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Shanghai, China and Gaithersburg, USA, September 28, 2021-Tianjing Bio (NASDAQ: IMAB) is a biopharmaceutical company that is moving from the clinical stage to commercialization, and is committed to innovative biopharmaceuticals The target biology research, antibody technology and clinical development and product commercialization in China and the United States provide new and effective treatment methods for the urgently needed cancer treatment fields on a global scale
.
The company announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has officially accepted the Phase II clinical trial of ebrolizumab (also known as TJ271) and pembrolizumab (Keytruda®) in the treatment of solid tumors Application
.
According to the agreement reached between Tianjing Biological and MacroGenics (Nasdaq: MGNX), Tianjing Biological has the exclusive right to develop and commercialize ebrotuzumab in Mainland China, Hong Kong, Macau and Taiwan
.
As one of the core clinical pipeline products of Tianjing Bio, Ebutuximab is the first monoclonal antibody targeting B7-H3 with Fc optimization function
.
B7-H3 plays a key role in regulating the anti-tumor immune response.
It is widely expressed in a variety of tumors, and its high expression is associated with poor tumor prognosis
.
Preclinical studies have shown that Ebutuximab achieves anti-tumor effects through dual mechanisms of antibody-dependent cell-mediated cytotoxicity and enhanced T cell immune response
.
The clinical research data carried out by MacroGenics also shows that the combination of Ebutuximab and PD-1 monoclonal antibody has the potential to treat a variety of tumors
.
The upcoming Phase II clinical trial is a basket study designed to evaluate the efficacy of ebrolizumab and pembrolizumab in the treatment of a variety of solid tumors, including non-small cell lung cancer (NSCLC) and urothelial cancer As well as other tumors for which treatment signals have been observed in previous studies
.
The results of a number of clinical studies conducted by MacroGenics on the treatment of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) and NSCLC with ebrolizumab showed that ebrolizumab is well tolerated , And observed the efficacy signal
.
According to the data of the Phase I extended cohort study published at the 2018 Annual Meeting of the Society for Cancer Immunotherapy (SITC), the objective response rate (ORR) of ebrolizumab combined with PD-1 monoclonal antibody in the treatment of SCCHN patients reached 33.
3%; for PD The ORR of NSCLC patients with L1 expression lower than 1% reached 35.
7%
.
Currently, MacroGenics is carrying out a phase II clinical study of ebbutorumab combined with retifanlimab (PD-1 monoclonal antibody) or tebotelimab (PD-1 x LAG-3 double antibody) for the first-line treatment of SCCHN
.
Dr.
Shen Huaqiong, Chief Executive Officer of Tianjing Biotech, said: “Ebrtox monoclonal antibody is currently the only B7-H3 monoclonal antibody in the clinical development stage in Greater China
.
This phase II study is based on a number of According to the clinical research results of monoclonal antibodies in the treatment of tumors, we hope to speed up the development process of Ebutuximab and promote the approval of this innovative drug in China
.
"About Ebutuximab is for B7 Family immunomodulatory protein, monoclonal antibody with Fc optimization function
.
B7-H3 is widely expressed in many different types of tumors and plays a key role in regulating anti-tumor immune response
.
Relevant clinical trials have been or are underway to evaluate the efficacy of ebrolizumab as a single-agent therapy or in combination with CTLA-4 or PD-1 in the treatment of tumors with overexpression of B7-H3
.
According to the agreement reached between Tianjing Biological and MacroGenics, Tianjing Biological has the exclusive right to develop and commercialize Ebutostomab in Mainland China, Hong Kong, Macau and Taiwan
.
About Tianjing Biology Tianjing Biology (NASDAQ: IMAB) is an innovative international biotechnology company focusing on the research, development, production and commercialization of differentiated and innovative biological drugs in the field of tumor immunity
.
The company’s mission is to "continuously develop innovative biological drugs and truly change the lives of patients".
Driven by the two-wheeled strategy of "fast product launch" and "rapid proof of concept", the company quickly established itself through diversified models such as independent research and development and global licensing cooperation.
Since then, it has more than 15 innovative drug R&D pipelines with global competitiveness
.
With its leading new drug R&D capabilities and the rapidly advancing GMP production capacity and commercialization layout, the company is rapidly growing from a clinical stage biotechnology company to a comprehensive global biopharmaceutical company covering the entire industry chain.
It is located in Shanghai (headquarters), Beijing, There are offices in Hangzhou, Hong Kong, Maryland, USA and San Diego, California
.
For more information, please visit http://ir.
i-mabbiopharma.
com and follow the official accounts of Tianjing Biopharma on LinkedIn, Twitter and WeChat
.
Forward-looking Statements of Tianjing Biotechnology This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including preclinical studies related to ebrotuzumab, and clinical trial data on patients The potential impact, the progress and expected clinical development plan, pharmaceutical regulatory milestones and commercialization of Ebutuximab by Tianjing Biological
.
Due to various important factors, actual results may differ materially from forward-looking statements
.
These factors include, but are not limited to, the risks of the following items: the ability of Tianjing Bio to prove the safety and efficacy of its drug candidates; the clinical results of the candidate drugs may not support further development or the approval of new drugs; The content and time of the regulatory approval decision; the ability of Tianjing Bio's drug candidates (if approved) to achieve commercial success; the ability of Tianjing Bio to obtain and maintain its technology and drug intellectual property protection; Tianjing Bio's reliance on third parties The status of drug development, production and other services; Tianjing Bio’s limited operating history and the ability to obtain further operating funds to complete the development and commercialization of drug candidates; The new crown virus brings about the company’s clinical development, commercial and other business operations Impact; and the various risks discussed more comprehensively in the "Risk Factors" section of Form 20-F of the most recent annual report by Tianjing Biological; and the potential risks, uncertainties and uncertainties in the subsequent submission of Tianjing Biological to the U.
S.
Securities and Exchange Commission.
Discussion of other important factors
.
All forward-looking statements are based on the information currently held by Tianjing Biological.
Unless otherwise required by law, Tianjing Biological has no obligation to publicly update or revise any forward-looking statements due to new information, future events or other reasons
.
.
The company announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has officially accepted the Phase II clinical trial of ebrolizumab (also known as TJ271) and pembrolizumab (Keytruda®) in the treatment of solid tumors Application
.
According to the agreement reached between Tianjing Biological and MacroGenics (Nasdaq: MGNX), Tianjing Biological has the exclusive right to develop and commercialize ebrotuzumab in Mainland China, Hong Kong, Macau and Taiwan
.
As one of the core clinical pipeline products of Tianjing Bio, Ebutuximab is the first monoclonal antibody targeting B7-H3 with Fc optimization function
.
B7-H3 plays a key role in regulating the anti-tumor immune response.
It is widely expressed in a variety of tumors, and its high expression is associated with poor tumor prognosis
.
Preclinical studies have shown that Ebutuximab achieves anti-tumor effects through dual mechanisms of antibody-dependent cell-mediated cytotoxicity and enhanced T cell immune response
.
The clinical research data carried out by MacroGenics also shows that the combination of Ebutuximab and PD-1 monoclonal antibody has the potential to treat a variety of tumors
.
The upcoming Phase II clinical trial is a basket study designed to evaluate the efficacy of ebrolizumab and pembrolizumab in the treatment of a variety of solid tumors, including non-small cell lung cancer (NSCLC) and urothelial cancer As well as other tumors for which treatment signals have been observed in previous studies
.
The results of a number of clinical studies conducted by MacroGenics on the treatment of recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) and NSCLC with ebrolizumab showed that ebrolizumab is well tolerated , And observed the efficacy signal
.
According to the data of the Phase I extended cohort study published at the 2018 Annual Meeting of the Society for Cancer Immunotherapy (SITC), the objective response rate (ORR) of ebrolizumab combined with PD-1 monoclonal antibody in the treatment of SCCHN patients reached 33.
3%; for PD The ORR of NSCLC patients with L1 expression lower than 1% reached 35.
7%
.
Currently, MacroGenics is carrying out a phase II clinical study of ebbutorumab combined with retifanlimab (PD-1 monoclonal antibody) or tebotelimab (PD-1 x LAG-3 double antibody) for the first-line treatment of SCCHN
.
Dr.
Shen Huaqiong, Chief Executive Officer of Tianjing Biotech, said: “Ebrtox monoclonal antibody is currently the only B7-H3 monoclonal antibody in the clinical development stage in Greater China
.
This phase II study is based on a number of According to the clinical research results of monoclonal antibodies in the treatment of tumors, we hope to speed up the development process of Ebutuximab and promote the approval of this innovative drug in China
.
"About Ebutuximab is for B7 Family immunomodulatory protein, monoclonal antibody with Fc optimization function
.
B7-H3 is widely expressed in many different types of tumors and plays a key role in regulating anti-tumor immune response
.
Relevant clinical trials have been or are underway to evaluate the efficacy of ebrolizumab as a single-agent therapy or in combination with CTLA-4 or PD-1 in the treatment of tumors with overexpression of B7-H3
.
According to the agreement reached between Tianjing Biological and MacroGenics, Tianjing Biological has the exclusive right to develop and commercialize Ebutostomab in Mainland China, Hong Kong, Macau and Taiwan
.
About Tianjing Biology Tianjing Biology (NASDAQ: IMAB) is an innovative international biotechnology company focusing on the research, development, production and commercialization of differentiated and innovative biological drugs in the field of tumor immunity
.
The company’s mission is to "continuously develop innovative biological drugs and truly change the lives of patients".
Driven by the two-wheeled strategy of "fast product launch" and "rapid proof of concept", the company quickly established itself through diversified models such as independent research and development and global licensing cooperation.
Since then, it has more than 15 innovative drug R&D pipelines with global competitiveness
.
With its leading new drug R&D capabilities and the rapidly advancing GMP production capacity and commercialization layout, the company is rapidly growing from a clinical stage biotechnology company to a comprehensive global biopharmaceutical company covering the entire industry chain.
It is located in Shanghai (headquarters), Beijing, There are offices in Hangzhou, Hong Kong, Maryland, USA and San Diego, California
.
For more information, please visit http://ir.
i-mabbiopharma.
com and follow the official accounts of Tianjing Biopharma on LinkedIn, Twitter and WeChat
.
Forward-looking Statements of Tianjing Biotechnology This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including preclinical studies related to ebrotuzumab, and clinical trial data on patients The potential impact, the progress and expected clinical development plan, pharmaceutical regulatory milestones and commercialization of Ebutuximab by Tianjing Biological
.
Due to various important factors, actual results may differ materially from forward-looking statements
.
These factors include, but are not limited to, the risks of the following items: the ability of Tianjing Bio to prove the safety and efficacy of its drug candidates; the clinical results of the candidate drugs may not support further development or the approval of new drugs; The content and time of the regulatory approval decision; the ability of Tianjing Bio's drug candidates (if approved) to achieve commercial success; the ability of Tianjing Bio to obtain and maintain its technology and drug intellectual property protection; Tianjing Bio's reliance on third parties The status of drug development, production and other services; Tianjing Bio’s limited operating history and the ability to obtain further operating funds to complete the development and commercialization of drug candidates; The new crown virus brings about the company’s clinical development, commercial and other business operations Impact; and the various risks discussed more comprehensively in the "Risk Factors" section of Form 20-F of the most recent annual report by Tianjing Biological; and the potential risks, uncertainties and uncertainties in the subsequent submission of Tianjing Biological to the U.
S.
Securities and Exchange Commission.
Discussion of other important factors
.
All forward-looking statements are based on the information currently held by Tianjing Biological.
Unless otherwise required by law, Tianjing Biological has no obligation to publicly update or revise any forward-looking statements due to new information, future events or other reasons
.
