Request Demo

Last update 23 Oct 2026

Benmelstobart

Last update 23 Oct 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-PD-L1 monoclonal antibody ( Apollomics/Chia Tai Tianqing Pharmaceutical Group), PD-L1 antibody ( Apollomics/Chia Tai Tianqing Pharmaceutical Group), APL 502

+ [7]

Target

PDL1

Action

inhibitors, stimulants

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors), T lymphocytes stimulants

Therapeutic Areas

NeoplasmsRespiratory DiseasesUrogenital Diseases+ [8]

Active Indication

Alveolar Soft Part SarcomaAdvanced Lung Non-Small Cell Squamous CarcinomaNon-small cell lung cancer stage III+ [35]

Inactive Indication

adenocarcinoma of biliary tractAdvanced Bile Duct CarcinomaAdvanced biliary tract cancer+ [29]

Originator Organization

Zhejiang Crownmab Biotech Co. Ltd.

Active Organization

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Nanjing Shunxin Pharmaceutical Co., Ltd.

Beijing Tide Pharmaceutical Co., Ltd.

+ [1]

Inactive Organization

Zhejiang Crownmab Biotech Co. Ltd.

License Organization

Zhejiang Crownmab Biotech Co. Ltd.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

China (30 Apr 2024),

Extensive stage Small Cell Lung Cancer

RegulationPriority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)

Structure/Sequence

Sequence Code 10067450H

Source: *****

Sequence Code 10067454L

Source: *****

114

Clinical Trials associated with Benmelstobart

NCT07890506

/ Not yet recruitingPhase 2IIT

A Multicenter, Open-Label, Phase II Clinical Study of Chidamide Combined With Benmelstobart, Nab-paclitaxel, and Immunogenic Radiotherapy as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer

This study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of chidamide combined with benmelstobart, nab-paclitaxel, and immunogenic radiotherapy (SBRT) as second-line treatment in patients with advanced biliary tract cancer (BTC). The study plans to enroll 41 BTC patients who have previously received first-line systemic therapy, and these patients will receive chidamide, benmelstobart, nab-paclitaxel, and SBRT. The primary endpoint is progression-free survival (PFS), and the secondary endpoints include objective response rate (ORR), duration of response (DoR), overall survival (OS), and safety.

Start Date01 Nov 2026

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

[+1]

NCT07849712

/ Not yet recruitingNot ApplicableIIT

Bemo-sufail Monoclonal Antibody Combined With Anlotinib As First-Line Treatment For Elderly Patients With Locally Advanced Or Metastatic Non-Small-Cell Lung Cancer: An Exploratory Clinical Study

This exploratory clinical study evaluates the efficacy and safety of combining benmelstobart (a PD-L1 inhibitor) with anlotinib (a multi-target anti-angiogenic TKI) as a first-line, chemotherapy-free treatment for elderly patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Start Date01 Oct 2026

Sponsor / Collaborator

Zhejiang Cancer Hospital

NCT07728955

/ Not yet recruitingPhase 3IIT

A Single-arm, Exploratory Clinical Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Anlotinib and Etoposide as First-line Therapy for Elderly Patients With Small-cell Lung Cancer or Those Who Are Intolerant to Intensive Chemotherapy

A single-arm exploratory clinical study to observe and evaluate the first-line treatment of elderly and treatment-intolerant patients with small cell lung cancer using benmelstobart in combination with anlotinib and etoposide.
Eligible patients are those with histologically or pathologically confirmed small cell lung cancer (SCLC) (AJCC 9th edition), who are treatment-naïve and considered elderly or intolerant to intensive therapy. Eligible subjects receive 4-6 cycles of benmelstobart injection combined with anlotinib hydrochloride and etoposide, followed by maintenance therapy with benmelstobart injection plus anlotinib hydrochloride, continued until disease progression or intolerable toxicity.
The study aims to evaluate the efficacy and safety of first-line treatment with benmelstobart injection in combination with anlotinib hydrochloride and etoposide in patients with advanced SCLC.

Start Date01 Aug 2026

Sponsor / Collaborator

Sun Yat-Sen Memorial Hospital

100 Clinical Results associated with Benmelstobart

100 Translational Medicine associated with Benmelstobart

100 Patents (Medical) associated with Benmelstobart

253

Literatures (Medical) associated with Benmelstobart

01 Nov 2026·EUROPEAN JOURNAL OF PHARMACOLOGY

PD-L1 antibody-induced cardiac dysfunction is regulated by CCR5-positive macrophages

Article

Author: Tang, Jian ; Wu, Wei-Yin ; Cai, Binni ; Wang, Yutian ; Yuan, Qian ; Lin, Jiale ; Song, Fei ; Li, Yun-Da ; Chen, Ruolan ; Li, Gang

The programmed death-ligand 1 (PD-L1) antibody, while revolutionizing oncology through immune checkpoint blockade, is increasingly associated with clinically significant cardiac immune-related adverse events (irAEs). This study systematically investigates the early cardiotoxic effects of PD-L1 inhibition using murine models, revealing through integrated cardiac functional assessments (systolic performance, myocardial deformation, and electromechanical synchronicity) and spatial transcriptomics that PD-L1 antibody treatment acutely disrupts cardiac synchronicity and contractile function. Mechanistic profiling identified monocyte-derived C-C motif chemokine receptor 5-positive (CCR5⁺) macrophage proliferation driven by PD-L1-induced C-C motif chemokine ligand 5 (CCL5) chemokine signaling, with flow cytometry/immunofluorescence confirming CD45⁺CD11b⁺F4/80⁺CCR5⁺ macrophage infiltration in treated myocardium. Therapeutic intervention with the CCR5 antagonist maraviroc demonstrated multi-modal cardiac protection: attenuating cardiac dysfunction, reducing CCR5⁺ macrophage recruitment, suppressing CCL5 overproduction, and modulating redox/apoptosis pathways through hypoxia-inducible factor 1α (HIF-1α)/pyruvate kinase isozyme type M2 (PKM2) Y105 phosphorylation regulation and apoptosis inhibition. Notably, although maraviroc failed to potentiate the anti-tumor effect of PD-L1 therapy, it effectively attenuated the PD-L1-associated myocardial toxicity without diminishing the anti-tumor response in melanoma-bearing mice. These findings delineate a CCL5/CCR5 axis as the central mechanism underlying early PD-L1-induced cardiotoxicity, while establishing CCR5 blockade as a translatable strategy for preventing immunotherapy-associated cardiac complications, with maraviroc demonstrating pleiotropic protective effects spanning immune modulation, metabolic reprogramming, and apoptosis control.

01 Oct 2026·COLLOIDS AND SURFACES B-BIOINTERFACES

Nanocomposites integrating antigen release and presentation for treatment of sarcoma

Article

Author: Wang, Qing ; Li, Wengang ; Zhou, Xiao ; Liu, Zhaohui ; Jiang, Jie ; Zheng, Jialiang ; Wu, Jincheng ; Mi, Yanjun ; Miao, Fenglin ; Tang, Mingkun ; Geng, Guojun

Soft-tissue sarcomas present a significant clinical challenge owing to their high postoperative recurrence rates and poor responsiveness to radiotherapy and chemotherapy. The insufficient infiltration of immune cells into the tumor microenvironment further limits the efficacy of immunotherapy. Photodynamic therapy (PDT) can induce immunogenic cell death (ICD) in tumor cells by releasing tumor-associated antigens. These antigens can be used to activate dendritic cells (DCs) in vitro and extract DC vesicles. These vesicles can activate T cells in a more effective and specific manner, promoting their maturation and tumor infiltration, thereby achieving effective tumor immunotherapy. After delivering photosensitizers to the tumor site via nanocarriers, the tumor antigens generated in situ by PDT can further enhance tumor accumulation and the anti-tumor immune response of these T cells. Based on this rationale, we developed a cell membrane-based nanoplatform that integrates PDT and T cell activation. Nanoparticles were fabricated by coating indocyanine green-loaded mesoporous polydopamine nanoparticles with a hybrid membrane derived from DCs activated by PDT-released antigens and tumor cells (DTM-MI). In vitro, DTM-MI demonstrated efficient tumor cell targeting and laser irradiation, produced abundant reactive oxygen species (ROS), and induced tumor cell death and release of ICD-related molecules. DTM-MI selectively accumulated in tumors of tumor-bearing mice in vivo Combined with PD-L1 antibody and laser irradiation, DTM-MI significantly inhibited tumor growth while elevating serum levels of immune-related cytokines, confirming anti-tumor immune activation. Lymph nodes showed increased T-cell and CD8 + T-cell populations, and tumor sites exhibited enhanced CD8 + T-cell and cytotoxic T lymphocyte (CTL) infiltration. The dual targeting of tumor cells and T cells by DTM-MI coupled with DC membrane-mediated T-cell activation and homing to PDT-treated regions facilitated potent tumor killing. Laser-triggered immunogenic cell death and antigen release further amplify T cell-mediated anti-tumor immunity, presenting a promising therapeutic approach for sarcomas.

01 Oct 2026·ANTICANCER RESEARCH

Hyperthermia Enhances the Effects of ICI by Increasing PD-L1 Expression Through Induction of CD8 ⁺ Cell Infiltration

Article

Author: Takeda, Hiroko ; Yamamoto, Hirofumi ; Haraguchi, Naotsugu ; Takeda, Tsutomu ; Kouda, Shihori ; Yokoyama, Yuhki ; Shibata, Satoshi ; Kubota, Yui ; Yamamoto, Hiroyuki

BACKGROUND/AIM:

Hyperthermia induces a multifactorial immune cascade reaction, potentially enhancing pharmacological effects of immune checkpoint inhibitors (ICIs) and overcoming limitations in their clinical application. This study aimed to clarify how hyperthermia affects tumor immunity and enhances the efficacy of ICIs.

MATERIALS AND METHODS:

Expression of phospho-signal transducer and activator of transcription 1 (p-STAT1), interferon regulatory factor-1 (IRF1), and programmed cell death 1 ligand 1 (PD-L1) was assessed on PD-L1-expressing MC-38 mouse colorectal cancer cells under hyperthermia or interferon gamma (IFN-γ) treatment. Effects of hyperthermia on p-STAT1, IRF1, CD8, and PD-L1 were also assessed in vivo. Antitumor effects and infiltrating CD8⁺ cells were evaluated in mice treated with PD-L1 antibody, hyperthermia, or a combination of the two. Immunohistochemistry was performed to assess PD-L1 expression and CD8+ cell infiltration in samples from a patient after treatment with hyperthermia for breast cancer and a patient after hyperthermia and ICI treatment for Lynch syndrome-related colorectal cancer.

RESULTS:

Expression of p-STAT1, IRF1, and PD-L1 was enhanced in vitro by IFN-γ treatment but not by hyperthermia. Hyperthermia enhanced the expression of p-STAT1, IRF1, CD8, and PD-L1 in vivo. The combination therapy of hyperthermia and PD-L1 antibody demonstrated a greater antitumor effect than either therapy alone. Infiltration of CD8⁺ T-cells was significantly increased by hyperthermia compared to the control and was even more strongly increased by treatment using hyperthermia combined with PD-L1 antibody. PD-L1 expression was mildly elevated in the sample from the patient with breast cancer and strongly elevated in that from the patient with colorectal cancer; CD8⁺ cell infiltration was also elevated significantly in both.

CONCLUSION:

Hyperthermia potentially enhances PD-L1 expression by increasing the efficiency of CD8⁺ cell infiltration into tumors and induces a strong antitumor effect in combination with an ICI.

News (Medical) associated with Benmelstobart

20 Oct 2026

·www.biopharmadive.com

Hype vs. reality: What pharma’s hottest R&D bets have actually proved

Last year, Bristol Myers Squibb put a spotlight on the kind of cash that comes with pharmas conviction in a new oncology strategy.The drugmaker agreed to pay BioNTech $1.5 billion upfront and another $2 billion in noncontingent anniversary payments to jointly develop and commercialize pumitamig, a bispecific antibody that targets the proteins PD-L1 and VEGF-A. Another $7.6 billion could follow if development, regulatory and commercial milestones are met, making the partnership a potential $11.1 billion wager on a drug that is still investigational.But that does not make the wager irrational. Pumitamig is part of a broader wave of medicines designed to combine checkpoint inhibition with a blockade of VEGF signaling, which helps tumors build blood vessels and thwart the immune system. The approach is accumulating substantial clinical evidence.Its also a useful example of a broader tension thats always run through drug R&D but may now be accelerating alongside the pace of science: Companies often have to commit enormous amounts of capital before the evidence is mature enough to provide anything resembling certainty.The same tension is playing out in B7-H3 antibody-drug conjugates and in vivo CAR-T, two other fields drawing major pharma investment at very different points on the proof curve.It is important to separate the biological rationale for the target from the clinical evidence for an individual ADC.Eric RichardsSVP, head of oncology product leadership, GSKThe crucial question for pharma isnt whether any of these biological approaches are real or hype. It is what theyve actually demonstrated in patients and how much confidence the available evidence can reasonably support.Ultimately, companies are paying promise prices on premise evidence, Mike Rea, the CEO of a new venture focused on drug R&D decision-making called Then, If, said in an email.A rational early bet, he said, should be able to identify the premise that has to hold for the price to make sense, specify how and when that premise will be tested and define what result would make the buyer walk away.Hype is when the premise is inferred from the fact that other people have bought it, Rea wrote.PD-(L)1/VEGF: The evidence is catching upFew oncology ideas have moved as quickly from intriguing clinical signal to strategic priority as PD-L1/VEGF bispecifics.The strongest evidence for the strategy so far comes from ivonescimab, developed by Akeso and licensed to Summit Therapeutics in several major markets. In the China-only phase 3 HARMONi-2 trial, ivonescimab beat Merck & Co.s star immunotherapy Keytruda on both progression-free and overall survival in previously untreated PD-L1-positive advanced non-small cell lung cancer, cutting the risk of progression or death by 49% and the risk of death by 27%.But the global picture is more complicated.Summits multiregional HARMONi trial studied ivonescimab in a different setting: EGFR-mutated non-small cell lung cancer after progression on a third-generation EGFR inhibitor, with both arms also receiving chemotherapy. The trial met its progression-free survival endpoint, reducing the risk of progression or death by 48%. At the prespecified primary overall survival analysis, however, the hazard ratio was 0.79 and the result narrowly missed the trials threshold for statistical significance.Longer follow-up has continued to show an overall survival trend, including similar hazard ratios in Western and Asian patients, but those later analyses do not retroactively change the statistical outcome of the prespecified primary analysis.That distinction matters because saying a PD-L1/VEGF works can mean different things: that a particular molecule works in a particular population; that the biological strategy can outperform established therapy; or that the entire class will repeatedly improve outcomes across geographies, tumor types and treatment settings.Pumitamig adds another piece to the puzzle. Interim global phase 2 data from 40 response-evaluable patients presented this year showed encouraging response rates when the drug was combined with chemotherapy in first-line non-small cell lung cancer, including in patients with low or negative PD-L1 expression. BioNTech and Bristol Myers have already moved the drug into a broad global phase 3 program.But response rates from an interim phase 2 cohort without a standard-of-care comparator are not the same thing as randomized survival evidence.The field has therefore moved well beyond pure speculation. The next proof point is whether multiple PD-L1/VEGF drugs can repeatedly beat modern standards of care in global randomized trials and whether those wins hold across populations rather than clustering around a small number of unusually successful assets.Summit, in written responses to PharmaVoice, argued that the evidence base is already broader than any single trial. The company said five randomized phase 3 ivonescimab studies have read out across its program and Akesos China studies, four with statistically significant improvements in overall survival; HARMONi later showed a nominal survival improvement with longer follow-up.More than 5,000 patients have been treated across Summit- or Akeso-sponsored studies, the company said. Summit also pointed to updated HARMONi data showing similar survival effects in Western, Asian and global populations and said the program provides clinical validation that simultaneous PD-1 and VEGF blockade can improve outcomes over established comparators in certain settings.But the company also outlined the remaining proof gap. Ivonescimab is not yet approved by the FDA or regulators in other markets where Summit holds rights, and Summit said the next phase of validation will come from global first-line phase 3 studies in lung, colorectal and bladder cancers. Those trials will test how well the strategy reproduces its strongest signals across broader populations, treatment settings and standards of care.B7-H3 ADCs: Two phase 3 wins change the argumentB7-H3 ADCs may be closer to a different inflection point: the moment when repeated late-stage wins begin to validate the target itself.Two separate B7-H3-directed ADCs demonstrated phase 3 survival benefits in relapsed small cell lung cancer this year, both in China.GSKs risvutatug rezetecan, or Ris-Rez, reduced the risk of death by 54% compared with the chemotherapy topotecan in a pivotal phase 3 trial. Median overall survival was 18.5 months with Ris-Rez versus 10.3 months with topotecan.Roche partner MediLink also reported a 54% reduction in the risk of death with tambotatug pelitecan, or Tam-Peli, in the phase 3 study. Median overall survival was 13.3 months versus 9.4 months for topotecan, while Tam-Peli reduced the risk of progression by 71%.One successful drug can validate a molecule. When two independently developed drugs aimed at the same target succeed in randomized phase 3 trials, the target-level argument becomes harder to dismiss.Pharma has already paid to be part of that argument. GSK licensed Ris-Rez from Hansoh Pharma for $185 million upfront and up to $1.5 billion in potential milestone payments. Roches 2026 deal for global rights to Tam-Peli outside mainland China, Hong Kong and Macau included $570 million in upfront and near-term payments, with additional milestones and royalties undisclosed.Price stands in for proof, and the more deals there are, the less anyone remembers that no new evidence has been added.Mike ReaPharma strategist, CEO of Then, IfStill, B7-H3 is not the only thing those drugs have in common. Both Ris-Rez and Tam-Peli also use topoisomerase inhibitor payloads. That makes target validation a more nuanced claim than simply counting wins. The phase 3 results provide powerful evidence that B7-H3 can be exploited therapeutically in small cell lung cancer. They do not establish that every B7-H3 ADC or every engineering approach built around the target will work.Additionally, the pivotal survival data for both Ris-Rez and Tam-Peli were generated in China, leaving global reproducibility as an important next test.Eric Richards, GSKs senior vice president and head of oncology product leadership, called the results strong evidence for Ris-Rez in relapsed SCLC and said they increase confidence in B7-H3 as a clinically actionable target. But he stressed that an ADCs performance reflects the target, antibody, linker, payload and drug-antibody ratio together not the target alone.GSK is now testing whether the China data reproduce globally in the phase 3 Embold SCLC-301 trial and a broader solid-tumor program. The target-level case is materially stronger than it was a year ago, but global reproducibility and broader class validation remain unresolved.Rea offered a similar test for when an individual drug begins to validate a broader thesis.One drug becomes evidence for a broader thesis when the confound is removed, he wrote, for example, when a structurally different molecule repeats the effect or a result holds in a different population against a different comparator.By that standard, the case for B7-H3 has strengthened materially, but shared payload characteristics and China-only pivotal data still leave important confounds unresolved.In vivo CAR-T: The money is far ahead of the datasetThe proof curve looks very different for in vivo CAR-T.Traditional autologous CAR-T requires a patients immune cells to be removed, engineered outside the body, expanded and reinfused. In vivo approaches aim to turn the patients body into the manufacturing site by delivering genetic instructions that reprogram T cells directly.If that works reliably, it could strip away some of CAR-Ts most stubborn logistical and manufacturing barriers. Pharma is spending as though that possibility matters.In June, Lilly completed its acquisition of Kelonia Therapeutics in a deal worth up to $7 billion in cash, including $3.25 billion upfront. Kelonias lead program, KLN-1010, uses an engineered lentiviral vector to generate anti-BCMA CAR-T cells inside patients with multiple myeloma.The clinical dataset behind that deal was real and tiny.Updated phase 1 results presented at ASCO this year covered six patients with heavily pretreated relapsed or refractory multiple myeloma. All achieved minimal residual disease negativity in bone marrow at one month and all had a clinical response. CAR-T cells expanded in the blood and remained detectable for months.Those results are striking for a first-in-human study. They are also six patients in an uncontrolled dose-escalation trial, with the longest reported follow-up measured in months rather than years.That is enough to demonstrate that in vivo generation of functional CAR-T cells in humans is possible and can produce antitumor activity. But its not enough to establish durability, comparative efficacy, reproducibility, rare safety risks or whether the platform can consistently match or improve upon established ex vivo CAR-T therapies.The modality also isnt a single technology. Companies are pursuing viral vectors, lipid nanoparticles and other delivery approaches, with different genetic payloads and distinct questions around targeting, persistence, control and off-target effects.The strategic race is nonetheless accelerating. Johnson & Johnson struck a collaboration with Sail Biomedicines in July to develop in vivo CAR-T programs for immune-mediated disease and received an exclusive option to acquire the company for $2.58 billion.That creates the sharpest gap of the three fields examined here between strategic conviction and definitive proof.The early human data show that the central biological premise is possible. They do not yet show that in vivo CAR-T can reliably reproduce the efficacy and durability of established CAR-Ts while delivering the simpler manufacturing, broader access and safety advantages that make the approach commercially transformative.Conviction is not validationBetting before certainty is not the problem; drug development requires it. The risk comes when the size of the bet begins to masquerade as evidence that the underlying premise has already been proved.A deal is a price, not a data point, Rea wrote.Yet deals can begin to function like evidence anyway. Internally, the deal thesis becomes the development plan while externally, one companys price becomes validation for the next bidder.Price stands in for proof, he said, and the more deals there are, the less anyone remembers that no new evidence has been added. '

Clinical ResultPhase 3Phase 1ImmunotherapyCell Therapy

27 Apr 2026

·www.biospace.com

Apollomics Reports Full Year 2025 Financial Results and Provides Clinical Updates and Business Progress

Phase 2 studies ongoing to advance global development of vebreltinib, a highly potent, de-risked and differentiated c-MET Inhibitor with best-in-class and first-in-class potential. To date, more than 600 patients and 170 healthy volunteers have been dosed with vebreltinib in clinical trials. Phase 2/3 IND submission for development of vebreltinib in combination with an EGFR inhibitor in the U.S. and select Asian countries for the treatment of NSCLC. FOSTER CITY, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company advancing innovative oncology therapies to transform the treatment landscape for patients with few or no options, today announced financial results for the full year ended December 31, 2025. “Our primary focus is to advance the global development of vebreltinib for the treatment of patients with c-MET alterations across different tumors,” said Hung-wen (Howard) Chen, Chief Executive Officer of Apollomics. “Based on guidance from the U.S. Food and Drug Administration (FDA), we anticipate submitting an Investigational New Drug Application for accelerated approval of vebreltinib for second-line treatment for non-small cell lung cancer (NSCLC) patients with c-MET amplification in the first half of 2027.” Pipeline Update Vebreltinib (APL-101) – a highly specific, CNS-penetrant c-MET inhibitor for treating NSCLC, brain tumors, and other solid tumors with MET dysregulation. It also shows significant potential in combination regimens, particularly with EGFR inhibitors. The China rights of APL-101 were out-licensed to Apollomics’ partner, Beijing Avistone Biotechnology Co., Ltd., while Apollomics retains the global (ex-China) rights. Vebreltinib has been approved by China’s National Medical Products Administration (NMPA) for three distinct indications: METex14 skipping NSCLC, MET-amplified NSCLC, and PTPRZ1-MET fusion high-grade gliomas. Notably, it is the first c-MET inhibitor approved for the latter two conditions. The Company is advancing global development of vebreltinib, prioritizing NSCLC with c-MET amplification while expanding its application across diverse MET alterations and tumor types. Simultaneously, the Company is investigating strategic combinations with other tumor inhibitors to fully maximize vebreltinib’s therapeutic potential. The Phase 2 component of the SPARTA clinical study, APL-101-01, is an ongoing open-label multi-cohort study for evaluation of efficacy and safety of vebreltinib for the treatment of a number of solid tumors, including NSCLC with MET Exon 14 skipping, NSCLC with c-MET amplification, brain tumors with MET fusion or MET amplification and other solid tumors with MET amplification or MET fusion. Apollomics is currently conducting the ongoing Phase 2 portion of the global SPARTA study at approximately 25 study sites in over 10 countries in North America, Europe and Asia-Pacific. As of April 2026, over 282 subjects have enrolled in the SPARTA study. Interim efficacy and safety data from the global multi-cohort Phase 2 SPARTA trial and from the multi-cohort Phase 2 KUNPENG trial demonstrated that vebreltinib appeared efficacious in NSCLC patients with MET Exon14 skipping mutation with or without co-occurring MET amplification. In March 2025, the Company announced a development and commercialization agreement for vebreltinib with LaunXP International Co., Ltd., an affiliate of LaunXP Biomedical Co., Ltd (Collectively, “LaunXP”). LaunXP will receive exclusive development and commercialization rights for vebreltinib in combination with an EGFR inhibitor in Asia (excluding mainland China, Hong Kong and Macau) for the treatment of NSCLC. Apollomics is committed to expanding its clinical pipeline through ongoing collaborations with global partners. These efforts will focus on investigating new combination therapies that maximize vebreltinib’s efficacy, ensuring the asset’s potential is fully realized across diverse patient populations. Immuno-Oncology Product Candidates APL-501 (Anti-PD-1 antibody) : APL-501 is an investigational, humanized, IgG4 monoclonal antibody that selectively binds to PD-1 on T lymphocytes and other immune cells. The China rights of APL-501 were out-licensed to Apollomics’ partner, Edding Genor Group Holdings Ltd., while Apollomics retains the global (ex-China) rights. Data from a Phase 1 study in advanced or relapsed/refractory solid tumors in Australia are currently being analyzed. APL-502 (benmelstobart, anti-PD-L1 antibody) : APL-502 is a novel IgG1 humanized monoclonal antibody against PD-L1. The China rights of APL-502 were out-licensed to Apollomics’ partner, Chia Tai-Tianqing Pharmaceutical Holdings Co., Ltd. (CTTQ), while Apollomics retains the global (ex-China) rights. APL-502 (also known as TQB-2450 in China) has been approved by China’s NMPA for three distinct indications: extensive-stage small cell lung cancer, recurrent/metastatic endometrial cancer, and late-stage unresectable or metastatic renal cell carcinoma. Ongoing clinical trials include the following tumor types: NSCLC, esophageal cancer, ovarian cancer, hepatocellular carcinoma, cholangiocarcinoma, primary mediastinal large B cell lymphoma, and alveolar soft part sarcoma. Business Highlights New senior management team : In September 2025, Apollomics appointed a new management team, led by Hung-wen (Howard) Chen, Chief Executive Officer, and Yi-kuei (Alex) Chen, Chief Operating Officer, and Peter Lin, Chief Financial Officer. Positive Turnaround Developments : With the appointment of a new board of directors and management team, the Company has made meaningful progress executing its strategic turnaround plan. In 2025, the Company successfully implemented significant cost reduction initiatives to streamline operations and enhance financial discipline. In parallel, Apollomics has strengthened its financial and legal position through the resolution of legacy matters, including the settlement of the Cayman litigation in November 2025, and the clearance of substantial outstanding legal and clinical program-related obligations. Furthermore, Apollomics has a renewed commitment to advancing its pipeline, including the relaunch of a previously paused clinical program for vebreltinib. Full Year 2025 Financial Results Cash, cash equivalents, bank deposits and money market funds as of December 31, 2025, were approximately $3.3 million, compared with $9.8 million as of December 31, 2024. In September 2025, the Company raised $4.1 million in a private investment in public equity (PIPE) financing, before transaction expenses. Revenue for the full year 2025 was $8.5 million compared to $0 for full year 2024. Revenue in 2025 is a result of the upfront payment related to the LaunXP licensing agreement for the development and commercialization in Asia (excluding mainland China, Hong Kong and Macau) of vebreltinib. Research and development expenses were approximately $5.5 million for full year 2025, compared to approximately $24.6 million for full year 2024. General and administrative expenses were approximately $12.4 million for full year 2025, compared to approximately $17.8 million for full year 2024. Net loss for the full year 2025 was $(10.9) million, or $(7.57) per diluted share, compared with a net loss of $(53.9) million, or $(52.80) per diluted share, for the full year 2024. As part of its strategic turnaround plan, Apollomics significantly reduced costs and expenses in 2025 compared to the previous year. For the full year 2025, operating expenses were $19.8 million compared to $55.7 million for the prior year, representing a 64% decrease year-over-year. About Apollomics Inc. Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics’ lead program is vebreltinib (APL-101), a potent, selective c-MET inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-MET alterations, which is currently in a Phase 2 multicohort clinical trial in the United States and other countries. For more information, please visit . Cautionary Statement Regarding Forward-Looking Statements This press release includes statements that constitute “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of present or historical fact included in this press release, regarding Apollomics’ strategy, prospects, plans, objectives and anticipated outcomes from the development and commercialization of vebreltinib are forward-looking statements. When used in this press release, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “seek,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. In addition, Apollomics cautions you that the forward-looking statements contained in this press release are subject to unknown risks, uncertainties and other factors, including those risks and uncertainties discussed in the Annual Report on Form 20-F for the year ended December 31, 2025, filed by Apollomics Inc. with the U.S. Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” and the other documents or to be by Apollomics with the SEC. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that Apollomics has filed and will time to time with the SEC. Forward-looking statements speak only as of the date made by Apollomics. Apollomics undertakes no obligation to update publicly any of its forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. Investor Contacts Peter Lin, Chief Financial Officer Apollomics, Inc. 1-650-209-4055 peter.lin@apollomicsinc.com Peter Vozzo ICR Healthcare Peter.Vozzo@icrhealthcare.com 1-443-213-0505 APOLLOMICS INC. CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE LOSS (All amounts in thousands of $, except for per share data) Years Ended December 31, 2025 2024 2023 $ $ $ Revenue $ 8,500 $ — $ — Other income 494 1,489 1,217 Foreign exchange (losses) gains (141 ) 145 1,191 Fair value change of financial assets at FVTPL — 198 821 Fair value change of financial liabilities at FVTPL (22 ) 222 1,597 Fair value change of convertible preferred shares — — (76,430 ) Research and development expenses (5,531 ) (24,566 ) (34,193 ) Administrative expenses (12,442 ) (17,768 ) (20,641 ) Impairment of intangible assets (1,717 ) (13,000 ) — Finance costs (65 ) (179 ) (150 ) Other expense (12 ) (140 ) (46,003 ) Loss before taxation (10,936 ) (53,599 ) (172,591 ) Income tax expenses (3 ) (259 ) (10 ) Loss and total comprehensive loss for the period, net of taxation, attributable to owners of the Company (10,939 ) (53,858 ) (172,601 ) Loss per share Basic and diluted ($) (7.57 ) (52.80 ) (231.99 ) APOLLOMICS INC. CONDENSED STATEMENTS OF FINANCIAL POSITION (All amounts in thousands of $) As of December 31, 2025 2024 $ $ Non-current assets Plant and equipment, net $ 3 $ 92 Right-of-use assets 577 927 Intangible assets, net — 1,737 Rental deposits 83 75 Total non-current assets 663 2,831 Current assets Deposits, prepayments and deferred expenses 470 501 Accounts receivable 2,305 — Cash and cash equivalents 3,276 9,766 Total current assets 6,051 10,267 Total assets 6,714 13,098 Current liabilities Other payables and accruals 6,117 7,166 Lease liabilities, current portion 209 233 Total current liabilities 6,326 7,399 Net current (liabilities) assets (275 ) 2,868 Total assets less current liabilities 388 5,699 Non-current liabilities Lease liabilities, non-current portion 434 733 Warrant liabilities at fair value through profit and loss (“FVTPL”) 124 102 Other non-current liabilities 3,018 — Total non-current liabilities 3,576 835 Net (liabilities) assets $ (3,188 ) $ 4,864 Equity Share capital 21 11 Share premium 670,384 666,528 Reserves 38,169 39,148 Accumulated deficits (711,762 ) (700,823 ) Total (deficit) equity $ (3,188 ) $ 4,864

Phase 2Phase 1License out/inDrug ApprovalFinancial Statement

31 Mar 2026

·allsci.com

Lancet: Chia Tai’s benmelstobart and anlotinib combo outperforms pembrolizumab in lung cancer trial

Researchers across 79 centers in China reported that a combination regimen of programmed death-ligand 1 (PD-L1) inhibitor benmelstobart plus the multi-kinase inhibitor anlotinib produced statistically significant improvements in progression-free survival over pembrolizumab monotherapy in PD-L1-positive, driver gene-negative advanced non-small-cell lung cancer (NSCLC), according to the CAMPASS Phase III trial. The results were published in The Lancet Oncology. The trial, funded by Chia Tai Tianqing Pharmaceutical Group, enrolled 531 patients and represents one of the first randomized Phase III datasets to demonstrate head-to-head superiority over pembrolizumab in this setting. Chia Tai is responsible for discovering benmelstobart and development in Greater China, while US-based biotech Apollomics partnered with the China-based firm for rights outside China. Pembrolizumab monotherapy has held a dominant position as first-line treatment for PD-L1-positive advanced NSCLC since its approval based on the KEYNOTE-024 and KEYNOTE-042 trials. However, a substantial proportion of patients progress within a year, and response rates in the broader PD-L1-positive population—defined as tumor proportion score (TPS) of 1% or greater—remain around 30% to 40%. The CAMPASS trial was designed to test whether adding anlotinib, a multi-target anti-angiogenic tyrosine kinase inhibitor, to the PD-L1-targeted benmelstobart could improve outcomes without the addition of chemotherapy. The CAMPASS results The trial randomized patients 2:1, with 354 receiving benmelstobart plus anlotinib and 177 receiving pembrolizumab plus placebo. Patients were aged 18 to 75 years, had an ECOG performance status of 0 or 1, and had no targetable EGFR or ALK mutations. Both squamous and non-squamous histologies were included. Enrollment ran from August 2021 through December 2022 across 79 sites in China. The primary endpoint was progression-free survival assessed by blinded independent central review per RECIST v1.1. Median PFS in the experimental arm was not reached at the time of analysis, compared with 8.9 months in the pembrolizumab arm. The hazard ratio was 0.51 (95% CI: 0.39–0.67; p<0.0001). The 12-month PFS rate was approximately 60% with benmelstobart plus anlotinib versus approximately 40% with pembrolizumab. The PFS benefit was consistent across prespecified subgroups, including patients with TPS 1%–49% and ≥50%, as well as across squamous and non-squamous histologies. Overall survival data, while still maturing with both medians not yet reached, showed a hazard ratio of 0.62 (95% CI: 0.44–0.88; p0.007), indicating an early OS signal in favor of the combination. The objective response rate was approximately 63% in the experimental arm versus 39% in the pembrolizumab arm, a statistically significant difference. The mechanistic rationale for the combination centers on the relationship between tumor angiogenesis and immune suppression. Tumors upregulate VEGF signaling to promote vascular growth, but this process also creates an immunosuppressive microenvironment by reducing T-cell infiltration and promoting regulatory T-cell accumulation. Anlotinib inhibits VEGFR, FGFR, PDGFR, and c-Kit, which normalizes tumor vasculature and is thought to improve T-cell trafficking into the tumor. Benmelstobart then blocks the PD-1/PD-L1 axis, reactivating cytotoxic T-cells within a more accessible microenvironment. The hypothesis is that anti-angiogenic therapy potentiates checkpoint inhibition by making tumors more immunologically permissive, rather than relying on checkpoint blockade alone. The safety profile reflected the dual-agent mechanism. Grade 3 or higher treatment-related adverse events occurred in approximately 60% of patients in the benmelstobart plus anlotinib arm, compared with approximately 35% in the pembrolizumab arm. Anlotinib-related toxicities, particularly hypertension and proteinuria, accounted for a meaningful share of the higher adverse event burden. Treatment discontinuation rates were higher in the experimental arm, however, no new or unexpected safety signals were identified. The investigators characterized the toxicity as manageable with dose modifications. Research context The CAMPASS regimen represents one among several competing approaches to the same problem. Akeso’s ivonescimab, a bispecific antibody targeting both PD-1 and VEGF within a single molecule, reported superiority over pembrolizumab in the HARMONi-2 Phase III trial in 2024 in a Chinese PD-L1-positive NSCLC population. Summit Therapeutics holds ex-China rights to ivonescimab, and the asset has attracted considerable attention as a potential pembrolizumab alternative in the first-line setting. The bispecific format is mechanistically adjacent to the CAMPASS combination but consolidates both activities into one molecule, which may carry pharmacokinetic and dosing advantages. Other China-developed IO combinations—including camrelizumab plus apatinib from Jiangsu Hengrui and sintilimab plus anlotinib from Innovent—are also in late-stage evaluation in overlapping populations. Roche’s atezolizumab plus bevacizumab plus chemotherapy (IMpower150) is approved in non-squamous NSCLC but includes cytotoxic chemotherapy, a distinction that the CAMPASS regimen avoids. The chemotherapy-free design is a feature it shares with the ivonescimab approach, with both positioning against pembrolizumab monotherapy in PD-L1-positive advanced NSCLC. The CAMPASS dataset was generated entirely in China, which carries implications for regulatory and commercial strategy. The trial population reflects a Chinese clinical context, and generalizability to Western populations will require additional data or bridging studies before regulatory submissions outside China. The benmelstobart program is also being evaluated in extensive-stage small-cell lung cancer, where a Phase III trial published in Nature Medicine in 2024 suggests Chia Tai Tianqing is pursuing a broader oncology footprint for the combination platform. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 3Clinical ResultDrug Approval

100 Deals associated with Benmelstobart

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Alveolar Soft Part Sarcoma	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	14 Apr 2026
Advanced Lung Non-Small Cell Squamous Carcinoma	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	10 Feb 2026
Non-small cell lung cancer stage III	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	10 Feb 2026
Metastatic Renal Cell Carcinoma	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	13 May 2025
Unresectable Renal Cell Carcinoma	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	13 May 2025
Endometrial Carcinoma	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	22 Nov 2024
Extensive stage Small Cell Lung Cancer	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	30 Apr 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Mismatch repair-deficient Endometrial Carcinoma	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	05 Sep 2024
Metastatic endometrial cancer	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Jul 2024
Recurrent Platinum-Resistant Ovarian Carcinoma	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	26 Sep 2021
metastatic non-small cell lung cancer	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	06 Aug 2021
Squamous non-small cell lung cancer	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	06 Aug 2021
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	21 Jul 2021
Non-Small Cell Lung Cancer	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	21 Jul 2021
Non-squamous non-small cell lung cancer	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	21 Jul 2021
Advanced biliary tract cancer	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	26 Jan 2021
Advanced Renal Cell Carcinoma	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	25 Aug 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06621095 (ALTER-PA-001, ESMO2026)	Phase 2	Metastatic Pancreatic Cancer First line	78	Anlotinib + Benmelstobart + AG	gnrldtqhcm(azfdilzoim) = uoghrkestv idltaxpaso (mjusciwwrl ) View more	Positive	23 Oct 2026
				AG (nab-paclitaxel + gemcitabine)	gnrldtqhcm(azfdilzoim) = dgypayftxw idltaxpaso (mjusciwwrl ) View more
NCT06637163 (ALTER-E008, ESMO2026)	Phase 2	Esophageal Squamous Cell Carcinoma Neoadjuvant	106	Benmelstobart plus concurrent chemoradiotherapy	qcieplmclr(rdbpfbieyg) = jzhnrkfefv vgldiseenn (ifezoharsg ) View more	Positive	23 Oct 2026
				concurrent chemoradiotherapy	qcieplmclr(rdbpfbieyg) = yrjobqegls vgldiseenn (ifezoharsg ) View more
NCT06662006 (ESMO2026)	Phase 2	Metastatic Pancreatic Cancer Second line	50	Nal-IRI/5-FU/LV + Benmelstobart + Anlotinib	wsbkxkswzo(npefnnqrun) = xpqpxotamp uvtmefsgem (xesigzsifq ) View more	Positive	23 Oct 2026
				Nal-IRI/5-FU/LV + Benmelstobart + Anlotinib (SBRT)	wsbkxkswzo(npefnnqrun) = sayevzkskj uvtmefsgem (xesigzsifq ) View more
NCT05252078 (ALTER-E005, ESMO2026)	Phase 2	Esophageal Squamous Cell Carcinoma Adjuvant	30	AnlotinibBenmelstobart + AnlotinibBenmelstobart	pzjhpekxwu(byvgrfweee) = tbysmxydbw efazgitqhw (dkcrfjhsaf, 19.6 - 30.8) View more	Positive	23 Oct 2026
NCT07643350 (BEAM-LUNG, Pubmed \| Front Immunol)	Phase 2	Non-small cell lung cancer stage III	152	Induction benmelstobart + anlotinib + platinum-based doublet chemotherapy followed by concurrent chemoradiotherapy and benmelstobart consolidation	rvgbfvpupl(ccturdwucg) = oyhcelvhdm ugcknjhcib (ttdcttixds, 54 - 75) View more	Positive	25 Sep 2026
WCLC2026	Phase 2	Small Cell Lung Cancer Maintenance	20	induction therapy: benmelstobart plus planlotinibsed chemotherapy + maintenance therapy: benmelstobart plus anlotinib (patients who had not progressed after induction therapy)	yjqbjivjlj(ptrqtfmmaj) = dksnrameao oiujzkbfco (osyawkcmmd, 6.5 - NR) View more	Positive	12 Sep 2026
ASCO2026	Phase 2	Locally Advanced Head and Neck Squamous Cell Carcinoma Neoadjuvant	36	Benmelstobart + Anlotinib + Chemotherapy	wvxsuyjuve(cmlzjbuntg) = mgythgnzbd juikbpsgcq (yiqgzeodoj, 66.3 - 95.8) View more	Positive	29 May 2026
NCT06637163 (ASCO2026)	Phase 2	Esophageal Squamous Cell Carcinoma Neoadjuvant	82	BEN+cCRT	vjkgcnxszt(zngjrkitke) = nqrvefsven ofgzyaviqx (imwtjeqocw ) View more	Positive	29 May 2026
				cCRT	vjkgcnxszt(zngjrkitke) = eamksgpmby ofgzyaviqx (imwtjeqocw ) View more
NCT06662006 (ASCO2026)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma Second line	46	NAL-IRI/5-FU/LV + benmelstobart + anlotinib (Cohort A)	azmhybzgdb(celzpcszwg) = vjaupjqfcm mdtrntagun (sjhakavigc, 1.9 - 32.9) View more	Positive	29 May 2026
				NAL-IRI/5-FU/LV + benmelstobart + anlotinib (Cohort B)	azmhybzgdb(celzpcszwg) = lfziobvqfr mdtrntagun (sjhakavigc, 12.0 - 64.9) View more
NCT04964479 (CAMPASS, Pubmed \| Lancet Oncol)	Phase 3	PD-L1 positive Non-Small Cell Lung Cancer First line PD-L1-positive	531	Benmelstobart plus Anlotinib	nxpndsqhpa(nhduwtszyi) = zdkcsqvarq xerupalhar (vlhutqmmgc, 9.2 - 12.6) View more	Positive	01 Apr 2026
				Pembrolizumab plus Placebo	twwoluozip(hpiglxvofh) = igdhneveji ziqeabatgb (clduicqloy ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis