstract Title: mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody in Locally Advanced MSS CRC (BASKETⅡ): A Prospective, Single-Arm, Open-Label, Phase 2 Study Abstract No: 74MO Session Type and Title: Mini Oral session: Gastrointestinal tumors Presentation Time: 2024-12-07, 10:20-10:25 Presenter: Jun Huang, The Sixth Affiliated Hospital, Sun Yat-sen University, CN Posters Abstract Title: Anlotinib plus Sintilimab as First-line Treatment for Patients with Advanced Colorectal Cancer (APICAL-CRC): an Open-Label, Single-arm, Phase 2 study Abstract No: 75P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Zhan Wang, Shanghai Changzheng Hospital, The Second Affiliated Hospital of Naval Medical University, CN Abstract Title: A single-arm, multicenter, Phase 2 study of hepatic arterial infusion chemotherapy (HAIC) combined with donafenib and sintilimab as first-line treatment for unresectable intrahepatic cholangiocarcinoma (CHANCE 2203) Abstract No: 137P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Gaojun Teng, Zhongda Hospital, Southeast University, CN Abstract Title: FOLFOX-HAIC combined with sintilimab and bevacizumab for advanced hepatocellular carcinoma: a single-arm, Phase 2 study Abstract No: 207P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Bin Liang/ Zizhuo Wang, Union Hospital Tongji Medical College Huazhong University of Science and Technology, CN Abstract Title: Updated results from Phase 2 study of HAIC plus sintilimab and bevacizumab biosimilar in patients with advanced hepatocellular carcinoma (HCC) Abstract No: 214P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Haibin Zhang, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital of Naval Medical University, CN Abstract Title: Anlotinib Combined with Sintilimab Versus Chemotherapy Combined with Immunotherapy in Perioperative NSCLC: A Phase 2 Study Abstract No: 599P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Tianqing Chu, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, CN Trial in Progress abstracts (TiP) Abstract Title: A randomized, controlled, multicenter Phase 3 study of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) as neoadjuvant treatment for resectable microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colon cancer: Trial in Progress Abstract No.: 119TiP Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Ruihua Xu, Sun Yat-sen University Cancer Center, CN Abstract Title: Efficacy and Safety of Combination Therapy of Sintilimab and Chemotherapy with Cryoablation in the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Abstract No.: 722TiP Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Zhiqiang Gao, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, CN Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are very pleased to present and share a robust set of clinical data at EAMO Asia 2024. Notably, we are highlighting the breakthrough potential for our TOPO1i CLDN18.2 ADC (IBI343) in pancreatic cancer, a global difficult-to-treat cancer. Consistent with the preliminary signal observed in small patient size, the data in dose expansion stage demonstrated encouraging efficacy and good safety, which reinforced our confidence in advancing its development. Given unique design of Fc-silent antibody, combined with stable linker and potent extecan payload, IBI343 pioneered in the exploration of CLDN18.2 ADC agents for PDAC treatment. As one of the few biopharmaceutical companies with both advanced technology platforms and a robust pipeline in "IO+ADC" areas, Innovent remains dedicated to transforming cancer treatment by delivering innovative, effective, and safe therapeutic options for doctors and patients." 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 target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem 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 WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 1Clinical ResultADCImmunotherapy

22 Nov 2024

·www.prnewswire.com

Akeso's Penpulimab Combination Therapy for First-line Treatment of Hepatocellular Carcinoma Accepted by NMPA

HONG KONG, Nov. 22, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the National Medical Products Administration (NMPA) of China has accepted its supplemental new drug application (sNDA) for penpulimab, a differentiated PD-1 monoclonal antibody, in combination with anlotinib for the first-line (1L) treatment of advanced hepatocellular carcinoma (HCC). This marks penpulimab's fifth indication, following its approval for first line treatment of squamous non-small cell lung cancer, first line and third-line or further treatment for metastatic nasopharyngeal carcinoma, and third-line treatment of relapsed or refractory classical Hodgkin lymphoma. The differentiated clinical value of the penpulimab combination therapy is expected to offer a more effective solution for patients with liver cancer. The sNDA for this new indication is supported by the ALTN-AK105-III-02 study, a multicenter, randomized, open-label, parallel-controlled Phase III clinical trial. The study demonstrated positive outcomes in both progression-free survival (PFS) and overall survival (OS). These encouraging clinical results were featured as a "Late Breaking Abstract (LBA)" at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. Clinical data highlights: Penpulimab combined with anlotinib regimen reduced the risk of disease progression or death by 47% compared to the control group (median PFS: 6.9 months vs. 2.8 months, HR=0.53, P<0.0001); Penpulimab combined with anlotinib regimen reduced the risk of death by 31% compared to the control group (median OS: 16.5 months vs. 13.2 months, HR=0.69, P=0.0013). The combination of penpulimab and anlotinib significantly improved both PFS and OS in HCC patients compared to sorafenib, with no new safety signals. This makes the combination a promising first-line treatment option for advanced HCC. The ALTN-AK105-III-02 study marks the second global Phase III trial to achieve positive results for the combination of an immune checkpoint inhibitor and an oral multi-targeted tyrosine kinase inhibitor in the first-line treatment of advanced HCC. These encouraging findings pave the way for this combination therapy to become a superior treatment option for patients with advanced hepatocellular carcinoma. About Penpulimab Penpulimab is a differentiated PD-1 monoclonal antibody with an IgG1 subtype and modified Fc region, enhancing immunotherapy efficacy while minimizing adverse reactions. Developed by Akeso Biopharma, its commercialization is managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group, a subsidiary of Sino Biopharm. Penpulimab has been approved for the following indications: First-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) in combination with chemotherapy. Relapsed or refractory classical Hodgkin lymphoma (cHL) after at least two lines of systemic chemotherapy. Recurrent/metastatic nasopharyngeal carcinoma (NPC) who have failed to respond to two or more prior lines of systemic therapy. Penpulimab in combination therapy for the first-line treatment of metastatic NPC, has had its marketing application accepted by the NMPA and the FDA. Additionally, the marketing application for its monotherapy use in third-line or further treatment of metastatic nasopharyngeal carcinoma has also been accepted by the FDA. Ongoing late-stage clinical trials of penpulimab are progressing for liver cancer, gastric cancer, and other indications. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin, and X (formerly Twitter) SOURCE Akeso, Inc. 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 ApprovalASCO

100 Deals associated with Anlotinib Dihydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB11885

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Endometrial Carcinoma	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	22 Nov 2024
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
Small Cell Lung Cancer	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Sep 2019
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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hepatocellular Carcinoma	NDA/BLA	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	21 Nov 2024
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
Uterine Cervical Cancer	Phase 3	ES	Advenchen Laboratories LLC	01 Dec 2015
Uterine Cervical Cancer	Phase 3	GB	Advenchen Laboratories LLC	01 Dec 2015
Refractory Thyroid Gland Carcinoma	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Jul 2015
Stomach Cancer	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Jun 2015
Ichthyosis, X-Linked	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	12 May 2015
Metastatic colon cancer	Phase 2	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Dec 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04007835 (CTONG-1803/ALTER-L001, Pubmed) Manual	Phase 2	EGFR positive non-small cell lung cancer	120	Anlotinib 12 mg/day + EGFR-TKIs	(ifvhtowaqg) = uoxyxzlfqo uruoipofmu (ucjwqlbogm, 6.8 - 11.7) View more	Positive	05 Jan 2025
				Anlotinib 12 mg/day + EGFR-TKIs (first-line 1st /2nd generation EGFR-TKIs)	(ifvhtowaqg) = paijgugytm uruoipofmu (ucjwqlbogm, 6.7 - 12.6)
Pubmed \| J Hematol Oncol	Not Applicable	Advanced Lung Non-Small Cell Carcinoma	-	Anlotinib 12 mg/day + EGFR-TKIs	lmepnkifgc(dpbgpidrei) = ilkjamchbf jnuhpxqzsl (jmypfjqjta ) View more	-	05 Jan 2025
NCT04325763 (TQB2450-Ⅲ-05, NEWS) Manual	Phase 3	Non-Small Cell Lung Cancer Consolidation	-	贝莫苏拜单抗	(rfkftcppeh) = dmfylmswnb mfqufcfnsc (ffxaxvfgkw )	Positive	19 Dec 2024
				贝莫苏拜单抗 + 安罗替尼	-
NCT04846634 (ALTER-L043, ESMO_IO2024) Manual	Phase 2	Locally Advanced Lung Non-Small Cell Carcinoma Adjuvant \| Neoadjuvant	90	Penpulimab + Chemotherapy + Anlotinib	(mfrwswsvur) = alilrofnfk aubfwhkglg (gccgaglvfv ) View more	Positive	12 Dec 2024
				Penpulimab + Chemotherapy	(mfrwswsvur) = yccyicnuag aubfwhkglg (gccgaglvfv ) View more
ESMO_IO2024 Manual	Not Applicable	Extensive stage Small Cell Lung Cancer Third line \| Second line \| First line	40	Serplulimab + Chemotherapy + Anlotinib (first-line)	(rxmmzyxbih) = vkudzhkiwp ggtfvvngkt (wrzhukueec, 15.6 - NR) View more	Positive	12 Dec 2024
ESMO_ASIA2024 Manual	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant	30	Anlotinib + Sintilimab	(foiiiuxoad) = welmxbaaln utifzotkov (xzkuuabciq ) View more	Positive	07 Dec 2024
				Chemotherapy + Immunotherapy	(foiiiuxoad) = rjvtjrsyaf utifzotkov (xzkuuabciq ) View more
NCT05262335 (ALTER-G-001, ESMO_ASIA2024) Manual	Phase 2	Gastrointestinal Neoplasms First line	58	anlotinib + oxaliplatin + capecitabine (CRC)	(szgzorsijr) = aymirexwqu hqrhecxkog (kkpklnbyhn ) View more	Positive	07 Dec 2024
				anlotinib + cisplatin + paclitaxel or docetaxel (ESCC)	(szgzorsijr) = idsivzkstb hqrhecxkog (kkpklnbyhn ) View more
NCT04271813 (ESMO_ASIA2024) Manual	Phase 2	Advanced gastric carcinoma First line	24	anlotinib + toripalimab	(goypnlepcb) = qegzcpcgrf aqxfeeilfj (ieoamgicvt, 32.2 - 75.6) View more	Positive	07 Dec 2024
NCT04271813 (ESMO_ASIA2024) Manual	Phase 2	Colorectal Cancer First line	29	Sintilimab plus Anlotinib	etsujrxbth(rdapbrzxek) = jjaszdsxjw pfzwtkpmfx (sxmmjmvnvh, 28.3–65.7) View more	Positive	07 Dec 2024
ALWAYS (ESMO_ASIA2024) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line	26	Aumolertinib plus Anlotinib	(jlkikcbyeb) = aqivhenmyd meryxaccpm (srwsyhjqsb, 80.4 - 99.9) View more	Positive	07 Dec 2024
				Aumolertinib plus Anlotinib (Intracranial)	(jlkikcbyeb) = ytplnwbluk meryxaccpm (srwsyhjqsb, 50.1 - 93.2) View more

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