RegulationConditional marketing approval (China), Fast Track (United States), Orphan Drug (United States), Breakthrough Therapy (China), Priority Review (China)

Structure/Sequence

Sequence Code 616719055

Source: *****

Sequence Code 616719118

Source: *****

249

Clinical Trials associated with Cadonilimab

NCT06832917

/ Not yet recruitingPhase 3IIT

A Prospective Multicenter, Two-arm Parallel, Open-label, Randomised Phase III Study to Explore the Efficacy and Safety of Cadonilimab Plus Chemotherapy After Short-course Radiotherapy in Locally Advanced Rectal Cancer

The goal of this clinical trial is to learn if neoadjuvant short-course radiation (SCRT) followed by 6 cycles of cadonilimab plus mFOLFOX6 works to treat patients with locally advanced rectal cancer (LARC). It will also learn about the safety of the combined regimen. The main questions it aims to answer are:
Does the neoadjuvant SCRT plus dual immunotherapy and chemotherapy can improve pathological complete response(pCR) rate? What medical problems do participants have when receiving chemotherapy plus cadonilimab compared to chemotherapy only?
Participants will:
Receiving cadonilimab plus mFOLFOX6 or mFOLFOX6 every 2 weeks for 3 months Visit the clinic once every 2 weeks for checkups and tests

Start Date31 Mar 2025

Sponsor / Collaborator

Shenzhen People's Hospital

NCT06878196

/ Not yet recruitingNot ApplicableIIT

ctDNA-guided First-line Immuno-de-escalation Therapy for Stage IVB and Recurrent Cervical Cancer: A Prospective, Single-arm, Multicenter Phase II Clinical Trial

This study aims to evaluate the clinical feasibility of first-line immunochemotherapy for stage IVB and recurrent cervical cancer guided by circulating tumor DNA (ctDNA), in order to explore the optimal treatment duration or criteria for discontinuation of first-line immunotherapy in patients with stage IVB cervical cancer or recurrent cervical cancer. To ensure the quality of the study, before the study begins, the research applicant and participants jointly discuss and formulate the research plan. Necessary steps should be taken during the design and implementation stages of the study to ensure that the collected data is accurate, consistent, complete, and credible.

Start Date10 Mar 2025

Sponsor / Collaborator

Obstetrics and Gynecology Hospital of Fudan University

NCT06851104

/ Not yet recruitingPhase 2IIT

A Prospective Study of Cadonilimab or PD-1 Inhibitor in Hepatocellular Carcinoma After Radical Surgery with High Risk of Recurrence

This study aims to compare the safety and tolerability of cadonilimab and programmed death 1 inhibitors applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrent factors.

Start Date01 Mar 2025

Sponsor / Collaborator

Guangxi Medical University

100 Clinical Results associated with Cadonilimab

100 Translational Medicine associated with Cadonilimab

100 Patents (Medical) associated with Cadonilimab

250

Literatures (Medical) associated with Cadonilimab

01 Mar 2025·Pesticide Biochemistry and Physiology

A comparative study of the controllable release and insecticidal efficacy for two typical carrier methods on diamide insecticide delivery system

Article

Author: Huang, Yucong ; Yang, Huiying ; Liu, Xingyu ; Liu, Bingrui ; Li, Yahui ; Li, Shaochen

Using nano/microcarriers of pesticides in sustainable pest management represents a promising strategy for enhancing pesticide efficiency while mitigating environmental harm. The reported pesticide loading methods include one-step self-assembly encapsulation and two-step absorption loading, but the controllable release and insecticidal efficacy of these two methods have been infrequently evaluated. Herein, the typical diamide insecticide cyantraniliprole (CTP) was employed as the model pesticide. A hydrogen bond-driven one-step self-assembly method and a chemical deposition method were utilized to fabricate highly dispersed polylactic acid (PLA) microspheres and calcium carbonate (CaCO₃) microspheres. The resulting CTP-loaded PLA microspheres (CTP-PLA MS) and CaCO₃ microspheres (CTP-CaCO₃ MS) both exhibited high adhesion, resistance to rain erosion, and insecticidal activity under laboratory conditions. However, the functional CTP-PLA MS demonstrated superior sustained pesticide release performance, higher pesticide loading capacity, and less application amount than that of CTP-CaCO₃ MS. At the same time, the acute toxicity of CTP-PLA MS exhibited slightly reduced acute toxicity to honeybees (Apis mellifera), signifying enhanced biocompatibility. Finally, the CTP-PLA MS maintained superior insecticidal efficacy than the normal CTP in controlling O. nubilalis at a low concentration. The present study represents a promising pesticide carrier as a highly efficient, eco-friendly agent for sustained management of O. nubilalis.

01 Mar 2025·Med

Neoadjuvant cadonilimab plus FLOT chemotherapy in locally advanced gastric/gastroesophageal junction adenocarcinoma: A multicenter, phase 2 study

Article

Author: Long, Bo ; Luo, Changjiang ; Che, Shengfu ; Mao, Jie ; Gao, Zhongti ; Jiao, Zuoyi ; Jiang, Xiangyan ; Zhang, Wenjuan ; Zhao, Da ; Huang, Zeping ; Zhang, Gengyuan ; Yang, Xiaojun ; Guan, Xiaoying ; Yu, Hongwei ; Jiang, Zebin ; Li, Yumin ; Chen, Shigong ; Yu, Zeyuan ; Yang, Hanteng ; Zhao, Xiaoning ; Li, Long ; Wei, Dengwen ; Yan, Hong ; Zhou, Huinian ; Zhu, Junmin

BACKGROUNDTreatment with cadonilimab and chemotherapy has shown promise as a first-line treatment for gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. However, its application in neoadjuvant settings has not yet been documented.METHODSThis multicenter, phase 2 trial (ChiCTR2200066893) was conducted at four hospitals across China. Treatment-naive patients with locally advanced G/GEJ adenocarcinoma (cT3/4, N+, M0) and who were human epidermal growth factor receptor 2 negative received 3-cycle or 4-cycle neoadjuvant treatment of cadonilimab plus FLOT (5-fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy, followed by gastrectomy and 4-cycle adjuvant FLOT chemotherapy. The primary endpoint was the pathological complete response (pCR) rate. Secondary endpoints included major pathological response (MPR), overall response rate (ORR), disease control rate (DCR), R0 resection rate, downstaging rate, and safety.FINDINGSBetween December 23, 2022, and December 15, 2023, 32 of 38 patients completed the scheduled treatment, achieving an R0 resection rate of 100% (32/32). The pCR rate was 21.1% (8/38, 90% confidence interval [CI]: 9.7-32.4), and the MPR rate was 44.7% (17/38, 90% CI: 30.9-58.5). Radiological evaluations were available for 28 of 38 patients by blinded independent central review. The ORR was 60.7% (17/28, 90% CI: 44.7-76.7), and the DCR was 100.0% (28/28, 90% CI: 100.0-100.0). Tumor downstaging occurred in 71.9% of patients (23/32), with consistent efficacy across all populations observed in the subgroup analysis. Grade 3 adverse events occurred in 31.6% of patients without severe safety issues.CONCLUSIONSNeoadjuvant cadonilimab plus FLOT chemotherapy treatment exhibits promising efficacy with manageable toxicities in locally advanced G/GEJ adenocarcinoma, providing preliminary evidence for further investigation.FUNDINGThis study was funded by Akeso Biopharma.

01 Mar 2025·Reproductive Toxicology

Hormonal mechanism and pathogenetic therapy of citalopram-induced infertility in female rats

Article

Author: Suleyman, Halis ; Gumusburun, Neset ; Bulut, Seval ; Mendil, Ali Sefa ; Suleyman, Bahadir ; Bakan, Nuri ; Delibasi, Ilhan Bahri ; Yilmaz, Betul Kalkan ; Altuner, Durdu ; Mammadov, Renad

Citalopram is a selective serotonin reuptake inhibitor (SSRI) and has been associated with reproductive dysfunction in women. In this study, the effects of citalopram on reproductive health in female rats were investigated. Albino Wistar rats was divided into six groups (each group/n=12): healthy (HG), citalopram (CTP), cabergoline (CBR), metyrapone (MTP), cabergoline+citalopram (CBR+CTP), and metyrapone+citalopram (MTP+CTP). Initially, cabergoline 0.1mg/kg and metyrapone 50mg/kg were administered orally. A dose of 10mg/kg of citalopram was given orally one hour later. For 30 days, the treatment protocol was applied once a day. Then, blood samples were taken from the tail veins of six rats from each group for prolactin and corticosterone analyses and ovaries were removed after euthanasia. The ovaries were examined for oxidants and antioxidants and histopathologically. During two months, the remaining animals were kept with male rats. The rats that did not deliver during this period were considered infertile. In terms of oxidants and antioxidants, there was no significant difference between the groups (p>0.05). In half of the female rats, citalopram caused infertility, increased levels of prolactin and corticosterone, and damaged the ovaries histopathologically (p<0.05). Cabergoline suppressed the elevation of prolactin by citalopram (p<0.001) but did not prevent infertility. In contrast, metyrapone significantly prevented the citalopram-induced increase in corticosterone, infertility, and tissue damage induced by citalopram (p<0.05). According to the results of our study, the preventive effect of drugs that suppress excessive corticosterone on citalopram-induced infertility in rats may be encouraging for further clinical studies.

News (Medical) associated with Cadonilimab

17 Mar 2025

·www.prnewswire.com

Akeso's Penpulimab Receives NMPA Approval for First-Line Treatment of Nasopharyngeal Cancer

HONG KONG, March 16, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) announced that its innovative, self-developed anti-PD-1 monoclonal antibody, penpulimab, has been officially approved by the National Medical Products Administration (NMPA) for the first-line treatment of recurrent or metastatic nasopharyngeal cancer (NPC) in combination with chemotherapy. Previously, penpulimab was approved for use as a third-line treatment for advanced NPC. With this new approval, penpulimab now provides comprehensive treatment coverage across all stages of NPC, offering patients a continuous immunotherapy option from first-line to third-line therapy. This marks the fourth approved indication for penpulimab. In addition to the two NPC indications, penpulimab is also approved for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) when combined with chemotherapy, as well as for monotherapy in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have previously received at least two lines of systemic chemotherapy. Furthermore, a supplemental New Drug Application (sNDA) for penpulimab in combination with anlotinib for first-line treatment of advanced hepatocellular carcinoma (HCC) is currently under review. Professor Hu Chaosu, one of the principal investigators of penpulimab at Fudan University Shanghai Cancer Center, said: "In China, there remains a significant unmet clinical need for NPC. As the only IgG1 subtype anti-PD-1 monoclonal antibody globally, penpulimab has demonstrated robust efficacy in clinical studies, enhancing the effectiveness of immunotherapy for NPC. The approval for first-line treatment marks a major milestone, as it provides a comprehensive treatment regimen for clinicians and patients, benefiting a large population of NPC patients in China, from first-line to third-line therapy." Professor Chen Xiaozhong, one of the principal investigators of penpulimab at Zhejiang Cancer Hospital, said: "Nasopharyngeal cancer (NPC) is a highly prevalent malignancy in certain regions, and patients with recurrent or metastatic NPC typically face a poor prognosis. Penpulimab has demonstrated a significantly high response rate and prolonged survival benefits in both first-line treatment of NPC and in patients with metastatic NPC who have failed multiple lines of prior therapy. Additionally, it has shown a favorable safety profile, with a low incidence of immune-related adverse events. " Dr. Xia Yu, Founder, Chairwoman, CEO, and President of Akeso, said: "We want to extend our sincere gratitude to all the researchers, clinical trial participants, and NPC patients who have contributed to this milestone. With its differentiated design, penpulimab has gained widespread recognition among clinicians and patients for its efficacy and safety in treating diseases like non-small cell lung cancer (NSCLC), Hodgkin lymphoma, and nasopharyngeal cancer. The approval for first-line treatment of advanced NPC will allow more patients in China to benefit from this new PD-1 monoclonal antibody, further improving survival outcomes." "As key drugs like cadonilimab, ivonescimab, and penpulimab receive approval for a wide range of indications, Akeso's commitment to innovation and excellence in drug development—from discovery to clinical application—is clearly demonstrated. These advancements are not only improving patient outcomes but also reaffirming our dedication to transforming global healthcare. Moving forward, Akeso will continue to pioneer breakthrough therapies with the potential to set new standards of care, driving positive change in treatment paradigms and improving the lives of patients worldwide." 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

Drug ApprovalImmunotherapy

06 Mar 2025

·www.prnewswire.com

Akeso Announces Completion of Patient Enrollment in The Phase III Clinical Trial of Cadonilimab for Adjuvant Treatment of High-Risk Recurrent Hepatocellular Carcinoma

HONG KONG, March 5, 2025 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce the completion of patient enrollment for its Phase III registrational clinical trial (COMPASSION-22/AK104-306) evaluating cadonilimab, the world's first PD-1/CTLA-4 bispecific antibody independently developed by the company, as an adjuvant treatment for hepatocellular carcinoma (HCC) with high recurrence risk following curative resection or ablation. The completion of patient enrollment in the COMPASSION-22/AK104-306 trial marks a significant milestone in the clinical development of cadonilimab for HCC. In addition to this Phase III study, another Phase III trial investigating cadonilimab in combination with lenvatinib and transarterial chemoembolization (TACE) for the treatment of unresectable intermediate to advanced HCC is currently progressing on schedule. The extensive exploration of combination therapies involving cadonilimab for HCC is expected to offer more effective treatment options for both early-stage and advanced HCC patients. HCC is one of the most common malignant tumors globally. According to 2024 data, there are about 865,000 new cases of liver cancer worldwide, with 370,000 occurring in China. The recurrence rate after surgery is high, especially in patients with high-risk factors, with a five-year recurrence rate exceeding 70%. Currently, no standard adjuvant treatment exists for HCC in clinical practice. Identifying effective adjuvant therapies to reduce recurrence risk and extend survival is a critical unmet need in HCC treatment. Cadonilimab is the world's first approved bispecific immunotherapy for cancer. Previous studies have shown its significant efficacy and favorable safety profile in treating HCC. Research presented at the 2023 European Society for Medical Oncology (ESMO) Asia Annual Meeting demonstrated that cadonilimab combined with FOLFOX-HAIC as neoadjuvant therapy for resectable multinodular HCC achieved a 100% disease control rate (DCR) with manageable safety. Furthermore, data from the 2023 ESMO Congress highlighted that cadonilimab combined with lenvatinib as a first-line treatment for advanced HCC showed superior antitumor activity compared to approved therapies, effectively controlling tumor progression and offering long-term survival benefits over current treatment options. Akeso will continue to advance cadonilimab clinical development for multiple malignant tumors, with the aim to provide more therapeutic options for patients worldwide. Currently, cadonilimab is currently involved in over 23 clinical studies across 16 indications, including gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer. It has already received approval for the treatment of recurrent/metastatic cervical cancer and first-line gastric cancer. The sNDA for cadonilimab for the treatment of first-line cervical cancer is currently under review. Additionally, five Phase III trials for HCC, non-small cell lung cancer (NSCLC), and gastric cancer are underway. Studies across multiple indications, including cervical cancer, gastric cancer, and NSCLC, have shown that cadonilimab offers meaningful efficacy benefits in all patient populations, regardless of PD-L1 expression levels (high, low, or negative). These patient data indicates that cadonilimab can also significantly broadens the eligible patient population that can benefit from cancer immunotherapies. 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, 23 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently 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

Phase 3ImmunotherapyASCOClinical ResultDrug Approval

27 Feb 2025

·www.prnewswire.com

Akeso Announces First ADC Drug Clinical Trial, Marking a New Era for "IO 2.0 + ADC" Strategy

HONG KONG, Feb. 27, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) announced the first patient has been enrolled in the Phase I clinical trial of AK138 D1 for the treatment of advanced malignancies in Australia. AK138D1, a self-developed and differentiated HER3-targeting ADC (antibody-drug conjugate), is Akeso's first ADC drug to enter clinical studies. Akeso is dedicated to transforming the global oncology treatment landscape by establishing new standards of care for cancer patients worldwide. A key element of this mission is the company's "IO 2.0 + ADC" strategy. Akeso's self-developed, first-in-class bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), have both received regulatory approval and are now available to patients in China. Akeso is the only global biopharmaceutical company with two approved bispecific checkpoint antibodies for cancer immunotherapy. The continued development of differentiated ADC therapies, such as AK138D1, further extend Akeso's ability to explore the full clinical potential of its innovative in-house pipeline and to create synergistic new combination treatment options includes that multiple checkpoints and tumor targets. Dr. Xia Yu, Founder, Chairwoman, President and CEO of Akeso said , "The initiation of the clinical study for AK138D1 in Australia marks a pivotal moment in Akeso's strategic advancement into next-generation ADC therapies. Building on our global prominence in bispecific antibodies and a robust pipeline of high-potential drug candidates, the development of AK138D1 and subsequent ADCs/bispecific ADCs will significantly bolster our product offering. This is part of Akeso's continued effort to redefine standard of care in cancer treatment. Following our achievements in bispecific antibody development, ADC therapies have emerged as a strategic priority for Akeso. Based on our extensive experience in bispecific antibody development, we are excited by the potential of our proprietary ADCs and bispecific ADCs. Our goal is to enhance drug efficacy while minimizing ADC toxicity, offering transformative treatment alternatives for patients worldwide. Moreover, Akeso has established cutting-edge ADC research, pilot production, and manufacturing facilities. These investments position us for high-quality clinical development and for global market expansion of our ADC portfolio." HER3 has emerged as an active target in cancer drug development and is the focus of ongoing research. Although experimental drugs targeting HER3 have not shown satisfactory antitumor effects over the past 30 years, studies indicate that HER3 is expressed or overexpressed in various malignancies, including breast cancer, ovarian cancer, lung cancer, colorectal cancer, melanoma, head and neck cancers, cervical cancer, and prostate cancer. Additionally, upregulation of HER3 and its synergistic interactions with other receptors contribute to tumor initiation, metastasis, and resistance to certain anticancer treatments, such as resistance to EGFR-targeted therapies, endocrine therapy in breast cancer, HER2-targeted therapies, and chemotherapy. About AK138D1 Injectable AK138D1 is a HER3-targeted antibody-drug conjugate (ADC), with a fully humanized anti-HER3 IgG1 antibody, patritumab. It is conjugated to the topoisomerase I inhibitor DXd through a cleavable linker, MC-AAA (maleimide-alanine-alanine-alanine). After binding to HER3 on tumor cells, the ADC is internalized into the tumor cells, where the linker is cleaved, releasing the membrane-permeable DXd. This leads to DNA damage and subsequent cell apoptosis. Currently, Akeso has initiated patient enrollment for a Phase I dose-escalation and expansion clinical study in Australia. This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AK138D1 for the treatment of advanced malignancies. 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, 23 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently 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, and X (formerly Twitter). 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

ADCPhase 1ImmunotherapyDrug Approval

100 Deals associated with Cadonilimab

External Link

KEGG	Wiki	ATC	Drug Bank
D12190	-	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	China	Akeso Pharmaceuticals, Inc.	26 Sep 2024
Stomach Cancer	China	Akeso Pharmaceuticals, Inc.	26 Sep 2024
Uterine Cervical Cancer	China	Akeso Pharmaceuticals, Inc.	28 Jun 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hepatocellular Carcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	14 Dec 2022
Locally Advanced Cervical Carcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	08 Jun 2022
Locally Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	17 Sep 2021
Locally Advanced Unresectable Gastric Adenocarcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	17 Sep 2021
Metastatic Cervical Carcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	02 Sep 2021
Recurrent Cervical Cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	02 Sep 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	China	Akeso Biopharma Co., Ltd.	27 Aug 2021
Metastatic gastric adenocarcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	19 Aug 2021
Metastatic Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	19 Aug 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05792735 (NeoCaCRT, ASCO_GI2025) Manual	Phase 2	Locally Advanced Rectal Carcinoma Neoadjuvant \|	27	SCRT + Cadonilimab + mFOLFOX6	(ucnsqxkgcx) = mtmkfrsviw vqeeeucdlh (wplzkulydd, 19.4 - 57.6) View more	Positive	23 Jan 2025
NCT05522894 (AK104-IIT-014, ASCO_GI2025) Manual	Phase 2	Advanced Esophageal Squamous Cell Carcinoma Maintenance \| First line	43	Cadonilimab + Paclitaxel + Cisplatin	(zrkivlboqb) = gevdsbanjw oeieqvttck (erazjwyscj, 66.1 - 91.1) View more	Positive	23 Jan 2025
NCT05522894 (AK104-IIT-014, ASCO_GI2025) Manual	Phase 2		43	Cadonilimab + Paclitaxel + Cisplatin (PD-L1 CPS≥10)	(zrkivlboqb) = jbfppufefg oeieqvttck (erazjwyscj, 77.1 - 100.0) View more	Positive	23 Jan 2025
NCT05839470 (SYLT-026, ASCO_GI2025) Manual	Phase 2	Metastatic Microsatellite Stable Colorectal Carcinoma First line	20	FOLFOXIRI + Bevacizumab + Cadonilimab	(gbwfcxxsdl) = vcpwybkufx neehvwzguh (rfhmrpaxyy ) View more	Positive	23 Jan 2025
NCT05008783 (Pubmed) Manual	Phase 3	HER2 negative Gastric Cancer \| HER2 negative Gastroesophageal Junction Adenocarcinoma First line	610	Cadonilimab + Chemotherapy	(ltpbtpawbr) = winygjpohw mdsioucjkx (ojiwcwoblz ) Met View more	Positive	22 Jan 2025
NCT05008783 (Pubmed) Manual	Phase 3		610	Placebo + Chemotherapy	(ltpbtpawbr) = aixkqacszk mdsioucjkx (ojiwcwoblz ) Met View more	Positive	22 Jan 2025
ESMO_IO2024 Manual	Phase 2	Advanced gastric carcinoma \| Advanced Gastroesophageal Junction Adenocarcinoma First line	19	Cadonilimab+SOX (HER2-negative)	(udhlgxidpb) = kiafmtsefs gtgpafwhdf (yezhawmvte ) View more	Positive	12 Dec 2024
ESMO_IO2024 Manual	Phase 2		19	Cadonilimab+Trastuzumab+SOX (HER2-positive)	(udhlgxidpb) = ahodptttaf gtgpafwhdf (yezhawmvte ) View more	Positive	12 Dec 2024
NCT05430906 (AK104-IIT-003, ESMO_IO2024) Manual	Phase 2	Ovarian Cancer Neoadjuvant	28	Cadonilimab + Platinum-Taxane Chemotherapy	(plpqrifqty) = emjnlerbuz cbrxdrmbkk (uqwmekpiek ) View more	Positive	12 Dec 2024
ESMO_IO2024 \| NEWS Manual	Not Applicable	Metastatic Gastroesophageal Junction Adenocarcinoma \| Metastatic gastric adenocarcinoma First line	31	Cadonilimab plus chemotherapy (SOX, XELOX or FOLFOX)	(wafdyfmaqz) = gdnzxacrfc qjnyuduluh (zidswntect ) View more	Positive	12 Dec 2024
ESMO_IO2024 \| NEWS Manual	Not Applicable		31	Cadonilimab plus chemotherapy (SOX, XELOX or FOLFOX) (PD-L1 CPS＜1)	(wafdyfmaqz) = qcqcnfsxoy qjnyuduluh (zidswntect ) View more	Positive	12 Dec 2024
ESMO_IO2024 Manual	Not Applicable	metastatic non-small cell lung cancer Second line \| Last line \| Third line	21	Cadonilimab (AK104) + Single-agent Chemotherapy	(pqvcquzbpn) = zzgcdvcvdk wrhtcuxmjt (uomhcanxoe ) View more	Positive	12 Dec 2024
NCT05815290 (ESMO_IO2024) Manual	Phase 2	Microsatellite instability-high colorectal cancer Neoadjuvant \|	34	Cadonilimab (AK104) 10mg/kg	(efjmrcfcuz) = dwhapzgcgv dzxrgzmqoo (kyuqcaxizm ) View more	Positive	12 Dec 2024
NCT05790200 (ESMO_ASIA2024) Manual	Phase 2	Nasopharyngeal Carcinoma	15	AK104 10 mg/kg + Chemotherapy	(elnkqnbwuy) = xxliblubnh wfzticsnqe (abzmgcrupp ) View more	Positive	07 Dec 2024

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