Celltrion is a South Korean biopharmaceutical company established in 2002 that develops, manufactures, and markets biosimilar drugs (highly similar versions of biologic drugs) with the goal of making advanced therapeutics more affordable and accessible to patients worldwide. Their first biosimilar drugs Remsima (infliximab) and Herzuma (trastuzumab) have been approved in multiple countries. Celltrion has extensive R&D, manufacturing, and clinical trial experience that has enabled the successful development and approval of their biosimilar monoclonal antibody drugs. They have a robust pipeline of additional biosimilar candidates in development.
Celltrion Healthcare Company Brochure(2016)celltrionh
Celltrion Healthcare is a biopharmaceutical company committed to developing and distributing more affordable biosimilar therapies. It has been developing biosimilar products since 1999 to increase patient access to treatments. Celltrion specializes in research and development of monoclonal antibodies and biologics, while Celltrion Healthcare conducts worldwide marketing, sales, and distribution. Their biosimilar products have been approved in over 70 countries. Celltrion is devoted to developing novel biologics and high-quality biosimilar monoclonal antibodies to increase global healthcare access.
Celltrion is developing several new drugs including monoclonal antibody therapies and cell culture vaccines for infectious diseases. They are preparing for non-clinical studies on CT-P19 and CT-P25 to treat infectious diseases and CT-P24 for infectious disease treatment in collaboration with Japanese and South Korean hospitals. CT-P27 for infectious disease is in preparation for Phase III clinical trials in the US and South Korea. Celltrion is also developing monoclonal antibody biosimilars including CT-P16 in EMA review process and CT-P05, CT-P14, CT-P15, CT-P17 under development for oncology and autoimmune diseases.
Senesco Technologies is developing a gene regulation technology to treat cancer. They are running a Phase 1b/2a clinical trial of their lead product, SNS01-T, to treat B-cell cancers like multiple myeloma and lymphoma. Preclinical studies show SNS01-T significantly inhibits tumor growth and improves survival in mouse models of these cancers. The presentation provides an overview of Senesco's technology, clinical trial status, financial information, and development plans to advance SNS01-T and expand to additional cancer indications.
Global cancer biosimilars market opportunity outlookKuicK Research
"Global Cancer Biosimilars Market Opportunity Outlook" Report Highlight & Findings:
Introduction & Mechanism of Cancer Biosimilars
Global Cancer Biosimilars Market Dynamics
FDA & EMA Guidelines on Development & Marketing of Biosimilars
Cancer Biosimilars Clinical Pipeline by Company, Indication & Phase
Cancer Biosimilars Clinical Pipeline: 100 Biosimilars
Marketed Cancer Biosimilars Clinical Insight
Marketed Cancer Biosimilars: 15 Biosimilars
Global cancer biosimilars market opportunity outlookKuicK Research
"Global Cancer Biosimilars Market Opportunity Outlook" Report Highlight & Findings:
Introduction & Mechanism of Cancer Biosimilars
Global Cancer Biosimilars Market Dynamics
FDA & EMA Guidelines on Development & Marketing of Biosimilars
Cancer Biosimilars Clinical Pipeline by Company, Indication & Phase
Cancer Biosimilars Clinical Pipeline: 100 Biosimilars
Marketed Cancer Biosimilars Clinical Insight
Marketed Cancer Biosimilars: 15 Biosimilars
Xmt 1536 gains fda fast track designation for ovarian cancer subsetDoriaFang
On August 11, 2020, Mersana Therapeutics announced that its antibody-conjugated drug (ADCs) XMT-1536 has obtained Fast Track Designation granted by the US FDA for the treatment of platinum-resistant high-grade serous ovarian cancer who have received up to three prior lines of systemic therapy or women who have received four prior lines of systemic therapy regardless of platinum status.
Celltrion Healthcare Company Brochure(2016)celltrionh
Celltrion Healthcare is a biopharmaceutical company committed to developing and distributing more affordable biosimilar therapies. It has been developing biosimilar products since 1999 to increase patient access to treatments. Celltrion specializes in research and development of monoclonal antibodies and biologics, while Celltrion Healthcare conducts worldwide marketing, sales, and distribution. Their biosimilar products have been approved in over 70 countries. Celltrion is devoted to developing novel biologics and high-quality biosimilar monoclonal antibodies to increase global healthcare access.
Celltrion is developing several new drugs including monoclonal antibody therapies and cell culture vaccines for infectious diseases. They are preparing for non-clinical studies on CT-P19 and CT-P25 to treat infectious diseases and CT-P24 for infectious disease treatment in collaboration with Japanese and South Korean hospitals. CT-P27 for infectious disease is in preparation for Phase III clinical trials in the US and South Korea. Celltrion is also developing monoclonal antibody biosimilars including CT-P16 in EMA review process and CT-P05, CT-P14, CT-P15, CT-P17 under development for oncology and autoimmune diseases.
Senesco Technologies is developing a gene regulation technology to treat cancer. They are running a Phase 1b/2a clinical trial of their lead product, SNS01-T, to treat B-cell cancers like multiple myeloma and lymphoma. Preclinical studies show SNS01-T significantly inhibits tumor growth and improves survival in mouse models of these cancers. The presentation provides an overview of Senesco's technology, clinical trial status, financial information, and development plans to advance SNS01-T and expand to additional cancer indications.
Global cancer biosimilars market opportunity outlookKuicK Research
"Global Cancer Biosimilars Market Opportunity Outlook" Report Highlight & Findings:
Introduction & Mechanism of Cancer Biosimilars
Global Cancer Biosimilars Market Dynamics
FDA & EMA Guidelines on Development & Marketing of Biosimilars
Cancer Biosimilars Clinical Pipeline by Company, Indication & Phase
Cancer Biosimilars Clinical Pipeline: 100 Biosimilars
Marketed Cancer Biosimilars Clinical Insight
Marketed Cancer Biosimilars: 15 Biosimilars
Global cancer biosimilars market opportunity outlookKuicK Research
"Global Cancer Biosimilars Market Opportunity Outlook" Report Highlight & Findings:
Introduction & Mechanism of Cancer Biosimilars
Global Cancer Biosimilars Market Dynamics
FDA & EMA Guidelines on Development & Marketing of Biosimilars
Cancer Biosimilars Clinical Pipeline by Company, Indication & Phase
Cancer Biosimilars Clinical Pipeline: 100 Biosimilars
Marketed Cancer Biosimilars Clinical Insight
Marketed Cancer Biosimilars: 15 Biosimilars
Xmt 1536 gains fda fast track designation for ovarian cancer subsetDoriaFang
On August 11, 2020, Mersana Therapeutics announced that its antibody-conjugated drug (ADCs) XMT-1536 has obtained Fast Track Designation granted by the US FDA for the treatment of platinum-resistant high-grade serous ovarian cancer who have received up to three prior lines of systemic therapy or women who have received four prior lines of systemic therapy regardless of platinum status.
2013 US Tumor Marker Testing Market: Opportunities and Strategies for SupplierReportsnReports
This 620-page report provides a comprehensive analysis of the US tumor marker testing market, including cancer statistics, current and emerging diagnostic tests, instrumentation technologies, test volume and sales forecasts through 2023 for various market segments. It highlights major opportunities for suppliers in reagent kits, instrumentation, automation, and software. The report profiles current and emerging suppliers and provides strategic recommendations to support business strategies.
Innovative Cancer Diagnostic Technologies and Emerging MarketsReportsnReports
This document provides a 1200-page report on innovative cancer diagnostic technologies and emerging markets published in November 2012. It identifies business opportunities in the cancer diagnostics market over the next ten years in 7 countries. The report examines trends, reviews current and emerging tests, forecasts sales of tumor markers by country/market, and profiles leading and potential market players. It also evaluates major diagnostic instruments and suggests strategies for suppliers.
OBI-999 is an antibody-drug conjugate targeting Globo H that is being developed by OBI Pharma. Preclinical studies show that OBI-999 selectively binds and is internalized by Globo H positive cancer cells, exhibits bystander killing of neighboring Globo H negative cells, and accumulates in tumors through target-mediated uptake. In animal models, OBI-999 demonstrated strong and dose-dependent antitumor activity against breast, gastric, pancreatic, and lung cancer xenografts, with some models achieving complete responses. A phase 1/2 clinical trial is ongoing to evaluate the safety, pharmacokinetics, and activity of OBI-999 in patients with advanced solid tumors
Global cancer tyrosine kinase inhibitors market & clinical pipeline outlo...KuicK Research
This document provides an overview of the global cancer tyrosine kinase inhibitors market and clinical pipeline outlook for 2020. It discusses tyrosine kinases' role in cancer signaling pathways and the development of tyrosine kinase inhibitors as targeted cancer therapies. The market for tyrosine kinase inhibitors is growing due to rising cancer incidence and a strong clinical pipeline. Over 400 tyrosine kinase inhibitors are in clinical development globally across various phases of trials. The future outlook for tyrosine kinase inhibitors is optimistic due to ongoing research and advancement in development approaches.
1. OBI Pharma is a global biopharmaceutical company focused on developing novel oncology therapies, including immunotherapies targeting tumor-associated carbohydrate antigens.
2. The company has a pipeline of monoclonal antibodies, vaccines, and antibody-drug conjugates in clinical and preclinical development targeting Globo H and other tumor-associated antigens.
3. Key clinical programs include Adagloxad Simolenin, a first-in-class active immunotherapy targeting Globo H antigen, and OBI-888, a novel monoclonal antibody targeting Globo H.
COTI-2 is a small molecule discovered by Critical Outcome Technologies to reactivate mutant p53 through zinc chelation. It demonstrates strong efficacy against a wide range of p53 mutations in vitro and significant tumor growth inhibition in vivo without inducing resistance. Further studies confirmed COTI-2's p53-dependent mechanism of action and ability to modulate the PI3K/AKT pathway. An IND filing is planned in mid-2014 to study COTI-2 in gynecological cancers.
The document provides an overview of Targovax's clinical programs for ONCOS-102 and TG01. For ONCOS-102, a Phase I/II trial in ovarian and colorectal cancer in combination with durvalumab was initiated in Q3 2017. Encouraging survival and immune response data was reported from the ongoing Phase I/II trial of TG01 in resected pancreatic cancer. Targovax is developing these programs to boost the effectiveness of immunotherapy and has clinical readouts expected in 2017-2019.
Targovax is developing two complementary and highly targeted approaches to cancer immunotherapy: a peptide-based targeted immunotherapy platform for patients with RAS-mutated cancers and a virus-based oncolytic immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes for patients with solid tumors.
Total Revenues $ 3,108 $ 3,245 $ 2,417 $ 2,652 $ 3,543 $ 630 $ 642 $ 1,340 $ 2,590 $ 1,040 $ 1,040 $ 1,140
Unilife Corporation is a medical device company that develops novel drug delivery syringes and devices. Its flagship product is the Unifill syringe, which has a glass barrel designed to be prefilled by pharmaceutical companies. The company's largest customer, Sanofi, will start receiving validation shipments of Unifill syringes in July 2011
Arming the patient's immune system to fight cancertargovax2017
This document summarizes a presentation by Targovax CEO Øystein Soug at a healthcare conference on December 15, 2016. Targovax is developing immunotherapies to enable the immune system to kill cancer cells, including oncolytic viruses, peptide vaccines, cell therapies, and checkpoint inhibitors. The presentation outlines Targovax's clinical trial pipeline and strategy, including trials of ONCOS-102 in CPI-refractory melanoma and mesothelioma and TG01 in resected pancreatic and colorectal cancers. Near-term value drivers include TG01 two-year survival data in pancreatic cancer in 1H2017 and ONCOS-102 interim data in melanoma in 2H2017.
Presentation the 38th jp morgan healthcare conference chineseNancy Ning Chen
1) Adagloxad Simolenin is OBI Pharma's lead cancer vaccine candidate targeting Globo H antigen expressed in several cancers.
2) In a Phase 2 trial in metastatic breast cancer, higher anti-Globo H antibody levels and Globo H tumor expression correlated with improved outcomes.
3) OBI Pharma is conducting a global Phase 3 trial of Adagloxad Simolenin in early-stage high-risk triple negative breast cancer to evaluate its ability to improve invasive disease-free survival.
This corporate presentation summarizes PharmaMar's pipeline and strategy:
- PharmaMar is a biotech company focused on developing marine-derived oncology drugs. It has a fully integrated platform from discovery to commercialization.
- The pipeline includes Yondelis® for soft tissue sarcoma and ovarian cancer, Aplidin® for multiple myeloma, and PM1183 which is being studied in small cell lung cancer, platinum-resistant ovarian cancer, and BRCA breast cancer.
- PM1183 has shown promising results in early clinical trials, achieving a 67% response rate in small cell lung cancer. Phase III trials are ongoing in platinum-resistant ovarian cancer.
Vaccine is expected to be launched early next year against omicronDoriaFang
In the face of the menacing Omicron strain, companies such as Sinovac, Cansino, Pfizer, BioNTech, Moderna, Johnson & Johnson, and AstraZeneca have all expressed their active response.
Sepsis is a serious medical condition caused by the body's response to an infection. It affects over 1.5 million people per year in the US and EU, with a mortality rate of 25-30%. Rapid diagnosis is key to treatment, which involves intensive care and can cost over €2,500 per day. Existing diagnostic tests are inadequate. Precysion is developing a new diagnostic tool using genetic biomarkers to predict sepsis risk before symptoms occur, enabling optimized individual treatment. It has the potential to save lives, reduce healthcare costs, and address a multi-billion euro market.
Future Horizons in the Japanese Cancer Diagnostics Market: Supplier Shares an...ReportsnReports
This document provides a 590-page report on the Japanese cancer diagnostics market, including test volume and sales forecasts through 2022 for 40 tumor markers across hospital, commercial, and physician office settings. It highlights key issues in the Japanese laboratory practice and analyzes economic, regulatory, demographic, and technological trends impacting the market. The report also profiles major suppliers and provides strategic recommendations.
Regenerative Medicine Industry Outlook 2014Pete Shuster
The document summarizes the regenerative medicine field based on a report from the Alliance for Regenerative Medicine, including an overview of major industry players and subsectors, clinical trials and products in development, financial performance and investments in 2013, and insights from a panel discussion on key areas of focus. It analyzes trends in cell and gene therapies, areas attracting pharmaceutical investment, and challenges facing the commercialization of regenerative medicine technologies and therapies.
Accelerate innovation and manufacturing in cell and gene therapy.pptxGenScript ProBio
The rapid expansion of the gene and cell therapy pipeline created constraints to accessing contract capacities around the globe. Innovation in gene and cell therapy expanded many drug development pipelines, and startups that are lacking internal production capacities heavily rely on contract manufacturing organizations (CDMO).
2013 US Tumor Marker Testing Market: Opportunities and Strategies for SupplierReportsnReports
This 620-page report provides a comprehensive analysis of the US tumor marker testing market, including cancer statistics, current and emerging diagnostic tests, instrumentation technologies, test volume and sales forecasts through 2023 for various market segments. It highlights major opportunities for suppliers in reagent kits, instrumentation, automation, and software. The report profiles current and emerging suppliers and provides strategic recommendations to support business strategies.
Innovative Cancer Diagnostic Technologies and Emerging MarketsReportsnReports
This document provides a 1200-page report on innovative cancer diagnostic technologies and emerging markets published in November 2012. It identifies business opportunities in the cancer diagnostics market over the next ten years in 7 countries. The report examines trends, reviews current and emerging tests, forecasts sales of tumor markers by country/market, and profiles leading and potential market players. It also evaluates major diagnostic instruments and suggests strategies for suppliers.
OBI-999 is an antibody-drug conjugate targeting Globo H that is being developed by OBI Pharma. Preclinical studies show that OBI-999 selectively binds and is internalized by Globo H positive cancer cells, exhibits bystander killing of neighboring Globo H negative cells, and accumulates in tumors through target-mediated uptake. In animal models, OBI-999 demonstrated strong and dose-dependent antitumor activity against breast, gastric, pancreatic, and lung cancer xenografts, with some models achieving complete responses. A phase 1/2 clinical trial is ongoing to evaluate the safety, pharmacokinetics, and activity of OBI-999 in patients with advanced solid tumors
Global cancer tyrosine kinase inhibitors market & clinical pipeline outlo...KuicK Research
This document provides an overview of the global cancer tyrosine kinase inhibitors market and clinical pipeline outlook for 2020. It discusses tyrosine kinases' role in cancer signaling pathways and the development of tyrosine kinase inhibitors as targeted cancer therapies. The market for tyrosine kinase inhibitors is growing due to rising cancer incidence and a strong clinical pipeline. Over 400 tyrosine kinase inhibitors are in clinical development globally across various phases of trials. The future outlook for tyrosine kinase inhibitors is optimistic due to ongoing research and advancement in development approaches.
1. OBI Pharma is a global biopharmaceutical company focused on developing novel oncology therapies, including immunotherapies targeting tumor-associated carbohydrate antigens.
2. The company has a pipeline of monoclonal antibodies, vaccines, and antibody-drug conjugates in clinical and preclinical development targeting Globo H and other tumor-associated antigens.
3. Key clinical programs include Adagloxad Simolenin, a first-in-class active immunotherapy targeting Globo H antigen, and OBI-888, a novel monoclonal antibody targeting Globo H.
COTI-2 is a small molecule discovered by Critical Outcome Technologies to reactivate mutant p53 through zinc chelation. It demonstrates strong efficacy against a wide range of p53 mutations in vitro and significant tumor growth inhibition in vivo without inducing resistance. Further studies confirmed COTI-2's p53-dependent mechanism of action and ability to modulate the PI3K/AKT pathway. An IND filing is planned in mid-2014 to study COTI-2 in gynecological cancers.
The document provides an overview of Targovax's clinical programs for ONCOS-102 and TG01. For ONCOS-102, a Phase I/II trial in ovarian and colorectal cancer in combination with durvalumab was initiated in Q3 2017. Encouraging survival and immune response data was reported from the ongoing Phase I/II trial of TG01 in resected pancreatic cancer. Targovax is developing these programs to boost the effectiveness of immunotherapy and has clinical readouts expected in 2017-2019.
Targovax is developing two complementary and highly targeted approaches to cancer immunotherapy: a peptide-based targeted immunotherapy platform for patients with RAS-mutated cancers and a virus-based oncolytic immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes for patients with solid tumors.
Total Revenues $ 3,108 $ 3,245 $ 2,417 $ 2,652 $ 3,543 $ 630 $ 642 $ 1,340 $ 2,590 $ 1,040 $ 1,040 $ 1,140
Unilife Corporation is a medical device company that develops novel drug delivery syringes and devices. Its flagship product is the Unifill syringe, which has a glass barrel designed to be prefilled by pharmaceutical companies. The company's largest customer, Sanofi, will start receiving validation shipments of Unifill syringes in July 2011
Arming the patient's immune system to fight cancertargovax2017
This document summarizes a presentation by Targovax CEO Øystein Soug at a healthcare conference on December 15, 2016. Targovax is developing immunotherapies to enable the immune system to kill cancer cells, including oncolytic viruses, peptide vaccines, cell therapies, and checkpoint inhibitors. The presentation outlines Targovax's clinical trial pipeline and strategy, including trials of ONCOS-102 in CPI-refractory melanoma and mesothelioma and TG01 in resected pancreatic and colorectal cancers. Near-term value drivers include TG01 two-year survival data in pancreatic cancer in 1H2017 and ONCOS-102 interim data in melanoma in 2H2017.
Presentation the 38th jp morgan healthcare conference chineseNancy Ning Chen
1) Adagloxad Simolenin is OBI Pharma's lead cancer vaccine candidate targeting Globo H antigen expressed in several cancers.
2) In a Phase 2 trial in metastatic breast cancer, higher anti-Globo H antibody levels and Globo H tumor expression correlated with improved outcomes.
3) OBI Pharma is conducting a global Phase 3 trial of Adagloxad Simolenin in early-stage high-risk triple negative breast cancer to evaluate its ability to improve invasive disease-free survival.
This corporate presentation summarizes PharmaMar's pipeline and strategy:
- PharmaMar is a biotech company focused on developing marine-derived oncology drugs. It has a fully integrated platform from discovery to commercialization.
- The pipeline includes Yondelis® for soft tissue sarcoma and ovarian cancer, Aplidin® for multiple myeloma, and PM1183 which is being studied in small cell lung cancer, platinum-resistant ovarian cancer, and BRCA breast cancer.
- PM1183 has shown promising results in early clinical trials, achieving a 67% response rate in small cell lung cancer. Phase III trials are ongoing in platinum-resistant ovarian cancer.
Vaccine is expected to be launched early next year against omicronDoriaFang
In the face of the menacing Omicron strain, companies such as Sinovac, Cansino, Pfizer, BioNTech, Moderna, Johnson & Johnson, and AstraZeneca have all expressed their active response.
Sepsis is a serious medical condition caused by the body's response to an infection. It affects over 1.5 million people per year in the US and EU, with a mortality rate of 25-30%. Rapid diagnosis is key to treatment, which involves intensive care and can cost over €2,500 per day. Existing diagnostic tests are inadequate. Precysion is developing a new diagnostic tool using genetic biomarkers to predict sepsis risk before symptoms occur, enabling optimized individual treatment. It has the potential to save lives, reduce healthcare costs, and address a multi-billion euro market.
Future Horizons in the Japanese Cancer Diagnostics Market: Supplier Shares an...ReportsnReports
This document provides a 590-page report on the Japanese cancer diagnostics market, including test volume and sales forecasts through 2022 for 40 tumor markers across hospital, commercial, and physician office settings. It highlights key issues in the Japanese laboratory practice and analyzes economic, regulatory, demographic, and technological trends impacting the market. The report also profiles major suppliers and provides strategic recommendations.
Regenerative Medicine Industry Outlook 2014Pete Shuster
The document summarizes the regenerative medicine field based on a report from the Alliance for Regenerative Medicine, including an overview of major industry players and subsectors, clinical trials and products in development, financial performance and investments in 2013, and insights from a panel discussion on key areas of focus. It analyzes trends in cell and gene therapies, areas attracting pharmaceutical investment, and challenges facing the commercialization of regenerative medicine technologies and therapies.
Accelerate innovation and manufacturing in cell and gene therapy.pptxGenScript ProBio
The rapid expansion of the gene and cell therapy pipeline created constraints to accessing contract capacities around the globe. Innovation in gene and cell therapy expanded many drug development pipelines, and startups that are lacking internal production capacities heavily rely on contract manufacturing organizations (CDMO).
Targovax is developing immunotherapies to enable the immune system to kill cancer cells. They have two platforms: oncolytic viruses and peptide vaccines. Their peptide vaccine TG01 showed encouraging 2-year survival data in a Phase I/II trial in pancreatic cancer patients, with a survival rate higher than historical controls. Their oncolytic virus ONCOS-102 is in a Phase I trial in CPI-refractory melanoma patients to see if it can activate the immune system and make those patients responsive to checkpoint inhibitors again. Targovax has multiple clinical readouts expected in 2017 and 2018 that could be value inflection points.
Advanced Medical Isotope Corporation is developing a brachytherapy device called RadioGel for cancer treatment in humans and animals. It plans to generate near-term revenue from veterinary clinics and international licensing while pursuing FDA approval. RadioGel consists of yttrium-90 phosphate particles delivered via a hydrogel vehicle that solidifies in the body. It has the potential to treat multiple cancer types more effectively than existing therapies.
Advanced Medical Isotope Corporation is developing a brachytherapy device called RadioGel for cancer treatment in humans and animals. The company plans to generate near-term revenue from veterinary clinics and international licensing while pursuing FDA approval for human use. RadioGel consists of yttrium-90 phosphate particles delivered via a hydrogel that solidifies inside the body. The company expects to begin sales to veterinary clinics in early 2018 and obtain international licensing deals. It is working with national labs and universities to optimize the device and treatment techniques.
This document discusses the growing field of cell-based therapies and efforts to standardize their production and use. It notes that while there are currently less than 40 cell therapies approved for commercial use, the field is growing rapidly with over 300 therapies in clinical trials. New technologies are being developed to streamline and automate cell therapy production in order to minimize variability and human error. These technologies could also help standardize biomedical research practices and improve reproducibility. The document argues that as tools for standardization move from industry into academic labs, they will change the way biomedical research is conducted.
The document discusses new technologies that are helping to standardize and streamline the commercial production of cell-based therapies. These tools are now being applied back in the lab to advance biomedical research. Some of the key technologies mentioned include automated tissue culture systems, cell processing workstations that provide contained cleanroom environments, and high-throughput systems for characterizing cells. Adopting these standardized approaches and technologies in research labs has the potential to improve reproducibility and help push the frontiers of cell-based research.
OneMedForum New York 2010 - Company Presentation. Access Pharmaceuticals, Inc., a emerging biopharmaceutical company that focuses on adding value to exciting product concepts in research by advancing those products through clinical development.
The document summarizes an FDA presentation on the regulation of cellular, tissue, and gene therapies. It provides an overview of the FDA organization relevant to these therapies. It discusses premarket review pathways, recent guidance documents, current activities around stem cells, gene therapy, and tissue safety, and international engagement efforts towards regulatory harmonization.
Global breast cancer monoclonal antibodies market outlook 2020 1KuicK Research
" Global Breast Cancer Monoclonal Antibodies Market Outlook 2020" Report Highlights:
Breast Cancer Monoclonal Antibodies Mechanism
Global Breast Cancer Monoclonal Antibody Market Analysis
Breast Cancer Monoclonal Antibodies Pipeline by Company & Phase
Breast Cancer Monoclonal Antibodies Pipeline: 62 mAb
Majority Breast Cancer Monoclonal Antibodies in Preclinical Phase: 17 mAb
Marketed Breast Cancer Monoclonal Antibodies: 6 mAb
MedicuRx Corporation is developing MR-01, a novel third-generation Camptothecin analogue under an exclusive license from Arno Therapeutics, for the treatment of Glioblastoma Multiforme (GBM). MR-01 has completed two phase 1 studies and a phase 2 study in GBM patients, demonstrating proof of concept. The phase 2 study achieved its primary endpoint of 6 month progression free survival in 6 of 32 patients. MedicuRx aims to advance MR-01 into phase 2b/3 studies based on these promising results for the treatment of GBM, an area of high unmet medical need.
Cancer immunomodulators market & pipeline insight 2020KuicK Research
"Cancer Immunomodulators Market & Pipeline Insight 2020" Report Highlights:
Introduction & Need of Cancer Immunomodulators
Cancer Immunomodulators Mechanism
Cancer Immunomodulators Clinical Pipeline By Company, Indication & Phase
Cancer Immunomodulators Clinical Pipeline: 747 Cancer Immunomodulators Drugs
Majority Cancer Immunomodulators in Preclinical Phase: 300 Marketed Cancer Immunomodulators Clinical Insight
Marketed Cancer Immunomodulators: 47
Cancer Immunomodulators Drug Patent Analysis
Download Cancer immunomodulators market & pipeline insight 2020KuicK Research
\"Cancer Immunomodulators Market & Pipeline Insight 2020\" Report Highlights:
Introduction & Need of Cancer Immunomodulators
Cancer Immunomodulators Mechanism
Cancer Immunomodulators Clinical Pipeline By Company, Indication & Phase
Cancer Immunomodulators Clinical Pipeline: 747 Cancer Immunomodulators Drugs
Majority Cancer Immunomodulators in Preclinical Phase: 300 Marketed Cancer Immunomodulators Clinical Insight
Marketed Cancer Immunomodulators: 47
Cancer Immunomodulators Drug Patent Analysis
Global cancer biosimilars market opportunity outlookKuicK Research
"Global Cancer Biosimilars Market Opportunity Outlook" Report Highlight & Findings:
Introduction & Mechanism of Cancer Biosimilars
Global Cancer Biosimilars Market Dynamics
FDA & EMA Guidelines on Development & Marketing of Biosimilars
Cancer Biosimilars Clinical Pipeline by Company, Indication & Phase
Cancer Biosimilars Clinical Pipeline: 100 Biosimilars
Marketed Cancer Biosimilars Clinical Insight
Marketed Cancer Biosimilars: 15 Biosimilars
Vivos Inc. presented a new brachytherapy tool called RadioGel for treating cancers in humans and animals. RadioGel consists of yttrium-90 phosphate particles delivered via a hydrogel vehicle. It is designed to deliver a high radiation dose directly to tumors while minimizing damage to healthy tissue. The company expects to generate near-term revenue from veterinary applications and international licensing as it pursues FDA approval for multiple human cancer indications starting with skin cancer. Vivos has strong leadership and advisors in place and an intellectual property protected platform technology to become an important new tool for cancer treatment.
The document discusses the International Council for Harmonization (ICH). ICH aims to harmonize technical requirements for pharmaceutical product registration among regulators in Europe, Japan, and the United States to reduce duplication of testing and make the development of new medicines more efficient. It outlines the structure of ICH, including its steering committee and expert working groups. ICH guidelines cover quality, safety, efficacy, and multidisciplinary topics. The overall goal is to streamline drug development while maintaining high standards for safety, quality and efficacy.
Targovax provides a summary of their company presentation on activating the immune system to fight cancer. They have two clinical programs, ONCOS oncolytic virus and TG neoantigen vaccine. ONCOS has ongoing clinical trials in mesothelioma, melanoma, ovarian and colorectal cancers. Early results show immune activation and clinical activity. Their focus is developing ONCOS as the lead product, with mesothelioma as the potential initial indication due to its orphan drug designation. Financially, Targovax has sufficient cash into the second half of 2019 to complete their planned clinical program.
Viatar CTC Solutions Inc. is a medical technology company focused on the treatment of patients with metastatic cancer. The Company's lead product, the Viatar™ Therapeutic Oncopheresis System, removes circulating tumor cells (CTCs) from whole blood using label-free cross-flow filtration. It is designed to be used as a periodic therapy to improve overall survival for a wide range of solid tumor types such as lung, breast, colon, prostate, and gastric cancers. This proprietary technology also powers the Company's liquid biopsy products, which are collection systems for use by genetic testing companies, researchers, and medical oncologists that provide a greater quantity and purity of circulating tumor cells for their molecular analysis and personalized medicine objectives. The Company’s liquid biopsy products are currently generating revenue, and sales are expected to increase in the coming quarters.
Celltrion is a leading global biopharmaceutical company that researches, develops,and manufactures antibody biosimilars and new biologics.Since our foundation, we have provided advanced and affordable treatment options for patients for a wide area of diseases, including autoimmune disease. Our launch of the world’s first antibody biosimilar product presented a new paradigm to the global biologics market, and the responsive and efficient development of COVID-19 therapeutics during the current global pandemic has helped people to return back to their everyday lives in full wellness.
We will continue to grow as a global biopharmaceutical company based on our know-how in biotherapeutics and driven business strategy.
셀트리온은 인류의 건강과 복지 증진에 기여한다는 사명감
으로, 바이오시밀러 및 바이오신약을 연구·개발·생산하고 있는 대한민국 대표 바이오 기업입니다.
뛰어난 기술력과 혁신적인 아이디어를 바탕으로, 세계최초 항체 바이오시밀러 개발에 성공하여 바이오의약품 시장의 패러다임을 변화시키고 전 세계 바이오시밀러 시장을 선도하고 있습니다.
Celltrion is Korea's leading biologics company dedic-
ated to research, development, and manufacture of biosimilars and new biopharmaceutical products, with a commitment of contributing to the promotion of human health and social welfare.
Equipped with state-of-the-art technology and a spirit of innovation, we succeeded in developing the world's first mAb biosimilar, bringing about a paradigm shift of the entire biopharmaceutical market, where Celltrion now stands at the forefront.
셀트리온은 인류의 건강과 복지 증진에 기여한다는 사명감
으로, 바이오시밀러 및 바이오신약을 연구·개발·생산하고 있는 대한민국 대표 바이오 기업입니다.
뛰어난 기술력과 혁신적인 아이디어를 바탕으로, 세계최초 항체 바이오시밀러 개발에 성공하여 바이오의약품 시장의 패러다임을 변화시키고 전 세계 바이오시밀러 시장을 선도하고 있습니다.
셀트리온은 인류의 건강과 복지 증진에 기여한다는 사명감으로,
바이오시밀러 및 바이오신약을 연구·개발·생산하고 있는
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The document discusses the results of a study on the effects of exercise on memory and thinking abilities in older adults. The study found that regular exercise can help reduce the decline in thinking abilities that often occurs with age. Older adults who exercised regularly performed better on cognitive tests and brain scans showed they had greater activity in important areas for memory and learning compared to less active peers.
Celltrion is a South Korean biopharmaceutical company founded in 2002 that develops, manufactures, and markets biosimilar drugs and novel therapeutics. Their goal is to make advanced biologic therapies affordable and accessible to all patients. They have developed the world's first approved biosimilar monoclonal antibodies Remsima (infliximab) and Herzuma (trastuzumab), and have a robust pipeline of additional biosimilar candidates in clinical trials. Beyond biosimilars, Celltrion is also developing novel monoclonal antibodies and other biologics for diseases like influenza, hepatitis B, and cancer.
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The Ultimate Guide to Setting up Market Research in Health Tech part -1
How to effectively start market research in the health tech industry by defining objectives, crafting problem statements, selecting methods, identifying data collection sources, and setting clear timelines. This guide covers all the preliminary steps needed to lay a strong foundation for your research.
This lays foundation of scoping research project what are the
Before embarking on a research project, especially one aimed at scoping and defining parameters like the one described for health tech IT, several crucial considerations should be addressed. Here’s a comprehensive guide covering key aspects to ensure a well-structured and successful research initiative:
1. Define Research Objectives and Scope
Clear Objectives: Define specific goals such as understanding market needs, identifying new opportunities, assessing risks, or refining pricing strategies.
Scope Definition: Clearly outline the boundaries of the research in terms of geographical focus, target demographics (e.g., age, socio-economic status), and industry sectors (e.g., healthcare IT).
3. Review Existing Literature and Resources
Literature Review: Conduct a thorough review of existing research, market reports, and relevant literature to build foundational knowledge.
Gap Analysis: Identify gaps in existing knowledge or areas where further exploration is needed.
4. Select Research Methodology and Tools
Methodological Approach: Choose appropriate research methods such as surveys, interviews, focus groups, or data analytics.
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5. Ethical Considerations and Compliance
Ethical Approval: Ensure compliance with ethical guidelines for research involving human subjects.
Data Privacy: Implement measures to protect participant confidentiality and adhere to data protection regulations (e.g., GDPR, HIPAA).
6. Budget and Resource Allocation
Resource Planning: Allocate resources including time, budget, and personnel required for each phase of the research.
Contingency Planning: Anticipate and plan for unforeseen challenges or adjustments to the research plan.
7. Develop Research Instruments
Survey Design: Create well-structured surveys using tools like Google Forms to gather quantitative data.
Interview and Focus Group Guides: Prepare detailed scripts and discussion points for qualitative data collection.
8. Sampling Strategy
Sampling Design: Define the sampling frame, size, and method (e.g., random sampling, stratified sampling) to ensure representation of target demographics.
Participant Recruitment: Plan recruitment strategies to reach and engage the intended participant groups effectively.
9. Data Collection and Analysis Plan
Data Collection: Implement methods for data gathering, ensuring consistency and validity.
Analysis Techniques: Decide on analytical approaches (e.g., statistical
As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
2. Advanced Therapeutics Within
Everyone’s Reach.
Our History
Since our foundation in 2002, we have concentrated our
investments in human resources, facilities and technologies with
the singular goal of becoming a global biopharmaceutical company
that develops, manufactures and markets affordable advanced
therapeutics based on recombinant DNA and molecular biology.
As of 2015, we have obtained marketing authorizations for
Remsima® and HerzumaTM
, our two biosimilar monoclonal
antibodies (mAbs). Remsima®, the world’s first biosimilar mAb, has
already been approved not only in Korea but also in many countries
around the world, including those in Europe and the US. HerzumaTM
,
the world’s first anti neoplastic biosimilar mAb, has thus far been
approved in Korea. Application for its approval is planned to be
submitted in other countries.
Our bid to become a world-class biopharmaceutical company
continues today with our eyes set firmly on serving the needs of
patients through development of affordable biosimilar mAbs and
innovative next-generation drugs.
To promote patient access to advanced
therapeutics, we have been committed
to bringing affordable drugs to patients
who previously had limited access to
them.
Every patient should have access to
advanced therapeutics they need.
At Celltrion, we believe that patients
deserve the very best treatment
without cost considerations being a
limiting factor.
Feb. 2002 Celltrion is founded
Jun. 2005 Supply Agreement with a US pharmaceutical company
Jul. 2005 Mechanical completion of Plant 1 (capacity: 50,000L)
Dec. 2007 Plant 1 receives cGMP facility approval by the US FDA
Aug. 2009 IND approval of HerzumaTM (for breast cancer treatment)
Oct. 2009 Completion of global sales network
Mar. 2010 IND approval of Remsima®
(for rheumatoid arthritis, ankylosing spondylitis treatment)
May. 2010 Strategic direct investment by Temasek
Dec. 2010 Mechanical completion of Plant 2 (capacity: 90,000L)
Dec. 2011 IND approval of biosimilar candidate CT-P10
(for rheumatoid arthritis and Non Hodgkin’s lymphoma)
Jul. 2012 Remsima® approved by Korea Ministry of Food and
Drug Safety (MFDS, formerly, KFDA)
Apr. 2013 IND approval of CT-P27 (for universal influenza treatment)
Aug. 2013 Remsima® approved by the EMA
Nov. 2013 Completion of global clinical trial phase 1 for CT-P27
Jan. 2014 HerzumaTM approved by the MFDS
Remsima® approved by Health Canada
Jul. 2014 Remsima® approved by MHLW (Japan), MoH (Turkey)
Aug. 2014 Completion of global clinic trial phase 2a for CT-P27
Feb. 2015 Remsima® launched in Europe (12 countries including
Germany, France, England, Italy, Spain)
Apr. 2015 Remsima® approved by ANVISA (Brazil), INHRR (Venezuela)
Oct. 2015 TruximaTM (CT-P10) filed for EMA approval
Dec. 2015 TruximaTM (CT-P10) filed for MFDS approval
Apr. 2016 Remsima® approved by the US FDA
Celltrion
3. Monoclonal antibodies-paving
a new way for biosimilars
Biologics, especially mAbs, are revolutionary therapeutics, considered to
be one of the fastest growing sectors of the pharmaceutical industry.
Biologics have introduced many novel therapeutics to life-threatening and
rare diseases since the late 1980’s.
Although mAbs have treated many patients through their unique mode
of action that targets specific antigens, these highly effective drugs have
been beyond the reach of far more patients due to their extremely high
price. Annual costs of biologics treatment can be as much as 20 times
greater than treatments using chemical drugs.
It is estimated that about USD 66 billion of branded biologic sales will
lose patent protection over the next few years, including some of the
bestselling ones.
With this opportune timing, many global pharmaceutical companies are
on the rush to develop biosimilar mAbs, with Celltrion at the head of the
competition.
The market landscape of biosimilars
• Patent expiry in many of the world’s largest biopharmaceuticals in the
coming years is allowing for biosimilar expansion.
• Rising healthcare expenditure outpacing economic growth is boosting
demand for more affordable drugs.
What do biosimilars mean for the healthcare industry?
• For healthcare providers: an opportunity to provide affordable care
• For patients: access to affordable advanced therapeutics
• For Celltrion: reaching its vision of promoting patient access to
advanced therapeutics at affordable price
Biosimilars, a new horizon in
global pharmaceutical industry
A new era of biosimilars has begun.
Biosimilars are officially approved
subsequent versions of innovator biologics
that may provide opportunities for
reducing the cost of treatment without
compromising quality.
Approximately 40 percent of biosimilars
currently in development are monoclonal
antibodies (mAbs).
That percentage is likely to only grow with
the rising demand for biosimilar versions
of the originator mAbs to offset prohibitive
costs of the originator mAbs.
BiosimilarIndustry
4. Stepwise business development to maximize success
and minimize risk
Since 2002, we have built world-class facilities, developed state-of-
the-art technologies and put quality systems in place.
We also secured the cash flow necessary for developing our own
products through our CMO business.
Using the technology and know-how in biologics development
we have thus accumulated over the years, we soon succeeded in
developing biosimilar mAbs and establishing global marketing and
sales network through strategical partnerships with a number of
major global pharmaceutical distributors.
Strong Capability of Research & Development
R&D is at the center of Celltrion’s mission as Celltrion strives to
transform innovative research into advanced therapeutics.
Over 250 well-experienced researchers (75% MS & 25% Ph.D) are
dedicated to the strong biosimilar pipeline and new product pipeline
including new monoclonal antibodies and vaccines that target
infectious diseases at Celltrion R&D Center.
Core research activities range from target screening to non-clinical
design. The capabilities of Celltrion R&D combined with well-
established infrastructures have led to successful drug development.
State-of-the-art manufacturing facilities
Celltrion boasts one of the world's largest state-of-the-art
mammalian cell culture plants with a total production capacity of
140,000L.
These plants were designed and constructed to comply with the US
FDA’s cGMP and the EMA’s GMP regulations.
Excellence in clinical study design and
global biosimilar mAb approval experience
From the very earliest stages of our biosimilar mAb development,
we have thoroughly reviewed regulatory requirements for each
individual country to design global clinical trials that would
encompass even the most stringent regulatory requirements.
Thanks in no small part to such unrelenting efforts, Celltrion
accomplished the historical feat of successfully obtaining approval
from the EMA, US FDA and the MFDS for Remsima®, the world’s
very first approved biosimilar mAb.
Key factors behind Celltrion’s successful
biosimilar mAb development
Celltrion was already
strategically preparing for
biosimilar mAb development
well before other global
biopharmaceutical companies
even realized the biosimilar
market potential.
Biosimilar Candidate Target(INN) Original Product Major Indication
CT-P17 Adalimumab Humira Rheumatoid arthritis
CT-P16 Bevacizumab Avastin Colon cancer
CT-P15 Cetuximab Erbitux Colorectal cancer
CT-P14 Palivizumab Synagis RSV Infant
CT-P05 Etanercept Enbrel Rheumatoid arthritis
BiosimilarDevelopment
Affordable solutions
for advanced therapeutics
Our biosimilar mAb
products & pipeline
In addition to HerzumaTM and Remsima®,
we have a robust pipeline consisting of as many as six biosimilar
mAb candidates. From this pipeline, we plan to launch products
on an annual basis. Following on the heels of Remsima® and
HerzumaTM, the development of CT-P10, our third biosimilar mAb, is
progressing on schedule with successful clinical trial phase 1 results.
CT-P10 is currently in global clinical trial phase 3. In 2015, Celltrion
submitted a Market Authorization Application (MAA) for CT-P10 to
the EMA.
Product Target(INN) Original Product Major Indication Current Status
Remsima®
Infliximab Remicade Rheumatoid arthritis
∙ MFDS approval 2012
∙ EMA approval 2013
∙ Health Canada, MHLW(Japan) and
TITCK(Turkey) approval 2014
∙ ANVISA(Brazil), INHRR(Venezuela)
approval 2015
∙ US FDA approval 2016
HerzumaTM
Trastuzumab Herceptin Breast cancer ∙ MFDS approval 2014
TruximaTM
Rituximab Rituxan Non-Hodgkin lymphoma ∙ Filed for EMA, MFDS approval
Biosimilar mAb products
Biosimilar mAb pipeline
5. 1) : “Indications approved vary among countries. This is a collective list of indications
approved by countries in which CT-P13 is approved. Country-specific information
is available upon request at gmkt@celltrion.com
Remsima®
global clinical
trial overview
Clinical trial period
March 2010 - November 2012
Number of patients
Total 874 | Phase 1: 250, Phase 3: 606
Number of countries and sites
Phase 1: 10 countries 46 sites
Phase 3: 19 countries 100 sites
• INN: Trastuzumab
• Approval status: Approved by the MFDS
• Indications: Metastatic breast cancer, early stage breast cancer and
metastatic gastric cancer with over-expression of human epidermal
growth factor receptor 2 protein (HER2)
• Protein type: Monoclonal antibody (mAb)
• Mechanism of action: The antibody specifically binds to the antigen
and suppresses the antigen signals to target and destroy tumor.
• Trastuzumab market size: Approximately USD 7 billion (as of 2015)
HerzumaTM
is our trastuzumab
biosimilar which had been
demonstrated comparable with the
originator trastuzumab for breast
cancer treatment by multinational
randomized double blind clinical
trials.
HerzumaTM
global clinical
trial overview
Clinical trial period (MBC)
August 2009 - June 2012
Number of patients
Total 557 | Phase 1: 174, Phase 3: 383
Number of countries and sites
Phase 1: 7 countries 31 sites
Phase 3: 22 countries 99 sites
Remsima®
is an alternative to the
originator infliximab in approved
countries. In more than seventy
countries Remsima®
is approved
and used for treatment of
rheumatoid arthritis and certain
other autoimmune diseases.
Remsima®&HerzumaTM
the world’s first
approved
biosimilar mAb
the only oncology
biosimilar mAb
approved based on
global clinical trial
results
• INN: Infliximab
• Approval status: Approved by the EMA, US FDA, Health Canada,
MHLW (Japan), ANVISA (Brazil) and the MFDS (Korea), etc.
• Indications1) : Rheumatoid arthritis, ankylosing spondylitis,
ulcerative colitis, Crohn's disease, psoriasis and psoriatic arthritis
• Protein type: Monoclonal antibody (mAb)
• Mechanism of action: Neutralizes tumor necrosis factor (TNF-alpha),
a common cause of autoimmune diseases such as rheumatoid arthritis
• TNF antagonist market size: Approximately USD 32.9 billion
(as of 2015)
*Under Phase 3 for EBC protocols
6. Universal influenza antibody CT-P27
Most notably, in August 2014, Celltrion completed phase 2a
clinical trial for CT-P27, a novel therapeutic antibody under
development for treatment against various types of influenza
viruses.
CT-P27, a cocktail injectable made up of two different monoclonal
antibodies developed by Celltrion, has been drawing keen
interests from the US and Chinese governments for targeting
neutralization of a broad spectrum of influenza viruses including
seasonal strains and potential pandemic strains. Through its mode
of action which is distinct from existing influenza treatments,
CT-P27 aims to neutralize even those influenza viruses that have
become resistant to currently existing neuraminidase inhibitors.
Celltrion projects that its non-clinical and clinical studies have the
potential to demonstrate CT-P27 as possible treatment of various
types of influenza virus infection.
Beyond
biosimilar mAbs
Our novel
Therapeutics
Beyond biosimilar mAbs,
Celltrion is also developing its own
novel biopharmaceuticals using the
R&D capabilities and technologies
it has accumulated over the years
through its biosimilar development.
Project Target Indication
CT-P27 (mAb) Influenza virus infections
CT-P26 (ADC) Breast cancer
CT-P25 (cell-based vaccine) Influenza
CT-P24 (mAb) Hepatitis B virus
CT-P19 (mAb) Rabies
In addition to CT-P26, Celltrion is developing an antibody-drug conjugate (ADC) for breast cancer. ADC’s are mAbs chemically linked
to cytotoxic drug so as to minimize side effects and maximize efficacy.
We are also developing an antiviral medication for pandemic and seasonal influenza which we hope will overcome the limitations of
existing vaccines and synthetic drugs.
NovelTherapeutics
Novel therapeutics pipeline
Innovation at work
Our novel therapeutics pipeline
7. Contact Information
Celltrion, Inc. 23, Academy-ro, Yeonsu-gu, 406-840, Incheon, South Korea T. +82-32-850-5000 F. +82-32-850-5078 Webpage. www.celltrion.com
E-MAIL・Business : contact@celltrion.com・Investment : investor@celltrion.com・Legal : legal@celltrion.com・Careers : recruit@celltrion.com
@2016.05Celltrion