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On March 24, 2021, Beijing time, Junshi Bio (1877.
HK, 688180.
SH) announced that the company’s self-developed recombinant humanized anti-PD-1 monoclonal antibody injection (generic name: teriprizumab) injection trade name: extension beneficial ® , product code: JS001) for late mucosal melanoma in first-line treatment by the State Drug Administration (NMPA) into the ground-breaking therapy program.
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According to the "Announcement of the National Medical Products Administration on Issuing the "Working Procedures for Breakthrough Therapy Drug Evaluation (Trial)" and other three documents" (No.
82 of 2020), the Center for Drug Evaluation gives priority to the allocation of drugs included in the breakthrough therapy drug program Resources to communicate, strengthen guidance and promote drug research and development, aiming to encourage research and creation of drugs with obvious clinical advantages .
In recent years, the incidence of malignant melanoma in China has been on the rise, with an annual growth rate of 3% to 5%, and it has become the fastest-increasing incidence of all malignant tumors.
Among them, mucosal melanoma is one of the main subtypes in my country, accounting for about 22% to 25%.
This subtype is more aggressive, easy to invade blood vessels, and prone to recurrence and metastasis.
The median overall survival (mOS) is generally less than 12 months, and the patient is not sensitive to traditional chemotherapy, and the response rate to single-agent immunotherapy is also extremely high.
Limited, its clinical treatment is still a major problem in the field of melanoma.
In order to meet the unmet clinical needs of the Chinese people, the team of Professor Guo Jun from Peking University Cancer Hospital pioneered the combination of teriprizumab and the anti-angiogenic drug axitinib therapy, bringing unprecedented first-line treatment options for mucosal melanoma New breakthrough.
Since 2017, "JS001 combined with axitinib first-line treatment of advanced mucosal melanoma phase Ib clinical study" made its first appearance at the World Melanoma Conference (WCM).
The updated results will be announced in the form of a poster or oral presentation at the annual meeting.
In August 2019, the research results were listed in the internationally renowned journal " Journal of Clinical Oncology " ( Journal of Clinical Oncology , IF: 32.
956), arousing global attention.
In May 2020, Professor Guo Jun presented an oral report on the updated results of the study at the ASCO annual meeting.
The results showed that teriprizumab combined with axitinib has a long-lasting effect in the treatment of patients with advanced mucosal melanoma , and the survival benefit is obvious .
The objective response rate (ORR) and disease control rate (DCR) are as high as 48.
5% and 84.
8%.
The median progression-free survival (mPFS) was 7.
5 months, the median duration of response (mDOR) was 13.
7 months, and the median overall survival (mOS) was 20.
7 months.
In view of the breakthrough results of this research, in March 2020 and January 2021, teriprizumab combined with axitinib in the treatment of mucosal melanoma has been awarded 1 orphan drug by the U.
S.
Food and Drug Administration (FDA) Qualifications and 1 fast track qualification.
Currently, an international multi-center, randomized controlled Phase III clinical trial of teriprizumab combined with axitinib for the first-line treatment of patients with mucosal melanoma is underway.
This study aims to evaluate the effectiveness and safety of teriprizumab combined with axitinib versus pembrolizumab (KEYTRUDA 544px;box-sizing:border-box ;overflow-wrap:break-word ;">® ) in the first-line treatment of patients with unresectable, locally advanced or metastatic mucosal melanoma.
The trial is planned to enroll 220 patients, who will be randomly divided into groups at a ratio of 1:1.
The primary study endpoint is progression-free survival (PFS), and the secondary study endpoints are objective response rate (ORR), overall survival (OS), duration of remission (DOR), safety and tolerability, etc.
On March 24, 2021, Beijing time, Junshi Bio (1877.
HK, 688180.
SH) announced that the company’s self-developed recombinant humanized anti-PD-1 monoclonal antibody injection (generic name: teriprizumab) injection trade name: extension beneficial ® , product code: JS001) for late mucosal melanoma in first-line treatment by the State Drug Administration (NMPA) into the ground-breaking therapy program.
Previously, the therapy has to get Mei Guo Food and Drug Administration (FDA) granted an orphan status identification and a fast-track qualifications.
On March 24, 2021, Beijing time, Junshi Bio (1877.
HK, 688180.
SH) announced that the company’s self-developed recombinant humanized anti-PD-1 monoclonal antibody injection (generic name: teriprizumab) injection trade name: extension beneficial ® , product code: JS001) for late mucosal melanoma in first-line treatment by the State Drug Administration (NMPA) into the ground-breaking therapy program.
Previously, the therapy has to get Mei Guo Food and Drug Administration (FDA) granted an orphan status identification and a fast-track qualifications.
On March 24, 2021, Beijing time, Junshi Bio (1877.
HK, 688180.
SH) announced that the company’s self-developed recombinant humanized anti-PD-1 monoclonal antibody injection (generic name: teriprizumab) injection trade name: extension beneficial ® , product code: JS001) for late mucosal melanoma in first-line treatment by the State Drug Administration (NMPA) into the ground-breaking therapy program.
Previously, the therapy has to get Mei Guo Food and Drug Administration (FDA) granted an orphan status identification and a fast-track qualifications.
On March 24, 2021, Beijing time, Junshi Bio (1877.
HK, 688180.
SH) announced that the company’s self-developed recombinant humanized anti-PD-1 monoclonal antibody injection (generic name: teriprizumab) injection trade name: extension beneficial ® , product code: JS001) for late mucosal melanoma in first-line treatment by the State Drug Administration (NMPA) into the ground-breaking therapy program.
Previously, the therapy has to get Mei Guo Food and Drug Administration (FDA) granted an orphan status identification and a fast-track qualifications.
On March 24, 2021, Beijing time, Junshi Bio (1877.
HK, 688180.
SH) announced that the company’s self-developed recombinant humanized anti-PD-1 monoclonal antibody injection (generic name: teriprizumab) injection trade name: extension beneficial ® , product code: JS001) for late mucosal melanoma in first-line treatment by the State Drug Administration (NMPA) into the ground-breaking therapy program.
Previously, the therapy has to get Mei Guo Food and Drug Administration (FDA) granted an orphan status identification and a fast-track qualifications.
On March 24, 2021, Beijing time, Junshi Bio (1877.
HK, 688180.
SH) announced that the company’s self-developed recombinant humanized anti-PD-1 monoclonal antibody injection (generic name: teriprizumab) injection trade name: extension beneficial ® , product code: JS001) for late mucosal melanoma in first-line treatment by the State Drug Administration (NMPA) into the ground-breaking therapy program.
Previously, the therapy has to get Mei Guo Food and Drug Administration (FDA) granted an orphan status identification and a fast-track qualifications.
On March 24, 2021, Beijing time, Junshi Bio (1877.
HK, 688180.
SH) announced that the company’s self-developed recombinant humanized anti-PD-1 monoclonal antibody injection (generic name: teriprizumab) injection trade name: extension beneficial ® , product code: JS001) for late mucosal melanoma in first-line treatment by the State Drug Administration (NMPA) into the ground-breaking therapy program.
Previously, the therapy has to get Mei Guo Food and Drug Administration (FDA) granted an orphan status identification and a fast-track qualifications.
On March 24, 2021, Beijing time, Junshi Bio (1877.
HK, 688180.
SH) announced that the company’s self-developed recombinant humanized anti-PD-1 monoclonal antibody injection (generic name: teriprizumab) injection trade name: extension beneficial ® , product code: JS001) for late mucosal melanoma in first-line treatment by the State Drug Administration (NMPA) into the ground-breaking therapy program.
Previously, the therapy has to get Mei Guo Food and Drug Administration (FDA) granted an orphan status identification and a fast-track qualifications.
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According to the "Announcement of the National Medical Products Administration on Issuing the "Working Procedures for Breakthrough Therapy Drug Evaluation (Trial)" and other three documents" (No.
82 of 2020), the Center for Drug Evaluation gives priority to the allocation of drugs included in the breakthrough therapy drug program Resources to communicate, strengthen guidance and promote drug research and development, aiming to encourage research and creation of drugs with obvious clinical advantages .
In recent years, the incidence of malignant melanoma in China has been on the rise, with an annual growth rate of 3% to 5%, and it has become the fastest-increasing incidence of all malignant tumors.
Among them, mucosal melanoma is one of the main subtypes in my country, accounting for about 22% to 25%.
In order to meet the unmet clinical needs of the Chinese people, the team of Professor Guo Jun from Peking University Cancer Hospital pioneered the combination of teriprizumab and the anti-angiogenic drug axitinib therapy, bringing unprecedented first-line treatment options for mucosal melanoma New breakthrough.
Since 2017, "JS001 combined with axitinib first-line treatment of advanced mucosal melanoma phase Ib clinical study" made its first appearance at the World Melanoma Conference (WCM).
The updated results will be announced in the form of a poster or oral presentation at the annual meeting.
In August 2019, the research results were listed in the internationally renowned journal " Journal of Clinical Oncology " ( Journal of Clinical Oncology , IF: 32.
956), arousing global attention.
In May 2020, Professor Guo Jun presented an oral report on the updated results of the study at the ASCO annual meeting.
The results showed that teriprizumab combined with axitinib has a long-lasting effect in the treatment of patients with advanced mucosal melanoma , and the survival benefit is obvious .
The objective response rate (ORR) and disease control rate (DCR) are as high as 48.
5% and 84.
8%.
The median progression-free survival (mPFS) was 7.
5 months, the median duration of response (mDOR) was 13.
7 months, and the median overall survival (mOS) was 20.
7 months.
In view of the breakthrough results of this research, in March 2020 and January 2021, teriprizumab combined with axitinib in the treatment of mucosal melanoma has been awarded 1 orphan drug by the U.
S.
Food and Drug Administration (FDA) Qualifications and 1 fast track qualification.
Currently, an international multi-center, randomized controlled Phase III clinical trial of teriprizumab combined with axitinib for the first-line treatment of patients with mucosal melanoma is underway.
This study aims to evaluate the effectiveness and safety of teriprizumab combined with axitinib versus pembrolizumab (KEYTRUDA 544px;box-sizing:border-box ;overflow-wrap:break-word ;">® ) in the first-line treatment of patients with unresectable, locally advanced or metastatic mucosal melanoma.
The trial is planned to enroll 220 patients, who will be randomly divided into groups at a ratio of 1:1.
The primary study endpoint is progression-free survival (PFS), and the secondary study endpoints are objective response rate (ORR), overall survival (OS), duration of remission (DOR), safety and tolerability, etc.
According to the "Announcement of the National Medical Products Administration on Issuing the "Working Procedures for Breakthrough Therapy Drug Evaluation (Trial)" and other three documents" (No.
82 of 2020), the Center for Drug Evaluation gives priority to the allocation of drugs included in the breakthrough therapy drug program Resources to communicate, strengthen guidance and promote drug research and development, aiming to encourage research and creation of drugs with obvious clinical advantages .
In recent years, the incidence of malignant melanoma in China has been on the rise, with an annual growth rate of 3% to 5%, and it has become the fastest-increasing incidence of all malignant tumors.
Among them, mucosal melanoma is one of the main subtypes in my country, accounting for about 22% to 25%.
This subtype is more aggressive, easy to invade blood vessels, and prone to recurrence and metastasis.
The median overall survival (mOS) is generally less than 12 months, and the patient is not sensitive to traditional chemotherapy, and the response rate to single-agent immunotherapy is also extremely high.
Limited, its clinical treatment is still a major problem in the field of melanoma.
In order to meet the unmet clinical needs of the Chinese people, the team of Professor Guo Jun from Peking University Cancer Hospital pioneered the combination of teriprizumab and the anti-angiogenic drug axitinib therapy, bringing unprecedented first-line treatment options for mucosal melanoma New breakthrough.
Since 2017, "JS001 combined with axitinib first-line treatment of advanced mucosal melanoma phase Ib clinical study" made its first appearance at the World Melanoma Conference (WCM).
The updated results will be announced in the form of a poster or oral presentation at the annual meeting.
In August 2019, the research results were listed in the internationally renowned journal " Journal of Clinical Oncology " ( Journal of Clinical Oncology , IF: 32.
956), arousing global attention.
In May 2020, Professor Guo Jun presented an oral report on the updated results of the study at the ASCO annual meeting.
The results showed that teriprizumab combined with axitinib has a long-lasting effect in the treatment of patients with advanced mucosal melanoma , and the survival benefit is obvious .
The objective response rate (ORR) and disease control rate (DCR) are as high as 48.
5% and 84.
8%.
The median progression-free survival (mPFS) was 7.
5 months, the median duration of response (mDOR) was 13.
7 months, and the median overall survival (mOS) was 20.
7 months.
In view of the breakthrough results of this research, in March 2020 and January 2021, teriprizumab combined with axitinib in the treatment of mucosal melanoma has been awarded 1 orphan drug by the U.
S.
Food and Drug Administration (FDA) Qualifications and 1 fast track qualification.
Currently, an international multi-center, randomized controlled Phase III clinical trial of teriprizumab combined with axitinib for the first-line treatment of patients with mucosal melanoma is underway.
This study aims to evaluate the effectiveness and safety of teriprizumab combined with axitinib versus pembrolizumab (KEYTRUDA 544px;box-sizing:border-box ;overflow-wrap:break-word ;">® ) in the first-line treatment of patients with unresectable, locally advanced or metastatic mucosal melanoma.
The trial is planned to enroll 220 patients, who will be randomly divided into groups at a ratio of 1:1.
The primary study endpoint is progression-free survival (PFS), and the secondary study endpoints are objective response rate (ORR), overall survival (OS), duration of remission (DOR), safety and tolerability, etc.
According to the "Announcement of the National Medical Products Administration on Issuing the "Working Procedures for Breakthrough Therapy Drug Evaluation (Trial)" and other three documents" (No.
82 of 2020), the Center for Drug Evaluation gives priority to the allocation of drugs included in the breakthrough therapy drug program Resources to communicate, strengthen guidance and promote drug research and development, aiming to encourage research and creation of drugs with obvious clinical advantages .
In recent years, the incidence of malignant melanoma in China has been on the rise, with an annual growth rate of 3% to 5%, and it has become the fastest-increasing incidence of all malignant tumors.
Among them, mucosal melanoma is one of the main subtypes in my country, accounting for about 22% to 25%.
This subtype is more aggressive, easy to invade blood vessels, and prone to recurrence and metastasis.
The median overall survival (mOS) is generally less than 12 months, and the patient is not sensitive to traditional chemotherapy, and the response rate to single-agent immunotherapy is also extremely high.
Limited, its clinical treatment is still a major problem in the field of melanoma.
In order to meet the unmet clinical needs of the Chinese people, the team of Professor Guo Jun from Peking University Cancer Hospital pioneered the combination of teriprizumab and the anti-angiogenic drug axitinib therapy, bringing unprecedented first-line treatment options for mucosal melanoma New breakthrough.
Since 2017, "JS001 combined with axitinib first-line treatment of advanced mucosal melanoma phase Ib clinical study" made its first appearance at the World Melanoma Conference (WCM).
The updated results will be announced in the form of a poster or oral presentation at the annual meeting.
In August 2019, the research results were listed in the internationally renowned journal " Journal of Clinical Oncology " ( Journal of Clinical Oncology , IF: 32.
956), arousing global attention.
In May 2020, Professor Guo Jun presented an oral report on the updated results of the study at the ASCO annual meeting.
The results showed that teriprizumab combined with axitinib has a long-lasting effect in the treatment of patients with advanced mucosal melanoma , and the survival benefit is obvious .
The objective response rate (ORR) and disease control rate (DCR) are as high as 48.
5% and 84.
8%.
The median progression-free survival (mPFS) was 7.
5 months, the median duration of response (mDOR) was 13.
7 months, and the median overall survival (mOS) was 20.
7 months.
In view of the breakthrough results of this research, in March 2020 and January 2021, teriprizumab combined with axitinib in the treatment of mucosal melanoma has been awarded 1 orphan drug by the U.
S.
Food and Drug Administration (FDA) Qualifications and 1 fast track qualification.
Currently, an international multi-center, randomized controlled Phase III clinical trial of teriprizumab combined with axitinib for the first-line treatment of patients with mucosal melanoma is underway.
This study aims to evaluate the effectiveness and safety of teriprizumab combined with axitinib versus pembrolizumab (KEYTRUDA 544px;box-sizing:border-box ;overflow-wrap:break-word ;">® ) in the first-line treatment of patients with unresectable, locally advanced or metastatic mucosal melanoma.
The trial is planned to enroll 220 patients, who will be randomly divided into groups at a ratio of 1:1.
The primary study endpoint is progression-free survival (PFS), and the secondary study endpoints are objective response rate (ORR), overall survival (OS), duration of remission (DOR), safety and tolerability, etc.
According to the "Announcement of the National Medical Products Administration on Issuing the "Working Procedures for Breakthrough Therapy Drug Evaluation (Trial)" and other three documents" (No.
82 of 2020), the Center for Drug Evaluation gives priority to the allocation of drugs included in the breakthrough therapy drug program Resources to communicate, strengthen guidance and promote drug research and development, aiming to encourage research and creation of drugs with obvious clinical advantages .
In recent years, the incidence of malignant melanoma in China has been on the rise, with an annual growth rate of 3% to 5%, and it has become the fastest-increasing incidence of all malignant tumors.
Among them, mucosal melanoma is one of the main subtypes in my country, accounting for about 22% to 25%.
This subtype is more aggressive, easy to invade blood vessels, and prone to recurrence and metastasis.
The median overall survival (mOS) is generally less than 12 months, and the patient is not sensitive to traditional chemotherapy, and the response rate to single-agent immunotherapy is also extremely high.
Limited, its clinical treatment is still a major problem in the field of melanoma.
In order to meet the unmet clinical needs of the Chinese people, the team of Professor Guo Jun from Peking University Cancer Hospital pioneered the combination of teriprizumab and the anti-angiogenic drug axitinib therapy, bringing unprecedented first-line treatment options for mucosal melanoma New breakthrough.
Since 2017, "JS001 combined with axitinib first-line treatment of advanced mucosal melanoma phase Ib clinical study" made its first appearance at the World Melanoma Conference (WCM).
The updated results will be announced in the form of a poster or oral presentation at the annual meeting.
In August 2019, the research results were listed in the internationally renowned journal " Journal of Clinical Oncology " ( Journal of Clinical Oncology , IF: 32.
956), arousing global attention.
In May 2020, Professor Guo Jun presented an oral report on the updated results of the study at the ASCO annual meeting.
The results showed that teriprizumab combined with axitinib has a long-lasting effect in the treatment of patients with advanced mucosal melanoma , and the survival benefit is obvious .
The objective response rate (ORR) and disease control rate (DCR) are as high as 48.
5% and 84.
8%.
The median progression-free survival (mPFS) was 7.
5 months, the median duration of response (mDOR) was 13.
7 months, and the median overall survival (mOS) was 20.
7 months.
In view of the breakthrough results of this research, in March 2020 and January 2021, teriprizumab combined with axitinib in the treatment of mucosal melanoma has been awarded 1 orphan drug by the U.
S.
Food and Drug Administration (FDA) Qualifications and 1 fast track qualification.
，、III。（KEYTRUDA544px;box-sizing:border-box ;overflow-wrap:break-word ;">®）、。220，1:1。（PFS），（ORR）、（OS）、（DOR）、。
《<（）>》（202082），，，。
，，3%~5%，。，22%~25%。，，，（mOS）12，，，。
，，。
Since 2017, "JS001 combined with axitinib first-line treatment of advanced mucosal melanoma phase Ib clinical study" made its first appearance at the World Melanoma Conference (WCM).
The updated results will be announced in the form of a poster or oral presentation at the annual meeting.
In August 2019, the research results were listed in the internationally renowned journal " Journal of Clinical Oncology " ( Journal of Clinical Oncology , IF: 32.
956), arousing global attention.
In May 2020, Professor Guo Jun presented an oral report on the updated results of the study at the ASCO annual meeting.
The results showed that teriprizumab combined with axitinib has a long-lasting effect in the treatment of patients with advanced mucosal melanoma , and the survival benefit is obvious .
The objective response rate (ORR) and disease control rate (DCR) are as high as 48.
5% and 84.
8%.
The median progression-free survival (mPFS) was 7.
5 months, the median duration of response (mDOR) was 13.
7 months, and the median overall survival (mOS) was 20.
7 months.
The survival benefit is obvious .
The objective response rate (ORR) and disease control rate (DCR) are as high as 48.
5% and 84.
8 %, the median progression-free survival (mPFS) was 7.
5 months, the median duration of response (mDOR) was 13.
7 months, and the median overall survival (mOS) was 20.
7 months.
In view of the breakthrough results of this research, in March 2020 and January 2021, teriprizumab combined with axitinib in the treatment of mucosal melanoma has been awarded 1 orphan drug by the U.
S.
Food and Drug Administration (FDA) Qualifications and 1 fast track qualification.
Currently, an international multi-center, randomized controlled Phase III clinical trial of teriprizumab combined with axitinib for the first-line treatment of patients with mucosal melanoma is underway.
This study aims to evaluate the effectiveness and safety of teriprizumab combined with axitinib versus pembrolizumab (KEYTRUDA 544px;box-sizing:border-box ;overflow-wrap:break-word ;">® ) in the first-line treatment of patients with unresectable, locally advanced or metastatic mucosal melanoma.
The trial is planned to enroll 220 patients, who will be randomly divided into groups at a ratio of 1:1.
The primary study endpoint is progression-free survival (PFS), and the secondary study endpoints are objective response rate (ORR), overall survival (OS), duration of remission (DOR), safety and tolerability, etc.
544px;text-align:justify;background-color:#FFFFFF;box-sizing:border-box ;'>
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About Terry Plymouth monoclonal antibody injection (extension beneficial 7px;">® )
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About Terry Plymouth monoclonal antibody injection (extension beneficial 7px;">® )
7px;">®7px;"> ®
8em solid #33415F;border-top:1em solid #33415F;height:0px;line-height:0;border-right:0.
8em solid transparent ;border-bottom:1em solid transparent ;">
544px;text-align:justify;font-size:16px;font-family:-apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;background-color:#FFFFFF;box-sizing:border-box ;'> Terry Plymouth monoclonal antibody injection (extension beneficial ® ), as approved by China's first domestically-listed monoclonal antibody drugs to PD-1 as a target, access to national science and technology major special project support.
The first indication approved for this product is for the treatment of unresectable or metastatic melanoma that has previously failed systemic treatment, and it has been awarded the 2019 and 2020 editions of the Chinese Society of Clinical Oncology (CSCO) Melanoma Diagnosis and Treatment Guidelines recommend.
544px;">2020 544px;">12 544px;">month extension beneficial ®544px;"> successfully passed the national health insurance negotiations, be included in 544px;">the new directory 544px;">.
544px;">February 2021, extension beneficial ®544px;"> obtain 544px;">State Drug Administration (NMPA) approved for previously treated with second-line treatment for recurrent and above systems / metastatic nasopharyngeal carcinoma patients fail.
The first indication approved for this product is for the treatment of unresectable or metastatic melanoma that has previously failed systemic treatment, and it has been awarded the 2019 and 2020 editions of the Chinese Society of Clinical Oncology (CSCO) Melanoma Diagnosis and Treatment Guidelines recommend.
544px;">2020 544px;">12 544px;">month extension beneficial ®544px;"> successfully passed the national health insurance negotiations, be included in 544px;">the new directory 544px;">.
544px;">February 2021, extension beneficial ®544px;"> obtain 544px;">State Drug Administration (NMPA) approved for previously treated with second-line treatment for recurrent and above systems / metastatic nasopharyngeal carcinoma patients fail.
® ® 544px;">2020 544px;">12 544px;">month extension beneficial ® ® 544px;">successfully passed the national health insurance negotiations, be included in 544px;">the new directory 544px;">.
544px;">February 2021, extension beneficial ® ® 544px;">obtain 544px;">State Drug Administration (NMPA) approved for previously treated with second-line treatment for recurrent and above systems / metastatic nasopharyngeal carcinoma patients fail.
544px;">National Medical Products Administration (NMPA)
544px;text-align:justify;font-size:16px;font-family:-apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;background-color:#FFFFFF;box-sizing:border-box ;'> In May 2020, the marketing application for new indications of 544px;">teriprizumab for the treatment of patients with locally advanced or metastatic urothelial cancer who have failed or intolerated systemic treatment in the past was accepted by the National Medical Products Administration NMPA.
It was included in the priority review procedure by NMPA in July 2020.
In February 2021, the marketing application for new indications of teriprizumab combined with chemotherapy for advanced first-line recurrent and metastatic nasopharyngeal carcinoma that has not received systemic treatment was accepted by the NMPA.
In March 2021, Junshi Biologics began to submit a rolling application for Teriplizumab to the U.
S.
FDA.
At present, 544px;">teriprizumab has been granted 1 breakthrough therapy designation, 1 fast track designation and 3 orphan drug designations by the FDA in the fields of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.
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It was included in the priority review procedure by NMPA in July 2020.
In February 2021, the marketing application for new indications of teriprizumab combined with chemotherapy for advanced first-line recurrent and metastatic nasopharyngeal carcinoma that has not received systemic treatment was accepted by the NMPA.
In March 2021, Junshi Biologics began to submit a rolling application for Teriplizumab to the U.
S.
FDA.
At present, 544px;">teriprizumab has been granted 1 breakthrough therapy designation, 1 fast track designation and 3 orphan drug designations by the FDA in the fields of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.
544px;">Terry Plymouth monoclonal antibody 544px;">Terry Plymouth mAb544px;'>544px;text-align:justify;font-size:16px;font-family:-apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;background-color:#FFFFFF;box-sizing:border-box ;overflow-wrap:break-word ;'>544px;">Tripriximab has been clinically developed since the beginning of 2016, and has carried out more than 30 clinical studies around the world, actively exploring its use in melanoma, nasopharyngeal cancer, urothelial cancer, lung cancer, gastric cancer, esophageal cancer, and liver cancer.
The efficacy and safety of indications such as, cholangiocarcinoma, breast cancer, kidney cancer, etc.
, and joint therapy cooperation with leading innovative pharmaceutical companies at home and abroad are also underway.
We look forward to allowing more patients in China and other countries to obtain internationally advanced tumors.
immunity therapy.
544px;">Tripriximab has been clinically developed since the beginning of 2016, and has carried out more than 30 clinical studies around the world, actively exploring its use in melanoma, nasopharyngeal cancer, urothelial cancer, lung cancer, gastric cancer, esophageal cancer, and liver cancer.
The efficacy and safety of indications such as, cholangiocarcinoma, breast cancer, kidney cancer, etc.
, and joint therapy cooperation with leading innovative pharmaceutical companies at home and abroad are also underway.
We look forward to allowing more patients in China and other countries to obtain internationally advanced tumors.
immunity therapy.
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About Junshi Bio
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us" style="margin:0px;padding:0px;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;transform:rotate(0deg);">5em 0px;padding:0px;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;">5em;max-width:100%;box-sizing:border-box ;overflow-wrap:break-word ;display:inline-block;vertical-align:top;height:2em;line-height:2em;color:#FFFFFF;background-color:#33415F;">
About Junshi Bio
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About Junshi Bio
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About Junshi Bio
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About Junshi Bio
About Junshi Bio
About Junshi Bio
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8em solid transparent ;border-bottom:1em solid transparent ;">544px;text-align:justify;font-size:16px;font-family:-apple-system-font, BlinkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif;background-color:#FFFFFF;min-height:1em;box-sizing:border-box ;overflow-wrap:break-word ;'>Junshi Bio (1877.
HK, 688180.
SH) was established in December 2012.
It is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies.
The company has a rich pipeline of products under research, including 28 innovative drugs and 2 biosimilars, covering five therapeutic areas, including malignant tumors, autoimmune system diseases, chronic metabolic diseases, neurological diseases and infectious diseases.
Junshi Bio (1877.
HK, 688180.
SH) was established in December 2012.
It is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies.
The company has a rich pipeline of products under research, including 28 innovative drugs and 2 biosimilars, covering five therapeutic areas, including malignant tumors, autoimmune system diseases, chronic metabolic diseases, neurological diseases and infectious diseases.
Junshi Bio (1877.
HK, 688180.
SH) was established in December 2012.
It is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies.
The company has a rich pipeline of products under research, including 28 innovative drugs and 2 biosimilars, covering five therapeutic areas, including malignant tumors, autoimmune system diseases, chronic metabolic diseases, neurological diseases and infectious diseases.
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