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Last update 08 May 2025

Apatinib Mesylate

Last update 08 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+ [28]

Inactive Indication

Adenoid Cystic CarcinomaAdvanced Bile Duct CarcinomaAdvanced biliary tract cancer+ [43]

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

860

Clinical Trials associated with Apatinib Mesylate

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

NCT06925243

/ RecruitingPhase 3IIT

Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Open-Label, Randomized Controlled Phase III Study

This study aims to compare the efficacy and safety of neoadjuvant apatinib combined with sintilimab and perioperative SOX chemotherapy versus neoadjuvant sintilimab combined with perioperative SOX chemotherapy in locally advanced intestinal-type gastric cancer/gastroesophageal junction adenocarcinoma. The primary questions include:
1. Whether the complete remission rate (pCR) of the apatinib combined with sintilimab and SOX regimen is higher than that of the sintilimab combined with SOX regimen.
2. The safety of the apatinib combined with sintilimab and SOX regimen.
Participants will be divided into:
1. Experimental Group: Participants will receive an intravenous injection of sintilimab (200 mg) combined with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area). Additionally, apatinib (250 mg) will be administered orally once daily during the first three neoadjuvant cycles.
2. Control Group: Participants will receive treatment with the sintilimab combined with the SOX regimen.
This treatment will be administered for three to four cycles prior to surgery, followed by radical surgery, including D2 or D2+ lymph node dissection. Surgery is scheduled four weeks after the last neoadjuvant therapy (NAT) cycle. Within 3 to 6 weeks post-surgery, patients will begin adjuvant SOX chemotherapy. Postoperative patients will receive four cycles of adjuvant SOX chemotherapy, administered every three weeks.

Start Date15 Apr 2025

Sponsor / Collaborator-

100 Clinical Results associated with Apatinib Mesylate

100 Translational Medicine associated with Apatinib Mesylate

100 Patents (Medical) associated with Apatinib Mesylate

2,770

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 Jul 2025·CELLULAR SIGNALLING

Apatinib combined with paclitaxel suppresses synergistically TNBC progression through enhancing ferroptosis susceptibility regulated SLC7A11/GPX4/ACSL4 axis

Article

Author: Cao, Di ; Wang, Jing ; Hu, Zhiqiang ; Ma, Xiaoxia ; Ding, Xiaoyun ; Zhang, Yan

Triple-negative breast cancer (TNBC) is highly heterogeneous, often leading to resistance to chemotherapy agents like paclitaxel (PTX) and resulting in suboptimal outcomes. The anti-angiogenic agent apatinib not only enhances chemotherapy sensitivity but also involves in regulating ferroptosis. However, the potential of combining apatinib with PTX to improve treatment efficacy in refractory TNBC by increasing tumor cell susceptibility to ferroptosis remains elusive. This study aims to elucidate whether inducing ferroptosis participates in the beneficial effects of apatinib combined with PTX to synergistically suppress TNBC. Herein, we demonstrated that the coadministration of apatinib and PTX exerted significant inhibitory effects on both primary tumor progression and distant metastases to pulmonary and hepatic tissues in TNBC-bearing murine models. Transcriptomic and proteomic analyses indicated that ferroptosis induction is a key mechanism by which the drug combination suppresses TNBC, as evidenced by a marked downregulation of SLC7A11, GPX4, NRF2, and FTH1, and a significant upregulation of ACSL4. In vitro, the combination of 5 μM apatinib and 8 nM PTX synergistically inhibited tumor cell proliferation, migration, and invasion. Notably, the combination therapy markedly augmented ferroptosis in tumor cells through the regulation of the SLC7A11/GPX4/ACSL4 axis, leading to increased intracellular iron accumulation and lipid peroxide generation, concomitant with a reduction in GSH levels. The effect of apatinib combined with PTX on enhancing ferroptosis susceptibility could be exploited as a combination treatment regimen for future TNBC therapy.

02 May 2025·MOLECULAR CANCER THERAPEUTICS

First-Line Apatinib Combined with Tislelizumab and Chemotherapy for Patients with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma with Poor Prognosis

Article

Author: Zhang, Caiyutian ; Chen, Yongshun ; Chen, Jiamei ; Qiu, Hu ; Wu, Yong ; Shi, Wei ; Zhao, Wensi ; Gong, Yi ; Tian, Yuanyuan ; Ke, Shaobo ; Wang, Jing ; Zhang, Wenjie

Abstract:

In this prospective, open-label, exploratory study (RENMIN-213), patients with previously untreated, HER2-negative, advanced G/GEJ adenocarcinoma with signet ring cell carcinoma or peritoneal metastasis were enrolled to receive eight cycles of apatinib, tislelizumab, and chemotherapy every 3 weeks, with a maintenance therapy with apatinib plus tislelizumab for a maximum of 1 year. Homogeneous patients receiving immune checkpoint inhibitors combined with chemotherapy at the same time were deemed as the control group for efficacy. The primary endpoint was progression-free survival. Secondary endpoints were objective response rate, disease control rate, duration of response, overall survival, biomarkers, health-related quality of life, and safety. A total of 33 patients [median (range) age, 60 (32–72) years; 21 (63.6%) male; 11 (33.3%) signet ring cell carcinoma; 30 (90.9%) peritoneal metastasis] were enrolled and deemed evaluable for efficacy analysis. Of these patients, 32 (97%) were without disease progression, of whom 1 (3.0%) patient had complete response and 18 (54.6%) had partial response. Six patients (18.2%) were able to undergo surgery after treatment. After propensity score matching, the median progression-free survival was 10.17 months (95% confidence interval, 7.13–13.21) in the apatinib combined with tislelizumab and chemotherapy group, as compared with 6.0 months in the immune checkpoint inhibitor combined with chemotherapy group. The median duration of response increased from 4.5 to 8.7 months. The objective response rate increased from 33.3% to 54.6%, and the disease control rate increased from 87.9% to 97.0%. Treatment-related grade 3 or higher adverse events for evaluable patients occurred in 11 patients (33.3%), and patients’ health-related quality of life improved after treatment.

100

News (Medical) associated with Apatinib Mesylate

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

28 Mar 2025

·www.fiercepharma.com

Fierce Pharma Asia—Novo's triple G obesity bet; Merck's latest China deal; Hengrui, Elevar's 2nd FDA snub

Novo Nordisk's China obesity deal, Merck's cardiovascular licensing deal, and an FDA rejection for Hengrui and Elevar's PD-1 combo made our news this week. Novo Nordisk snapped up an obesity asset from China's United Laboratories in a deal worth up to $2 billion. Merck & Co. got a lipoprotein(a) inhibitor from Jiangsu Hengrui Pharma for cardiovascular disease. Hengrui and Elevar Therapeutics' PD-1 liver cancer combination was again tripped up by manufacturing at the FDA.1. Novo Nordisk pens $2B deal for triple G agonist tied to 15% weight loss at 12 weeksNovo Nordisk has bought into the “triple G” idea, gaining a GLP-1/GIP/glucagon triple agonist from China’s United Laboratories for up to $2 billion. The candidate, coded UBT251, would be a direct competitor to Eli Lilly’s retatrutide. In a phase 1b trial, weekly UBT251 at the highest subcutaneous dose of 6 mg led to an average 15.1% weight loss from baseline after 12 weeks.2. Merck & Co. pens $200M upfront deal for Hengrui's midstage heart disease medIn another China deal potentially worth up to $2 billion, Merck & Co. is paying $200 million upfront for a phase 2 lipoprotein(a) inhibitor from Hengrui Pharma. Elevated Lp(a) in the blood, as a risk factor for cardiovascular disease, has become an increasingly popular target. Lilly has a clinical candidate called muvalaplin, and AstraZeneca last year licensed a preclinical one from China’s CSPC Pharma.3. FDA rejects Hengrui, Elevar's PD-1 cancer drug combination—againIn a piece of bad news for Hengrui, the FDA has once again rejected its Elevar Therapeutics-partnered combination of the PD-1 inhibitor camrelizumab and VEGFR inhibitor rivoceranib. Like the first rejection last year, the FDA this time also raised problems with Hengrui’s camrelizumab manufacturing facility in China.4. AbbVie takes Genmab to court, accusing partner of being 'willfully blind' to ADC trade secret theftAbbVie has sued Genmab over the Danish company’s $1.8 billion acquisition of Sino-American biotech ProfoundBio last year. The Illinois pharma alleged that Genmab was “intentionally and willfully blind” to Profound’s alleged theft of its antibody-drug conjugate trade secrets. Genmab said it “categorically refutes allegations and will vigorously defend the company.”5. J&J combo signals new era in EGFR lung cancer with survival win against AstraZeneca's TagrissoJohnson & Johnson’s Rybrevant and its Yuhan-partnered Lazcluze significantly reduced the risk of death by 25% versus AstraZeneca’s Tagrisso in first-line EGFR-mutated non-small cell lung cancer, according to a high-stakes readout from the phase 3 Mariposa trial. J&J believes the overall survival win sets the combo up to be the new standard of care. But the high-maintenance nature of the regimen poses a challenge.6. Drugmakers fear Trump tariffs will drive up manufacturing costs, hurt medicine access: BIO surveyTrump again threatens tariffs on pharmaceuticals in 'not too distant' futurePresident Donald Trump said his administration will announce tariffs on pharmaceuticals “in the not too distant” future. But in a recent survey conducted by the Biotechnology Innovation Organization, a large proportion of biopharma companies polled said tariffs on EU, Canada or China will drive up manufacturing costs. Many respondents also fear that tariffs could disrupt R&D and regulatory plans.7. FDA calls out 'particularly concerning' claims on HCP site for Taiho's LytgobiThe FDA has taken issue with Taiho Oncology’s doctor-facing web page for the cholangiocarcinoma drug Lytgobi. The agency raised concerns that some descriptions of the drug’s overall survival and progression-free survival data from a single-arm phase 2 study were misleading. The agency is giving the firm 15 working days to submit a written response.8. Eisai lays out road map to blockbuster sales projections for Leqembi's 'milestone' 2027 year9. Contractors WuXi Bio, WuXi XDC eye continued growth after logging solid performances in 202410. Gavi terminates COVID vaccine deal with Clover, demands $224M repayment11. Ascletis slashes funding for former core programs in pivot to obesity12. ImmuneOnco axes CD47 bispecific as pipeline prioritization pressures hit Chinese biotech13. India's Aspen Biopharma Labs hit with FDA warning letter citing infrastructure, contamination and records problems14. Biotech designed to commercialize Ascendis' endocrinology drugs in China files $86M IPO15. Bharat Biotech enters cell and gene therapy market with $75M production investment: reports16. Bayer gains Puhe’s cancer drug candidate in another China deal (release)17. Kaken agrees to $180M deal to develop Alumis' lead TYK2 inhibitor in Japan

VaccinePhase 2Phase 1Clinical ResultPhase 3

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.

to view more data

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 Non-Small Cell Lung Cancer	Phase 3	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	15 Jun 2020
Ovarian Cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	12 May 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	ywgijjlfpr(vigzdjpbab) = boklceiiaf tsbsteaghf (emlmoxbjeg, 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	hrwrltuhkj(olnvwaaycm) = iwpaxliyil rgzskwfmny (kkdrebmpmp, 49.0 - 81.4) Met View more	Positive	18 Apr 2025
ChiCTR2000029082 (ESMO_TAT2025)	Phase 2	Metastatic hepatocellular carcinoma Second line	-	Apatinib + HAIC	oilavaksvw(sirmyfxmxw) = skcpartfuw nxbvqirqlu (zbegksqexw ) 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.	tvhdmrnnrb(kthldksquq) = kivivytzwa khfetbomjj (lhhbhtzqea, 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	zwonygjamp(vzhwdgdauu) = xndydlcmmv jfhvwsinwf (ltgvxxdzfv, 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	sufmxdegij(xqnabjdjqv) = srfaxgqkdh egdbdgcuon (jtodccmilm, 53.0 - 85.3) View more	Positive	07 Feb 2025
NCT04559607 (ASCO_GI2025) Manual	Phase 2	Unresectable Hepatocellular Carcinoma	200	TACE+ camrelizumab + apatinib	npdrekqmzn(wiprgfedgj) = yxyfxtbzlf aohillfwyu (gzxvgkeabo, 8.8 - 13.8) View more	Positive	23 Jan 2025
NCT04559607 (ASCO_GI2025) Manual	Phase 2	Unresectable Hepatocellular Carcinoma	200	TACE	npdrekqmzn(wiprgfedgj) = smitypvjqg aohillfwyu (gzxvgkeabo, 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	xiqjhjfhmp(zvqqtkcekv) = olbonmwlrb xbhojdxpmj (lsiiropbku ) View more	Positive	12 Dec 2024
ESMO_IO2024 Manual	Not Applicable	Unresectable Hepatocellular Carcinoma Second line	33	Apatinib+PD-1 inhibitor	xiqjhjfhmp(zvqqtkcekv) = asxyeeestu xbhojdxpmj (lsiiropbku ) View more	Positive	12 Dec 2024
NCT05412589 (VIC-TRIPLET, ESMO_ASIA2024) Manual	Phase 2	Hepatocellular Carcinoma \| Portal Vein Thrombosis	35	Camrelizumab + Apatinib + FOLFOX chemotherapy	rwdpbcxngm(lxegrhippd) = dauhjescoo isvjvqnueb (sukotviguw ) 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)	rwdpbcxngm(lxegrhippd) = ojjivzwbsy isvjvqnueb (sukotviguw ) View more	Positive	07 Dec 2024
ChiCTR2000041170 (Pubmed) Manual	Phase 3	Unresectable Hepatocellular Carcinoma	243	DEB-TACE + Apatinib	coqhjhlesz(yqbmajiiot) = odqokhrnce lzriyiigyl (vsklqghnnu, 6.6 - 8.3) View more	Positive	13 Nov 2024
ChiCTR2000041170 (Pubmed) Manual	Phase 3	Unresectable Hepatocellular Carcinoma	243	DEB-TACE	coqhjhlesz(yqbmajiiot) = kaidltrfbz lzriyiigyl (vsklqghnnu, 5.0 - 5.9) View more	Positive	13 Nov 2024

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