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Last update 11 Mar 2026

Nimotuzumab

Last update 11 Mar 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

BIOMAb EGFR, CIMAher, Nituzumab

+ [18]

Target

EGFR

Action

antagonists

Mechanism

EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists)

Therapeutic Areas

NeoplasmsNervous System DiseasesDigestive System Disorders+ [6]

Active Indication

Pancreatic CancerSquamous Cell Carcinoma of Head and NeckNasopharyngeal Carcinoma+ [18]

Inactive Indication

AdenocarcinomaAdenosquamous CarcinomaAdvanced Colorectal Adenocarcinoma+ [20]

Originator Organization

Center For Molecular Immunology

Active Organization

Oncoscience GmbHInnogene Kalbiotech Pte Ltd.

Biotech Pharmaceutical Co., Ltd.

+ [4]

Inactive Organization

Daiichi Sankyo Co., Ltd.

Eurofarma Laboratórios SA

YM BioSciences, Inc.

+ [2]

License Organization

CIMYM Biosciences, Inc.Oncoscience AG

YM BioSciences, Inc.

+ [3]

Drug Highest PhaseApproved

First Approval Date

India (11 Sep 2006),

Head and Neck Neoplasms

RegulationOrphan Drug (European Union)

Structure/Sequence

Sequence Code 9615890L

Source: *****

Sequence Code 1191632866H

Source: *****

235

Clinical Trials associated with Nimotuzumab

NCT07457528

/ RecruitingPhase 2IIT

Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

This trial is conducted in patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 46 patients with resectable locally advanced esophageal cancer in Tianjin cancer hospital. Patients will be treated with serplulimab, nimotuzumab plus concurrent chemoradiotherapy (41.4Gy/1.8Gy/23F) . Six to eight weeks after the completion of neoadjuvant chemoradiotherapy, patients who are considered operable by surgeons will undergo radical resection of esophageal cancer. Postoperative pathological assessment includes MPR rate, pCR rate, and pathological response grade, etc. This trial aims to explore the safety and efficacy of adding serplulimab and nimotuzumab to neoadjuvant chemoradiotherapy, with a focus on whether the combined treatment regimen can enhance the efficacy and safety of neoadjuvant chemoradiotherapy.

Start Date12 Mar 2026

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

NCT07445048

/ Not yet recruitingPhase 3IIT

A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial of Postoperative Radiotherapy Combined With Nimotuzumab Followed by Bemcentinib in High-Risk Patients With Head and Neck Squamous Cell Carcinoma Who Are Ineligible for Cisplatin Chemotherapy

A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Bemcentinib in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy.
The primary endpoint is disease-free survival (DFS). A total of 185 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 370 patients. Enrollment is expected to be completed within 2 years, followed by a 3-year follow-up period after the last patient is enrolled.

Start Date05 Mar 2026

Sponsor / Collaborator

The Ninth People's Hospital of Shanghai Jiaotong University Medical College

NCT07446270

/ Not yet recruitingPhase 2IIT

A Cohort Clinical Study to Evaluate the Efficacy and Safety of Tunlametinib Combined With Anti-EGFR Monoclonal Antibody in Patients With RAS-mutated Advanced Gastrointestinal Malignancies

Efficacy of Tunlametinib in Combination With Anti-EGFR Monoclonal Antibody in Patients With RAS-Mutated Advanced Gastrointestinal Malignancies

Start Date03 Mar 2026

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

100 Clinical Results associated with Nimotuzumab

100 Translational Medicine associated with Nimotuzumab

100 Patents (Medical) associated with Nimotuzumab

336

Literatures (Medical) associated with Nimotuzumab

01 Feb 2026·ANTI-CANCER DRUGS

Adiponectin Receptor 1-vascular endothelial growth factor axis mediates resistance to epidermal growth factor receptor–targeted therapy in nasopharyngeal carcinoma

Article

Author: Li, Wanxia ; Wu, Shuting ; Liu, Xiong ; Zhang, Guohua ; Cheng, Zilu ; Peng, Xiaohong

Nasopharyngeal carcinoma (NPC) is highly prevalent in Southeast Asia and southern China, with most patients diagnosed at advanced stages. Although epidermal growth factor receptor (EGFR)–targeted therapies have shown clinical promise, their long-term efficacy is limited. This study explores the regulatory role of AdipoR1 in EGFR-targeted therapy response and evaluates adiponectin as a potential strategy to overcome treatment resistance. NPC cell lines (5-8F and CNE1) were treated with nimotuzumab for short (24 h) and long (72 h) durations. mRNA and protein expression of vascular endothelial growth factor (VEGF), AdipoR1/R2, and other pathway components were assessed using quantitative reverse transcription polymerase chain reaction (qRT-PCR) and western blotting. Adiponectin was applied to explore its regulatory role in VEGF expression and EGFR signaling. Prolonged treatment of NPC cells with nimotuzumab inhibited EGFR downstream signaling [protein kinase B, mammalian target of rapamycin (mTOR), extracellular signal-regulated kinase], reduced cell invasion and migration initially, but invasive capacity gradually recovered over time. VEGF expression remained unchanged at 24 h but significantly increased after 72 h, promoting angiogenesis in cocultured HUVECs. Long-term nimotuzumab exposure downregulated AdipoR1 expression, while adiponectin restored AdipoR1 and VEGF levels with decreased mTOR expression, not EGFR, indicating that the mTOR pathway may mediate this regulation. In addition, nimotuzumab elevated the expression of lipid metabolism-related genes, FABP4 and CD36, which was mitigated by A-PN cotreatment. Prolonged EGFR-targeted therapy in NPC upregulates VEGF via AdipoR1 downregulation, reducing treatment efficacy. Adiponectin restores AdipoR1, suppresses VEGF, and reverses this effect, possibly through mTOR inhibition, suggesting a potential strategy to improve long-term therapeutic outcomes.

01 Feb 2026·Journal of Extracellular Vesicles

Antibody‐Targeted Artificial T Cell and Natural Killer Cell Derived Vesicles for Cancer Immunotherapy

Article

Author: Hernández, Tays ; Medina, Andrés X. ; Livingstone, David W. ; Geyer, Clarence Ronald ; DeCoteau, John ; Parlekar, Brijesh ; Sutherland, Ashley R. ; Bernhard, Wendy

ABSTRACT:

T cell and NK92 cell‐derived extracellular vesicles or artificial cell‐derived vesicles (ACDVs) exhibit anti‐cancer effects through inherited cytotoxic proteins like perforin and granzyme or transmembrane receptors like FasL and TRAIL. The anti‐cancer potential of artificial T and NK vesicles has been improved by attaching targeting moieties to their surface using genetic engineering or covalent surface modifications. However, the genetic engineering of immune cells from which the vesicles are derived is laborious, expensive, and inefficient, and naturally derived exosomes are released in low quantities. Here, we compared the properties of tumour‐targeted and untargeted ACDVs from activated‐T cells and NK92 cells.We examined whether the cancer cell‐killing capacity of ACDVs derived from activated‐T and NK92 cells could be targeted to cancer cells by conjugating tumour‐targeting antibodies to their surface. We targeted T and NK92 ACDVs to cancer cells possessing the xenoantigen, N‐glycolyl neuraminic acid GM3 ganglioside, using the 14f7hT antibody or the tumour antigen, epidermal growth factor receptor, using the nimotuzumab antibody. Antibody targeting improved the cell interaction, internalization, and cytotoxicity of T and NK92 ACDVs. Interestingly, the T‐ACDVs retained perforin, granzyme, FasL and TRAIL, whereas NK92 ACDVs retained perforin, granzyme and FasL. Based on their ease of production and lower cost, we chose NK92 ACDVs for in vivo and ex vivo studies. Intravenously injected nimotuzumab‐conjugated NK92 ACDVs decreased the tumour volumes of EGFR‐expressing ovarian cancer xenografts in mice. 14F7hT‐conjugated NK92 ACDVs showed cytotoxic activity against chronic lymphocytic leukaemia biopsies.This research shows the potential for using antibody‐conjugated, cytotoxic T and NK ACDVs as a feasible and effective approach for tumour‐targeted immunotherapy.

01 Jan 2026·Journal of the Chinese Medical Association

Surgical margin assessment after neoadjuvant chemotherapy plus nimotuzumab in locally advanced oral squamous cell carcinoma

Article

Author: Bao, Yang ; Shi, Yaoyao ; Cui, Zifeng ; Chen, Si ; Zhang, Suxin ; Chai, Guochao ; Hao, Jiamei ; Peng, Shixiong

Background::

The surgical safety margin of the oral squamous cell carcinoma (OSCC) is not clear. We investigate the effect of nimotuzumab (N) combined with nab-paclitaxel, cisplatin, and fluorouracil (APF) neoadjuvant chemotherapy on the surgical margin.

Methods::

This was a single-center retrospective study, included 18 to 75 ages diagnosed newly histologically confirmed OSCC patients at the Fourth Hospital of Hebei Medical University between September 2019 and December 2021. Patients were divided into neoadjuvant chemotherapy and surgery group (G1 group, N + APF), chemotherapy and surgery group (G2 group, APF alone), and surgery group (G3 group). Tissue samples of the tumor core zone (P0), adjacent (P1, 3-5 mm from tumor), distal adjacent (P2, 7-10 mm from tumor), and surgical margin (P3, 15 mm from tumor) were collected. The main indicators of pathological evaluation were pathologic complete response (pCR) and major pathologic response (MPR). Chi-square or Fisher test was used for the pathological response rate of qualitative data, and t test or analysis of variance (ANOVA) was used for protein expression changes of quantitative data. A threshold value of p < 0.05 indicated statistical significance.

Results::

In the G1 (n = 15) and G2 (n = 20) groups, various degrees of degeneration and necrosis were observed in the tumor retraction area. Nine cases of MPR and four cases of pCR in the G1 group; eight cases of MPR and three cases of pCR in the G2 group. The expressions of p53, eIF4E, and EGFR in the samples of the three groups decreased from P0 to P2 ( p < 0.05). In the molecular tumor shrinkage area, the expression levels of p53, eIF4E, and EGFR in the shrinkage zone were lower than those in the negative margin.

Conclusion::

There is no significant statistical difference between APF plus nimotuzumab or APF alone in the pathological remission rate. The surgical margin was defined to 1.5 cm clinical margin after tumor regression.

News (Medical) associated with Nimotuzumab

14 Sep 2022

·www.globenewswire.com

MediciNova Receives Issue Notification for a New Patent Covering MN-166 (ibudilast) for the Treatment of Glioblastoma

LA JOLLA, Calif., Sept. 14, 2022 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received an Issue Notification from the U.S. Patent and Trademark Office for a new patent which covers MN-166 (ibudilast) for the treatment of glioblastoma. This new patent is expected to expire no earlier than February 2039. The allowed claims cover a method of treating a patient diagnosed with glioblastoma or recurrent glioblastoma, wherein the patient expresses unmethylated MGMT, using MN-166 (ibudilast) in combination with one or more other therapeutic agents including temozolomide (TMZ), carmustine, bevacizumab, procarbazine, hydroxyurea, irinotecan, lomustine, nimotuzumab, sirolimus, mipsagargin, cabozantinib, onartuzumab, patupilone (epothilone B), and recombinant oncolytic poliovirus (PVS-RIPO). The allowed claims cover a wide range of doses of MN-166 (ibudilast) as well as the other therapeutic agents. The allowed claims also cover different types of glioblastoma including classical glioblastoma, proneural glioblastoma, mesenchymal glioblastoma, and neural glioblastoma. Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc. commented, “We are very pleased to receive the issue notification for this new patent as it offers additional coverage compared to our other two patents covering glioblastoma. We have an ongoing clinical trial of MN-166 in combination with temozolomide for the treatment of recurrent glioblastoma at the Dana-Farber Cancer Institute, Harvard Medical School. Results of our glioblastoma animal model study showed that median survival was longer in the group that received combination treatment with MN-166 plus temozolomide compared to the group that received the standard treatment of temozolomide alone, and this data was presented at the American Society of Clinical Oncology (ASCO) annual meeting. Encouragingly, the FDA granted orphan-drug designation to MN-166 as adjunctive therapy to temozolomide for the treatment of glioblastoma based on this data.” About Glioblastoma According to the American Association of Neurological Surgeons, glioblastoma is an aggressive brain cancer that often results in death during the first 15 months after diagnosis. Glioblastoma develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. Glioblastoma is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that glioblastoma represents about 15% of all primary brain tumors and approximately 10,000 cases of glioblastoma are diagnosed each year in the U.S. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with glioblastoma. Median survival is about 11-15 months for adults with more aggressive glioblastoma (IDH-wildtype) who receive standard treatment of surgery, temozolomide, and radiation therapy. About MN-166 (ibudilast) MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in glioblastoma and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2021 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT:Geoff O'BrienVice PresidentMediciNova, Inc.info@medicinova.com

Radiation TherapySmall molecular drugASCOCollaborateIPO

25 Sep 2019

·www.biospace.com

Biocon Biologics Expands its R&D Footprint Through Acquisition

60,000 sq. ft World-class Integrated R&D Facility at TICEL Bio Park to House 250 scientists 60,000 sq. ft World-class Integrated R&D Facility at TICEL Bio Park to House 250 scientists Bengaluru, Karnataka, India: September 24, 2019: Biocon Ltd (BSE code: 532523, NSE: BIOCON), Asia’s premier biopharmaceuticals company, today announced that its subsidiary, Biocon Biologics , has acquired R&D capital assets for a 60,000 sq. ft state-of-the-art ‘bench to pilot scale’ Biologics research facility at TICEL Bio Park in Chennai, India. Biocon Biologics has acquired these assets from Pfizer Healthcare India Ltd. Dr Christiane Hamacher, CEO, Biocon Biologics, said: “The high-end integrated R&D facility in Chennai will enable Biocon Biologics to expand its R&D capability and accelerate its journey towards meeting its strategic long-term goal of addressing the needs of millions of patients worldwide. This investment will allow us to fast-forward development of our biosimilars from lab to pilot scale. R&D is at the core of what we do and I believe this facility will enable us to pursue breakthrough innovation in pursuit of providing affordable access to high quality biosimilars and inclusive healthcare solutions aimed at transforming patient lives globally.” The facility will house an early stage research and innovation center including a pilot scale R&D Unit, well-equipped with cell line development, drug substance process development from bench scale to 400 litre scale bioreactors, drug product formulation laboratories and analytical R&D laboratories. The facility is expected to be operational in a few months post qualification and will house over 250 scientists who will have access to state of the art R&D labs equipped with over 500 high- end process and analytical instrumentation. The new facility provides Biocon Biologics a significant time advantage in comparison to setting up a greenfield R&D project and will accelerate the global development of our biosimilars portfolio. Currently, Biocon Biologics has a 200,000 sq. ft state of the art Research & Development Centre at Biocon Park, Bengaluru, India. The Company has a product pipeline of 28 molecules, including 11 with Mylan, few with Sandoz and rest on its own. The financial details of the deal are confidential. TICEL Bio Park at Chennai, Tamil Nadu, India, is a hub for the biotech R&D industry in major domains such as medical biotechnology, nutraceuticals, agricultural biotechnology and bioinformatics and provides world class infrastructure support. About Biocon Biologics Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as the fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in the developed markets of EU, U.S. and Japan. It has obtained approvals and commercialized a range of biosimilars, including monoclonal antibodies for cancer, Pegfilgrastim, rh-Insulin and Insulin Glargine on its own or through partners in key global markets. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives. About Biocon Ltd: Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is a fully-integrated, innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune diseases. The Company has developed and commercialized a range of Biosimilars (Monoclonal Antibodies, Pegfilgrastim, rh- Insulin and Insulin Glargine), Novel Biologics and differentiated Small Molecules in India and key emerging markets. It has a large portfolio of biosimilars and promising novel assets in immunotherapy under global development. Some of its key formulations brands are INSUGEN® (rh-insulin), Basalog One® (prefilled Glargine pen), CANMAb™ (Trastuzumab), KRABEVA® (Bevacizumab), BIOMAb-EGFR® (Nimotuzumab) and ALZUMAb™ (Itolizumab). Follow-us on Twitter: @bioconlimited FOR MORE INFORMATION MEDIA RELATIONS Seema Ahuja Sr. VP & Global Head, Corporate Communications (+91 80 2808 2222 ( +91 99723 17792 * seema.ahuja@biocon.com INVESTOR RELATIONS Saurabh Paliwal Head, Investor Relations ( +91 80 6775 2040 ( +91 95383 80801 * investor.relations@biocon.com DISCLAIMER : This press release may include statements of future expectations and other forward-looking statements based on management’s current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release.

ImmunotherapyDrug ApprovalAcquisition

25 Apr 2014

·www.daiichisankyo.com

Daiichi Sankyo Announces Discontinuation of Phase 3 Clinical Trial in Japan of Nimotuzumab (DE-766) in Lung Cancer

PDF (61KB)PDF For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Joji Nakayama, President and CEO (Code no.: 4568, First Section, Tokyo Stock Exchange) Please address inquiries to Noriaki Ishida, Corporate Officer, Vice President, Corporate Communications Department Telephone: +81-3-6225-1126 http://www.daiichisankyo.com/ TOKYO, Japan (April 25, 2014) - Daiichi Sankyo Company, Limited announced today the discontinuation of the phase 3 clinical trial conducted in Japan for nimotuzumab (DE-766) in Lung Cancer. The phase 3 clinical trial was a multicenter, randomized, double-blind, placebo-controlled study investigating nimotuzumab for first-line therapy in patients with unresectable and locally advanced squamous cell lung cancer. Patients received either nimotuzumab in combination with concurrent chemoradiotherapy or a placebo in combination with concurrent chemoradiotherapy. The study was discontinued based on the recent recommendation of the Independent Data Monitoring Committee which observed safety issues in certain patients who received a combination of cisplatin, vinorelbine, radiotherapy, and nimotuzumab. About Unresectable and Locally Advanced Squamous Cell Lung Cancer In Japan, lung cancer is the first leading cause of cancer death with about 70,000 deaths in 2011.i Non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, and large cell carcinoma) occupies more than 80 percent of lung cancer. Concurrent chemoradiotherapy for a radical cure is currently used as the standard treatment for patients with stage III locally advanced non-small cell lung cancer, in which radical surgery is not possible but radiotherapy is.ii Of these cases, between 30 and 40 percent are squamous cell carcinoma and EGFR is known to be overexpressed.iii About Nimotuzumab and EGFR Nimotuzumab is an intravenously administered recombinant humanized monoclonal antibody directed against human Epidermal Growth Factor Receptor (EGFR) and is produced by CIMAB S.A. (Cuba). nimotuzumab blocks the binding of Epidermal Growth Factor (EGF) to its receptor interfering with the cell signaling pathway. Nimotuzumab has been approved for head and neck cancer, glioma, and esophageal cancer in several countries and used in 29 completed and 26 on-going trials worldwide without any major safety concern so far. EGFR is known to be overexpressed in a wide variety of human tumors.iv Overexpression of EGFR in tumors correlates with increased metastasis, decreased survival, and a poor prognosis. It is known that EGFR is activated by exposure to radiation. In 2006, Daiichi Sankyo introduced nimotuzumab from CIMAB S.A. and CIMYM BioSciences Inc. (Canada) and has the rights to develop and commercialize in Japan. Reference i) Vital Statistics of Japan (Ministry of Health, Labour and Welfare); 2011. ii) Lung Cancer Clinical Practice Guidelines (Japan Lung Cancer Society); 2012. iii) Ito T, Ishii G, Nagai K, et al. Low podoplanin expression of tumor cells predicts poor prognosis in pathological stage IB squamous cell carcinoma of the lung, tissue microarray analysis of 136 patients using 24 antibodies. Lung Cancer 2009; 63(3):418–424. iv) Salomon DS, Brandt R, Ciardiello F, et al. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol Hematol 1995; 19:183-232.

Phase 3Drug Approval

100 Deals associated with Nimotuzumab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Nimotuzumab	L01XC	DB06192

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pancreatic Cancer	China	Biotech Pharmaceutical Co., Ltd.	07 Jun 2023
Squamous Cell Carcinoma of Head and Neck	Indonesia	Innogene Kalbiotech Pte Ltd.	19 Oct 2022
Nasopharyngeal Carcinoma	China	Biotech Pharmaceuticals Pty Ltd	07 Jan 2008
Glioma	Ukraine	Oncoscience AG	10 Oct 2007
Head and Neck Neoplasms	India	Biocon Biopharmaceuticals Pvt Ltd.	11 Sep 2006

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	Phase 3	China	Biotech Pharmaceutical Co., Ltd.	01 Aug 2024
Gastrooesophageal junction cancer	Phase 3	China	Biotech Pharmaceutical Co., Ltd.	01 Aug 2024
stomach adenocarcinoma	Phase 3	China	Biotech Pharmaceutical Co., Ltd.	01 Aug 2024
Metastatic Colorectal Carcinoma	Phase 3	-	Biotech Pharmaceutical Co., Ltd.	01 Apr 2024
Advanced Head and Neck Squamous Cell Carcinoma	Phase 3	China	Biotech Pharmaceutical Co., Ltd.	01 Nov 2021
Cervical Squamous Cell Carcinoma	Phase 3	China	Biotech Pharmaceutical Co., Ltd.	10 May 2016
Esophageal Squamous Cell Carcinoma	Phase 3	China	Biotech Pharmaceutical Co., Ltd.	13 Nov 2015
Metastatic Esophageal Squamous Cell Carcinoma	Phase 3	China	Biotech Pharmaceutical Co., Ltd.	01 Nov 2015
Uterine Cervical Cancer	Phase 3	Algeria	-	28 Oct 2015
Pancreatic adenocarcinoma metastatic	Phase 3	China	Biotech Pharmaceutical Co., Ltd.	01 Apr 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_ASIA2025	Phase 3	Advanced Nasopharyngeal Carcinoma	352	nimotuzumab during induction chemotherapy	rzjoofpkpy(wxchsxxzhz) = wkmclrhyoh hzlltmafhq (zwamrchsyu ) View more	Positive	06 Dec 2025
ESMO_ASIA2025	Phase 3	Advanced Nasopharyngeal Carcinoma	352	nimotuzumab during CCRT	rzjoofpkpy(wxchsxxzhz) = jbmlzvhadt hzlltmafhq (zwamrchsyu ) View more	Positive	06 Dec 2025
NCT06414577 (ESMO_ASIA2025)	Phase 2	Refractory Nasopharyngeal Carcinoma	36	Liposomal irinotecan 70 mg/m2+nimotuzumab 400 mg	jwwvaaigmx(srbumplwgr) = itjihbvpjl vchwjromby (qwbdvkqzlk ) View more	Positive	06 Dec 2025
NCT06938503 (ESMO2025)	Phase 2	Locally Advanced Pancreatic Adenocarcinoma First line	15	Nimotuzumab + AG regimen	myfqcfgjqc(hjwtxhazwu) = hcjvmuapmw jwsbtduzjg (ntjzvjxllb ) View more	Positive	17 Oct 2025
NCT00957086 (IHN01, ESMO2025)	Phase 3	Squamous Cell Carcinoma of Head and Neck Adjuvant	422	Nimotuzumab + Nimotuzumab	qvzrkxktsg(ggjeizjgkw) = kynhyetwjs quflmuvrhq (axldikzmwg ) View more	Negative	17 Oct 2025
NCT00957086 (IHN01, ESMO2025)	Phase 3	Squamous Cell Carcinoma of Head and Neck Adjuvant	422	Placebo + Cisplatin	qvzrkxktsg(ggjeizjgkw) = oiqeykuziy quflmuvrhq (axldikzmwg ) View more	Negative	17 Oct 2025
ESMO2025	Phase 2	Locally Advanced Pancreatic Adenocarcinoma	8	Nimotuzumab plus NALIRIFOX	eboguwnfbj(bicdzmyyqr) = hrvbgkwtmb tlahfmaqgb (sipcjuwhaj ) View more	Positive	17 Oct 2025
ASCO2025	Not Applicable	Advanced Nasopharyngeal Carcinoma EBV DNA level	43	Serplulimab plus docetaxel and cisplatin	mqwwpeyjvy(yebducdihd) = patients with renal impairment experienced no additional adverse effects mdkjndperj (sfhmxkwgmt ) View more	-	30 May 2025
NCT04456322 (ASCO2025)	Phase 3	Advanced Nasopharyngeal Carcinoma positive EGFR expression	381	RT plus Nimotuzumab	qovhvnvuda(gxpvamxfbc) = mjvepgzvyk sziynfgjek (neydbkheot, -2.8 to 6.0)	Positive	30 May 2025
NCT04456322 (ASCO2025)	Phase 3	Advanced Nasopharyngeal Carcinoma positive EGFR expression	381	RT plus Cisplatin	qovhvnvuda(gxpvamxfbc) = kcwyruzpdy sziynfgjek (neydbkheot )	Positive	30 May 2025
NCT06771596 (CC11, ASCO2025)	Phase 2	Cervical Squamous Cell Carcinoma	40	Nimotuzumab 400 mg	drchviallf(ojbplruqbr) = dfyvwhjmrh lexjarjgeh (dtsjqyvjxh, 62.53 - 88.97) View more	Positive	30 May 2025
NCT06771596 (CC11, ASCO2025)	Phase 2	Cervical Squamous Cell Carcinoma	40	Cisplatin 40mg/m2	drchviallf(ojbplruqbr) = islpjkuwfm lexjarjgeh (dtsjqyvjxh, 59.33 - 86.91)	Positive	30 May 2025
ASCO2025	Phase 2	Advanced Esophageal Squamous Cell Carcinoma Second line PD-1/PD-L1	46	Camrelizumab plus Nimotuzumab	rupttqrkvw(xqkyhexgfc) = kgkqkymmki lrmeshjclm (dihfarrmda, 19.5% - 48.0) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Adenocarcinoma of Lung EGFR mutation	19	Nimotuzumab + Chemotherapy	yowzcnmrbx(mhxvakwzeh) = jvdakkwaax dqltnipzsq (wgquieugvg, 33.2 - 76.3) View more	Positive	30 May 2025

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