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Last update 24 Oct 2026

Apatinib Mesylate

Last update 24 Oct 2026

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+ [5]

Active Indication

Germline BRCA-mutated, HER2-negative metastatic breast cancerHepatocellular CarcinomaGastroesophageal junction adenocarcinoma+ [46]

Inactive Indication

Adenoid Cystic CarcinomaAdvanced biliary tract cancerAdvanced cancer+ [48]

Originator Organization

Advenchen Laboratories LLC

Active Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

HRYZ (Shanghai) Biotech Co., Ltd.

Inactive Organization

Elevar Therapeutics, Inc.

Bukwang Pharmaceutical Co., Ltd.

Shanghai Shengdi Pharmaceutical 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), Orphan Drug (South Korea), National Science and Technology Major Project (China), Special Review Project (China)

Structure/Sequence

Molecular FormulaC25H27N5O4S

InChIKeyFYJROXRIVQPKRY-UHFFFAOYSA-N

CAS Registry1218779-75-9

1,115

Clinical Trials associated with Apatinib Mesylate

NCT07314203

/ Not yet recruitingPhase 3IIT

Clinical Efficacy of Adebrelimab With or Without Apatinib Mesilate and SOX Neoadjuvant Therapy in Locally Advanced Gastric Cancer

Exploring the pathological complete response rate (pCR) of locally advanced gastric cancer treated with adebelimab combined or not combined with apatinib mesylate and SOX neoadjuvant therapy

Start Date25 Dec 2026

Sponsor / Collaborator

Fujian Medical University

ChiCTR2600134805

/ Not yet recruitingNot Applicable

A Clinical Study of Apatinib Mesylate Combined with Adebrelimab in Soft Tissue Sarcoma After First-Line Chemotherapy Failure— Phase II, open-label, single-arm exploratory study

Start Date01 Nov 2026

Sponsor / Collaborator

Shandong First Medical University Affiliated Tumor Hospital (Shandong Cancer Research Institute Shandong Tumor Hospital)

NCT07874425

/ Not yet recruitingPhase 2IIT

An Exploratory Clinical Study of Retlirafusp Alfa Combined With Zeprumetostat, Apatinib, and Chemotherapy as First-Line Treatment for Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

The goal of this exploratory study is to evaluate the efficacy and safety of zeprumetostat in combination with retlirafusp alfa, apatinib, and chemotherapy as first-line treatment in patients with HER2-negative unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma who have not received prior anticancer therapy.

Start Date01 Oct 2026

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Apatinib Mesylate

100 Translational Medicine associated with Apatinib Mesylate

100 Patents (Medical) associated with Apatinib Mesylate

2,241

Literatures (Medical) associated with Apatinib Mesylate

01 Feb 2027·TISSUE & CELL

COL1A1 modulates apatinib sensitivity through promoting glycolysis and angiogenesis in gastric cancer cells

Article

Author: He, Ming-Fang ; Ding, Yi-Mei ; Liu, Ya-Xian ; Wu, Jia-Qi ; Huang, Xin-En ; Chen, Ying-Ying ; Zhou, Su-Hui

BACKGROUND:

Our previous bioinformatic study identified Collagen type I alpha 1 chain (COL1A1) as a candidate regulator associated with gastric cancer (GC) progression and response to anti-angiogenic therapy. However, whether COL1A1 influences the sensitivity of GC cells to apatinib and the underlying mechanisms remains unclear.

METHODS:

Multiple bioinformatics platforms were used to investigate the correlation between COL1A1 expression and GC progression and prognosis. Gain- and loss-of-function assays were conducted in GC cell lines to validate the regulatory role of COL1A1 in apatinib sensitivity. Functional validation included a series of in vitro and in vivo studies. Protein expression profiling was further performed to quantify key proteins involved in glycolytic and angiogenic signaling pathways.

RESULTS:

High COL1A1 expression was associated with tumor progression and poor prognosis in GC patients. Knockdown of COL1A1 enhanced the sensitivity of MKN-74 cells to apatinib and weakened their proliferative, migratory, invasive, and colony-forming abilities in vitro, as well as tumor growth and metastasis in vivo. Overexpression of COL1A1 in SNU-1 cells had the opposite effects. Mechanistically, COL1A1 modulated glycolytic reprogramming and profoundly affected the angiogenic potential of GC cells, uncovering its role in driving therapeutic evasion.

CONCLUSION:

COL1A1 may contribute to reduced apatinib sensitivity in GC cells, at least partly by enhancing glycolytic metabolism and angiogenic activity. These findings suggest that COL1A1 is a potential regulator worthy of further investigation for improving the therapeutic response to apatinib in GC.

01 Dec 2026·JOURNAL OF MAMMARY GLAND BIOLOGY AND NEOPLASIA

Synergistic Anticancer Effects of Apatinib and PD-L1 Inhibition in Breast Cancer

Article

Author: Xu, Juanjuan ; Guo, Cairu ; Han, Danyang

Abstract:

Studies in breast cancer have demonstrated that apatinib exhibits both antiangiogenic and antitumor effects, while PD-L1 inhibitors have similarly shown meaningful clinical benefit. Building upon these observations, this study evaluated the potential synergistic antitumor effects of combining apatinib with a PD-L1 inhibitor and examined the mechanistic basis for their interaction in breast cancer. Notably, we found that this regimen could significantly suppress the proliferation, migration, and invasion of MCF-7 and MDA-MB-231 cells, and promote cell apoptosis. In addition, the levels of p-ERK, NF-κB, and Slug were markedly reduced in vitro. Collectively, these findings support the potential clinical utility of combining apatinib and PD-L1 inhibition, as evidenced by consistent in vitro and in vivo synergy.

01 Nov 2026·BIOMEDICINE & PHARMACOTHERAPY

Sunitinib induces senolysis associated with modulation of platelet-derived growth factor receptor beta

Article

Author: Park, Tae Jun ; Kim, Byung Ju ; Lee, Yun-Il ; Lee, Young-Sam ; Ryu, Sung Jin ; Lee, Sung Bae ; Kim, Jae-Ryong ; Cho, Hyun-Ji ; Kim, Young Zoon ; Kim, Eok-Cheon ; Yun, Ahyeon ; Park, Sang Chul ; Hwang, Jeong-A

Receptor tyrosine kinases are critical regulators of cell survival, mediating responses to environmental changes and maintaining biological responsiveness. However, despite growing interest in developing senolytics that target survival factors in senescent cells as a promising strategy to overcome age-related diseases, the therapeutic potential of RTKs in senescence remains largely unexplored. In this study, we aimed to identify senolytic compounds that modulate RTK signaling and ameliorate age-related phenotypes by selectively inducing senescent cell death. Using a drug screening approach, we identified sunitinib, a multi-targeted RTK inhibitor that effectively suppresses PDGFR activation and induces apoptosis specifically in senescent HDFs (sHDFs) by activating caspase-9, -3, and -7. Moreover, in a mouse model of bleomycin-induced lung fibrosis in which senescent cells accumulate in the tissue, sunitinib reduced senescent cells and suppressed SASP expression. These findings, together with the observed increase in PDGFRβ phosphorylation in aged cells, led us to hypothesize that modulating PDGFRβ activity could induce senolysis. Indeed, knockdown of PDGFRβ expression sensitized senescent cells to cell death, with minimal effects on non-senescent HDFs (nsHDFs). At the mechanistic level, PDGFRβ and its downstream pathways, including the JAK2-STAT3 pathway, contributed to the senolytic response to sunitinib. Notably, sunitinib-induced JAK1 phosphorylation contributed to resistance to sunitinib in nsHDFs. Our findings suggest that sunitinib is a promising senolytic agent and that targeting PDGFRβ may represent a previously unknown approach to senolytics. Therefore, our study may provide a potential therapeutic strategy for age-related diseases associated with chronic inflammation.

122

News (Medical) associated with Apatinib Mesylate

21 Oct 2026

·www.prnewswire.com

Hengrui Pharma Previews ESMO Congress 2026: 64 Research Findings Highlight Continued Progress Across Innovative Pipelines to Advance Clinical Value

64 research findings have been accepted, including three Proffered Paper presentations and three Rapid Oral presentations, spanning more than ten areas of oncology and supportive care. More than 10 studies have been selected to highlight the latest findings on HER2- and HER3-targeted antibody-drug conjugates (ADCs) in breast and lung cancers, advancing research on novel targets and exploring their clinical value across a range of applications. Hengrui Pharma continues to expand the clinical value of established products and advance its innovative pipeline, while developing new approaches for difficult-to-treat cancers such as pancreatic cancer. Hengrui puts patient needs at the center of its mission to deliver life-changing clinical value. SHANGHAI, Oct. 20, 2026 /PRNewswire/ -- The European Society for Medical Oncology (ESMO) Congress 2026 will take place in Madrid, Spain, from October 23 to 27. Hengrui Pharma will present 64 research findings at the congress, including three studies accepted for Proffered Paper presentations, three for Rapid Oral presentations, 32 for Posters and 26 for e-Posters. The ESMO Congress is a major global platform for innovative oncology drug development and scientific exchange. Hengrui Pharma has participated for 11 consecutive years since 2016, with a total of 119 research findings accepted between 2023 and 2025. This year, the number of accepted findings continues to grow, covering more than ten cancer areas, including esophageal, gastric, liver, biliary tract, pancreatic, rectal, breast, lung, cervical, prostate and nasopharyngeal cancers, as well as thymic epithelial tumors and sarcomas. The company will also host an exhibition booth for the second consecutive year, showcasing its latest progress in exploring novel targets, expanding the clinical value of its products, and developing its innovative pipeline. Proffered Paper Presentations Highlight Novel Targets as Hengrui Pharma Advances ADC Innovation Two independently developed ADCs from Hengrui Pharma, the HER2-targeted trastuzumab rezetecan (SHR-A1811) and the HER3-targeted ruzaltatug rezetecan (SHR-A2009), have both been selected for Proffered Paper presentations at the ESMO Congress. The studies address clinical treatment needs in breast and lung cancers, respectively. The data from these studies will be presented during the congress. The Proffered Paper presentation on trastuzumab rezetecan will focus on progress from HORIZON-Breast06, a randomized phase 3 study in HER2-low advanced breast cancer, led by principal investigator Academician Binghe Xu of the Cancer Hospital at the Chinese Academy of Medical Sciences. One of the most representative products from Hengrui Pharma's ADC research and development platform, trastuzumab rezetecan is being developed for more than ten indications, including breast, lung, gastric, colorectal and cervical cancers. It is also among the innovative medicines with the highest number of breakthrough therapy designations in China. The study will further explore the therapeutic potential of trastuzumab rezetecan in this patient population and provide new evidence to support the expansion of its clinical applications. The congress will also feature interim analyses from HERON-Lung01, a phase 3 trial comparing ruzaltatug rezetecan (SHR-A2009) with platinum-based chemotherapy in patients with EGFR-mutated advanced non-small-cell lung cancer that has progressed after EGFR tyrosine kinase inhibitor (EGFR-TKI) treatment. The trial is led by principal investigator Professor Yi-Long Wu of Guangdong Provincial People's Hospital. In July 2026, following positive results from HERON-Lung01, China's National Medical Products Administration (NMPA) accepted for review the marketing application for ruzaltatug rezetecan, intended to treat adults with EGFR-mutated locally advanced or metastatic non-squamous NSCLC whose disease has progressed following EGFR-TKI therapy. In addition, a Phase III clinical trial is currently underway to evaluate ruzaltatug rezetecan in combination with EGFR TKI as a first-line treatment for patients with EGFR-mutated locally advanced or metastatic NSCLC. Outside China, ruzaltatug rezetecan has received Fast Track designation from the US Food and Drug Administration (FDA) for the treatment of patients with EGFR-mutated metastatic NSCLC whose disease has progressed following treatment with a third-generation EGFR-TKI and platinum-based chemotherapy.[1] As development progresses from early exploration to larger-scale evaluation of efficacy, the latest findings on ruzaltatug rezetecan will provide new clinical evidence on the therapeutic potential of HER3-targeted ADCs in patients with non-small-cell lung cancer. With HER2 and HER3 among its key targets, Hengrui Pharma has built an ADC development pipeline spanning multiple targets and continues to expand potential applications across cancer types and treatment settings. Its portfolio combines further development of established targets with exploration of emerging targets. Advancing Commercialization and R&D Innovation to Expand Clinical Value At this year's ESMO Congress, Hengrui Pharma will also present the latest research findings from its established products and innovative pipeline. Camrelizumab, a domestically developed PD-1 inhibitor with a leading number of approved indications and cancer types covered, will be featured in a Proffered Paper presentation about UNION, a phase 3 trial of neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy for locally advanced rectal cancer. Hengrui Pharma will also use the Rapid Oral session to present the latest findings on its phase 2 study into Nectin-4-targeted ADC SHR-A2102 in recurrent or metastatic cervical cancer, providing evidence to support further exploration of its clinical development potential in additional cancer types. Alongside expanding existing treatment options, Hengrui Pharma is actively pursuing therapies for difficult-to-treat cancers such as pancreatic cancer. A combination regimen based on its independently developed KRAS G12D inhibitor HRS-4642 has been selected for a Rapid Oral presentation. This presentation will feature preliminary results from a phase 2 study of HRS-4642 plus chemotherapy, with or without adebrelimab, as perioperative therapy for KRAS G12D-mutant pancreatic cancer. HRS-4642 injection in combination with gemcitabine and nab-paclitaxel has been granted breakthrough therapy designation by the CDE of the NMPA for the first-line treatment of advanced or metastatic pancreatic cancer with a KRAS G12D mutation[2]. The research may offer new treatment possibilities for patients with pancreatic cancer and new approaches to exploring targeted therapies for KRAS mutations. From expanding the clinical value of established products to pursuing advances in its innovative pipeline and difficult-to-treat cancers, Hengrui Pharma continues to drive clinical value through R&D innovation, opening up more treatment possibilities for patients with cancer. Expanding Development Pathways to Bring Chinese Innovation to the World Following its first exhibition booth in 2025, Hengrui Pharma will again host a booth at this year's ESMO Congress, providing a platform for international scientific exchange on its innovative products and related research. Representatives from Hengrui Pharma's leading R&D and innovation teams will also attend the congress to engage with oncology experts and researchers from around the world and explore how pharmaceutical innovation can benefit more patients globally. Jo Feng, President and COO of Hengrui Pharma, said: "This year marks the eleventh time we have participated in ESMO, with 64 research presentations - a new record for Hengrui. We look forward to sharing our latest advances in innovative drug development, presenting clinical evidence demonstrating meaningful benefits for patients, and bringing more Chinese innovation to benefit patients worldwide." Hengrui Pharma will present additional research data and updates throughout this year's ESMO Congress, further demonstrating the exploration and development of innovative Chinese medicines in global oncology. About Hengrui Pharma Hengrui Pharma is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Driven by a patient-focused philosophy since its founding in 1970, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology. For more information, visit us at Hengrui.com and follow us on LinkedIn. About Hengrui Oncology Hengrui Oncology is one of Hengrui Pharma's core strategic business areas. Following decades of development, it has established a comprehensive portfolio spanning seven major disease areas, including gastrointestinal and breast cancers, as well as oncology supportive care. As of June 2026, 14 independently developed Class 1 innovative medicines, including AiRuiKa® (Camrelizumab for Injection), HengQu® (Herombopag Olamine Tablets) and AiWeiDa® (Trastuzumab Rezetecan for Injection), had been launched in China. Supported by its global R&D system and a range of international collaborations, Hengrui Oncology is accelerating its transition from innovation in China to innovation for the world, offering more precise, accessible and high-quality treatment options for patients with cancer. For more information, please visit: Appendix: Presentation Schedule for Key Hengrui Oncology Studies at ESMO Congress 2026 ( link ) As of 19 October, 2026 Abstract number: LBA13 Study title: Trastuzumab rezetecan (SHR-A1811) in HER2-low advanced breast cancer (BC): a randomized, phase 3 study (HORIZON-Breast06) Presenter: Ying Fan (Cancer Hospital, Chinese Academy of Medical Sciences) Session name: Proffered paper 1: Breast cancer, early and advanced stage Session time: October 23, 13:40 - 13:50 (local time) Therapeutic area / subcategory: Breast cancer Product: Trastuzumab rezetecan (SHR-A1811) Venue: Alicante Auditorium, Hall 6 Abstract number: LBA72 Study title: Ruzaltatug rezetecan, a HER3-directed ADC, vs platinum-based chemotherapy (PBC) in EGFR-mutated advanced NSCLC progressing after EGFR-TKI: interim analyses (IA) from the phase 3 HERON-Lung01 trial Presenter: Chongrui Xu (Guangdong Provincial People's Hospital) Session name: Proffered paper 2: NSCLC, metastatic Session time: October 26, 09:24 - 09:34 (local time) Therapeutic area / subcategory: Lung cancer / Non-small-cell lung cancer Product: Ruzaltatug rezetecan (SHR-A2009) Venue: Alicante Auditorium, Hall 6 Abstract number: LBA85 Study title: HRS-4642 Plus Chemotherapy ± Adebrelimab as Perioperative Therapy in KRAS G12D-Mutant Pancreatic Cancer: Preliminary Results of a Phase 2 Study Presenter: Chenlei Wen (Ruijin Hospital, Shanghai Jiao Tong University School of Medicine) Session name: Rapid oral 2: Gastrointestinal tumour, upper digestive Session time: October 26, 14:45 - 14:50 (local time) Therapeutic area / subcategory: Gastrointestinal cancers / Pancreatic cancer Products: HRS-4642 ± adebrelimab Venue: Barcelona Auditorium, Hall 9 Abstract number: 3530O Study title: Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (LARC): The phase 3 UNION trial Presenter: Zhen Yu Lin (Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) Session name: Proffered paper: Gastrointestinal tumours, lower digestive Session time: October 25, 11:10 - 11:20 (local time) Therapeutic area / subcategory: Gastrointestinal cancers / Rectal cancer Product: Camrelizumab Venue: Almeria Auditorium - Hall 9 Abstract number: 1244RO Study title: SHR-A2102, a novel nectin-4-targeted antibody-drug conjugate, in patients with recurrent or metastatic cervical cancer: results from a phase 2 study Presenter: Jieping Chen (Sun Yat-sen University Cancer Center) Session name: Rapid oral 1: Gynaecological cancers Session time: October 23, 16:20 - 16:25 (local time) Therapeutic area / subcategory: Gynecological cancers / Cervical cancer Product: SHR-A2102 Venue: Burgos Auditorium - Hall 3 Abstract number: 4155RO Study title: Rivoceranib in patients with pretreated metastatic thymic epithelial tumors: phase II multi-center KCSG LU23-09 (THRIVE) trial Presenter: Sehhoon Park (Seoul, Republic of Korea) Session name: Rapid oral: Non-metastatic NSCLC and other thoracic malignancies Session time: October 26, 11:02 - 11:07 (local time) Therapeutic area / subcategory: Other / Thymic epithelial tumors Product: Apatinib Venue: Burgos Auditorium - Hall 3 SOURCE Hengrui Pharma 21% more press release views with Request a Demo

Phase 2Phase 3Fast TrackBreakthrough TherapyClinical Result

14 Oct 2026

·www.biospace.com

Elevar Therapeutics Resubmits New Drug Application to FDA for Combination of Camrelizumab plus Rivoceranib for Use as a First-line Treatment Option for Unresectable or Metastatic Hepatocellular Carcinoma

Combination achieved mOS of 23.8 months in patients with unresectable or metastatic HCC FORT LEE, N.J., Oct. 14, 2026 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients with cancer, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, an anti-PD-1 antibody, as a first-line systemic treatment option for unresectable or metastatic hepatocellular carcinoma (uHCC). In July 2026, the FDA issued a Complete Response Letter (CRL) for a previous NDA submitted in January 2026. Following work with the FDA and its partner, Hengrui Pharma, Elevar resubmitted the NDA on October 9, 2026, in response to the CRL. “Our Elevar team has remained steadfast in our commitment to bring a novel combination therapy for uHCC to patients and healthcare providers, as uHCC remains an area of significant unmet medical need,” said Dong-Gun Kim, chief executive officer of Elevar Therapeutics. “Following submission of our response to the Complete Response Letter (CRL), we look forward to continued engagement with the FDA as it reviews the NDA for this combination therapy, which demonstrated positive overall survival and progression-free survival results and a manageable safety pro the CARES-310 study.” The NDA is based on the global Phase 3 CARES-310 study, in which first-line camrelizumab plus rivoceranib combination therapy achieved a median overall survival of 23.8 months in patients with unresectable or metastatic HCC, compared to sorafenib’s mOS of 15.2 months (HR = 0.64, 95% CI 0.52 - 0.79, P< 0.0001). Results observed across multiple patient subgroups were generally consistent. In December 2025, the final analysis was published in The Lancet Oncology , a leading international medical journal. In addition, prior to regulatory approval, the combination regimen was included as a first-line treatment option for advanced HCC in the 2025 Barcelona Clinic Liver Cancer treatment strategy and European Society for Medical Oncology guidelines in recognition of the treatment’s clinical relevance. For more information about the combination of camrelizumab and rivoceranib, visit ElevarTX.com . About Hepatocellular Carcinoma Hepatocellular carcinoma (HCC) is the most common type of liver cancer and most frequently develops in people with chronic underlying liver inflammation, which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. More than 800,000 people worldwide are diagnosed with liver cancer each year and it is also a leading cause of cancer deaths, accounting for more than 700,000 annually, according to the American Cancer Society. About Rivoceranib Rivoceranib, an oral small-molecule tyrosine kinase inhibitor (TKI), is a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFRs), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Several clinical studies were completed in patients with uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf ® ). Rivoceranib, under the name apatinib (Aitan ® ), was the first TKI approved in gastric cancer in China (October 2014). It was also approved in China in combination with camrelizumab as a first-line treatment for unresectable or metastatic HCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety pro other TKIs and VEGF inhibitors. Orphan drug designations have been granted for gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Hengrui Pharma, is the license-holder of rivoceranib in the Chinese territory. About Camrelizumab Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid cancers. Camrelizumab is developed by Hengrui Pharma. Under the brand name AiRuiKa ® , Camrelizumab is currently approved for 10 indications in China, covering lung cancer, liver cancer, esophageal cancer, nasopharyngeal cancer, and cervical cancer. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the EMA in August 2024. In October 2023, Elevar licensed camrelizumab in combination with rivoceranib for HCC for commercialization from Hengrui Pharma worldwide excluding Greater China and South Korea. About Elevar Therapeutics Elevar Therapeutics, Inc., is a fully integrated biopharmaceutical company built on the promise of elevating treatment outcomes for cancer patients. A subsidiary of HLB Co., Ltd. based in Fort Lee, New Jersey, Elevar’s expertise is rooted in oncology and grounded in compassion. Our team of experienced scientists and industry leaders is highly focused on identifying and developing medicines for complex yet under-treated health conditions, with a shared goal of making a meaningful difference in the lives of patients. For more information, follow us on LinkedIn and X or visit ElevarTX.com . Media Contact: Mason Levinson mlevinson@rosecomm.com Cell: (908) 358-4826

Phase 3Orphan DrugImmunotherapyNDAClinical Result

24 Sep 2026

·www.fiercepharma.com

Elevar wins FDA nod for bile duct cancer drug Lyrfigtu, a first for a Korean firm

The FDA came to Elevar Therapeutics bearing gift ahead of the mid-autumn festival. The U.S. agency has approved the company’s Lyrfigtu (lirafugratinib) for patients with previously treated bile duct cancer harboring an FGFR2 gene fusion or other rearrangement. As Jin Yang-gon, chairman of HLB Group, Elevar’s parent company, noted in a YouTube announcement , Lyrfigtu marks the first novel cancer drug from a Korean company to secure FDA approval. “The greatest gift brought by this new drug approval is the newfound confidence spreading throughout the company, bolstered by the achievement of becoming a firm with a global anti-cancer drug,” Jin said during the auto English-dubbed announcement. “Our goal was to complete new drug development independently, rather than relying on technology exports, which require waiting for others to develop and produce results.” Compared with existing FGFR inhibitors such as Incyte’s Pemazyre and Taiho’s Lytgobi , Lyrfigtu was designed with increased selectivity for FGFR2, while sparing other proteins of the FGFR family, to minimize toxicities. Elevar obtained the asset from Relay Therapeutics in 2024 for $75 million in upfront and regulatory milestone payments and up to $425 million in potential commercial milestones. In a single-arm trial called Refocus, Lyrfigtu registered an objective response rate of 46% and a median duration of response reaching 11.8 months among 116 patients with cholangiocarcinoma new to FGFR inhibitor treatment but who had received prior chemotherapy or chemoimmunotherapy. The median progression-free survival was 11.3 months. “Lyrfigtu’s unique, irreversible, covalent-binding mechanism enables potent and sustained inhibition of FGFR2, including many resistance mutations that can emerge with earlier FGFR inhibitors,” Lipika Goyal, M.D., from the Stanford Cancer Center and lead author of the Refocus trial, said in a Sept. 23 announcement. “This FDA approval brings an important next-generation precision medicine option directly to patients with advanced bile duct cancer.” Elevar expects to make Lyrfigtu to patients in the U.S. this year. The company also filed an application with the European Medicines Agency on Sept. 15, Jin said. Jin touted Lyrfigtu’s potential in other cancer types, including ongoing clinical trials in a tumor-agnostic setting, as well as opportunities to be combined with other anticancer drugs by Big Pharma. Now that the drug has been approved, the company expects patient enrollment in clinical trials to accelerate, Jin said. The milestone of an FDA approval came years late for Elevar and its parent HLB. The company’s first U.S. approval was supposed to be the combination of camrelizumab and rivoceranib, partnered with China’s Hengrui Pharma, for the first-line treatment of liver cancer. However, beginning with a pair of complete response letters in May 2024, the two drugs have been rejected three times, all because of manufacturing shortfalls at Hengrui’s facilities. Following the most recent snub in July, Hengrui has solved the issues, and the partners are now gathering updated safety data for a resubmission, according to Jin.

100 Deals associated with Apatinib Mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
D11288 D11289	Apatinib Mesylate	L01XE L01E	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
PD-L1 positive Transitional 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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2400089020 (CAPTAIN-1st, ESMO2026)	Phase 2	Nasopharyngeal Carcinoma First line	23	Gemcitabine + Cisplatin + Camrelizumab + Apatinib	dphjyrfktz(cmxexbkygf) = ngigngvdlx pfefbdzshk (txruiikkfz ) View more	Positive	23 Oct 2026
				Gemcitabine + Cisplatin + Camrelizumab + Apatinib (Treatment-naïve)	myhlbhhxkz(bpcviedaib) = nttqnpjslo mfwnstmcvm (qsbmnooxjv ) View more
ChiCTR2400085775 (ESMO2026)	Phase 2	Advanced biliary tract cancer First line	21	Camrelizumab+apatinib+gemcitabine+oxaliplatin	gdthhznqco(jhejrnldxb) = yvqbwesdwz oqehszuhlw (qlwbkxlljx ) View more	Positive	23 Oct 2026
ChiCTR2100045061 (ESMO2026)	Phase 2	-	39	Camrelizumab+apatinib (conjunctival melanoma)	ahxuedcupw(uhviccoyqd) = xdqjlbtukw mgxuptlcho (tbgjhwjuia, 0.7 - 5.4)	Positive	23 Oct 2026
				Camrelizumab+apatinib (sebaceous carcinoma of the eyelid)	ahxuedcupw(uhviccoyqd) = rowersapyx mgxuptlcho (tbgjhwjuia, 3.2 - NE)
ESMO2026	Not Applicable	Unresectable Hepatocellular Carcinoma	323	Camrelizumab plus rivoceranib	cprkrljwig(eanltmlawi) = ptfntkxutv zfhsixiodg (djjylzfyzw ) View more	Positive	23 Oct 2026
NCT06485466 (ESMO2026)	Phase 4	Unresectable Hepatocellular Carcinoma	101	TACE combined with camrelizumab (200 mg every 3 weeks) and apatinib (250 mg once daily)	rxdjxdikpe(emgboyuevl) = dakooldklt uzbgshwurz (cocwrvhbhx ) View more	Positive	23 Oct 2026
				camrelizumab (200 mg every 3 weeks) and apatinib (250 mg once daily)	rxdjxdikpe(emgboyuevl) = ggxhefcbty uzbgshwurz (cocwrvhbhx, 3.7 - 7.5) View more
NCT07479732 (ESMO2026)	Phase 1	Metastatic osteosarcoma	52	Apatinib plus liposomal irinotecan	xjfhgcmrlu(kjajvzkfxz) = apydyrvbwy qtxljytkaj (uovekfhamu )	Positive	23 Oct 2026
NCT06200233 (KCSG LU23-09, ESMO2026)	Phase 2	Thymic Epithelial Tumor	40	Rivoceranib 700 mg	cxbiuoueku(erqcqntmuk) = wyszwwluho zidfarowjd (ubcocljkyt, 22.1 - 50.5) View more	Positive	23 Oct 2026
				Rivoceranib 700 mg (thymoma)	yvxdpaxqmr(bgbevtktfu) = dooqrahuir cevnqzcdfr (bvlrsfegeb, 3.3 - NR) View more
ESMO2026	Not Applicable	Advanced Gastric Adenocarcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma Third line	3,978	Nivolumab	amoyyhirci(sgfbyfsllr) = Grade ≥3 toxicity was higher versus placebo (ATTRACTION-2 OR 2.53; ANGEL OR 2.49), while JAVELIN G300 showed lower toxicity versus chemotherapy (OR 0.22). hpdbjhnahs (arxjrkyhzs )	Positive	23 Oct 2026
				Trifluridine/tipiracil
ChiCTR2500097888 (ESMO2026)	Phase 2	-	24	Irinotecan liposome plus vincristine and apatinib	gsvayjiwrv(ojqdzbxkfy) = aokdwcvojd zahfbnogbi (wuvauoiffv, 0.9 - 11.5) View more	Positive	23 Oct 2026
				Irinotecan liposome plus vincristine and apatinib (alveolar/embryonal RMS)	umssinfpro(vwqzxubsyw) = zvrzkihihs utehwtxbsf (sfyivermea ) View more
NCT05139095 (IGCS2026)	Phase 2	Gestational Trophoblastic Disease First line	32	Camrelizumab plus Apatinib and EMA/CO chemotherapy	oivlcpfxsi(lgdfjzozas) = yaiaiejayf eunmammmjz (husnotarsx, 79.2 - 99.2) View more	Positive	01 Oct 2026

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