RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Australia), Priority Review (Singapore), Conditional marketing approval (China)

Structure/Sequence

Sequence Code 453640391L

Source: *****

Sequence Code 524455911H

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681

Clinical Trials associated with Toripalimab

NCT05479045

/ Not yet recruitingPhase 2IIT

A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients

This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III/IV ovarian cancer (OC).

Start Date01 Jan 2026

Sponsor / Collaborator

Georgetown University

[+1]

NCT07140679

/ Not yet recruitingPhase 2IIT

A Phase II Trial of Adjuvant Toripalimab in High Risk Localized Colon Cancer With Mismatch Repair Deficiency

This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer.

Start Date08 Sep 2025

Sponsor / Collaborator

Emory University

[+2]

NCT07101614

/ Not yet recruitingPhase 2IIT

An Open-label, Randomized, Multi-center, Multi-cohort Clinical Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC).

The objective of this study is to evaluate the efficacy and safety of chemotherapy plus toripalimab, with or without JS004,as neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). TNBC patients were randomly assigned in a 2:2:1 ratio to receive either JS004 plus toripalimab plus chemotherapy, toripalimab plus chemotherapy, or chemotherapy alone.Surgery will be performed within 5 weeks after the last dose of neoadjuvant treatment.

Start Date01 Sep 2025

Sponsor / Collaborator

ShengJing Hospital

100 Clinical Results associated with Toripalimab

100 Translational Medicine associated with Toripalimab

100 Patents (Medical) associated with Toripalimab

723

Literatures (Medical) associated with Toripalimab

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·Journal of Gastrointestinal Cancer

Toripalimab in Esophageal Cancer: A Systematic Review and Meta-Analysis

Review

Author: Awadalla, Elian Khalafalla ; Khalifa, Mostafa A ; Allam, Salma ; Dway, Ali ; Saleh, Ahmad Omar ; Hashim, Hashim Talib ; Shimal, Aya Ahmed ; Ahmed, Marafi Jammaa ; Alzedaar, Jubran Khaled ; Abdultawab, Roaa ; Ghuraibawi, Mohammedbaqer ; Al-Hadrawi, Asala Hussein ; Saud, Hadeel Basheer Bin

BACKGROUND:

Esophageal cancer (EC) remains a highly aggressive malignancy with a poor prognosis despite advancements in treatment. Toripalimab, a PD-1 inhibitor, has demonstrated the potential to improve clinical outcomes. This systematic review and meta-analysis assess the efficacy and safety of Toripalimab in EC.

METHODS:

Following PRISMA 2020 guidelines, we conducted a systematic review and meta-analysis, searching PubMed, Embase, Scopus, ScienceDirect, and Google Scholar up to January 2025. Eligible studies evaluated Toripalimab in esophageal cancer, including randomized controlled trials and non-randomized controlled trials. Primary outcomes included overall survival (OS), progression-free survival (PFS), and objective response rate (ORR), while safety outcomes assessed treatment-related adverse events. Data were synthesized using random-effects models, with heterogeneity evaluated via Cochrane's Q and I² statistics.

RESULTS:

The pooled analysis included six studies involving 678 patients. Toripalimab demonstrated promising efficacy, with a Complete Response (CR) rate of 33%, Partial Response (PR) rate of 36%, pathological complete response (pCR) rate of 30%, and major pathological response (MPR) rate of 46%. The R0 resection rate was 87%, while OS and PFS rates were reported at 78% and 50%, respectively. Anemia (56%), alopecia (54%), leukopenia (54%), and fatigue (30%) were the most frequently reported adverse effects. Other common adverse effects included nausea (29%), constipation (18%), and vomiting (20%).

CONCLUSIONS:

Toripalimab demonstrates significant potential in treating esophageal cancer, with favorable response rates and survival outcomes. However, the high incidence of adverse effects highlights the need for supportive care and ongoing research. While based on limited sample sizes and single-arm studies that may introduce bias and affect generalizability in this review, we provide valuable preliminary insights into toripalimab's potential, highlighting the need for larger randomized trials to build on these findings.

01 Oct 2025·NEOPLASIA

Disitamab vedotin combined with toripalimab and radiotherapy for multimodal organ-sparing treatment of muscle invasive bladder cancer: a proof-of-concept study

Article

Author: Zhang, Ruiyun ; Xie, Feng ; Xia, Jun ; Zhuang, Guanglei ; Chen, Haige ; Zhang, Tianxiang ; Cao, Dengfeng ; Zhang, Lu ; Tang, Haoran ; Qian, Lei ; Zang, Jingyu ; Ding, Yu ; Wu, Yuchen ; Jin, Di

PURPOSE:

Although trimodal therapy is currently the standard organ-sparing approach for muscle-invasive bladder cancer (MIBC), its clinical benefit is limited, and noninvasive biomarkers to guide dynamic decision-making are lacking. Here, we present a proof-of-concept study evaluating disitamab vedotin (RC48, a HER2-targeted antibody-drug conjugate) combined with toripalimab (JS001, anti-PD-1) and radiotherapy for bladder preservation in localized HER2-positive MIBC.

PATIENTS AND METHODS:

In the first-stage of an open-label phase II clinical trial (ClinicalTrials.gov identifier: NCT05979740), six patients were enrolled and received disitamab vedotin, toripalimab, and radiotherapy. Adverse events were documented according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0). Tumor response was evaluated every 12 weeks by radiographic imaging, cystoscopy with biopsies, and urine cytology. In parallel, we performed longitudinal liquid biopsy analyses of circulating tumor DNA (ctDNA) and urinary tumor DNA (utDNA) using PredicineCARE assay.

RESULTS:

The combination was overall tolerable, with no grade 4 treatment-related adverse events or deaths. Five patients (83.3 %) achieved a complete response and remained recurrence-free. Notably, utDNA testing showed high accuracy in monitoring therapeutic effectiveness and enabled early detection of tumor relapse, whereas ctDNA was largely undetectable across blood samples.

CONCLUSIONS:

These findings establish the feasibility, efficacy, and potential biomarker utility of a novel bladder-preserving regimen, setting the stage for a paradigm shift in MIBC management.

487

News (Medical) associated with Toripalimab

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

27 Aug 2025

·www.globenewswire.com

TREOS Bio Partners with Charité Berlin and Junshi Biosciences to Launch Pivotal Phase II Clinical Trial in Refractory MSS Colorectal Cancer

Bridge financing of $2.1 million supports initiation of pivotal Phase II study in 140 patients with microsatellite stable metastatic colorectal cancer, addressing 85% of CRC cases with limited treatment optionsLONDON, Aug. 27, 2025 (GLOBE NEWSWIRE) -- TREOS Bio Ltd., a clinical-stage biotechnology company developing next-generation off-the-shelf peptide cancer immunotherapies, today announced the execution of clinical collaboration agreements with Charité – Universitätsmedizin Berlin and Junshi Biosciences for the initiation of OBERTO-202, a potentially registration-enabling Phase II clinical trial evaluating PolyPEPI1018 in combination with toripalimab (Junshi Biosciences' PD-1 inhibitor) and standard of care in microsatellite stable (MSS) metastatic colorectal cancer (CRC). The company also completed a $2.1 million bridge financing from existing investors, bringing total financing raised to date to $47M, not counting non-dilutive support from grants and clinical collaborations. The OBERTO-202 study will be conducted as an investigator-led trial at Charité – Universitätsmedizin Berlin, one of Europe's largest university hospitals, with Prof. Sebastian Stintzing as principal investigator and in collaboration with 14 other leading academic hospitals. The trial will evaluate PolyPEPI1018 and toripalimab in combination with standard of care (Lonsurf + Avastin) versus standard of care alone in approximately 140 patients with relapsed/refractory MSS CRC. "The collaboration with Charité Berlin and Junshi Biosciences represents a significant milestone as we work toward demonstrating the potential of our precision immunotherapy approach in one of the largest oncology markets with significant unmet medical need," said Dr. Christopher Gallen, Chairman and CEO of TREOS Bio. "The bridge financing provides us with the runway to advance our lead program toward what we anticipate will be a registration-enabling Phase II study." “This randomized, controlled clinical trial represents a logical next step in the development of PolyPEPI1018,” said Dr. Hagop Youssoufian, Chair of Medical Strategy of TREOS Bio and Adjunct Professor of Medicine at Brown University. “Leveraging the built-in antigenic diversity of this unique active immunotherapy that can dampen multiple immunosuppressive mechanisms, in combination with toripalimab and chemotherapy, provides an exciting opportunity to overcome the well-known resistance to immunotherapies in MSS CRC.” PolyPEPI1018 is TREOS Bio's lead off-the-shelf multi-peptide active cancer immunotherapy designed to convert immunologically "cold" tumors to "hot" tumors. The therapy has demonstrated encouraging clinical activity across three Phase I/II trials (44 patients in total) in advanced MSS CRC conducted in partnership with the Mayo Clinic, with consistent correlations between immune activation and clinical benefit. MSS CRC represents approximately 85% of all colorectal cancer cases and affects an estimated 130,000 new patients annually in the US alone and over 1.6 million new patients globally. Current immunotherapies, including checkpoint inhibitors, have shown limited efficacy in this patient population. About TREOS Bio TREOS Bio is a clinical-stage biotechnology company developing precision cancer immunotherapies based on its proprietary PASCal (Personal Antigen Selection Calculator) platform. The company's lead program, PolyPEPI1018, is an off-the-shelf multi-peptide immunotherapy targeting shared tumor antigens with demonstrated clinical activity in MSS colorectal cancer. TREOS Bio has partnerships with leading institutions including Mayo Clinic, Charité – Universitätsmedizin Berlin, Roche and Junshi Biosciences. For more information, visit www.treosbio.com. Forward-Looking Statements This press release contains forward-looking statements regarding TREOS Bio's clinical development plans and anticipated timelines. Actual results may differ materially from those indicated by such forward-looking statements. Media Contact:Sidharth Mehtasmehta@allelecapital.com

Phase 2Immunotherapy

27 Aug 2025

·www.globenewswire.com

Junshi Biosciences Announces 2025 Interim Financial Results and Provides Corporate Updates

SHANGHAI, Aug. 26, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its 2025 interim financial results and provided corporate updates. FINANCIAL HIGHLIGHTS As of June 30, 2025, the total revenue of Junshi Biosciences was approximately RMB1,168 million for the first half of 2025, representing an increase of approximately 49% compared to 2024, driven mainly by pharmaceutical sales. In particular, the domestic sales revenue of our core product, TUOYI® (toripalimab), reached approximately RMB954 million, an increase of approximately 42% from 2024.Total research and development (“R&D”) expenses of the company were approximately RMB745 million for the first half of 2025, an approximately 36% increase compared to 2024. The higher R&D expenses were mainly due to the company’s focus on more competitive and innovative R&D pipelines and accelerated clinical development during the first half of 2024.Loss attributable to owners of the company fell to RMB413 million, representing a decrease of approximately RMB232 million or approximately 36% compared to 2024.During the first half of 2025, net cash inflow from financing activities was approximately RMB1,386 million, primarily attributable to the successful placement of the company’s new H shares on June 20, 2025, which generated a net inflow of approximately RMB940 million. This net cash inflow fully offset the cash outflows from operating and investing activities, leading to an overall increase in bank balances and cash.As of June 30, 2025, the aggregate balance of bank balances and cash and financial products of the company was approximately RMB3,490 million, ensuring a relatively stable liquidity position to support the company’s continued development. BUSINESS HIGHLIGHTS During the first half of 2025, we focused on addressing “unmet medical needs”. We have made original, innovative and breakthrough progress in the discovery, R&D and commercialization of innovative therapies and novel drugs with accelerating international development. The following are achievements and milestones we have reached: Advancements in the pipeline: the company’s innovative R&D field has expanded from monoclonal antibodies to the research and development of various drug modalities, including small molecules drugs, antibody drug conjugates (“ADC”), bi-specific or multi-specific antibodies, fusion protein, nucleic acid drugs and vaccines, as well as the exploration of next-generation innovative therapies including cancer and autoimmune diseases. The product pipelines cover five major therapeutic areas including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurologic diseases and infectious diseases. A total of four drugs (TUOYI®, JUNMAIKANG, MINDEWEI and JUNSHIDA) have been commercialized, around 30 assets are undergoing clinical trials, and over 20 drug candidates are in preclinical drug development. In January 2025, the indication of TUOYI® for the treatment of unresectable or metastatic melanoma after failure of standard systemic therapy was approved by the National Medical Products Administration of China (the “NMPA”) for conversion from conditional approval to regular approval.In January 2025, the investigational new drug (“IND”) application for JS212 (a recombinant humanized epidermal growth factor receptor (“EGFR”) and human epidermal growth factor receptor 3 [“HER3”] bispecific ADC) was accepted by the NMPA and subsequently approved in March 2025.In January 2025, the indication of MINDEWEI for the treatment of adult patients with mild to moderate coronavirus disease 2019 (“COVID-19”) was approved by the NMPA for conversion from conditional approval to regular approval.In January 2025, the New Chemical Entity (“NCE”) application for 1) toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (“NPC”) and 2) toripalimab, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after platinum-containing chemotherapy was approved by the Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (the “TGA”). Toripalimab became the first immuno-oncology treatment for NPC in Australia.In February 2025, the IND application for JS213 (a PD-1 and interleukin-2 (“IL-2”) bifunctional antibody fusion protein) was approved by the NMPA.In March 2025, the supplemental new drug application (the “sNDA”) for TUOYI® in combination with bevacizumab for the first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma (“HCC”) was approved by the NMPA.In March 2025, the new drug application (the “NDA”) for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC was approved by the Singapore Health Sciences Authority (the “HSA”). Toripalimab became the first approved immuno-oncology treatment for NPC in Singapore.In April 2025, the sNDA for TUOYI® for the first-line treatment of unresectable or metastatic melanoma was approved by the NMPA. This was toripalimab’s 12th indication in the Chinese Mainland.In May 2025, the two sNDAs for the ongericimab injection (a recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: JUNSHIDA) for: 1) adult patients with heterozygous familial hypercholesterolemia (“HeFH”); 2) alone or in combination with ezetimibe, in adult patients with non-familial hypercholesterolemia and mixed dyslipidemia who are statin-intolerant or statins contraindicated, were approved by the NMPA. Ongericimab became the first domestic PCSK9-targeted drug approved for statin-intolerant patients.In June 2025, the IND application for the JT118 injection (“JT118”) was accepted. JT118 is a “two-in-one” recombinant protein vaccine composed of a tandem fusion of monkeypox virus antigens A35 (an extracellular enveloped virus antigen) and M1 (an intracellular mature virus antigen), and is intended mainly for the prevention of monkeypox virus infection.In June 2025, the indications of toripalimab for the first-line treatment of NPC and the first-line treatment of esophageal squamous cell carcinoma (“ESCC”) were officially approved for marketing in the United Arab Emirates (the “UAE”) and Kuwait. External collaborations In January 2025, TopAlliance Biosciences, a wholly-owned subsidiary of the company, entered into a distribution and marketing agreement with LEO Pharma. TopAlliance Biosciences will grant LEO Pharma the exclusive right to store, distribute, promote, market and sell toripalimab in all current member states and any future member states of the European Union (the “EU”) and the European Economic Area (the “EEA”), Switzerland as well as the United Kingdom (the “UK”) (the “Territory”). LEO Pharma shall pay TopAlliance Biosciences an upfront payment of EUR15 million, milestone payment(s) for any subsequent approved indication(s) for toripalimab in the Territory, and a revenue share of a double-digit percentage on the net sales of toripalimab throughout the Territory. Business operations In June 2025, the company convened the 2024 annual general meeting, at which all resolutions were considered and approved.In June 2025, the company completed the placing of new H shares under general mandate (the “Placing”), pursuant to which an aggregate of 41,000,000 H shares (the “Placing Shares”) were successfully allotted and issued at HK$25.35 per H share. The net proceeds (after deduction of commissions and estimated expenses) amounted to approximately HK$1,026 million, which will be used for innovative drug development and general corporate purposes such as replenishment of working capital. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in 40 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com. Junshi Biosciences Contact InformationIR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800

Drug ApprovalFinancial StatementLicense out/inVaccinePhase 1

100 Deals associated with Toripalimab

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic melanoma	China	Shanghai Junshi Biosciences Co., Ltd.	22 Apr 2025
Unresectable Melanoma	China	Shanghai Junshi Biosciences Co., Ltd.	22 Apr 2025
Advanced Hepatocellular Carcinoma	China	Shanghai Junshi Biosciences Co., Ltd.	18 Mar 2025
Metastatic Esophageal Squamous Cell Carcinoma	European Union	Topalliance Biosciences, Inc.	19 Sep 2024
Metastatic Esophageal Squamous Cell Carcinoma	Iceland	Topalliance Biosciences, Inc.	19 Sep 2024
Metastatic Esophageal Squamous Cell Carcinoma	Liechtenstein	Topalliance Biosciences, Inc.	19 Sep 2024
Metastatic Esophageal Squamous Cell Carcinoma	Norway	Topalliance Biosciences, Inc.	19 Sep 2024
Nasopharyngeal Neoplasms	European Union	Topalliance Biosciences, Inc.	19 Sep 2024
Nasopharyngeal Neoplasms	Iceland	Topalliance Biosciences, Inc.	19 Sep 2024
Nasopharyngeal Neoplasms	Liechtenstein	Topalliance Biosciences, Inc.	19 Sep 2024
Nasopharyngeal Neoplasms	Norway	Topalliance Biosciences, Inc.	19 Sep 2024
Oesophageal squamous cell carcinoma recurrent	European Union	Topalliance Biosciences, Inc.	19 Sep 2024
Oesophageal squamous cell carcinoma recurrent	Iceland	Topalliance Biosciences, Inc.	19 Sep 2024
Oesophageal squamous cell carcinoma recurrent	Liechtenstein	Topalliance Biosciences, Inc.	19 Sep 2024
Oesophageal squamous cell carcinoma recurrent	Norway	Topalliance Biosciences, Inc.	19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma	European Union	Topalliance Biosciences, Inc.	19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma	Iceland	Topalliance Biosciences, Inc.	19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma	Liechtenstein	Topalliance Biosciences, Inc.	19 Sep 2024
Unresectable Esophageal Squamous Cell Carcinoma	Norway	Topalliance Biosciences, Inc.	19 Sep 2024
Triple Negative Breast Cancer	China	Shanghai Junshi Biosciences Co., Ltd.	18 Jun 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Transitional Cell Carcinoma	NDA/BLA	China	Shanghai Junshi Biosciences Co., Ltd.	09 Aug 2025
Neoplasms	NDA/BLA	Canada	Apotex, Inc.	01 Dec 2024
Nasopharyngeal Cancer, Recurrent	NDA/BLA	European Union	Tmc Pharma (Eu Ltd.	14 Nov 2022
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	China	Shanghai Junshi Biosciences Co., Ltd.	11 Jul 2024
Refractory Classic Hodgkin Lymphoma	Phase 3	China	Shanghai Junshi Biosciences Co., Ltd.	28 Dec 2023
Small cell lung cancer limited stage	Phase 3	United States	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	China	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	Belgium	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	France	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	Georgia	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05664971 (WCLC2025)	Phase 1/2	Extensive stage Small Cell Lung Cancer First line	44	Tifcemalimab 200 mg + Toripalimab 240 mg + Chemotherapy	zfgnfizubv(tgkddocfvo) = zlqrlprjgh coxycdvupe (ludtjuiquh ) View more	Positive	09 Sep 2025
NCT04418648 (WCLC2025) Manual	Phase 2	Small cell lung cancer limited stage	96	Toripalimab consolidation	damcveaibu(yjfyipamuk) = yuxknapbbd hhooobgxfp (gkkcdefivg ) View more	Positive	09 Aug 2025
NCT04418648 (WCLC2025) Manual	Phase 2	Small cell lung cancer limited stage	96	Observation	damcveaibu(yjfyipamuk) = ldbxszkezr hhooobgxfp (gkkcdefivg, 3.2 - 20.5) View more	Positive	09 Aug 2025
Pubmed Manual	Phase 1	Advanced Hepatocellular Carcinoma Second line	28	Porustobart (HBM4003) + Toripalimab	rsolxtfddb(ekgicuskhu) = ddysszopyu wfajpcmftb (ewgwmcqeds, 9.0 - 43.6) View more	Positive	01 Aug 2025
Pubmed Manual	Phase 1	Advanced Hepatocellular Carcinoma Second line	28	Porustobart (HBM4003) + Toripalimab (anti-PD-1/PD-L1 naïve and had received first-line anti-VEGFR tyrosine kinase inhibitor)	rsolxtfddb(ekgicuskhu) = xhaxnwjsze wfajpcmftb (ewgwmcqeds ) View more	Positive	01 Aug 2025
NCT04144608 (Pubmed \| Med) Manual	Phase 2	Non-Small Cell Lung Cancer	29	Toripalimab + Platinum-doublet chemotherapy	fsssqdmgff(myfdovgatd) = clpgloggew cvsynvedzc (ckinpypjoq ) View more	Positive	01 Jun 2025
NCT04025931 (ASCO2025) Manual	Phase 2	Soft Tissue Sarcoma	69	Chidamide + toripalimab	chajaavsjh(yqcjtnlinm) = cxfkhzsbmo aexikeatcp (frsfgvdaag ) View more	Positive	30 May 2025
NCT06592326 (ASCO2025 \| PRNewswire) Manual	Phase 1/2	Transitional Cell Carcinoma First line	40	9MW2821 + toripalimab	yotlojpgeh(tgmrjdawjf) = mhleghxjxs nitnjgjszp (wqyxyknoah ) View more	Positive	30 May 2025
ChiCTR2100046715 (ASCO2025)	Phase 2	Advanced Esophageal Squamous Cell Carcinoma First line	33	Toripalimab + Paclitaxel + Carboplatin + Radiotherapy	ywywqrbfvp(heantrhjmb) = nkhnrobzwr adjmpseczw (cjqdjkrdga ) View more	Positive	30 May 2025
NCT06416696 (TorCH-CC, ASCO2025)	Phase 2	Uterine Cervical Cancer Maintenance	43	Toripalimab + CRT + Maintenance Therapy	vhyspteacc(oyimkwbaql) = whacwtwckv jtmivmqdwn (xbbeiyrilc )	Positive	30 May 2025
NCT04118855 (NEOTAX, ASCO2025)	Phase 2	Renal Cell Carcinoma Neoadjuvant	40	Toripalimab plus Axitinib	pdnbbhfztb(icqmukjvqi) = tlltevwldm srwzohywqe (ijzxrstpzj ) View more	Positive	30 May 2025
NCT06178159 (ASCO2025)	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	-	Disitamab vedotin + Pertuzumab	xdlwjfgqra(mssqykfixw) = frdfkgvyzi xdmiziwrob (ysmmaxyudg, 4.33 - 48.09) View more	Positive	30 May 2025
NCT06178159 (ASCO2025)	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	-	Disitamab vedotin + Pertuzumab + Toripalimab	xdlwjfgqra(mssqykfixw) = udydehcczj xdmiziwrob (ysmmaxyudg, 23.04 - 76.96) View more	Positive	30 May 2025

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