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Last update 16 Sep 2025

Tislelizumab

Last update 16 Sep 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Tirelizumab, Tiselizumab, Tislelizumab (USAN/INN)

+ [7]

Target

PD-1

Action

inhibitors

Mechanism

PD-1 inhibitors(Programmed cell death protein 1 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesDigestive System Disorders+ [9]

Active Indication

Esophageal CarcinomaPD-L1 positive Esophageal Squamous Cell CarcinomaLocally Advanced Gastric Adenocarcinoma+ [116]

Inactive Indication

Advanced Triple-Negative Breast CarcinomaAlveolar Soft Part SarcomaAnaplastic Large-Cell Lymphoma+ [29]

Originator Organization

BeOne Medicines Ltd.

Active Organization

BeOne Medicines Ltd.

Glenmark Pharmaceuticals Ltd.

BeiGene (Suzhou) Co. Ltd.

+ [12]

Inactive Organization

Novartis Pharmaceuticals Corp.

Celgene Corp.

HUTCHMED (China) Ltd.

+ [1]

License Organization

Glenmark Specialty SA

BeOne Medicines Ltd.

Hutchison MediPharma Ltd.

+ [13]

Drug Highest PhaseApproved

First Approval Date

China (26 Dec 2019),

Hodgkin's Lymphoma

RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Special Review Project (China), Conditional marketing approval (China)

Structure/Sequence

Sequence Code 577079733L

Source: *****

Sequence Code 616719194H

Source: *****

795

Clinical Trials associated with Tislelizumab

NCT07136077

/ Not yet recruitingPhase 2IIT

A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy

To find out if a combination of fruquintinib and tislelizumab can control CRC in patients who have received treatment for the disease but still have "positive" ctDNA tests for MRD (meaning there is evidence of MRD based on this test).

Start Date05 Feb 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+2]

NCT07172412

/ Not yet recruitingPhase 2IIT

An Umbrella Ib/II Phase Study Evaluating the Efficacy and Safety of First-Line Combination Therapy in the Treatment of Extensive-Stage Small Cell Lung Cancer

This is an open-label umbrella study conducted in first treatment ES-SCLC patients, employing a novel umbrella trial design (biomarker-integrated multi-arm trial with a shared ICI+chemotherapy control arm). Eligible patients were assigned to trial arms based on biomarker expression levels. Biomarker subgroups were defined as: (1) High ASCL1/NEUROD1/DLL3 expression: DLL3-CAR-NK cells combined with ICI + etoposide + carboplatin (DLL3 group); (2) Myc overexpression: XPO1 inhibitor selinexor combined with ICI + etoposide + carboplatin (XPO1 group); (3) VIM/AXL high expression group treated with anlotinib combined with ICI + etoposide + carboplatin (anlotinib group).

Start Date01 Nov 2025

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

NCT07131319

/ Not yet recruitingPhase 2/3IIT

Spatially Fractionated Radiotherapy (SFRT) Synchronized With Tislelizumab Plus Platinum-based Dual-agent Chemotherapy for Induction Treatment of Initially Unresectable Stage Ⅲ Non-small Cell Lung Cancer: A Clinical Study

The aim of this clinical trial is to understand whether spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment is effective in treating initially unresectable stage Ⅲ non-small cell lung cancer (NSCLC). It will also explore the safety of this treatment modality. The main questions it aims to answer are:
Will spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment increase the surgical resection rate of patients with initially unresectable stage Ⅲ non-small cell lung cancer? What adverse reactions will patients experience when receiving spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment?

Start Date30 Oct 2025

Sponsor / Collaborator

The Second Affiliated Hospital of Nanchang University

100 Clinical Results associated with Tislelizumab

100 Translational Medicine associated with Tislelizumab

100 Patents (Medical) associated with Tislelizumab

623

Literatures (Medical) associated with Tislelizumab

31 Dec 2025·Human Vaccines & Immunotherapeutics

Durable response to third-line combination therapy in a metastatic colorectal cancer patient with BRAF V600E mutation: A case report

Article

Author: Qian, Xiaoping ; Li, Li ; Zhang, Qun

In metastatic colorectal cancer (mCRC), the BRAFV600E mutation subtype is one of the subtypes with the worst prognosis. The long-term abnormal activation of multiple signaling pathways caused by the BRAF V600E mutation is closely related to the formation of BRAF inhibitor resistance and drug-resistant tumor cell subpopulations. These factors significantly impact the survival and prognosis of CRC patients. Therefore, treating mCRC patients with the BRAFV600E mutation, particularly in later stages, is challenging. We reported a case of an mCRC patient with the BRAF V600E mutation in the primary and metastatic tumors. After the failure of second-line treatment, this patient received a combination therapy including immunotherapy (tislelizumab), radiotherapy, and targeted therapy (fruquintinib). Through comprehensive imaging evaluations and continuous monitoring of tumor markers, we were astonished to observe that the patient has achieved and maintained a complete response (CR) for over 12 months. This case supports the efficacy of combination therapy in mCRC patients with the BRAF V600E mutation.

31 Dec 2025·ANNALS OF MEDICINE

Cost-effectiveness of PD-1 inhibitors combined with chemotherapy for first-line treatment of oesophageal squamous cell carcinoma in China: a comprehensive analysis

Article

Author: Xu, Kai ; Zhang, Lingli ; Yu, Man ; Lin, Yingtao ; Su, Dan ; Li, Xin ; Shang, Jingjing ; Sun, Qingli ; Gong, Jinhong ; Qian, Xiaodan

BACKGROUND:

Programmed death-1 (PD-1) inhibitors combined with chemotherapy have become a standard first-line treatment for advanced oesophageal squamous cell carcinoma (ESCC). Given the high costs associated with immunotherapy, evaluating the cost-effectiveness of different PD-1 inhibitors in the Chinese healthcare setting is essential for guiding treatment decisions and policy development.

METHODS:

A cost-effectiveness analysis was conducted comparing six PD-1 inhibitors-sintilimab, toripalimab, tislelizumab, camrelizumab, serplulimab, and pembrolizumab-combined with chemotherapy for first-line treatment of advanced ESCC. A partitioned survival model was used to calculate incremental cost-effectiveness ratios (ICERs) from healthcare system perspective, with a willingness-to-pay (WTP) threshold set at $36,598.19 per quality-adjusted life year (QALY). Sensitivity analyses were performed to evaluate the robustness of the results.

RESULTS:

The ICERs for toripalimab, camrelizumab, pembrolizumab, serplulimab, sintilimab, and tislelizumab were $32,356.79/QALY, $48,410.64/QALY, $312,743.54/QALY, $121,200.84/QALY, $29,663.42/QALY, and $35,304.33/QALY, respectively. Sintilimab, toripalimab, and tislelizumab were below the WTP threshold. Among all regimens, the top three in life years (LYs) gained were toripalimab, serplulimab, and tislelizumab. Sensitivity analysis showed that utility values and drug prices were key factors influencing ICERs. Probabilistic analysis indicated that toripalimab, sintilimab, and tislelizumab had the highest probabilities of being cost-effective, at 83.1%, 81.4%, and 70.0%, respectively.

CONCLUSION:

Sintilimab, toripalimab, and tislelizumab are the most cost-effective PD-1 inhibitors when combined with chemotherapy for the first-line treatment of advanced ESCC in China, with ICERs below the WTP threshold. While all six PD-1 inhibitors demonstrated clinical benefits, pembrolizumab and serplulimab were less favourable from a cost-effectiveness standpoint. Sensitivity analysis confirmed that drug prices and utility values are significant determinants of cost-effectiveness.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

A case report: capillary leak syndrome in a patient receiving high-dose methotrexate, Tislelizumab and zanubrutinib for CNS lymphoma

Article

Author: Hou, Yuxi ; Li, Wenpeng

PURPOSE:

The high-dose methotrexate (MTX) regimen is a first-line treatment for primary central nervous system diffuse large B-cell lymphoma (PCNS-DLBCL). However, MTX-related kidney injury is a severe treatment complication. No cases of capillary leak syndrome (CLS) causing delayed MTX metabolism-associated renal failure have been reported.

CASE PRESENTATION:

A 48-year-old female presented to Zibo Central Hospital in April 2024 with headaches. Contrast-enhanced magnetic resonance imaging (MRI) of the brain revealed a space-occupying lesion in the right occipital lobe. A stereotactic biopsy was performed to determine the nature of the lesion. Postoperative pathology confirmed DLBCL. The patient underwent a TZM regimen, which included Tislelizumab, MTX, and Zanubrutinib. On the first day following MTX, the patient developed generalized edema, shortness of breath, and reduced urine output. Laboratory tests revealed hypoxemia, low albumin levels, and acute kidney injury. Based on these findings, the patient was diagnosed with CLS. To quickly lower the blood MTX concentration, pleural effusion drainage and continuous renal replacement therapy (CRRT) were performed. The treatment was successful, and the patient recovered and was discharged.

CONCLUSION:

CLS is a serious complication for DLBCL patients receiving high-dose MTX therapy.

514

News (Medical) associated with Tislelizumab

07 Sep 2025

·www.prnewswire.com

Ivonescimab Plus Chemotherapy Demonstrates Consistent Global Benefit: HARMONi Data Update Shows OS HR=0.78, Nominal P=0.0332

The overall survival (OS) hazard ratio (HR) in the HARMONi trial was 0.78, with a nominal p-value of 0.0332 In the North American patients, the OS HR was 0.70 The HARMONi trial has already demonstrated clinically meaningful and statistically significant progression-free survival (PFS) outcomes In the HARMONi trial, clinical endpoint benefits, including OS and PFS, were consistent across Western and Asian patient populations, and these results were also in alignment with the clinical data from the HARMONi-A trial conducted in China HONG KONG, Sept. 7, 2025 /PRNewswire/ -- Akeso, Inc. (HKEX: 9926.HK) is pleased to share today that its global partner, Summit Therapeutics Inc. (NASDAQ: SMMT), announced the updated overall survival (OS) results from the global Phase III HARMONi clinical trial of ivonescimab, a novel PD-1/VEGF bispecific antibody, at the Presidential Symposium in the 2025 World Conference on Lung Cancer (WCLC). Longer-term follow-up of western patients showed improving, favorable trend in OS, yielding a hazard ratio (HR) of 0.78 and a nominal p-value of 0.0332. Meanwhile, Akeso recently announced that the HARMONi-A study conducted in China has also recently reached the OS clinical endpoint, achieving clinically meaningful and statistically significant OS benefit. The OS data from this study will be presented at upcoming academic conferences. The results from the first international multi-center Phase III HARMONi study of ivonescimab, along with those from the Phase III HARMONi-A study conducted in China, demonstrated consistent and robust clinical efficacy in both progression-free survival (PFS) and OS. These findings provide strong evidence that ivonescimab not only offers significant advantages in terms of rapid onset of action and effective disease control in cancer treatments but also provide survival benefits to patients. The data further support ivonescimab's consistent efficacy and safety across diverse global populations, including both international and Chinese cohorts, reinforcing its potential for broad therapeutic benefit for cancer patients worldwide. Approximately 38% of patients were recruited from western countries. The trial results were presented by Jonathan Goldman, MD, Professor of Medicine at UCLA in the Hematology/Oncology Division, UCLA Director of Clinical Trials in Thoracic Oncology, Associate Director of Early Drug Development, and Chair of University of California Lung Cancer Consortium. Clinically Meaningful Efficacy As previously disclosed, ivonescimab in combination with chemotherapy showed a positive trend in OS in the primary analysis without achieving a statistically significant benefit with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057). The statistical analysis plan for the study required a p-value of 0.0448 in order to achieve statistical significance at the time of the primary analysis of overall survival. Median overall survival was 16.8 months for those patients administered ivonescimab plus chemotherapy vs. 14.0 months for those receiving placebo plus chemotherapy. It was noted at the time of the primary analysis that the median follow-up time for western patients was 9.2 months and less than the median overall survival at the time of the primary analysis, and these patients may continue to be followed for long-term outcomes. In September 2025, an additional analysis was performed, whereby the western patients were followed to increase their time on study (Asian patients were locked at the time of the primary analysis). In this analysis that included longer-term follow-up of western patients (median follow-up time of western patients of 13.7 months), a hazard ratio consistent with the primary analysis was observed with an improved nominal p-value (HR=0.78; 95% CI: 0.62 – 0.98; nominal p=0.0332). Median OS for this analysis remained the same in both arms from the primary analysis. Median OS in western patients receiving ivonescimab was 17.0 months compared to 14.0 months for those receiving placebo (HR=0.84); median OS in North American patients, specifically, had not yet been reached in the ivonescimab arm compared to 14.0 months in the placebo arm (HR=0.70). The hazard ratios for western patients in totality, as well as patients from the North American and European regions individually, improved from the primary OS analysis to the analysis with longer-term follow-up of western patients. Consistent benefit was observed across pre-defined subgroups. As previously disclosed at the prespecified primary data analysis for PFS, ivonescimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement with a hazard ratio of 0.52 (95% CI: 0.41 – 0.66; p<0.00001). PFS was measured by blinded independent central radiology review committee (BICR) compared to placebo in combination with chemotherapy. Median PFS for ivonescimab vs. placebo plus chemotherapy was 6.8 months vs. 4.4 months, respectively. The PFS analysis was event driven and was conducted with 345 patients enrolled. There was a consistent observed benefit across pre-defined subgroups. In a longer-term follow-up of PFS, which included all western patients and at least six months of follow-up time for all patients, ivonescimab plus chemotherapy demonstrated a consistent, clinically meaningful improvement in PFS with an observed HR of 0.57 (95% CI: 0.46 – 0.71). With the longer-term follow-up analysis, a consistent benefit in western vs. Asian patients was observed, as well as in patients with tumors with either PD-L1 positive or negative expression. This longer-term follow-up analysis of PFS was performed at the time of the primary OS analysis. Overall response rates were higher in the ivonescimab arm (45%) vs. the placebo arm (34%); median duration of response was longer in those patients administered ivonescimab plus chemotherapy (7.6 months) compared to those receiving placebo and chemotherapy (4.2 months) Ivonescimab demonstrated a favorable safety and tolerability profile with no new safety signals identified. The safety results from the HARMONi study were consistent with those observed in the HARMONi-A trial. Ivonescimab has shown positive results in the HARMONi-2 trial, a randomized, double-blind, head-to-head Phase III study against pembrolizumab monotherapy, which led to its approval for first-line treatment of PD-L1-positive NSCLC (its second approved indication). Besides that, ivonescimab plus chemotherapy has now also demonstrated significant positive outcomes in another head-to-head Phase III study against tislelizumab plus chemotherapy in first-line squamous NSCLC. This clinical outcome demonstrates that ivonescimab shows significant clinical breakthroughs, whether compared to PD-1 monotherapy, or compared to PD-1 in combination with chemotherapy (the optimal standard of care for many cancer treatments), or compared to VEGF-related therapies in the area of anti-angiogenesis. This highlights the remarkable capability of ivonescimab to make leapfrog advancements in cancer treatment. Ivonescimab continues to validate its clinically meaningful profile and potential with a strategically expanded development program targeting key immuno-oncology settings: Phase III trials for Lung cancer (8 registrational/Phase III trials, 4 already met primary endpoints): First-line NSCLC, squamous and non-squamous (versus pembrolizumab + chemotherapy; global trial) First-line squamous NSCLC (versus tislelizumab + chemotherapy) NSCLC after progression on EGFR-TKI therapy (HARMONi-A and HARMONi studies) First-line PD-L1-positive NSCLC (versus pembrolizumab monotherapy) First-line PD-L1-high expressing NSCLC (versus pembrolizumab) IO-resistant NSCLC Consolidation therapy for limited-stage small cell lung cancer (LS-SCLC) without progression after concurrent chemoradiotherapy (cCRT) Phase III trials for core immuno-oncology indications (first-line therapy): First-line biliary tract cancer (versus durvalumab + chemotherapy) First-line PD-L1-positive head and neck squamous cell carcinoma (HNSCC) in combination with ligufalimab (anti-CD47) versus pembrolizumab Phase III trials for cold tumors and more： First-line triple-negative breast cancer (TNBC) First-line MSS/pMMR colorectal cancer (representing about 95% of CRC cases) First-line pancreatic cancer Additional global Phase III trials are in advanced stages of planning An extensive clinical foundation includes over 20 Phase II studies across more than 10 additional tumor types, generating compelling efficacy and safety data to enable rapid transition to further registrational studies worldwide. Ivonescimab uniquely targets both PD-1 and VEGF, producing a synergistic anti-tumor effect. This dual mechanism not only combines the benefits of PD-1 and VEGF inhibition but also overcomes the efficacy and safety limitations of each target alone, resulting in pronounced clinical benefits. These advantages have been confirmed across multiple Phase III trials and real-world use, rapidly establishing ivonescimab as a next-generation leader in immunotherapy and anti-angiogenic therapy. Akeso is implementing a dual-path strategy to maximize the value of ivonescimab world wide: accelerating domestic commercialization and label expansion in China, while simultaneously advancing global development in partnership with Summit Therapeutics. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultDrug Approval

02 Sep 2025

·www.prnewswire.com

Akeso Announces Completion of Patient Enrollment in Phase III Clinical Trial for Ivonescimab as First-Line Treatment for Biliary Tract Cancer Compared to PD-L1 Therapy

HONG KONG, Sept. 2, 2025 /PRNewswire/ -- Akeso (9926.HK) has recently announced the completion of patient enrollment in its Phase III, multicenter, randomized, controlled, registrational study evaluating ivonescimab, in combination with standard therapy, against durvalumab (PD-L1) combination therapy, for the first-line treatment of advanced biliary tract cancer (BTC) (AK112-309/HARMONi-GI1). This Phase III trial is being conducted in China. Ivonescimab has previously shown significant positive results in the randomized, double-blind, controlled Phase III study (HARMONi-2), where it was compared head-to-head with pembrolizumab. These results led to its approval as a first-line treatment for PD-L1-positive non-small cell lung cancer (NSCLC), marking its second approved indication. In addition, the Phase III trial of ivonescimab in combination with chemotherapy compared to tislelizumab combined with chemotherapy as a first-line treatment for squamous NSCLC, also delivered significant positive outcomes. These results highlight ivonescimab's strong clinical breakthroughs. Whether compared to PD-1 monotherapy, PD-1 plus chemotherapy (current standard therapies for various cancers), or VEGF-related treatments, ivonescimab has consistently demonstrated its ability to drive clinical innovation. Ivonescimab continues to validate its clinically meaningful profile and potential with a strategically expanded development program targeting key immuno-oncology settings: Phase III trials for Lung cancer (8 registrational/Phase III trials, 4 already met primary endpoints): First-line NSCLC, squamous and non-squamous (versus pembrolizumab + chemotherapy; global trial) First-line squamous NSCLC (versus tislelizumab + chemotherapy) NSCLC after progression on EGFR-TKI therapy (HARMONi-A and HARMONi studies) First-line PD-L1-positive NSCLC (versus pembrolizumab monotherapy) First-line PD-L1-high expressing NSCLC (versus pembrolizumab) IO-resistant NSCLC Consolidation therapy for limited-stage small cell lung cancer (LS-SCLC) without progression after concurrent chemoradiotherapy (cCRT) Phase III trials for core immuno-oncology indications (first-line therapy ): First-line biliary tract cancer (versus durvalumab + chemotherapy) First-line PD-L1-positive head and neck squamous cell carcinoma (HNSCC) in combination with ligufalimab (anti-CD47) versus pembrolizumab Phase III trials for cold tumors and more: First-line triple-negative breast cancer (TNBC) First-line MSS/pMMR colorectal cancer (representing about 95% of CRC cases) First-line pancreatic cancer Additional global Phase III trials are in advanced stages of planning An extensive clinical foundation includes over 20 Phase II studies across more than 10 additional tumor types, generating compelling efficacy and safety data that enable rapid transition to further registrational studies worldwide. Ivonescimab uniquely targets both PD-1 and VEGF, producing a synergistic anti-tumor effect. This dual mechanism not only combines the benefits of PD-1 and VEGF inhibition but also overcomes the efficacy and safety limitations of each target alone, resulting in pronounced clinical benefits. These advantages have been confirmed across multiple Phase III trials and real-world use, rapidly establishing ivonescimab as a next-generation leader in immunotherapy and anti-angiogenic therapy. For context, pembrolizumab (anti-PD-1) is approved for over 40 oncology indications, and bevacizumab (anti-VEGF) for more than 10. Akeso is implementing a dual-path strategy to maximize the value of ivonescimab worldwide: accelerating domestic commercialization and label expansion in China, while simultaneously advancing global development in partnership with Summit Therapeutics. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3ImmunotherapyDrug ApprovalPhase 2Clinical Result

28 Aug 2025

·www.prnewswire.com

Asieris Pharmaceuticals Releases 2025 Semi-Annual Report with Sustained Commercial Momentum and Breakthrough Innovation Poised for Launch

SHANGHAI, Aug. 28, 2025 /PRNewswire/ -- Asieris Pharmaceuticals today released its 2025 Semi-Annual Report, highlighting strong growth momentum. The company's Commercial Operation 2.0 has begun to deliver results, with sales rising steadily and first-half targets achieved. APL-1702, a breakthrough therapy for precancerous cervical lesions, is in the final stages before its China launch. Hexvix®, China's first approved blue-light imaging agent for bladder cancer, marks a new era for photodynamic blue-light cystoscopy. Meanwhile, the company's pipeline continued to advance, with achievements presented at major international academic conferences. As of the end of this reporting period, Asieris has 12 products in the pipeline and 16 ongoing research projects. The company holds approximately RMB 1.825 billion in cash, cash equivalents, and trading financial assets, providing a solid foundation for continued growth. Operating Revenue Up 61.8% YoY as Commercial Operation 2.0 Delivers Early Results In the first half of 2025, despite intensifying market competition, the company steadily advanced Commercial Operation 2.0, strengthening its commercial framework and improving operational efficiency. During the reporting period, operating revenue reached RMB 130 million, up 61.8% year over year, achieving the first-half business targets set at the beginning of the year. Building on Commercial Operation 2.0, the company continued to refine market strategies and strengthen execution, driving steady sale growth of its two marketed products, Ouyoubi and Dipaite. In the first half of the year, the company's enhanced evidence-based promotion and a stronger academic network laid a robust foundation for improving outcomes for patients with breast cancer. Ouyoubi was selected for the sixth batch of Shanghai Catalog of Innovative and Priority Biopharmaceutical Products, a move expected to broaden patient access. Meanwhile, the company has been actively preparing for the launch of Ounalin (eribulin mesylate injection), expanding its portfolio to address both early- and late-stage breast cancers. For Dipaite, the commercial team has proactively adapted to evolving treatment paradigms, precisely targeting clinical scenarios. Through medical education programs, the company has enhanced physicians' experience in managing renal cancer patients across the care continuum, improving patient adherence and treatment duration. Efforts to secure both hospital formulary listings and pharmacy access have accelerated, further improving patient access to therapy. Strong sales of Ouyoubi and Dipaite highlight the company's strengthening commercialization capabilities. As the company's first commercialized products, they provide a solid foundation for the launch and market uptake of its subsequent core products. Breakthrough Innovation Poised for Imminent Market Impact In women's health, APL-1702, a first-in-class treatment set to debut in China, is on track to become the world's first non-invasive therapy for high-grade squamous intraepithelial lesion (HSIL) of the cervix, supported by robust clinical evidence and validated in an international Phase III trial. Following the acceptance of its marketing application by China's National Medical Products Administration (NMPA) in May 2024, the company has made APL-1702 a strategic priority. The regulatory review is progressing smoothly, with the NMPA having initiated a second round of technical evaluation. APL-1702's innovation, clinical promise, and societal value have earned strong endorsement from gynecology and pharmaceutical experts. With cervical lesions increasingly affecting younger women in China and current treatments relying on cervical excision, managing precancerous lesions during the critical fertility-preservation window has become a major challenge. Experts believe APL-1702 could address this unmet clinical need, transform the treatment landscape, and support the development of a fertility-friendly society. To fast-track the commercialization of APL-1702, the company has undertaken multiple pre-launch initiatives. Phase III trial results have been presented at leading academic conferences, and more than 10 expert advisory meetings have been held to support updates to clinical guidelines and consensus. At the China International Import Expo, the product was showcased globally, and the company signed medium- to long-term strategic partnerships with the China Women's Development Foundation and the Cancer Foundation of China. All of these projects were launched in the first half of 2025. To improve access and affordability, disease-burden and policy research have been conducted. The company is also accelerating the build-out of its commercial team, implementing an omni-channel strategy focused on public hospitals, and optimizing the supply chain to ensure patients can benefit immediately upon approval. In urologic oncology, Hexvix®, China's first approved imaging agent for bladder cancer, has ushered in a new era of blue-light cystoscopy. The company is actively supporting its partner R.WOLF in advancing the regulatory review of the SYSTEM BLUE blue-light cystoscopy system in China, with approval targeted by the end of 2025. Once approved, the system, combined with Hexvix®, is expected to improve outcomes for patients nationwide. To expand market opportunities and strengthen strategic control, the company plans to introduce its single-use blue-light flexible cystoscope to China and accelerate regulatory approval. The aim is to allow patients to fully benefit from blue-light cystoscopy by avoiding unnecessary surgical trauma, preserving bladder function, enhancing quality of life, and reducing total five-year treatment costs through earlier diagnosis. The company is refining its launch strategy for Hexvix®, initially targeting patients with strong willingness to pay out-of-pocket or coverage through commercial insurance, focusing on urology centers in top-tier and oncology hospitals in major cities. Over time, as clinical guidelines are updated and urology expert endorsements are established, coupled with the launch of single-use blue-light cystoscopes, the company plans to gradually expand penetration into urology centers across key hospitals nationwide, achieving broad access to blue-light cystoscopy. Focusing on Core Areas to Accelerate Key Programs Guided by its strategic priorities, several of Asieris' pipeline candidates have made solid progress and been highlighted at international academic conferences, showcasing the company's robust R&D capabilities and clinical development expertise in its focus areas. These achievements further underscore the "first-in-class" and "best-in-class" potential of multiple pipeline products. In women's health, breast cancer, and gynecologic oncology, the results of the international, multicenter Phase III trial of APL-1702 were selected for an oral presentation at the 2025 International Photodynamic Association (IPA) World Congress. The company has also reached agreement with the U.S. FDA on the design of another Phase III trial to support potential U.S. approval of APL-1702 and is seeking overseas partners to prepare for the U.S. IND submission. APL-2302, a potential best-in-class USP1 inhibitor, has received IND approval from both the U.S. FDA and China's NMPA for Phase I/IIa trials in advanced solid tumors, with the first Phase Ia subject enrolled in March 2025. Data to date indicate favorable safety, tolerability, and pharmacokinetic profiles. Preclinical studies of APL-2501 (CLDN6/9 ADC) and research on its proprietary linker platform were selected for poster presentations at the 2025 American Association for Cancer Research (AACR) Annual Meeting. The program has progressed as planned into CMC and GLP toxicology studies, with toxicology-grade material expected by year-end and toxicology studies to follow. IND submission is targeted for mid-2026. In urologic oncology, APL-2401, a potential best-in-class FGFR2/3 inhibitor, is in the IND-enabling phase. Its research findings were selected for poster presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting, with IND approval anticipated by the end of 2025. APL-1202, in combination with tislelizumab, has completed a Phase I/II trial as neoadjuvant therapy for muscle-invasive bladder cancer, demonstrating positive efficacy signals. The Phase II analysis results have been selected for poster presentation at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). In other disease areas, APL-1401, a DBH inhibitor for moderate-to-severe active ulcerative colitis, has shown positive preliminary results in a Phase Ib trial, providing a strong foundation for further studies. APL-1202, for the treatment of free-living amoebae (FLA) infections, has received IND approval from China's NMPA. The company has also signed an investigational drug supply agreement under the Expanded Access IND Program with the Centers for Disease Control and Prevention (CDC) of the United States. Subject to CDC expert evaluation, the drug may be used for the treatment of FLA infections. Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, commented, "In the first half of 2025, the company reached multiple milestones, steadily fulfilling our growth expectations. A remarkable achievement is the smooth progression of the regulatory review for APL-1702, our breakthrough therapy for precancerous cervical lesions, now entering the final stages ahead of its China launch and set to benefit patients soon. At the same time, robust growth of our existing commercial products has strengthened our commercialization foundation and reinforced our confidence. Our pipeline's latest achievements and clinical progress have garnered wide recognition at leading international conferences, underscoring our strong R&D capabilities and innovative edge. With relentless focus on innovation and execution, we are confident that Asieris will continue to transform patient care, deliver solid returns to shareholders, and create lasting value for society." Disclaimer: This document is intended to disclose the company's latest developments and is not a product promotion advertisement. The relevant information is not intended for patients but is provided solely for the reference of healthcare professionals. If you like to learn more about these diseases, please consult healthcare professionals. The aforementioned content includes forward-looking statements concerning the company's future plans and development strategies. These statements do not represent binding commitments by the company to investors. Investors are cautioned to consider investment risks. SOURCE Asieris WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 1Phase 2Phase 3

100 Deals associated with Tislelizumab

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KEGG	Wiki	ATC	Drug Bank
D11487	Tislelizumab	L01XC	DB14922

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Esophageal Carcinoma	Japan	BeOne Medicines Ltd.	27 Mar 2025
PD-L1 positive Esophageal Squamous Cell Carcinoma	United States	BeiGene USA, Inc.	03 Mar 2025
Locally Advanced Gastric Adenocarcinoma	European Union	BeOne Medicines Ltd.	19 Dec 2024
Locally Advanced Gastric Adenocarcinoma	Iceland	BeOne Medicines Ltd.	19 Dec 2024
Locally Advanced Gastric Adenocarcinoma	Liechtenstein	BeOne Medicines Ltd.	19 Dec 2024
Locally Advanced Gastric Adenocarcinoma	Norway	BeOne Medicines Ltd.	19 Dec 2024
Locally Advanced Gastroesophageal Junction Adenocarcinoma	European Union	BeOne Medicines Ltd.	19 Dec 2024
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Iceland	BeOne Medicines Ltd.	19 Dec 2024
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Liechtenstein	BeOne Medicines Ltd.	19 Dec 2024
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Norway	BeOne Medicines Ltd.	19 Dec 2024
Metastatic gastric adenocarcinoma	European Union	BeOne Medicines Ltd.	19 Dec 2024
Metastatic gastric adenocarcinoma	Iceland	BeOne Medicines Ltd.	19 Dec 2024
Metastatic gastric adenocarcinoma	Liechtenstein	BeOne Medicines Ltd.	19 Dec 2024
Metastatic gastric adenocarcinoma	Norway	BeOne Medicines Ltd.	19 Dec 2024
Metastatic Gastroesophageal Junction Adenocarcinoma	European Union	BeOne Medicines Ltd.	19 Dec 2024
Metastatic Gastroesophageal Junction Adenocarcinoma	Iceland	BeOne Medicines Ltd.	19 Dec 2024
Metastatic Gastroesophageal Junction Adenocarcinoma	Liechtenstein	BeOne Medicines Ltd.	19 Dec 2024
Metastatic Gastroesophageal Junction Adenocarcinoma	Norway	BeOne Medicines Ltd.	19 Dec 2024
Resectable Lung Non-Small Cell Carcinoma	China	BeiGene Guangzhou Biologics Manufacturing Co. Ltd.	16 Oct 2024
Extensive stage Small Cell Lung Cancer	China	BeiGene Guangzhou Biologics Manufacturing Co. Ltd.	25 Jun 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
stomach adenocarcinoma	NDA/BLA	European Union	BeiGene Ireland Ltd.	17 Oct 2024
Unresectable Lung Non-Small Cell Carcinoma	NDA/BLA	Canada	BeiGene Switzerland GmbH	01 Feb 2024
Squamous Cell Carcinoma	NDA/BLA	China	BeOne Medicines Ltd.	06 Sep 2018
Colorectal Cancer	Phase 3	France	BeOne Medicines Ltd.	16 Apr 2025
Colorectal Cancer	Phase 3	France	Veracyte, Inc.	16 Apr 2025
Lung Cancer	Phase 3	France	Veracyte, Inc.	16 Apr 2025
Lung Cancer	Phase 3	France	BeOne Medicines Ltd.	16 Apr 2025
Non-small cell lung cancer stage III	Phase 3	France	BeOne Medicines Ltd.	16 Apr 2025
Non-small cell lung cancer stage III	Phase 3	France	Veracyte, Inc.	16 Apr 2025
Pancreatic Cancer	Phase 3	France	BeOne Medicines Ltd.	16 Apr 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05267054 (ADVANTIG-101, CTgov)	Phase 1/2	Diffuse large B-cell lymphoma refractory \| Diffuse large B-cell lymphoma recurrent	53	Tislelizumab+Ociperlimab (Ociperlimab + Tislelizumab)	olktdccngt = efhhikqkzz qwmeromhyf (lxewufkpvs, xvhzpdwzzd - whgkabreri) View more	-	15 Sep 2025
				Rituximab+Ociperlimab (Ociperlimab + Rituximab)	olktdccngt = pwsuumlyem qwmeromhyf (lxewufkpvs, ckottfhltf - psztbxggfo) View more
WCLC2025	Phase 2	metastatic non-small cell lung cancer	30	Chemoradiotherapy + Tislelizumab	srvdfkcxov(pkszcgqdow) = jwcedokzfk efrwfdsghh (nxpwrlleru ) View more	Positive	09 Sep 2025
WCLC2025	Phase 2	Non-small cell lung cancer stage III Adjuvant \| Neoadjuvant	28	Tislelizumab + Chemotherapy	xkprqeibhp(ecilossela) = nbsrgbcjfr rleetczilv (abawwnwvpp ) View more	Positive	09 Sep 2025
NCT05577702 (BGBLC202, WCLC2025)	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant	121	Tislelizumab (PD-L1 TC ≥50%, TIS (anti-PD-1))	cjwlfatkzj(kxuzatqbjs) = tvorrhxhbg mqqzdnuiqh (ydppcvjocw ) View more	Positive	08 Sep 2025
				Tislelizumab+OciperlimabTislelizumab+Ociperlimabociperlimab (anti-TIGIT) (PD-L1 TC ≥50%, TIS plus ociperlimab (anti-TIGIT))	cjwlfatkzj(kxuzatqbjs) = vedqwxcwmg mqqzdnuiqh (ydppcvjocw ) View more
NCT06456138 (ATTRAS001, WCLC2025)	Phase 1	Advanced Lung Non-Small Cell Carcinoma Third line \| Second line KRAS mutation	12	trametinib+Anlotinib+Tislelizumab	btllznatht(roulqtlbrq) = fgnjlglhtf exqozxqvet (fmtvamcaxv ) View more	Positive	08 Sep 2025
ChiCTR2400086532 (WCLC2025)	Phase 2	Non-small cell lung cancer stage III	28	Tislelizumab+Platinum containing dual drug chemotherapy	czqvbjhuvy(pmpcdukths) = elxqrtdcag vibhtsmhvi (mjiyuunhkn ) View more	Positive	07 Sep 2025
NCT03358875 (RATIONALE303，BGBA317303, WCLC 12025 \| WCLC 22025 \| Pubmed)	Phase 3	Advanced Lung Non-Small Cell Carcinoma Second line \| Third line Driver gene negative	805	Tislelizumab	lmdzjpblmu(mwuiefglzn) = zvwhjekahd nsrezlefej (ixisdqcfhr, 15.2 - 19.1) View more	Superior	07 Sep 2025
				Docetaxel	lmdzjpblmu(mwuiefglzn) = mirxbrknvy nsrezlefej (ixisdqcfhr, 9.6 - 13.5) View more
NCT05014828 (BGB-A317-212, CTgov)	Phase 2	Advanced Malignant Solid Neoplasm	58	tislelizumab+lenvatinib (Safety Run-In)	pkkijdcdoq = hubxeqyrcq zhdblhyzet (hwaefwjcls, vfavjyhaeh - seoorqxepd) View more	-	24 Aug 2025
				tislelizumab+lenvatinib (Squamous Cell Carcinoma of the Head and Neck (SCCHN))	gmyskmgbqe = sjfyfecvrv sgkfqnyxir (jobvjhxhqc, rpvapofpah - rqgcdxrclv) View more
NCT05023109 (ZSAB-TOP, Signal Transduct Target Ther) Manual	Phase 2	Advanced biliary tract cancer First line TIGIT	45	Tislelizumab+Ociperlimab+Gemcitabine+Cisplatin	xacseseeug(keqnmaimtr) = ydillkmtzy xgssyodjiy (fvwuzycmnr, 35.1 - 67.1) View more	Positive	21 Aug 2025
				Tislelizumab+Ociperlimab+Gemcitabine+Cisplatin (TIGIT+/PD-L1+)	xacseseeug(keqnmaimtr) = fpwlbxftbd xgssyodjiy (fvwuzycmnr, 47.6 - 92.7)
NCT04577963 (CTgov)	Phase 1/2	Locally Advanced Malignant Solid Neoplasm \| Endometrial Carcinoma \| Advanced Malignant Solid Neoplasm ... View more	52	IO (Part 1: Solid Tumor of Any Type (IO-Treated/IO-Na?ve in the Metastatic Setting))	jifmvaqlou = hzvrujhrnz uslfqcmfhr (szugnsalwc, cpcumzzlks - rbabfzvtke) View more	-	14 Jul 2025
				tislelizumab+fruquintinib (Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting))	pzwfqtafkh = abjcvjaemr gtjekhphyf (rcwbnfqvvd, ssumqrxony - ckzaudhtvr) View more

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