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

Structure/Sequence

Sequence Code 577079733L

Source: *****

Sequence Code 616719194H

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715

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]

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

NCT06883552

/ Not yet recruitingPhase 2IIT

An Open-label, Single-arm Clinical Study of Stapokibart Injection in Combination with Tislelizumab Injection in Patients with Non-Small Cell Lung Cancer

This is a single-arm study evaluating the efficacy and safety of Stapokibart Injection in combination with Tislelizumab Injection in patients with driver gene-negative NSCLC who have failed prior PD-1/PD-L1 inhibitor therapy.

Start Date01 Oct 2025

Sponsor / Collaborator

Sichuan University

100 Clinical Results associated with Tislelizumab

100 Translational Medicine associated with Tislelizumab

100 Patents (Medical) associated with Tislelizumab

610

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.

511

News (Medical) associated with Tislelizumab

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

28 Aug 2025

·firstwordpharma.com

BeOne’s Tevimbra notches fifth lung cancer approval in EU

BeOne Medicines’ anti-PD-1 antibody Tevimbra (tislelizumab) bagged a fifth lung cancer indication in the EU, with the European Commission (EC) authorising it for non–small-cell lung cancer (NSCLC) in the neoadjuvant/adjuvant setting.Specifically, Tevimbra is now indicated in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by Tevimbra monotherapy as adjuvant treatment, for adults with resectable NSCLC at high risk of recurrence.The latest clearance is backed by compelling data from the Phase III RATIONALE-315 study. The trial previously met its dual primary endpoints of event-free survival (EFS) and major pathologic response at the interim analyses.OS cherry on topResults from the trial’s preplanned final analysis — to be presented at the World Conference on Lung Cancer (WCLC) next month — showed that the Tevimbra-based regimen delivered a significant and clinically meaningful overall survival (OS) benefit versus chemotherapy plus placebo, yielding a hazard ratio (HR) of 0.65. The company noted that Tevimbra is only the second PD-1 inhibitor to achieve this critical endpoint in the perioperative NSCLC setting."Delivering a statistically significant [OS] benefit…alongside the [EC’s] approval of Tevimbra in perioperative resectable NSCLC marks a pivotal moment for patients and physicians," said Mark Lanasa, chief medical officer of solid tumours at BeOne.The final analysis further indicated that the earlier EFS benefit was sustained (HR = 0.58), with benefits observed across major subgroups regardless of PD-L1 expression, disease stage and histology.Tevimbra is already approved in the EU for first-line gastric or gastroesophageal junction adenocarcinoma, unresectable oesophageal squamous cell carcinoma (ESCC), second-line ESCC after platinum chemotherapy, first-line extensive-stage small-cell lung cancer, multiple NSCLC indications across first- and second-line settings, and most recently first-line nasopharyngeal carcinoma.

Clinical ResultPhase 3Drug Approval

27 Aug 2025

·www.prnewswire.com

Harbour BioMed Reports 2025 Interim Results

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, Aug. 27, 2025 /PRNewswire/ -- Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, today announced its interim results for the six months ended June 30, 2025. Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: "In the first half of 2025, Harbour BioMed achieved several significant milestones. During the reporting period, the company's profit grew more than fiftyfold year over year, demonstrating strong growth momentum. Out-licensing and collaborations based on our innovative products have contributed significantly to revenue growth and have become a recurring source of income. These results underscore the sustainability of our ability to translate innovation into commercial value and reflect the success of our diversified business model, which includes strategic partnerships, licensing collaborations, platform collaborations, and innovation incubation. Leveraging our industry-leading Harbour Mice® platform and its extended 2.0 technology platform, Harbour BioMed has built a strong global collaboration ecosystem, positioning the Company as a cornerstone of global antibody drug development. Looking ahead, we will continue to focus on innovation and accelerate the development of next-generation biologics to deliver better treatment options for patients worldwide." As of June 30, 2025, Harbour BioMed reported total revenue of approximately US$101.3 million for the first half of the year, representing a 327% increase year over year. Net profit reached approximately US$73.0 million, a 51-fold increase compared with the same period in 2024. The Company also reported a strong cash position of about US$320 million, a 92% increase since the end of the previous year. During the reporting period, the company delivered strong performance, highlighting the success of its business model and solid financial position. Advancing a Robust and Differentiated Pipeline Harbour Therapeutics, a sub-brand parallel to Nona Biosciences, is now individually responsible for the development of the Company's products pipeline on immunology and oncology. Harbour Therapeutics has established a rich and differentiated pipeline and continues to expand collaborations with leading global pharmaceutical companies and academic institutions to efficiently advance its programs. During the reporting period, several key clinical-stage projects achieved significant progress, alongside continued advancement of a robust portfolio of next-generation therapies. Key products in the clinical stage include: Batoclimab (HBM9161) is the first anti-FcRn monoclonal antibody completed Phase I to pivotal trials in China. As a novel, fully human anti-FcRn monoclonal antibody, batoclimab has the potential to be a breakthrough treatment option for a wide range of autoimmune diseases. In December 2023, the Company voluntarily planned to include additional long-term safety data and re-submitted the Biologic License Application (BLA) for batoclimab to the National Medical Products Administration of China (NMPA) in June 2024. In July 2024, NMPA accepted the BLA for batoclimab for the treatment of gMG. The Phase III pivotal clinical trial results of batoclimab were published in JAMA Neurology in March 2024, demonstrating sustained efficacy and safety with long-term use of batoclimab in the treatment of gMG. HBM9378 is a fully human monoclonal antibody against thymic stromal lymphopoietin (TSLP) generated from the H2L2 Harbour Mice® platform. It binds to the TSLP ligand and inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. TSLP is a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological conditions, including asthma and chronic obstructive pulmonary disease (COPD), where its inhibition has demonstrated benefit in a wide array of inflammatory phenotypes. HBM9378 has been engineered to achieve an extended half-life and effector silencing and is subcutaneously administered. The Company received IND approval of HBM9378 for moderate-to-severe asthma from the NMPA in February 2022 and completed a Phase I clinical trial in healthy subjects in China. In November 2024, the Company submitted an IND application for HBM9378 for COPD to the NMPA, which was approved in January 2025. In January 2025, the Company and Kelun-Biotech entered into an exclusive license agreement with Windward Bio, under which Windward Bio was granted an exclusive license for the research, development, manufacturing and commercialization of HBM9378 globally (excluding Greater China and several Southeast and West Asian countries). In July 2025, Windward Bio initiated the global phase 2 POLARIS trial to evaluate the dosing, safety, and efficacy of HBM9378/WIN378 in patients with asthma. Initial data are expected in mid-2026. Porustobart (HBM4003) is a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody discovered and developed using the HCAb Harbour Mice® platform. It is also the first fully human heavy-chain-only antibody which entered clinical development globally. Compared with conventional CTLA-4 antibodies, porustobart has unique, favourable properties, including significant Treg cell depletion and optimized pharmacokinetics for improved safety. Additionally, by enhancing antibody-dependent cellular cytotoxicity (ADCC), porustobart increases the potential to selectively deplete intratumoral Treg cells, helping to overcome the efficacy and toxicity bottleneck of current CTLA-4 therapies. The Company has implemented a global development plan for multiple types of solid tumors with an adaptive treatment design for porustobart. Positive efficacy and safety data have been observed in the monotherapy trial targeting advanced solid tumors, as well as in combination trials with PD-1 inhibitors for melanoma, CRC, NEN and HCC. Final data from the study of HBM4003 in combination with toripalimab for advanced HCC were published in Clinical Cancer Research in August 2025. Data from the Phase II study of HBM4003 in combination with tislelizumab for the treatment of microsatellite stable (MSS) metastatic colorectal cancer will be presented at the ESMO Congress 2025. HBM1020 is a first-in-class fully human monoclonal antibody generated from the H2L2 Harbour Mice® platform targeting B7H7. As a newly discovered member of the B7 family, B7H7 expression is found to be non-overlapping with PD-L1 expression in multiple tumor types, potentially playing a more significant role in tumor immune evasion. With its excellent product design and target features, HBM1020 presents great potential to address significant unmet medical needs for solid tumors. In September 2024, the Company presented the latest clinical data for patients with advanced solid tumors at the ESMO Congress 2024. The data demonstrated excellent safety and tolerability profiles for HBM1020. Of the 15 patients who received post-treatment tumor assessments, 7 patients (46.7%) achieved stable disease (SD), with two patients showing tumor shrinkage of 11% and 25%. Key products in the next-generation innovation portfolio include: HBM7004 is a novel B7H4xCD3 bispecific antibody. Using HBICE® bispecific technology and Harbour Mice® platform, this bispecific antibody was designed to provide innovative solutions for cancer immunotherapy from both efficacy and safety perspectives. The development of B7H4xCD3 bispecific HBICE® further consolidates the Company's bispecific immune cell engager platform, demonstrating the HBICE® platform's versatility and plug-and-play advantages. In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window. The Company is currently conducting IND-enabling studies for HBM7004. HBM7020 is a BCMAxCD3 bispecific antibody generated using the fully human HBICE® bispecific technology and Harbour Mice® platform. HBM7020 can crosslink targeted cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and cell elimination. By incorporating dual anti-BCMA binding sites for optimal cell targeting and monovalent-optimized CD3 activity to minimize CRS, HBM7020 demonstrated potent cytotoxicity with broad applications in both immunological and oncology diseases. In August 2023, HBM7020 obtained IND clearance from the NMPA to commence a Phase I trial for cancer in China. In 2024, the Company restructured its development strategy to target immunological diseases. In June 2025, Harbour BioMed entered global strategic collaboration with Otsuka. Under the terms of the agreement, Otsuka is granted an exclusive license to develop, manufacture, and commercialize HBM7020 globally, excluding Greater China (Mainland China, Hong Kong, Macau and Taiwan). R2006 (CD19xCD3 bispecific antibody) and HBM7026 (BCMAxCD19xCD3 trispecific antibody) are two T-cell engagers (TCEs) in preclinical development. TCEs have emerged as an important therapeutic strategy for autoimmune diseases, as B-cell depletion has been shown to help restore immune system balance in multiple autoimmune conditions. TCEs can achieve deep depletion of B cells in peripheral blood, lymph nodes, and bone marrow, thereby resetting the immune system. Newly generated B cells subsequently return to a naïve and non-pathogenic state, potentially reducing inflammation and autoimmune responses. CD19 is a marker broadly expressed on precursor and mature B cells, while BCMA is highly expressed on mature B cells and plasma cells. Leveraging its fully human HCAb technology and optimized anti-CD3 antibodies, Harbour BioMed is developing TCEs with enhanced safety, reduced immunogenicity, and lower risk of cytokine release syndrome. In March 2025, Harbour BioMed launched Élancé Therapeutics ("Élancé"). Harnessing Harbour BioMed's proprietary HCAb-based bispecific antibody technology, Élancé aims to develop innovative therapies addressing key challenges in current obesity treatment, including muscle preservation and long-term efficacy. Élancé is building a metabolic disease pipeline of multiple preclinical bispecific antibody programs. By integrating dual-targeting strategies with enhanced safety profiles, these therapies have the potential to complement and expand upon existing treatment options, including various agonists of GLP-1 receptor, GIP receptor, and GCG receptor and further expand the boundaries of obesity treatment. Harbour BioMed is leveraging its fully human antibody and HCAb platforms to develop next-generation biologics for central nervous system (CNS) disorders, including bispecific antibodies and other "Antibody-Plus (Ab+)" therapies. The pipeline in this area is currently under development, with the goal of creating more complex molecules to address the treatment challenges of CNS disorders, including neurodegenerative diseases and neuroinflammation. Maximizing Platform Potential Through Diversified Collaborations Harbour BioMed remains committed to global collaboration. In March 2025, the Company entered into a global strategic collaboration with AstraZeneca to discover and develop next-generation multi-specific antibodies for immunology, oncology and beyond. The strategic collaboration includes an option to license multiple programs utilizing Harbour BioMed's proprietary Harbour Mice® fully human antibody technology platform in multiple therapeutic areas. Furthermore, AstraZeneca acquired 9.15% newly issued shares of Harbour BioMed with a $105 million equity investment. Harbour BioMed will establish an innovation center in Beijing, China to be co-located with AstraZeneca. During the reporting period, Harbour BioMed also signed several licensing and collaboration agreements with global partners. In January 2025, the Company and Kelun-Biotech entered into a licensing agreement with Windward Bio for HBM9378/SKB378 (also known as WIN378), granting Windward Bio to research, develop, manufacture, and commercialize HBM9378/SKB378 globally, excluding Greater China and several Southeast and West Asian countries. In June 2025, Harbour BioMed entered a global strategic collaboration with Otsuka Pharmaceutical to advance the development of HBM7020, a BCMA x CD3 bispecific T-cell engager for the treatment of autoimmune diseases. In February 2025, Harbour BioMed entered into a strategic collaboration with Insilico Medicine, a clinical-stage biotechnology company powered by generative AI, to accelerate the discovery of novel therapeutic antibodies by combining complementary strengths in antibody discovery and artificial intelligence. Leveraging its technological advantages, Harbour BioMed established Nona Biosciences to better empower industry innovators and support collaborators by providing integrated solutions from "Idea to IND" (I to ITM). As a global biotechnology company, Nona Biosciences has established innovative platforms in antibody discovery, protein engineering, antibody-drug conjugation, HCAb-CAR screening, and drug delivery technologies, to accelerate the development of next-generation therapies across academic institutions, leading biotech companies, and multinational pharmaceutical companies. In December 2024, Nona Biosciences entered into a collaboration with Kodiak Sciences (Nasdaq: KOD). This partnership aims to advance the discovery of novel multi-target antibodies to treat ophthalmic diseases, leveraging Nona's proprietary Harbour Mice® fully human antibody platform. In the same month, Nona Biosciences announced a research collaboration and license agreement with Candid Therapeutics to discover next-generation TCEs. In the first half of 2025, Nona Biosciences further expanded its global partnerships, entering into collaborations with Invetx, the University of Alabama at Birmingham, Atossa Therapeutics, and Visterra, unlocking the potential of its proprietary platforms to support partners in advancing biotherapeutics pipeline development and related research. In addition, Nona Biosciences continues to expand the capabilities of its technology platforms. In March 2025, Nona Biosciences launched Hu-mAtrIx™, an innovative AI-assisted drug discovery engine integrates seamlessly with the company's proprietary Harbour Mice® technology platform, aiming to accelerate antibody discovery across multiple key therapeutic areas, including neurodegenerative and metabolic diseases, and more. These collaborations further highlight the Company's unique strengths in advancing innovation. Building on its industry-leading technology platforms and flexible business model, the Company will continue to expand capabilities, strengthen partnerships, and maximize platform value. Incubating Breakthrough Therapies for the Future Harbour BioMed continues to explore the scalability of its platform applications to fully unlock their potential. The Company is incubating several joint ventures focused on next-generation therapies, including multivalence antibodies, cell therapies, and more. By expanding the application scope of its platform technologies, Harbour BioMed aims to create additional value and accelerate next-generation innovation. In November 2024 and July 2025, NK Cell-Tech (an incubated company of Harbour BioMed) announced the completion of its Series A++ and Series A+++ financing rounds, respectively, to further advance its pipeline development and clinical progress. In February 2025, HBM Alpha Therapeutics, a joint venture between Harbour BioMed and Boston Children's Hospital (an affiliate of Harvard Medical School), announced a strategic collaboration and license agreement with a business partner. In March 2025, Harbour BioMed launched Élancé Therapeutics, a new venture leveraging the Company's proprietary HCAb-based bispecific antibody technology to develop innovative therapies addressing key challenges in current obesity treatment, including muscle preservation and long-term efficacy. In addition, Élancé will refine and expand Nona Biosciences' Hu-mAtrIxTM AI platform to support bispecific antibody discovery, with AI applications guiding antibody sequence discovery, enrichment, optimization, bispecific geometry design, and developability/immunogenicity/pharmacokinetics (PK) assessments, as well as patient biomarker studies. Prospects and Outlook: Innovation and Collaboration The achievements and growth momentum Harbour BioMed demonstrated in the first half of 2025 give us strong confidence in the future. Harbour BioMed has proven its ability to successfully navigate a complex market environment and is well-positioned to deliver innovative therapies for patients with immunology and oncology diseases in the near future. Since its establishment, Harbour BioMed has been committed to developing innovative therapies for patients worldwide and has grown into an innovative biopharmaceutical company distinguished by its proprietary technologies and differentiated pipeline. In 2024, the Company successfully completed the BLA submission for HBM9161. Harbour BioMed will further accelerate the advancement of its portfolio, progressing multiple clinical trials for innovative programs which target both novel and established pathways, including HBM4003, HBM9378, and HBM1020. In addition, Harbour BioMed is expanding the capabilities of its platforms into immunology and inflammation, leveraging its powerful Harbour Mice® and HBICE® drug discovery engines to continue identifying novel high-quality candidates. The value of Nona Biosciences' antibody discovery platform and flexible collaboration model has been fully validated through a series of partnerships since its establishment in 2022. Building on this foundation, Harbour BioMed continues to strengthen global collaborations, offering one-stop solutions to academic institutions, biotech startups, and multinational pharmaceutical companies, and unlocking the full potential of its platforms through business partnerships. Looking ahead, Harbour BioMed will continue to advance its globalization strategy. As its preclinical products mature, the company expects to welcome more global collaboration opportunities in 2025. Accordingly, Harbour BioMed will further optimize internal resource allocation, focus on advancing self-developed assets from its proprietary platforms, and continue expanding Nona Biosciences' collaboration network—injecting fresh momentum into the Company's long-term sustainable growth. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions. Harbour BioMed's proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICATM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice®, HBICE®, and HBICATM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit . SOURCE Harbour BioMed WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Phase 2License out/inImmunotherapy

100 Deals associated with Tislelizumab

External Link

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


WCLC2025	Phase 2	metastatic non-small cell lung cancer	30	Chemoradiotherapy + Tislelizumab	hjdfhzenwk(uncxyasbey) = wqrqawwmgj wcooxtgcak (cexxhxwttf ) View more	Positive	09 Sep 2025
WCLC2025	Phase 2	Non-small cell lung cancer stage III Adjuvant \| Neoadjuvant	28	Tislelizumab + Chemotherapy	zczlkyjylk(encupjkxaj) = bjytrcazqv hvrsicdncs (javbsfxsir ) 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))	ohjcntsvgu(pbfaicygrm) = wllcwxzfct fhhvbzyejh (tspekzscpc ) View more	Positive	08 Sep 2025
				Tislelizumab+OciperlimabTislelizumab+Ociperlimabociperlimab (anti-TIGIT) (PD-L1 TC ≥50%, TIS plus ociperlimab (anti-TIGIT))	ohjcntsvgu(pbfaicygrm) = fmsplhnbyn fhhvbzyejh (tspekzscpc ) View more
NCT06456138 (ATTRAS001, WCLC2025)	Phase 1	Advanced Lung Non-Small Cell Carcinoma Third line \| Second line KRAS mutation	12	trametinib+Anlotinib+Tislelizumab	eokylwpmyi(xpwqcbfbyb) = hvouovllgd oharppevcp (btowebkkkv ) View more	Positive	08 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	qpduemvpmb(afcaxbpktc) = svgagubogm qattjcoqgm (mrpdzuxjrw, 15.2 - 19.1) View more	Superior	07 Sep 2025
				Docetaxel	qpduemvpmb(afcaxbpktc) = tbnvccpbyw qattjcoqgm (mrpdzuxjrw, 9.6 - 13.5) View more
ChiCTR2400086532 (WCLC2025)	Phase 2	Non-small cell lung cancer stage III	28	Tislelizumab+Platinum containing dual drug chemotherapy	jfmmxpmrwq(adzjsrfpty) = lcadbyphxv fhmlqcohwl (nfuddiuzxq ) View more	Positive	07 Sep 2025
NCT05014828 (BGB-A317-212, CTgov)	Phase 2	Advanced Malignant Solid Neoplasm	58	tislelizumab+lenvatinib (Safety Run-In)	ciwnlpjanv = pwyuvobwna zvjdgdjjel (wlazckjmqq, shtorytsrb - uamykvtjrd) View more	-	24 Aug 2025
				tislelizumab+lenvatinib (Squamous Cell Carcinoma of the Head and Neck (SCCHN))	mylozfffod = vawxfgtehr mrdsxftkpz (oatelocnaw, jlsvomeamw - ctorhxlodd) View more
NCT05023109 (ZSAB-TOP, Signal Transduct Target Ther) Manual	Phase 2	Advanced biliary tract cancer First line TIGIT	45	Tislelizumab+Ociperlimab+Gemcitabine+Cisplatin	pbjelittgg(shbakilpiw) = dzagoepolw uiwyjjnlmb (ulwieulvrn, 35.1 - 67.1) View more	Positive	21 Aug 2025
				Tislelizumab+Ociperlimab+Gemcitabine+Cisplatin (TIGIT+/PD-L1+)	pbjelittgg(shbakilpiw) = fjfvwdtljg uiwyjjnlmb (ulwieulvrn, 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))	afctiioagy = usjxkxoose qweyqtyweg (xpfxtcehtf, raxiubsbnk - hixeluetjo) View more	-	14 Jul 2025
				tislelizumab+fruquintinib (Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting))	snvxngrxpj = zxnvabfooi pgxdegefxw (proxfjyuoj, qlendluwfo - kulizqxwuu) View more
NCT03783442 (RATIONALE-306, ESMO_GI2025) Manual	Phase 3	Locally Advanced Esophageal Squamous Cell Carcinoma	88	Tislelizumab 200 mg + chemotherapy	csungxhlgc(dkajzfacfb) = fiperoqnwh obzsezmqfk (cwfiacyxxo, 19.4 - 36.3) View more	Positive	05 Jul 2025
				Placebo + chemotherapy	csungxhlgc(dkajzfacfb) = qyvycbcbwv obzsezmqfk (cwfiacyxxo, 9.0 - 21.7) View more

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