This is a single arm, open-label, phase II trial investigating the combination of ivonescimab with standard FOLFOX chemotherapy in 1L therapy for HER2- GEA.

Start Date12 Dec 2025

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

NCT07038915

/ Not yet recruitingPhase 2IIT

STRIVE: A Single-arm Phase 2 Study on Treatment of Lung Squamous Cell Carcinoma by Tiragolumab Plus Ivonescimab for Patients Who Progressed on Platinum Doublets and Anti-PD-1/PD-L1

To learn if the drug combination of tiragolumab and ivonescimab can help to control LSCC that got worse after standard treatment with platinum doublets and anti-PD-1/PD-L1 therapy.

Start Date03 Dec 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT07057791

/ Not yet recruitingPhase 2IIT

Phase II Dose Optimization Study of Platinum/Etoposide Plus Ivonescimab (CEI) as First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

Eligible untreated participants with Extensive Stage Small Cell Lung Cancer (ES-SCLC) who are ? 18 years of age will be randomized to receive ivonescimab 10 milligrams per kilogram (mg/kg) or ivonescimab 20 mg/kg in combination with carboplatin and etoposide.
Ivonescimab is a type of drug called a bispecific antibody. Antibodies are proteins that specifically recognize and bind to other types of proteins called antigens. Antibodies and antigens can work together to help the immune system fight cancer cells. Bispecific antibody, meaning it targets two different molecules at the same time.
Ivonescimab is a new drug that may help the immune system attack cancer cells and may also block certain pathways that cancer uses to grow and spread. This dual action of ivonescimab aims to help the immune system to fight the cancer and also disrupt tumor growth by blocking blood vessel formation that tumors use to grow.
Participants will receive induction with 4 cycles of ivonescimab (dose determined by randomization) with standard of care carboplatin and etoposide followed by maintenance therapy with ivonescimab at the same dose received during induction. Treatment will continue until disease progression, unacceptable toxicity or participant withdrawal.
The purpose of this study is to determine what dose of ivonescimab works best in combination with carboplatin and etoposide chemotherapy in ES-SCLC. We will also examine the side effects, good and bad, associated with ivonescimab.

Start Date01 Dec 2025

Sponsor / Collaborator

Summit Therapeutics, Inc.

100 Clinical Results associated with Ivonescimab

100 Translational Medicine associated with Ivonescimab

100 Patents (Medical) associated with Ivonescimab

Literatures (Medical) associated with Ivonescimab

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

Author: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

01 Aug 2025·Nature Reviews Clinical Oncology

The next generation of immunotherapies for lung cancers

Review

Author: Yang, Weiwei ; Zhang, Li ; Zhao, Hongyun ; Zhao, Shen

Immunotherapies, specifically immune-checkpoint inhibitors (ICIs) targeting PD-(L)1 or CTLA4, have revolutionized the treatment of lung cancer; however, many patients do not have a response to ICIs and most of those with an initial tumour response eventually have disease progression owing to acquired resistance. Over the past few years, numerous therapeutic strategies have been explored to address the problems of intrinsic and acquired resistance to ICIs. In 2024, regulatory approvals of the bispecific PD-1 × VEGF antibody ivonescimab for the treatment of non-small-cell lung cancer in China and the bispecific DLL3 × CD3 T cell engager tarlatamab for patients with small cell lung cancer in the USA provided clinical proof-of-concept for overcoming the challenge of ICI resistance using novel immunotherapeutic agents, thereby increasing enthusiasm for the exploration of next-generation immunotherapies for lung cancer. A large variety of immunotherapies with diverse targets and mechanisms of action are currently being tested in clinical trials involving patients with lung cancer. In this Review, we provide an overview of these emerging immunotherapies in clinical development for non-small-cell lung cancer and/or small cell lung cancer, including novel immune-checkpoint modulators, immune cell engagers, adoptive cell therapies and therapeutic cancer vaccines. We describe the designs of these agents and the mechanisms by which they might overcome resistance to the current generation of ICIs. We also discuss hurdles impeding the clinical translation of each immunotherapeutic modality and potential strategies to address these challenges, using representative examples of agents that have entered the later phases of clinical testing.

12 Jun 2025·Antibody therapeutics

A novel bispecific antibody CVL006 superior to AK112 for dual targeting of PD-L1 and VEGF in cancer therapy

Article

Author: Shen, Xiaokun ; Huang, Hao ; Wu, Ziai ; Cao, Liang ; Pan, Junfang ; Li, Zhongyuan ; Song, Zeng ; Chen, XiaoBing ; Wang, Chunyan ; Huang, Jinwen

Abstract:

Background:

Preclinical and clinical studies highlight the enhanced anticancer efficacy of combining anti-VEGF/VEGFR drugs with immune checkpoint inhibitors (ICIs). PD-L1/VEGF bispecific antibodies outperform monotherapy or combined PD-L1 inhibitors and anti-VEGF antibodies by simultaneously blocking the PD-1/PD-L1 immune pathway and VEGF-driven angiogenesis, providing a dual mechanism for superior antitumor activity.

Methods:

We developed CVL006, a novel bispecific antibody, by fusing an anti-PD-L1 VHH domain with a humanized IgG1 anti-VEGF monoclonal antibody. CVL006 retains antibody-dependent cellular cytotoxicity (ADCC) functionality. Preclinical evaluations included binding affinity and specificity assessments, dual-pathway blockade testing, and in vivo efficacy comparisons to atezolizumab and PD-1/VEGF bispecific antibody AK112 (ivonescimab).

Results:

CVL006 demonstrated high affinity and specificity for human PD-L1 and VEGF. It effectively inhibited VEGF/VEGFR signaling and the PD-L1/PD-1 axis, suppressing VEGF-induced angiogenesis and reactivating T cells. This reactivation led to increased cytokine secretion critical for immune response. In vivo studies revealed CVL006’s superior antitumor efficacy, achieving greater tumor growth inhibition and angiogenesis suppression than atezolizumab. CVL006 also outperformed AK112 in preclinical models, showcasing robust antitumor activity.

Conclusions:

CVL006 integrates immune checkpoint inhibition and tumor vascularization disruption, offering a comprehensive anticancer strategy. Its superior preclinical performance compared to atezolizumab and AK112 underscores its therapeutic potential, paving the way for further development and clinical translation.

219

News (Medical) associated with Ivonescimab

28 Jul 2025

·pipelinereview.com

NMPA Accepts sNDA for Ivonescimab in Combination with Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer

HONG KONG, China I July 28, 2025 I Akeso, Inc. (9926.HK) (“Akeso” or the “Company”) is pleased to announce that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC). This submission represents the third accepted application for ivonescimab in China, following previous filings for its combination therapy in EGFR-TKI resistant locally advanced or metastatic non-squamous NSCLC (nsq-NSCLC), as well as its monotherapy for first-line treatment of PD-L1 positive advanced NSCLC. PD-1 combined with chemotherapy has become a cornerstone in cancer therapy. The sNDA for ivonescimab’s new indication is based on the strong positive outcomes from its Phase III trial (AK112-306/HARMONi-6 study), which showed that ivonescimab combined with chemotherapy is superior to tislelizumab plus chemotherapy. Building on the success of its head-to-head comparison with pembrolizumab, ivonescimab’s ability to outperform PD-1 combination therapy marks a significant step forward in the evolution of global cancer immunotherapy. Currently, ivonescimab is involved in over 12 registrational/Phase III clinical trials worldwide, including six head-to-head studies with PD-1/L1 inhibitors. These trials span a diverse range of malignancies, such as various subtypes of lung cancer, first-line colorectal cancer, first-line head and neck squamous cell carcinoma, first-line biliary tract cancer, first-line pancreatic cancer, and first-line triple-negative breast cancer, among others. Ivonescimab has established a broad and strategic footprint across key cancer immunotherapy indications. As part of the company’s “IO+ADC” 2.0 oncology strategy, ivonescimab is positioned as a cornerstone agent in immuno-oncology, being evaluated in combination with innovative therapies targeting novel mechanisms and pathways. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. (9926.HK, “Akeso”) contains “forward-looking statements”. These statements reflect the current beliefs and expectations of Akeso’s management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso’s other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world’s first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 2 new drugs with 2 new indications are under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin . SOURCE: Akeso

ImmunotherapyPhase 3Drug Approval

24 Jul 2025

·www.prnewswire.com

Akeso Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer

HONG KONG, July 23, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the first patient has been enrolled in the pivotal/registration Phase III clinical trial (AK112-310/HARMONi-GI2) of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by the company. The trial is investigating ivonescimab in combination with chemotherapy, with or without ligufalimab (CD47 monoclonal antibody), for the first-line treatment of metastatic pancreatic cancer. Pancreatic cancer remains one of the most challenging types of tumors to find effective treatments for. While immunotherapies have demonstrated significant efficacy in different types of of solid tumors, pancreatic cancer's unique immune evasion mechanisms and its highly immunosuppressive tumor microenvironment (TME) have rendered it resistant to current therapies. As a result, previous Phase III studies on using immunotherapies as first-line treatments for metastatic pancreatic cancer have mostly failed. To date, no immunotherapy has been approved for first line metastatic pancreatic cancer. Ivonescimab, in combination with chemotherapy and/or ligufalimab, has the potential to address the current lack of effective options in first-line immunotherapy for metastatic pancreatic cancer. This randomized, controlled, multi-center Phase III trial is a key component of Akeso's broader strategy to address the significant unmet clinical needs in global oncology. Pancreatic cancer is an extremely aggressive form of malignancy that often result in poor patient prognosis. Its global incidence is on the rise, and the mortality rate closely mirrors the incidence, resulting in alarmingly low overall survival rates. In 2022, approximately 511,000 new cases of pancreatic cancer were diagnosed worldwide, and 467,000 deaths were recorded. Early diagnosis remains challenging, with around 80% of patients being diagnosed at an advanced stage. Even those diagnosed with early-stage or locally advanced disease may see progression to metastatic pancreatic cancer within a year following surgery or other treatments. Current first-line treatments are predominantly chemotherapies and have showed very limited success, with a median overall survival (OS) of less than one year. PD-1 and VEGF are often co-expressed in the tumor microenvironment. As a PD-1/VEGF bispecific antibody, Ivonescimab can accumulate in the TME and effectively block both the PD-1 and the VEGF signaling pathways. While these pathways are independently active, they are also complementary. Inhibition of both PD-1 and VEGF enhances immune cells' ability to target and destroy tumor cells. In addition, ligufalimab binds to CD47 on tumor cells, disrupting the interaction with signal regulatory protein alpha (SIRPα) on phagocytic cells. This process boosts phagocytosis and inhibits tumor growth. The combination of ivonescimab with ligufalimab is expected to synergistically enhance anti-tumor activity, offering a potential breakthrough in the first-line treatment for metastatic pancreatic cancer. Professor Yu Xianjun, Director of Fudan University Shanghai Cancer Center, Professor Ying Jie'er from Zhejiang Cancer Hospital, and Professor Tai Sheng from Harbin Medical University Cancer Hospital are the co-principal investigators of HARMONi-GI2 study. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 2 new drugs with 2 new indications are under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 3

18 Jul 2025

·www.prnewswire.com

Weekly Recap: 14 Health Press Releases You Need to See

A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including a breakthrough in dental manufacturing, a new alopecia treatment and an app to help women navigate perimenopause. NEW YORK, July 18, 2025 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Weekly Health Press Release Roundup, July 14-18, 2025. Zimmer Biomet Announces Definitive Agreement to Acquire Monogram Technologies, Expanding Robotics Suite with Autonomous Solutions The proposed transaction creates the broadest, most flexible portfolio of orthopedic robotics and navigation technologies to meet surgeons' needs. Cardinal Health announces One Voice Initiative to support independent pharmacy advocacy This investment furthers Cardinal Health's longstanding advocacy around the future of independent pharmacies and ongoing partnerships with industry organizations to support pharmacists' efforts to build relationships with elected officials at all levels of government.  Sun Pharma Announces Launch of LEQSELVI™ (deuruxolitinib) in the United States for the Treatment of Severe Alopecia Areata LEQSELVI demonstrated rapid results in clinical trials with one third of patients regaining almost all of their hair by Week 24. Some patients (3%) achieved 80% or more scalp coverage as fast as 8 weeks. Waters and BD's Biosciences & Diagnostic Solutions Business to Combine, Creating a Life Science and Diagnostics Leader Focused on Regulated, High-Volume Testing The transaction will bring together complementary technologies to serve high-volume testing in attractive and regulated end-markets. The combined company will have best-in-class liquid chromatography, mass spectrometry, flow cytometry, and diagnostic solutions, doubling Waters' total addressable market to approximately $40 billion. Illimis Therapeutics Closes 58 billion KRW ($42 million) Series B Financing to accelerate CNS and Immune Disease Drug Development via GAIA Platform The proceeds will be used to accelerate the development of GAIA-based Alzheimer's Disease therapeutics, expand its target indications to various immune disorders, and broaden its pipeline of potential blockbuster drug candidates. The company is actively pursuing early-stage collaborations with global pharmaceutical companies and research institutions to add value to internal programs. Nanoscope Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for MCO-010, the First Gene-Agnostic Therapy to Treat Retinitis Pigmentosa If approved, MCO-010 has the potential to be the standard of care for retinitis pigmentosa, delivered via a one-time, in-office intravitreal injection with the ability to restore vision in patients with severe vision loss regardless of their underlying genetic mutation. OpenEvidence, the Fastest-Growing Application for Physicians in History, Announces $210 Million Round at $3.5 Billion Valuation OpenEvidence rapidly surfaces relevant medical knowledge, synthesizes medical research, and gives clinicians the power to make faster, more evidence-based decisions—accelerating both medical literature review and clinical decision support. By reducing the lag between new evidence and bedside application, OpenEvidence enables improved patient outcomes. Flo for Perimenopause is Launching to Empower the 1 Billion+ Women Who Experience Perimenopause Without the Support They Deserve The in-app feature offers educational content that is backed by research and insights, and created in collaboration with a team of 100+ medical experts. With Flo for Perimenopause, Flo Health is redefining how women navigate one of the most misunderstood and underserved stages of life. Akeso Announces First Patient Enrolled in the Phase III Trial (AK112-312/HARMONi-GI6) of Ivonescimab for First-Line Treatment of Advanced Metastatic Colorectal Cancer Colorectal cancer remains the third most common cancer globally and the second leading cause of cancer-related deaths. In 2022, over 1.9 million new cases were reported, with approximately 904,000 deaths. Of these, about 95% of mCRC cases are classified as microsatellite stable (MSS) or proficient mismatch repair (pMMR), which traditionally show poor responses to immunotherapy and the tumors are often referred to as an "immune desert." HeyGears Achieves Breakthrough in Multi-Material Resin 3D Printing, Overcoming Bottlenecks in Dental Manufacturing HeyGears' biocompatible photopolymer resin materials and high-precision 3D printing solutions ensure the quality and reliability of the results. AI-powered digital workflows optimize every step, from model design to post-processing, achieving highly efficient and intelligent large-scale dental production. SandboxAQ and iOncologi Partner to Accelerate Brain Cancer Treatment with AI-driven Drug Discovery For Glioblastoma "Our collaboration with iOncologi aims to create a new and effective treatment for this challenging condition, pairing the most comprehensive oncology datasets with advanced quantitative AI tools and simulation techniques, greatly accelerating the drug discovery process," said Jack Hidary, CEO of SandboxAQ. Edgepark expands diabetes offerings with two new product innovations "Diabetes is one of the fastest-growing conditions in the United States, and the introduction of innovations like a one-year wearable system and blood glucose biosensors that can be used without a prescription will no doubt play a pivotal role in the well-being of the patients we serve," said Anthony Alvarez, SVP and GM of Edgepark. Citius Oncology Expands Distribution Network for LYMPHIR with Execution of Distribution Services Agreement with Cencora This new agreement expands Citius Oncology's commercial distribution network, providing additional access and product availability upon launch. The agreement with Cencora, a leader in specialty pharmaceutical distribution and services, builds on a previously announced distribution services agreement to support long-term scalability and market reach of LYMPHIR. Viome and Scripps Research Partner to Develop First At-home RNA Screening Test to Prevent Colon Cancer Before It Strikes Scripps Research and Viome will conduct the observational clinical study in a cohort of healthy patients undergoing routine gastrointestinal exams. Leveraging Viome's RNA sequencing and AI platform, trained on the world's largest gene expression database, the test seeks to identify molecular signals years before standard screenings. For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. 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For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AcquisitionPhase 3

100 Deals associated with Ivonescimab

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
PD-L1 positive Non-Small Cell Lung Cancer	China	Akeso-Sino Pharma Co., Ltd.	22 Apr 2025
EGFR positive Non-squamous non-small cell lung cancer	China	Akeso-Sino Pharma Co., Ltd.	21 May 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Squamous Carcinoma	NDA/BLA	China	Akeso Pharmaceuticals, Inc.	25 Jul 2025
Advanced Lung Non-Small Cell Squamous Carcinoma	NDA/BLA	China	Akeso-Sino Pharma Co., Ltd.	25 Jul 2025
Non-Small Cell Lung Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	30 Jun 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 3	-	Akeso Biopharma Co., Ltd.	01 Jun 2025
Small Cell Lung Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	29 May 2025
Small cell lung cancer limited stage	Phase 3	China	Akeso Biopharma Co., Ltd.	29 May 2025
Metastatic Pancreatic Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	14 May 2025
Adenocarcinoma of large intestine	Phase 3	China	Akeso Biopharma Co., Ltd.	09 May 2025
Metastatic Colorectal Carcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	09 May 2025
PD-L1 negative Triple Negative Breast Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	07 Feb 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05899608 (HARMONi-3, ASCO2025)	Phase 3	metastatic non-small cell lung cancer First line \| Maintenance	1,080	Ivonescimab plus chemotherapy	hsrhvtdyqd(hfxnezeitl) = kkqvudipuo urzntkivpb (wvwfqrndze ) View more	Positive	30 May 2025
				Pembrolizumab plus chemotherapy	hsrhvtdyqd(hfxnezeitl) = xbeolkqyho urzntkivpb (wvwfqrndze ) View more
NCT06375486 (ASCO2025)	Phase 2	Unresectable Hepatocellular Carcinoma First line HBV infection \| portal vein tumor thrombosis \| extrahepatic spread	27	Ivonescimab + HAIC	wtswvoauik(offkvnckky) = qmmmqrotgu qtibkswybu (nzwqebuvhs ) View more	Positive	30 May 2025
NCT05840016 (AK112-306 \| HARMONi-6, Company_Website) Manual	Phase 3	Squamous non-small cell lung cancer First line	532	ivonescimab + chemotherapy	yztwccwiwq(hyxztblegr) = in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS). jecqhqttkx (nukoxqxvus ) Met View more	Superior	22 Apr 2025
				tislelizumab + chemotherapy
NEWS Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	-	伊沃西单抗 20 mg/kg (队列1)	vpvbilntua(veqwucrbna) = sivecbufwt tstzaeuagn (tunhzwznua ) View more	Positive	20 Jan 2025
				伊沃西单抗 20 mg/kg或30 mg/kg + 联合化疗 (队列2)	vpvbilntua(veqwucrbna) = jamhtjfxeq tstzaeuagn (tunhzwznua ) View more
NCT05184712 (HARMONi-A, ESMO_IO2024 \| NEWS) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	322	Ivonescimab (Ivo) + Pemetrexed/Carboplatin	xqqylkhckz(fdrejonlso) = zvmixvoowj fqvajhbyve (pmzwwmpmkd ) View more	Positive	12 Dec 2024
				Placebo + Pemetrexed/Carboplatin	xqqylkhckz(fdrejonlso) = ekjhncvhsa fqvajhbyve (pmzwwmpmkd ) View more
NCT05227664 (SABCS2024) Manual	Phase 2	Triple Negative Breast Cancer First line	30	Ivonescimab + Paclitaxel/Nab-paclitaxel	xicwddyjha(yoqajqqfli) = xmhcnrzenv wdvlkgqejr (yzjndfxdpn ) View more	Positive	26 Nov 2024
				Ivonescimab + Paclitaxel/Nab-paclitaxel (PD-L1 CPS ≥10)	xicwddyjha(yoqajqqfli) = basytyuote wdvlkgqejr (yzjndfxdpn ) View more
NCT05227664 (ESMO2024) Manual	Phase 2	Triple Negative Breast Cancer First line HER2 Negative \| ER Negative \| PR Negative	30	Ivonescimab 20Paclitaxel + Pnab-paclitaxelg/m2	lkffvbtmhu(llobrpjgmv) = khfmielmrt tvxlkxewrf (krrxtwvufh ) View more	Positive	16 Sep 2024
				Ivonescimab 20Paclitaxel + Nnab-paclitaxel100 mg/m2	lkffvbtmhu(llobrpjgmv) = chfjvyzajy tvxlkxewrf (krrxtwvufh ) View more
NCT05229497 (ESMO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line PD-L1 Positive	30	Ivonescimab monotherapy	larfqznzxh(mwfdqeswat) = rtycoahqhc rcxlmkglof (cgayedtnhv ) View more	Positive	14 Sep 2024
				Ivonescimab plus ligufalimab	larfqznzxh(mwfdqeswat) = obqofyvfxk rcxlmkglof (cgayedtnhv ) View more
NCT05382442 (ESMO2024) Manual	Phase 2	Metastatic Colorectal Carcinoma First line KRAS \| BRAF \| MSS	40	FOLFOXIRI + Ivonescimab	lcpalnafyc(wksqofwniv) = xxaesgjupz wvyxzquvdj (fikvmtkxco ) View more	Positive	14 Sep 2024
				FOLFOXIRI + Ivonescimab + Ligufalimab	lcpalnafyc(wksqofwniv) = cjsujmoebv wvyxzquvdj (fikvmtkxco ) View more
NCT05247684 (WCLC2024) Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma	60	Ivonescimab 20 mg/kg	ttnvsfmlhu(shfcmmlpod) = The most common TRAEs (incidence ≥5%) of grade 3 or higher were decreased neutrophil count and decreased white blood cell count cwjtvwbmyi (zdtmdecyki ) View more	Positive	08 Sep 2024
				Ivonescimab 30 mg/kg

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