Delving into the Latest Updates on Ipilimumab N01 with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Anti-CTLA-4 antibody (Innovent Biologics), Ipilimumab Biosimilar (Innovent Biologics (Suzhou) Co. Ltd.), Ipilimumab biosimilar (Innovent Biologics)

+ [8]

Target

CTLA4

Action

inhibitors

Mechanism

CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication

Mismatch repair-deficient Colonic CancerAdvanced Hepatocellular CarcinomaAdvanced biliary tract cancer+ [1]

Inactive Indication

Acral Lentiginous Malignant MelanomaAdvanced cancerAdvanced Cervical Carcinoma+ [10]

Originator Organization

Innovent Biologics (Suzhou) Co. Ltd.

Active Organization

Innovent Biologics (Suzhou) Co. Ltd.

Inactive Organization

Suzhou Xinda Biotechnology Co., Ltd.

Innovent Biologics, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (22 Dec 2025),

Mismatch repair-deficient Colonic Cancer

RegulationPriority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)

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Structure/Sequence

Sequence Code 143797L

The sequence is quoted from: *****

Sequence Code 9060585H

The sequence is quoted from: *****

This study is a randomized, controlled, open-label, multicenter, seamless Phase II/III trial designed to evaluate the efficacy and safety of the combination regimen of IBI310 and sintilimab in participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who are: (1) treatment-naive to systemic therapy; and (2) either unsuitable for curative-intent surgical resection or local therapy, or have experienced disease progression following prior surgical resection or local therapy.

Start Date27 Mar 2026

Sponsor / Collaborator

Innovent Biomedical Technology (Hangzhou) Co., Ltd.

NCT07487662

/ Not yet recruitingPhase 2IIT

TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk: A Multicenter, Multigroup, Randomized, Phase Ⅱ Exploratory Clinical Trial

Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide. The recurrence rate after curative resection for early-stage HCC remains extremely high, with 2-year and 5-year recurrence rates reaching 50% and 70%, respectively. Currently, no standard perioperative treatment is recommended in domestic and international guidelines.
Recently, data from a phase III clinical study, investigating neoadjuvant and adjuvant therapy with camrelizumab plus apatinib in resectable HCC patients at intermediate-to-high risk of recurrence, demonstrated that the neoadjuvant and adjuvant therapy combining targeted therapy and immunotherapy could significantly reduce postoperative recurrence. The median recurrence-free survival (RFS) in the target-immunotherapy group was 42.1 months, which was remarkably longer than 19.4 months in the surgery-alone group.
Local therapies (TACE, ablation) can induce immunogenic cell death of tumors and remodel the tumor microenvironment, thereby exerting synergistic effects with immunotherapy. This strategy is expected to further improve recurrence-free survival in HCC patients after surgery.
This clinical trial aims to explore the efficacy and tolerability of the following regimens compared with surgery alone:
1. TACE or ablation combined with anti-CTLA-4 and anti-PD-1 immunotherapy;
2. TACE or ablation combined with anti-CTLA-4 + anti-PD-1 + lenvatinib;
3. Dual immunotherapy with anti-CTLA-4 and anti-PD-1;
4. Anti-CTLA-4 + anti-PD-1 + lenvatinib. Efficacy differences between groups will be compared using Bayesian statistical methods based on non-informative priors.

Start Date18 Mar 2026

Sponsor / Collaborator

Sun Yat-Sen University

[+1]

NCT07422753

/ Not yet recruitingPhase 2IIT

A Prospective, Single-Center, Randomized, Double-Blind Clinical Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 in the Treatment of Advanced Hepatocellular Carcinoma

The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy of a combination therapy involving TACE, sintilimab, bevacizumab, and ipilimumab N01 for the treatment of advanced hepatocellular carcinoma (HCC). It also aims to explore the potential synergistic mechanisms of this combination. The main questions it aims to answer are:
Is the combination of TACE, sintilimab, bevacizumab, and ipilimumab N01 effective and safe for patients with advanced HCC? How do different sequencing schedules of ipilimumab N01 compare in terms of safety and efficacy? What potential biomarkers can predict treatment response?
Researchers will compare three different treatment groups:
Group A: Receives TACE and a single dose of ipilimumab N01 administered 3 weeks after the first dose of sintilimab and bevacizumab.
Group B: Receives TACE and a single dose of ipilimumab N01 administered concurrently with the first dose of sintilimab and bevacizumab.
Group C: Receives TACE, sintilimab and bevacizumab (without ipilimumab N01).
Participants will:
Be screened for eligibility and be randomly assigned to one of the three treatment groups.
Receive the assigned study treatment according to their group's schedule. Undergo regular clinic visits for safety checkups, tumor imaging assessments, and response evaluation using RECIST v1.1 and RECICL criteria.
Provide biological samples for exploratory biomarker analysis, including:
Peripheral blood at baseline and before each treatment cycle (every 3 weeks). Tumor biopsy specimens at baseline and 6 weeks after the first treatment. Surgical specimens if the patient undergoes conversion surgery.
Participate in follow-up visits:
A safety follow-up visit 30 days after the last study drug dose or before starting new anti-cancer therapy.
Subsequent survival follow-up contacts every 90 days to collect information on survival status and any subsequent anti-cancer treatments.

Start Date01 Mar 2026

Sponsor / Collaborator

The Second Affiliated Hospital Zhejiang University

100 Clinical Results associated with Ipilimumab N01

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100 Translational Medicine associated with Ipilimumab N01

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100 Patents (Medical) associated with Ipilimumab N01

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5

Literatures (Medical) associated with Ipilimumab N01

01 May 2026·INTERNATIONAL JOURNAL OF CANCER

Surufatinib combined with sintilimab and IBI310 for the treatment of high‐grade advanced‐neuroendocrine neoplasms: A single arm, open‐label, single‐center, phase II study

Article

Author: Zhang, Miao ; Lu, Ming ; Shen, Lin ; Zhang, Panpan ; Wang, Yakun

Abstract:

This single‐center, open‐label, single‐arm phase II trial (NCT05165407) aimed to evaluate the efficacy and safety of surufatinib (250 mg orally once daily) combined with sintilimab (200 mg intravenously every 3 weeks) and IBI310 (1 mg/kg intravenously every 6 weeks) in patients with advanced high‐grade neuroendocrine neoplasms (HG‐NENs). The primary endpoint was the objective response rate (ORR). Secondary endpoints included the disease control rate (DCR), duration of response (DoR), progression‐free survival (PFS), overall survival (OS), and safety. As of March 28, 2025, 24 patients with measurable baseline lesions and at least one post‐treatment tumor assessment were included in the efficacy‐evaluable analysis set. The ORR was 37.5% (95% confidence interval [CI]: 18.8–59.4); DCR, 79.2% (95% CI: 57.8–92.9); and median DoR, 14.8 months. Among 31 treated patients in the full analysis set population, the median PFS was 3.81 months (95% CI: 2.79–4.50), and the median OS was 13.44 months (95% CI: 10.28–not estimable). Subgroup analyses showed improved response in patients with the following characteristics: female sex, age <55 years, ECOG performance status of 1, received ≤1 prior treatment line, without liver metastases, and <2 metastatic sites. Treatment‐related adverse events (TRAEs) occurred in 96.8% of patients; 45.2% experienced grade ≥3 TRAEs. Among them, 71.0% experienced TRAEs attributed to sintilimab/IBI310, and 87.1% to surufatinib. Serious adverse events occurred in 45.2% of patients. These findings suggest that surufatinib, IBI310, and sintilimab may offer clinical benefit with manageable toxicity in patients with advanced HG‐NENs.

01 Oct 2025·CANCER CELL

Neoadjuvant treatment of IBI310 plus sintilimab in locally advanced MSI-H/dMMR colon cancer: A randomized phase 1b study

Article

Author: Qiu, Meng ; Wan, Xiangbin ; Li, Leping ; Luo, Jia ; Li, Liren ; Wang, Yaxu ; Xu, Jianmin ; Zhao, Peng ; Jiang, Wu ; Wang, Guihua ; Fu, Zan ; Liu, Haiyi ; Mo, Xianwei ; Xu, Rui-Hua ; Yuan, Xianglin ; Chen, Gong ; Guo, Qun ; Zhou, Hui ; Zhong, Haijun ; Du, Xiaobo ; Tang, Jianqiang ; Wu, Xiaojun ; Ma, Jinfeng ; Wang, Quan ; Li, Yongqiang ; Sun, Yanlai ; Song, Zhangfa ; Wang, Feng ; Deng, Yanhong ; Hu, Yingbin ; Ding, Peirong ; Zhang, Rongxin ; Jiang, Weiqin ; Kang, Liang ; Liu, Heli ; Lu, Xiaoxiao ; Huang, Xiwen ; Lin, Junzhong ; Wang, Nanya ; Ge, Jie ; Liu, Linlin ; Zhou, Yanbing ; You, Jun ; Yuan, Weitang ; Li, Taiyuan

Although neoadjuvant immunotherapy showed promising efficacy in locally advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) colon cancer, whether dual immune checkpoint inhibition provides additional benefit over anti-PD-1 monotherapy remains unclear. This randomized phase 1b trial (NCT05890742) evaluated a neoadjuvant regimen of IBI310 (anti-cytotoxic T lymphocyte-associated antigen 4 [CTLA-4]) plus sintilimab (n = 52) versus sintilimab monotherapy (n = 49). Surgery was performed in 51 and 45 patients, respectively. The primary endpoint, pathological complete response (pCR) rate, was significantly higher in the combination compared to the monotherapy arm within the modified intent-to-treat (mITT) population (78.4% versus 46.7%, p = 0.0015), with consistent results in the intent-to-treat (ITT) population (76.9% versus 42.9%). Safety in both arms was comparable and manageable without new safety signals. After a median follow-up of 21.4 months, no disease recurrences occurred. One death occurred in each arm due to postoperative complication and adverse events. These findings demonstrate the added benefit of neoadjuvant IBI310 plus sintilimab over sintilimab monotherapy for locally advanced MSI-H/dMMR colon cancer.

01 May 2025·Med

IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial

Article

Author: Tang, Yaling ; Zhang, Guonan ; Huang, Yi ; Ma, Xinyan ; Li, Huayi ; Zhao, Weidong ; Qian, Jianhua ; Xu, Qin ; Zhang, Jieqing ; Zheng, Hong ; Wang, Danbo ; Gao, Qinglei ; Zhou, Hui ; Tang, Ying ; Peng, Zikun ; Qiu, Hui ; Ji, Jianghai ; Yin, Kang ; Liu, Jihong ; Cai, Chujun ; An, Ruifang ; Wang, Li ; Shen, Yiyang ; Zhang, Hongfei ; Wang, Shuyan ; Wang, Xia ; Xie, Han ; Li, Guiling ; Chang, Baoping ; Yuan, Jianlin ; Ma, Cailing ; Sun, Li ; He, Aiqin ; Zhu, Lijing ; Jiao, Xiaofei ; Xu, Yu ; Wang, Ya ; Zhu, Jianqing ; Lou, Ge ; Wang, Jing ; Xia, Bairong ; Ma, Ding ; Duan, Wei ; Lu, Liqin ; Wang, Ke ; Li, Li ; Cheng, Yan ; Zhu, Hong ; Yu, Guohua ; Huang, Jianli ; Zhang, Youzhong ; Chen, Youguo ; Huang, Bowen

BACKGROUND:

It remains unclear whether adding CTLA-4 blockade to PD-1/PD-L1 blockade improves clinical outcomes in cervical cancer (CC).

METHODS:

In this randomized, double-blind, placebo-controlled, phase 2 study (ClinicalTrials.gov: NCT04590599), patients with recurrent/metastatic CC (R/M CC) who experienced disease progression after or during platinum-based chemotherapy were enrolled from 37 centers across China and randomly assigned (1:1), stratified by PD-L1 expression and prior treatment lines, to receive either IBI310 plus sintilimab or placebo plus sintilimab intravenously every 3 weeks for 12 weeks, followed by sintilimab alone. The primary endpoint was the objective response rate (ORR). Pivotal secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.

FINDINGS:

205 patients were randomized to receive IBI310-sintilimab (n = 103) or placebo-sintilimab (n = 102). The ORR difference between the IBI310-sintilimab arm (32.3%, 95% confidence interval [CI]: 23.3%-42.5%) and the placebo-sintilimab arm (23.5%, 95% CI: 15.5%-33.1%) was not significant (p = 0.17). IBI310-sintilimab and placebo-sintilimab exhibited median PFS values of 3.6 (95% CI: 2.7-6.3) and 4.2 months (95% CI: 2.8-6.2), respectively (hazard ratio [HR] = 0.91, 95% CI: 0.65-1.27; p = 0.58). The median OSs were 13.9 months (95% CI: 11.5-25.6) in the IBI310-sintilimab arm and 17.2 months (95% CI: 13.7-25.9) in the placebo-sintilimab arm (HR = 1.12, 95% CI: 0.79-1.58; p = 0.54). Adding IBI310 to sintilimab increased the incidence of grade ≥3 treatment-related adverse events (55% versus 19%).

CONCLUSIONS:

Compared to single-agent PD-1/PD-L1 blockade, dual blockade of CTLA-4 and PD-1/PD-L1 did not significantly improve clinical outcomes in R/M CC.

FUNDING:

This work was funded by Innovent Biologics (Suzhou).

14

News (Medical) associated with Ipilimumab N01

09 Apr 2026

·www.biospace.com

Innovent’s CDMO gets green light to make biologics at large Chinese plant

iStock, Evgeny Gromov The license, which Innovent’s Altruist business said is the first of its kind, positions the CDMO to support commercial clients as it works to expand the plant’s capacity to 172,000 liters. Innovent Biologics’ contract manufacturing business has secured a license for a production plant in China with four 20,000-liter-scale bioreactors. The Hangzhou facility is the first 20,000-liter biologics production plant in China to gain a license to make drug products, Altruist Biologics, Innovent’s contract development and manufacturing organization (CDMO), said in a press release on Wednesday. China’s National Medical Products Administration (NMPA) granted the license after assessing the Hangzhou site’s compliance with good manufacturing practices (GMPs). The assessment confirmed that the plant’s quality systems, GMP facilities and technologies meet the NMPA’s requirements for drug production quality management, according to Altruist. The company received the license two months after qualifying the facility. Work on the Hangzhou site is continuing, with Altruist aiming to raise the facility’s capacity to 172,000 liters. The plan is a significant expansion of the company’s manufacturing footprint, which includes a 60,000-liter plant in Suzhou, a city west of Shanghai. Across the plants, Altruist is establishing the capacity to develop modalities including antibodies, fusion proteins and antibody-drug conjugates (ADCs), and to make molecules for clinical and commercial supply. A standalone bioconjugation facility for ADCs, a focus modality for rival Chinese CDMO WuXi Biologics, is part of the plan for Hangzhou. Altruist has invested in areas from cell line development to aseptic fill-finish to support clients at a time when companies are rethinking global supply chains. The Biosecure Act informed changes at companies such as Amicus Therapeutics, which worked with its supplier WuXi to establish a second facility outside China as lawmakers threatened to restrict business with the Asian country. Pressures to return production to the U.S. have intensified since the Biosecure Act was proposed. Nevertheless, companies have shifted to regional supply models that could drive demand for Chinese capacity. Companies, including AstraZeneca , are building Chinese sites to serve Chinese patients. The Hangzhou license is a milestone for a business that Innovent created in 2022. Innovent, a Chinese biopharma company, has established 140,000 liters of manufacturing capacity. The capabilities, which it claims give it “world-leading single-batch antibody production scale,” support approved products such as the anti-CTLA-4 antibody Tabosun and the Eli Lilly-partnered dual GLP-1/glucagon drug mazdutide.

ADCLicense out/inIND

09 Feb 2026

·www.pharmaceutical-technology.com

Innovent and Lilly to advance new oncology and immunology medicines

Lilly will hold exclusive rights to develop and commercialise the programmes outside Greater China. Credit: Tada Images / Shutterstock.com. Innovent Biologics and Eli Lilly and Company have entered a strategic collaboration agreement to accelerate the global development of new medicines in the fields of oncology and immunology. The partnership represents the seventh agreement between the two companies and aims to expedite the delivery of new therapies to patients worldwide. Under the agreement, Innovent will utilise its antibody technology platforms and clinical execution capabilities to lead research programmes from concept through clinical proof-of-concept, concluding at the Phase II clinical trial stage in China. Lilly will hold exclusive rights to develop and commercialise these programmes outside Greater China while Innovent will retain all rights within Greater China. Innovent will receive a $350m upfront payment under this agreement. The company is also eligible for development, regulatory and commercial milestone payments totalling up to approximately $8.5bn, subject to achieving designated milestones. In addition, Innovent will obtain tiered royalties on net sales of each product outside Greater China. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Innovent founder, board chairman and CEO Dr Michael Yu said. “We’re delighted to partner with Lilly, our trusted global pharmaceutical partner for over ten years, to pursue novel medicines to improve treatment outcomes for patients with cancer and immune disorders. “This alliance moves beyond traditional licensing to create a seamless, end-to-end innovation ecosystem that combines our agile discovery and early-stage development engine with Lilly’s extensive global scale and creates a highly efficient model for cross-border synergy. “This partnership validates Innovent’s R&D capabilities and allows us to accelerate the translation of scientific discoveries into impactful global medical solutions together with our partner, with the ultimate goal of bringing world-class medicines to patients across the globe.” In December 2025, Innovent received China’s NMPA approval for the new drug application (NDA) for Tabosun (ipilimumab N01 injection), a CTLA-4 monoclonal antibody for colon cancer.

License out/inPhase 2NDADrug Approval

29 Dec 2025

·www.pharmaceutical-technology.com

Innovent receives NMPA approval for Tabosun colon cancer treatment

MSI-H/dMMR colon cancer comprises 15% of resectable cases and responds poorly to chemotherapy. Credit: NMK-Studio/Shutterstock.com. Innovent Biologics has received China’s National Medical Products Administration (NMPA) approval for the New Drug Application (NDA) for Tabosun (ipilimumab N01 injection), a CTLA-4 monoclonal antibody for colon cancer. The approval covers its use in combination with sintilimab as a neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer. This marks a significant regulatory milestone for the combination therapy, providing a new treatment option for patients with MSI-H or dMMR colon cancer in China. Short-term neoadjuvant treatment with the ipilimumab N01 and sintilimab combination has shown a substantial improvement in pathological complete response rate, potentially benefiting a wider group of patients with MSI-H/dMMR colon cancer. Innovent stated that immune checkpoint blockade therapies, including PD-1 and CTLA-4 agents, have changed the landscape of cancer treatment. The combination of ipilimumab N01 and sintilimab as a neoadjuvant therapy has been found to significantly improve pathological complete response rates and may reduce the need for adjuvant chemotherapy in many patients. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence A Phase Ib trial published in the Cancer Cell journal enrolled 101 patients as of 17 June 2025 and randomised them to receive ipilimumab N01 plus sintilimab (n=52) or sintilimab alone (n=49). In the per-protocol population, the pathological complete response rate was 80% in the combination arm compared to 47.7% with sintilimab alone. Neither group experienced recurrence over a median follow-up of 21.4 months. Approval was based on the pivotal Phase III NeoShot trial, which assessed efficacy and safety for neoadjuvant ipilimumab N01 and sintilimab versus direct radical surgery. Primary endpoints included event-free survival and pathological complete response rate. Interim analysis by the Independent Data Monitoring Committee (iDMC) confirmed the primary endpoint was met. Pharmaceutical Technology Excellence Awards - Nominations Closed Nominations are now closed for the Pharmaceutical Technology Excellence Awards . A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact. Excellence in Action Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing , Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines. Discover the Impact

Clinical ResultPhase 3Drug ApprovalImmunotherapy

100 Deals associated with Ipilimumab N01

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External Link

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
Mismatch repair-deficient Colonic Cancer	China	Innovent Biologics (Suzhou) Co. Ltd.	22 Dec 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Hepatocellular Carcinoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	01 Feb 2021
Acral Lentiginous Malignant Melanoma	Phase 3	China	Innovent Biologics (Suzhou) Co. Ltd.	17 Apr 2020
Melanoma	Phase 3	China	Suzhou Xinda Biotechnology Co., Ltd.	17 Apr 2020
Advanced biliary tract cancer	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	10 Mar 2023
Nasopharyngeal Carcinoma	Phase 2	China	Suzhou Xinda Biotechnology Co., Ltd.	07 Jul 2021
Advanced Cervical Carcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	23 Nov 2020
Microsatellite instability-high colorectal cancer	Phase 2	China	Innovent Biologics, Inc.	07 Aug 2020
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	13 Dec 2019
Epstein-Barr virus associated gastric carcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	13 Dec 2019
Signet Ring Cell Carcinoma	Phase 2	China	Innovent Biologics (Suzhou) Co. Ltd.	13 Dec 2019

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Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05890742 (NeoShot-III, PRNewswire) Manual	Phase 3	Mismatch repair-deficient Colonic Cancer Neoadjuvant MSI-High \| Deficient DNA Mismatch Repair (dMMR)	50	伊匹木单抗N01 + 信迪利单抗	byqkozacol(otqupsfyos) = lxncnsqehx wshoxjxtdy (uhglhsclob )	Positive	25 Dec 2025
NCT05890742 (NeoShot-1b, Pubmed) Manual	Phase 1	Mismatch repair-deficient Colonic Cancer Neoadjuvant Deficient DNA Mismatch Repair (dMMR) \| MSI-High	101	IBI310 + sintilimab	uwqtymwgra(qyczhkdhuw) = oxakwaogyw tqpiylgiug (fbmeapiaod ) View more	Positive	01 Oct 2025
				sintilimab	uwqtymwgra(qyczhkdhuw) = teyqgnnxvw tqpiylgiug (fbmeapiaod ) View more
NCT04590599 (Pubmed \| Med)	Phase 2	Uterine Cervical Cancer	-	IBI310 plus sintilimab	gzdcinjqax(yqwcgcydhq) = 55% versus 19% zypowzranq (rkufkcgyve ) View more	-	01 May 2025
				Placebo plus sintilimab
NCT05890742 (PRNewswire) Manual	Phase 1	Microsatellite instability-high colorectal cancer Deficient DNA Mismatch Repair (dMMR) \| MSI-High	101	IBI310 + sintilimab	gpwcgsowwt(mblctafpgy) = otdcfcmjgs vzxzetpcmu (jhwhjwfgrx ) View more	Positive	02 Jun 2024
				sintilimab	gpwcgsowwt(mblctafpgy) = nxuhqzvpyf vzxzetpcmu (jhwhjwfgrx ) View more
NCT05890742 (ASCO2024) Manual	Phase 1	Microsatellite instability-high colorectal cancer First line \| Neoadjuvant microsatellite instability-high \| mismatch repair-deficient	101	IBI310 1mg/kg + sintilimab 200 mg Q3W	wcobephtnk(aocviicxpi) = axfffhqtjl hctxracrki (djaxaufamg, 66.3 - 90.0) View more	Positive	24 May 2024
				Sintilimab 200 mg Q3W	wcobephtnk(aocviicxpi) = piexncqzhi hctxracrki (djaxaufamg, 32.5 - 63.3) View more
NCT05118334 (phase Ib study, Pubmed \| Cancer Med)	Phase 1	metastatic non-small cell lung cancer anti‐PD‐1 \| L1	30	IBI310 1 mg/kg	gjprgkoclo(lfgzvlhoxf) = qqrtvptosw hsmmloebxv (ahziqbcbui, 21.3 - 73.4) View more	Positive	01 Feb 2024
				IBI310 3 mg/kg	yskxyhrynz(jhxechosfw) = qfzqkerqnh oqayekxguv (zyugpbltsz, 1.7 - 40.5) View more
NCT04202601 (ESMO 12023 \| ESMO 22023) Manual	Phase 2	Epstein-Barr virus associated gastric carcinoma First line \| Second line EBV Positive	49	Sintilimab 3mg/kg plus IBI310 1mg/kg	johhyathgf(pkrnxgsurk) = imkeyqnrmr twwmjjxzmr (racatwimjq ) View more	Positive	23 Oct 2023
				Sintilimab 3mg/kg plus IBI310 1mg/kg (treatment-naïve)	gmgbofvlmz(wbajxahdwc) = uugpjxirxi apandugkcr (asaavbzgvh, 40.6 - 79.8) View more
NCT04401813 (ASCO_GI2022) Manual	Phase 1	Advanced Hepatocellular Carcinoma	29	sintilimab+IBI310	xcdaykojjm(iujbqixztj) = tfxwbhucwr xniliqmfcm (qyyifpvzuy ) View more	Positive	19 Jan 2022
NCT03545971 (ESMO 12021 \| ESMO 22021) Manual	Phase 1	Locally Advanced Melanoma	44	IBI310	xhsjotdqrk(daxbsorsmf) = part A: only one treatment-related AE (TRAE) of grade 3 (gamma glutamyltransferase increased); part B: ≥grade 3 TRAE occurred in 20.6% of 34 pts sqzxfdopla (swzsjscxpn ) View more	Positive	16 Sep 2021
				IBI310+sintilimab

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Ipilimumab N01

Overview

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Translational Medicine

Deal

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Clinical Trial

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Biosimilar

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