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Last update 30 May 2025

Apatinib Mesylate

Last update 30 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Apatinib, Rivoceranib, Rivoceranib mesilate

+ [5]

Target

VEGFR2

Action

antagonists

Mechanism

VEGFR2 antagonists(Vascular endothelial growth factor receptor 2 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases+ [4]

Active Indication

Germline BRCA-mutated, HER2-negative metastatic breast cancerHepatocellular CarcinomaGastroesophageal junction adenocarcinoma+ [27]

Inactive Indication

Adenoid Cystic CarcinomaAdvanced Bile Duct CarcinomaAdvanced biliary tract cancer+ [58]

Originator Organization

Advenchen Laboratories LLC

Active Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Inactive Organization

Elevar Therapeutics, Inc.

Bukwang Pharmaceutical Co., Ltd.

HRYZ (Shanghai) Biotech Co., Ltd.

License Organization

QureBio Ltd.

Bukwang Pharmaceutical Co., Ltd.

Elevar Therapeutics, Inc.

+ [6]

Drug Highest PhaseApproved

First Approval Date

China (17 Oct 2014),

Gastroesophageal junction adenocarcinomastomach adenocarcinoma

RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Special Review Project (China), Orphan Drug (South Korea), National Science and Technology Major Project (China)

Structure/Sequence

Molecular FormulaC25H27N5O4S

InChIKeyFYJROXRIVQPKRY-UHFFFAOYSA-N

CAS Registry1218779-75-9

869

Clinical Trials associated with Apatinib Mesylate

NCT06973330

/ Not yet recruitingPhase 2IIT

Sintilimab Plus Apatinib and SOX as First-line Treatment in Patients With AFP Gastric or Gastroesophageal Junction Adenocarcinoma: a Single-arm, Multi-center, Phase II Trial

This is a multi-center, prospective, open label phase II study evaluating the safety and efficacy of standard first-line chemotherapy SOX regimen combined with Sintilimab (anti-PD-1 antibody) and Apatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Anhui Provincial Cancer Hospital. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with SOX regimen combined with Sintilimab plus Apatinib every 3 weeks(4 cycles) followed by sintilimab+apatinib until disease progression or intolerable adverse reactions or death(up to 24 months).Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests.

Start Date01 May 2025

Sponsor / Collaborator

Anhui Provincial Cancer Hospital

NCT06881017

/ Not yet recruitingPhase 2IIT

Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping: an Umbrella Phase II Exploratory Clinical Study

This study is a prospective, umbrella-design, Phase II clinical trial. Eligible participants with advanced or metastatic gastric cancer who are treatment-naïve for advanced-stage systemic therapy will undergo biomarker profiling (HER2, CLDN18.2, and PD-L1) via next-generation sequencing (NGS) or immunohistochemistry (IHC). Participants will be stratified into distinct molecular subtypes and assigned subtype-specific therapeutic regimens. The primary objectives are to assess treatment efficacy (e.g., objective response rate) and safety profiles across molecularly defined cohorts.

Start Date01 May 2025

Sponsor / Collaborator

China Medical University

ChiCTR2500099852

/ SuspendedPhase 4IIT

Adebrelimab combined with apatinib and chemotherapy in NSCLC treated with first-line PD-1 inhibitor therapy:a prospective, single-center, single-arm clinical study

Start Date15 Apr 2025

Sponsor / Collaborator

Affiliated Hospital of Jiangnan University

100 Clinical Results associated with Apatinib Mesylate

100 Translational Medicine associated with Apatinib Mesylate

100 Patents (Medical) associated with Apatinib Mesylate

2,806

Literatures (Medical) associated with Apatinib Mesylate

01 Dec 2025·Journal of Gastrointestinal Cancer

Third- or Further-Line Treatment in Patients with MSS Type Metastatic Colorectal Cancer

Article

Author: Gou, Miaomiao ; Qian, Niansong ; Dai, Guanghai ; Zhang, Yong ; Wang, Zhikuan

BACKGROUND:

The survival benefit from later-line treatment for patients with metastatic colorectal cancer (mCRC) remains disappointing. Here, in a real-world study, we were aimed to evaluate which choice will affect the survival of mCRC patients after standard treatment in Chinese patients.

METHODS:

A total of 129 patients with refractory mCRC were involved in the study. They received targeted monotherapy or combined with chemo-agents or PD-1 inhibitor before death. Overall survival (OS) and progression-free survival (PFS) were reviewed and evaluated from clinical features and treatment options.

RESULTS:

Among the 129 patients, the median age was 56 years (25-81). The mOS from third-line was 12.5 months. OS of patients who treated with chemo plus targeted therapy group in third-line was shown to be superior to pd-1 inhibitor in combination with antiangiogenic agents or antiangiogenic monotherapy group (15.6 m vs. 10.5 m vs. 8.4 m, p < 0.05). Patients had received triplet-drugs (bevacizumab plus low-dose irinotecan and oxaliplatin) and had prolonged survival compared to those had not (21.3 m vs 10.3 m, p = 0.004). OS between patients who had immunotherapy history or not was not significantly different (p > 0.05). The mPFS was 3.5 months in patients who had administered with antiangiogenic targeted agents plus anti-pd-1 and 4.7 months in chemo plus targeted therapy group and 2.2 months in the other group. In the triplet drugs group, preliminary results showed that ORR was 13.3% and DCR was 80%. The median PFS was 5.1 m, and the median OS was 10.6 m.

CONCLUSIONS:

Triplet drugs resulted in significantly longer overall survival, and immunotherapy may have limited benefit in MSS type CRC patients.

01 Nov 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Tumor microenvironment-responsive nanoregulator CoMnMOF superparticles for enhanced microwave dynamic therapy via multi-pronged amplification of reactive oxygen species

Article

Author: Wang, Dongdong ; Chen, Zengzhen ; Chen, Xiaowei ; Tan, Longfei ; Fu, Changhui ; Meng, Xianwei ; Ren, Xiangling ; Wu, Qiong

Microwave dynamic therapy (MDT) is promising in tumor therapy by generation of toxic reactive oxygen species (ROS), whose therapeutic efficacy is severely compromised by hypoxia and the antioxidant defense in the tumor microenvironment (TME). To address these bottlenecks, we designed a multifunctional nanoregulator CoMnMOF@Apatinib@l-menthol@RBC-HA (denoted as CMALRH) to achieve enhanced MDT via a multi-pronged ROS amplification strategy. We demonstrated that the enhanced ROS generation is attributed to the up-regulate O₂ level, down-regulate vascular endothelial growth factor (VEGF) expression and deplete glutathione (GSH). Meanwhile, CMALRH is verified to perform superior microwave (MW) thermal effect, thus remarkably potentiating the efficacy of anti-tumor therapy. The experiments in vitro and in vivo confirmed the enhanced MDT in combination with microwave thermal therapy can successfully inhibit the proliferation of breast cancer. This TME based ROS amplification strategy provides an avenue for the development of remarkably high efficiency MDT and MW thermal therapy.

01 Oct 2025·COLLOIDS AND SURFACES B-BIOINTERFACES

Apatinib-loaded silicate nanoparticles coated with macrophage membranes and PD-1 antibody for enhanced chemo-immunotherapy in ovarian cancer via VEGFR2 and PD-1 dual inhibition

Article

Author: Zhou, Shunqing ; Liu, Jianli ; Jin, Yuemei ; Wang, Yuhan ; Li, Hongru

Ovarian cancer remains one of the most challenging malignancies to treat due to its aggressive nature and resistance to conventional therapies. In this study, we developed a nanoparticle-based system (Apa@SiO₂@MP) that combines chemotherapy with immune checkpoint inhibition for enhanced treatment of ovarian cancer. The system consists of mesoporous silica nanoparticles (SiO₂ NPs) coated with macrophage membranes (MP) and functionalized with programmed death 1 (PD-1) antibody, designed to improve the delivery and targeting of apatinib, a tyrosine kinase inhibitor. The system demonstrated effective drug encapsulation, controlled release, and stability in physiological environments. In vitro assays revealed that Apa@SiO₂@MP had minimal cytotoxicity in normal cells but significantly reduced cell viability in ovarian cancer cells (SKOV-3), highlighting its cancer-targeting ability. Apatinib effectively inhibited VEGFR2 expression and induced reactive oxygen species (ROS) production, further promoting anti-cancer effects. In vivo, Apa@SiO₂@MP treatment led to enhanced tumor inhibition, as well as significant immune response activation, including increased CD4⁺ and CD8⁺ T cells and elevated IFN-γ levels. This study provides a promising multi-modal strategy for overcoming challenges in cancer therapy by integrating chemotherapy, immunotherapy, and targeted drug delivery, offering potential for improved treatment outcomes in ovarian cancer.

101

News (Medical) associated with Apatinib Mesylate

23 May 2025

·www.prnewswire.com

CARsgen's Satri-cel Abstract Available on ASCO Website

SHANGHAI, May 22, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that an abstract of the research results of the confirmatory Phase II clinical trial of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against protein Claudin18.2) for advanced gastric/gastroesophageal junction cancer (G/GEJC) in China (CT041-ST-01, NCT04581473) is available on the American Society of Clinical Oncology ("ASCO") website. Title Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01) Abstract Number 4003 Session Type and Title Oral Abstract Session – Gastrointestinal Cancer— Gastroesophageal, Pancreatic, and Hepatobiliary Session Date and Time May 31, 2025, 3:00–6:00 PM CDT This open-label, multicenter, randomized controlled trial (RCT) was conducted in China to compare the efficacy and safety of satri-cel versus standard of care (SOC) in CLDN18.2 positive, advanced G/GEJC patients with failure to at least 2 prior lines of treatment. The primary endpoint was PFS assessed by the Independent Review Committee (IRC). Key secondary endpoint was OS. Data cutoff date was Oct 18, 2024. Patients were randomized (2:1) to satri-cel arm or TPC arm. For satri-cel arm, satri-cel dose of 250×106 cells were infused up to 3 times. For TPC arm, one of the standard of care (SOC) drugs (apatinib, paclitaxel, docetaxel, irinotecan or nivolumab) was given per physician's decision. Those who experienced disease progression or drug intolerance in TPC arm could receive subsequent satri-cel, if eligible. From Mar 29, 2022 to Aug 16, 2024, a total of 156 patients were randomized to satri-cel arm (n = 104) or TPC arm (n = 52). Twenty patients in TPC arm received subsequent satri-cel. Median number of prior systemic therapies was 2 in both arms, and 26.9% vs 19.2% had received ≥3 lines. 71.2% vs 65.4% were Lauren diffuse/mixed type. 69.2% vs 59.6% had peritoneal metastasis. In ITT population (i.e., all randomized patients), satri-cel arm showed significant improvement in mPFS by IRC (3.25m vs 1.77m; HR 0.366, 95% CI:0.241, 0.557; p < 0.0001) meeting the primary endpoint with a 63% reduction in risk of disease progression or death. Even with 15.4% (n=16) patients in satri-cel arm failing to receive infusion and nearly 40% (n=20) patients in TPC arm receiving subsequent satri-cel, satri-cel arm still demonstrated a clear trend toward OS benefit (mOS 7.92m vs 5.49m; HR 0.693, 95% CI: 0.457, 1.051; one-sided p = 0.0416) , showing over 30% reduction in mortality risk. More importantly, in mITT population (i.e. patients who were actually treated), 136 patients received study drug (satri-cel 88 patients vs TPC 48 patients), mPFS by IRC was 4.37m vs 1.84m, HR 0.304 (95% CI: 0.195, 0.474), representing a 70% reduction in risk of disease progression or death. The mOS was 8.61m vs 5.49m, HR 0.601 (95%CI: 0.385, 0.939), corresponding to 40% reduction in mortality risk. These results demonstrate that satri-cel treatment benefits were pronounced in patients who actually received CAR-T infusion. Of particular note, 20 TPC patients with subsequent satri-cel infusion achieved an mOS of 9.20 months. When analyzing all 108 patients who received satri-cel infusion (88 patients in satri-cel arm and 20 patients in TPC arm), the mOS reached 9.17 months, while the mOS of 28 patients in TPC arm who did not receive satri-cel treatment was only 3.98 months (HR 0.288; 95% CI: 0.169-0.492). These findings provide further evidence that satri-cel infusion can deliver substantial survival benefits for patients. Furthermore, satri-cel demonstrated a favorable overall safety profile. Only 4 cases of Grade 3 cytokine release syndrome (CRS) were reported, and no Grade 4-5 CRS events were observed. No immune effector cell-associated neurotoxicity syndrome (ICANS) was reported. This is the first confirmatory RCT of CAR-T therapy in solid tumors. Satri-cel demonstrated significant PFS improvement and a clinically meaningful OS benefit with a manageable safety profile in CLDN18.2 positive G/GEJC patients with failure to at least 2 prior lines of treatment, compared to standard therapy. These results support satri-cel as a potential new SOC for advanced G/GEJC. About Satri-cel Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2 positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation of China's National Medical Products Administration for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in September 2020 for the treatment of G/GEJA. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, . No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. SOURCE CARsgen Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultASCOCell TherapyOrphan DrugPhase 2

23 Apr 2025

·www.prnewswire.com

Seven Oral Presentations: Innovent to Present Breakthrough Clinical Data of IBI363（PD-1/IL-2α-bias）and Other Novel Drug Candidates at the 2025 ASCO Annual Meeting

SAN FRANCISCO and SUZHOU,China, April 23, 2025 /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 clinical data for its innovative bispecific antibodies and ADC molecules, including oral presentations for IBI363 (PD-1/IL-2α-bias) and IBI343 (CLDN18.2 ADC), will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 from May 30 to June 3, 2024, in Chicago, Illinois, U.S. Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are delighted to announce that at 2025 ASCO Annual Meeting, the first wave of three indications under development for IBI363—melanoma, colorectal cancer(CRC), and non-small cell lung cancer (NSCLC)—have all been accepted for oral presentations, highlighting the significant attention garnered by the next-generation bispecific antibodies, in particular PD-1-based immunotherapy. Additionally, following its oral presentation at ESMO Asia last December, the Phase 1b data of IBI343 in pancreatic cancer has once again secured an oral presentation at ASCO, further solidifying its potential in this challenging therapeutic area. The maturing PoC data for these innovative candidates has strengthened our confidence in advancing them into pivotal-stage development, with the goal of unlocking their clinical value for global unmet clinical needs. As one of the few biopharmaceutical companies with both the advanced technology platforms and robust pipeline in "IO+ADC" areas, Innovent will continue to make breakthroughs in the field of cancer treatment, and is committed to providing physicians and patients with more innovative, effective and safe treatment options." Details on the abstracts are listed below: Oral Presentation 1. Presentation Title: Efficacy and safety results of a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, in patients with immunotherapy-treated, advanced acral and mucosal melanoma Abstract Number: 2502 Session Type: Oral Abstract Session Title: Developmental Therapeutics-Immunotherapy Session Date & Time: 5/31/2025 3:00 PM-6:00 PM CDT Presenter: Jun Guo, MD, Beijing Cancer Hospital 2. Presentation Title: Efficacy and safety of IBI363 monotherapy or in combination with bevacizumab in patients with advanced colorectal cancer Abstract Number: 104 Session Type: Oral Abstract Session Title: Clinical Science Symposium—Turning "Cold" Tumors "Hot" Session Date & Time: 6/1/2025 9:45 AM-11:15 AM CDT Presenter: Zhenyu Lin, MD, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 3. Presentation Title: First-in-class PD-1/IL-2α-bias bispecific antibody, IBI363, in patients with advanced immunotherapy-treated non-small cell lung cancer (NSCLC) Abstract Number: 8509 Session Type: Oral Abstract Session Title: Clinical Science Symposium—Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies Session Date & Time: 6/3/2025 9:45 AM-11:15 AM CDT Presenter: Jianya Zhou, MD, The First Affiliated Hospital, Zhejiang University School of Medicine 4. Presentation Title: Claudin18.2 (CLDN18.2) expression and efficacy in pancreatic ductal adenocarcinoma (PDAC): results from a Phase 1 dose expansion cohort evaluating IBI343 Abstract Number: 4017 Session Type: Rapid Oral Abstract Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: 6/2/2025 11:30 AM-1:00 PM CDT Presenter: Xianjun Yu, MD, Fudan University Shanghai Cancer Center 5. Presentation Title: Sintilimab (anti-PD-1) plus ifosfamide, carboplatin and etoposide (ICE) in second-line classical Hodgkin lymphoma (cHL): Results of a multicenter, randomized, controlled, double-blind Phase 3 study (ORIENT-21) Abstract Number: 7007 Session Type: Oral Abstract Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Session Date & Time: 5/30/2025 2:45 PM-5:45 PM CDT Presenter: Peng Liu,MD, Cancer Hospital, Chinese Academy of Medical Sciences 6. Presentation Title: Short-course radiotherapy followed by sintilimab and CAPOX as total neoadjuvant treatment in locally advanced rectal cancer: A prospective, randomized controlled trial (SPRING-01) Abstract Number: 3519 Session Type: Rapid Oral Abstract Session Title: Gastrointestinal Cancer-Colorectal and Anal Session Date & Time: 6/1/2025 11:30 AM-1:00 PM CDT Presenter：Changqing Jing, MD, Shandong Provincial Hospital 7. Presentation Title: Dynamic circulating tumor DNA-driven, risk-adapted systematic therapy in n as opharyngeal carcinoma: The EP-STAR trial Abstract Number: 6010 Session Type: Oral Abstract Session Title: Clinical Science Symposium -Biomarker-Driven Adaptive Therapy: New Horizons in Head and Neck Cancer Session Date & Time: 6/2/2025 3:00 PM-4:30 PM CDT Presenter: Ying Sun, MD, Sun Yat-sen University Cancer Center Poster Presentation 1. Presentation Title: A multicenter, randomized, controlled, open-label, Phase 2 study of the PD-1/IL-2α-bias bispecific antibody fusion protein IBI363 in mucosal and acral melanoma: Trial in Progress Abstract Number: TPS9594 Session Type: Poster Session Title: Melanoma/Skin Cancers Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT Presenter: Bin Lian, MD, Peking University Cancer Hospital & Institute 2. Presentation Title: IBI354, an anti-HER2 antibody-drug conjugate, in patients with locally advanced unresectable or metastatic ovarian cancers: updated results from a Phase 1 trial Abstract Number: 5565 Session Type: Poster Session Title: Gynecologic Cancer Session Date & Time: 6/1/2025 9:00 AM-12:00 PM CDT Presenter: Jin Shu, MD, Chongqing University Cancer Hospital 3. Presentation Title: IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients with HER2-positive breast cancer (BC) and other solid tumors: Updates from a Phase 1 study Abstract Number: 1029 Session Type: Poster Session Title: Breast Cancer—Metastatic Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT Presenter: Charlotte Rose Lemech, BSc, FRACP, MBBS , Scientia Clinical Research 4. Presentation Title: Safety and efficacy of the anti-TROP2 antibody-drug conjugate (ADC) IBI130 in patients with advanced triple-negative breast cancer (TNBC) and other solid tumors: Results from the Phase 1 study Abstract Number: 1102 Session Type: Poster Session Title: Breast Cancer—Metastatic Session Date & Time: 6/2/2025 9:00 AM-12:00 PM CDT Presenter: Fan Wu, MD, Fujian Cancer Hospital 5. Presentation Title: A multiregional, randomized, controlled, open-label, Phase 3 study of the anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) arcotatug tavatecan (IBI343) in gastric or gastroesophageal junction adenocarcinoma (G/GEJA): Trial in Progress Abstract Number: TPS4201 Session Type: Poster Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT Presenter: Lin Shen, MD, Beijing Cancer Hospital 6. Presentation Title: Phase 2 trial of transarterial chemoembolization followed by sintilimab (anti-PD-1), oxaliplatin, and S-1 combined with either trastuzumab (HER-2 positive) or apatinib (HER-2 negative) as first-line therapy for gastric cancer with liver metastases. Abstract Number: 4050 Session Type: Poster Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary Session Date & Time: 5/31/2025 9:00 AM-12:00 PM CDT Presenter: Dan Sha, MD, Shandong Provincial Hospital *Abstracts of TYVYT ®(sintilimab) are from investigator-initiated clinical trials (IIT), except one abstract, #7007. 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 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 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. Statement: (1) Innovent does not recommend the use of any unapproved drug (s)/indication (s). (2) Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. 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 1ASCOImmunotherapyClinical ResultPhase 2

11 Apr 2025

·www.fiercepharma.com

Bristol Myers combo follows Roche, AstraZeneca immunotherapy rivals into first-line liver cancer

Helping win the FDA's approval in first-line liver cancer, Opdivo and Yervoy significantly reduced the risk of death by 21% compared with either Lenvima or Nexavar in a late-stage trial. Bristol Myers Squibb has received the FDA’s green light to introduce another immunotherapy-based treatment in first-line liver cancer.The company’s combination of Opdivo and Yervoy is now approved for patients with newly diagnosed unresectable or metastatic hepatocellular carcinoma, the FDA said Friday.The immunotherapy regimen combines two well-established agents and may offer the potential for a longer life compared with traditional targeted therapy, Wendy Short Bartie, Bristol Myers’ senior VP of U.S. oncology commercialization, said in an interview with Fierce Pharma.The first-line approval also converted a previous accelerated approval for Opdivo-Yervoy as a second-line liver cancer treatment. Further, it puts BMS toe to toe with two other immuno-oncology regimens—Roche’s Tecentriq and Avastin, and AstraZeneca’s Imfinzi and Imjudo.All three combos got their FDA approvals based on phase 3 evidence showing that they could help patients live longer versus traditional targeted therapy. The BMS regimen is unique in that its comparator included Merck & Co. and Eisai’s Lenvima, which is considered a more powerful tyrosine kinase inhibitor in the first-line liver cancer armamentarium. According to results from the CheckMate-9DW trial, Opdivo and Yervoy significantly reduced the risk of death by 21% compared with either Lenvima or Bayer’s Nexavar. The BMS cocktail extended patients’ median survival time by 3.1 months to 23.7 months.Opdivo and Yervoy mounted that statistically significant showing despite the control arm’s 20.6 months of median overall survival notably outperforming historical data, including in phase 3 trials that got Roche and AZ their first-line liver cancer nods from the FDA in 2020 and 2022, respectively. An updated analysis from Imbrave-150 showed that Tecentriq and Avastin reduced the risk of death by 34% versus Nexavar alone, with a median overall survival of 19.2 months and 15.6 months, respectively.In the phase 3 Himalaya trial, AZ’s Imfinzi and Imjudo slashed the risk of death by 22% compared with Nexavar. The median overall survival was 16.6 months for the PD-L1/CTLA-4 combo or 13.8 months for control.The CheckMate-9DW results and increasing evidence positioning Lenvima as a more efficacious first-line liver cancer drug than Nexavar raised the question of whether Opdivo-Yervoy—or any one of the three immunotherapy regimens—can beat Lenvima head to head.CheckMate-9DW isn’t designed to answer that question. Merck tried by pairing Lenvima with Keytruda, but the phase 3 Leap-002 trial failed to show a statistically significant survival benefit for that combo against Lenvima monotherapy.BMS’ Bartie also pointed to Opdivo and Yervoy’s tumor response data. The combo triggered a 36% objective response rate in the trial, compared with 13% of patients responding to either Lenvima or Nexavar. Median duration of response was more than doubled with the combo at 30.4 months versus 12.9 months for the control, although this comparison is not included in the statistical plan of the trial.What’s more, at three years, about 38% of patients on the Opdivo-Yervoy pairing remained alive in CheckMate-9DW, versus 24% of those in the control arm.“We’ve consistently heard in market research from our customers is that they will use immunotherapy combinations when the data demonstrates that it is significantly better than [Lenvima] or [Nexavar], as an example,” Bartie said. “I think when you look at the strength of this data, particularly the overall survival rates, that is what will drive physician choice.” Besides the three Big Pharma players, Jiangsu Hengrui Pharma and its partner Elevar Therapeutics are also trying to bring their China-approved checkpoint inhibitor-based combination of camrelizumab and rivoceranib to the first-line treatment setting for liver cancer in the U.S. The FDA recently rejected the partners’ applications for the second time, again because of manufacturing issues.

Clinical ResultPhase 3Drug ApprovalImmunotherapyAccelerated Approval

100 Deals associated with Apatinib Mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Apatinib Mesylate	L01XE	DB14765

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Germline BRCA-mutated, HER2-negative metastatic breast cancer	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Dec 2024
Hepatocellular Carcinoma	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	07 Jan 2021
Gastroesophageal junction adenocarcinoma	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	17 Oct 2014
stomach adenocarcinoma	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	17 Oct 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic hepatocellular carcinoma	NDA/BLA	United States	Elevar Therapeutics, Inc.	21 Oct 2024
Unresectable Hepatocellular Carcinoma	NDA/BLA	United States	Elevar Therapeutics, Inc.	17 May 2023
Stomach Cancer	NDA/BLA	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	09 Aug 2011
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	21 Sep 2020
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	16 Sep 2020
Advanced Triple-Negative Breast Carcinoma	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	06 Jul 2020
Breast Cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	03 Jul 2020
Metastatic breast cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	03 Jul 2020
PD-L1 positive Lung Cancer	Phase 3	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	15 Jun 2020
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	15 Jun 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


RM-202 (AACR2025)	Phase 2	Adenoid Cystic Carcinoma	72	Rivoceranib 700 mg	tkcahqveko(hygfdlygwz) = ilvtfxntoq ivyvgysrpa (tmorzijdxh, 7.9 - 25.7) View more	Positive	28 Apr 2025
NCT04609176 (CAP 06, NEWS \| Pubmed) Manual	Phase 2	Stomach Cancer \| Gastroesophageal junction adenocarcinoma First line	36	卡瑞利珠单抗+阿帕替尼+SOX	jboyhflbax(hulodsnyax) = bfgqhaphao hmonrsnidw (ayuotwzmzn, 49.0 - 81.4) Met View more	Positive	18 Apr 2025
ChiCTR2000029082 (ESMO_TAT2025)	Phase 2	Metastatic hepatocellular carcinoma Second line	-	Apatinib + HAIC	pridpjonyh(nvsvmolqck) = fycxxarryq ieazufmcne (eyqlmrawip ) View more	Positive	03 Mar 2025
NCT05001412 (Signal Transduct Target Ther) Manual	Phase 1	Extensive stage Small Cell Lung Cancer First line	40	2 cycles of etoposide and carboplatin (EC) as induction treatment followed by 2-4 cycles of camrelizumab, apatinib plus EC, then maintenance camrelizumab plus apatinib.	mtggzhqbhk(vcdlrwttyp) = equdtobzii vkamtalkxa (chhmfnsbzn, 73.9 - 96.9) View more	Positive	18 Feb 2025
ASCO_GU2025 Manual	Phase 2	Squamous Cell Carcinoma of the Penis	23	Apatinib 500 mg	alrbqznonk(mgjexgrsou) = zminzrkbgy qcaxdaoxya (ikxoqmqnoq, 10 - 42) View more	Negative	13 Feb 2025
NCT04722718 (NeoSAC, Signal Transduct Target Ther) Manual	Phase 2	Triple Negative Breast Cancer Neoadjuvant HER2 Negative \| PR Negative \| ER Negative	34	Apatinib + sintilimab + nab-paclitaxel + carboplatin	wjaxhnurxh(dfahntckud) = hjvdrvfbvw vwmmmkwlut (ahaucqassd, 53.0 - 85.3) View more	Positive	07 Feb 2025
NCT04559607 (ASCO_GI2025) Manual	Phase 2	Unresectable Hepatocellular Carcinoma	200	TACE+ camrelizumab + apatinib	uquucxalkc(yoekjvdamx) = wsvsgtsmhg ierlakdktn (phldszypkx, 8.8 - 13.8) View more	Positive	23 Jan 2025
NCT04559607 (ASCO_GI2025) Manual	Phase 2	Unresectable Hepatocellular Carcinoma	200	TACE	uquucxalkc(yoekjvdamx) = fneqnnevqw ierlakdktn (phldszypkx, 2.0 - 4.1) View more	Positive	23 Jan 2025
ESMO_IO2024 Manual	Not Applicable	Unresectable Hepatocellular Carcinoma Second line	33	Regorafenib+PD-1 inhibitor	bubumnftdc(oitwxtckvm) = uvvusrztge dmlfrzkvht (hueljgzowj ) View more	Positive	12 Dec 2024
ESMO_IO2024 Manual	Not Applicable	Unresectable Hepatocellular Carcinoma Second line	33	Apatinib+PD-1 inhibitor	bubumnftdc(oitwxtckvm) = hsgiulagdc dmlfrzkvht (hueljgzowj ) View more	Positive	12 Dec 2024
NCT05412589 (VIC-TRIPLET, ESMO_ASIA2024) Manual	Phase 2	Hepatocellular Carcinoma \| Portal Vein Thrombosis	35	Camrelizumab + Apatinib + FOLFOX chemotherapy	qohgxjtotq(vwrpczefzq) = fiwqjobqkv bgqvogxkbv (fcsbuqzdkz ) View more	Positive	07 Dec 2024
NCT05412589 (VIC-TRIPLET, ESMO_ASIA2024) Manual	Phase 2	Hepatocellular Carcinoma \| Portal Vein Thrombosis	35	Camrelizumab + Apatinib + FOLFOX chemotherapy (PVTT-Vp0)	qohgxjtotq(vwrpczefzq) = tpjrrgwbba bgqvogxkbv (fcsbuqzdkz ) View more	Positive	07 Dec 2024
ChiCTR2000041170 (Pubmed) Manual	Phase 3	Unresectable Hepatocellular Carcinoma	243	DEB-TACE + Apatinib	rskksrwwbp(loezsvocop) = nsredpktrl qfnzjgyxom (btknqjvmrf, 6.6 - 8.3) View more	Positive	13 Nov 2024
ChiCTR2000041170 (Pubmed) Manual	Phase 3	Unresectable Hepatocellular Carcinoma	243	DEB-TACE	rskksrwwbp(loezsvocop) = sjaqvkrosx qfnzjgyxom (btknqjvmrf, 5.0 - 5.9) View more	Positive	13 Nov 2024

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