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On September 13, BeiGene announced that the U.
S.
Food and Drug Administration (FDA) has accepted its anti-PD-1 antibody drug Bezean® (tislelizumab injection) for a new drug listing application (BLA).
It is used to treat patients with unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic treatment
.
According to the "Prescription Drug User Fees Act" (PDUFA), the target date for the FDA to make a resolution on the marketing application of Bezeran® is July 12, 2022
.
S.
Food and Drug Administration (FDA) has accepted its anti-PD-1 antibody drug Bezean® (tislelizumab injection) for a new drug listing application (BLA).
It is used to treat patients with unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic treatment
.
According to the "Prescription Drug User Fees Act" (PDUFA), the target date for the FDA to make a resolution on the marketing application of Bezeran® is July 12, 2022
.
This listing application is a joint application by Baekje and Novartis, based on the results of a randomized, open, multi-center global phase 3 clinical trial RATIONALE 302 (NCT03430843), which aims to evaluate the selection of researchers for the comparison of Bazeran® The effectiveness and safety of advanced chemotherapy for second-line treatment of patients with advanced or metastatic ESCC
.
The test results have been announced on ASCO 2021
.
In addition, this declaration is also based on the safety data of 1972 patients who received Bazeran® monotherapy in 7 clinical trials
.
.
The test results have been announced on ASCO 2021
.
In addition, this declaration is also based on the safety data of 1972 patients who received Bazeran® monotherapy in 7 clinical trials
.
In addition to the United States, the market application for the indications of Bezian® for the treatment of locally advanced or metastatic ESCC patients who have progressed or become intolerable after receiving first-line standard chemotherapy has been accepted in China and is currently under review
.
.
Esophageal cancer is the most common gastrointestinal malignancy field of tumor one, divided into squamous cell carcinoma and adenocarcinoma
.
At present, both the NCCN and the domestic CSCO guidelines recommend immune regimens for the treatment of esophageal squamous cell carcinoma, which has officially entered the age of immunotherapy
.
.
At present, both the NCCN and the domestic CSCO guidelines recommend immune regimens for the treatment of esophageal squamous cell carcinoma, which has officially entered the age of immunotherapy
.
The RATIONALE 302 study is a randomized, open, multi-center, global phase 3 clinical trial (NCT03430843), which aims to evaluate the effectiveness and safety of Baizian® versus chemotherapy selected by investigators as the second-line treatment for patients with advanced or metastatic ESCC Sex
.
The primary endpoint of the trial is the overall survival (OS) of the intention-to-treat (ITT) population; the key secondary endpoint is the OS of patients with high PD-L1 expression (defined as a visually estimated comprehensive positive score [vCPS] ≥10%).
Key endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and safety
.
.
The primary endpoint of the trial is the overall survival (OS) of the intention-to-treat (ITT) population; the key secondary endpoint is the OS of patients with high PD-L1 expression (defined as a visually estimated comprehensive positive score [vCPS] ≥10%).
Key endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and safety
.
A total of 512 patients from 11 countries or regions in Asia, Europe and North America were enrolled in the trial, and they were randomly assigned to the tislelizumab group or chemotherapy group 1:1
.
According to research PI Professor Lin Lin, due to the huge differences in the distribution of pathological types of esophageal cancer between the East and the West, in order to ensure the high quality and high level of clinical research, and truly produce global representative research results, RATIONALE 302 has made a research design.
After full consideration, the study population fully covers many countries and regions such as Asia, Europe, and the United States, and the proportion of patients enrolled is relatively even.
This is very different from the past global clinical studies where the Chinese population was the main population and the international population was relatively small.
Different
.
.
According to research PI Professor Lin Lin, due to the huge differences in the distribution of pathological types of esophageal cancer between the East and the West, in order to ensure the high quality and high level of clinical research, and truly produce global representative research results, RATIONALE 302 has made a research design.
After full consideration, the study population fully covers many countries and regions such as Asia, Europe, and the United States, and the proportion of patients enrolled is relatively even.
This is very different from the past global clinical studies where the Chinese population was the main population and the international population was relatively small.
Different
.
In addition, in the selection of treatment options for the control group, the researcher team has also fully considered the differences in clinical practice in different countries and regions, and used the chemotherapy drugs selected by the researcher as a control, making the overall research results a high-level cycle applicable to different countries.
Proof of medical evidence
.
Proof of medical evidence
.
At this year's ASCO annual meeting, BeiGene announced the research data of RATIONALE 302
.
The results showed that the primary endpoint of the study, the median overall survival (OS) of the intention-to-treat (ITT) population was 8.
6 months, which reduced the risk of death by more than 30%, and the objective response rate (ORR) reached 20.
3%.
Dazzling
.
.
The results showed that the primary endpoint of the study, the median overall survival (OS) of the intention-to-treat (ITT) population was 8.
6 months, which reduced the risk of death by more than 30%, and the objective response rate (ORR) reached 20.
3%.
Dazzling
.
It is worth noting that RATIONALE 302 is not only the first global study of esophageal squamous cell carcinoma, but also the only phase 3 study that benefits the whole population in the world
.
The results of the study show that tislelizumab is better than chemotherapy in the second-line monotherapy of esophageal squamous cell carcinoma, and it brings good OS benefits to patients
.
The results of this test provide strong support for BeiGene's communication with global regulatory agencies
.
Today, BeiGene submitted a BLA to the FDA based on this clinical trial and was accepted
.
.
The results of the study show that tislelizumab is better than chemotherapy in the second-line monotherapy of esophageal squamous cell carcinoma, and it brings good OS benefits to patients
.
The results of this test provide strong support for BeiGene's communication with global regulatory agencies
.
Today, BeiGene submitted a BLA to the FDA based on this clinical trial and was accepted
.
At present, 4 PD-1 models in China have submitted marketing applications to the FDA
.
The first submission was Junshi’s tereprizumab.
It announced in March this year that it would begin rolling submission of BLA.
Recently, the rolling submission of data has been completed for first-line and third-line treatment of nasopharyngeal cancer; Cinda also announced the letter in May.
Dilimumab's marketing application was accepted by the FDA, and the first-line treatment of non-squamous NSCLC, the PDUFA date is March 2021; in the same month, Kangfang/Tianqing's Paimrizumab also submitted a marketing application to the FDA for the third-line treatment of nasopharynx Cancer, and was selected into the RTOR program
.
.
The first submission was Junshi’s tereprizumab.
It announced in March this year that it would begin rolling submission of BLA.
Recently, the rolling submission of data has been completed for first-line and third-line treatment of nasopharyngeal cancer; Cinda also announced the letter in May.
Dilimumab's marketing application was accepted by the FDA, and the first-line treatment of non-squamous NSCLC, the PDUFA date is March 2021; in the same month, Kangfang/Tianqing's Paimrizumab also submitted a marketing application to the FDA for the third-line treatment of nasopharynx Cancer, and was selected into the RTOR program
.
This time BeiGene's tislelizumab also took an important step towards the sea
.
This product has been authorized by Novartis for US$2.
2 billion.
With the blessing of Novartis, the prospects are promising
.
.
This product has been authorized by Novartis for US$2.
2 billion.
With the blessing of Novartis, the prospects are promising
.
On September 13, BeiGene announced that the U.
S.
Food and Drug Administration (FDA) has accepted its anti-PD-1 antibody drug Bezean® (tislelizumab injection) for a new drug listing application (BLA).
It is used to treat patients with unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic treatment
.
According to the "Prescription Drug User Fees Act" (PDUFA), the target date for the FDA to make a resolution on the marketing application of Bezeran® is July 12, 2022
.
S.
Food and Drug Administration (FDA) has accepted its anti-PD-1 antibody drug Bezean® (tislelizumab injection) for a new drug listing application (BLA).
It is used to treat patients with unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic treatment
.
According to the "Prescription Drug User Fees Act" (PDUFA), the target date for the FDA to make a resolution on the marketing application of Bezeran® is July 12, 2022
.
This listing application is a joint application by Baekje and Novartis, based on the results of a randomized, open, multi-center global phase 3 clinical trial RATIONALE 302 (NCT03430843), which aims to evaluate the selection of researchers for the comparison of Bazeran® The effectiveness and safety of advanced chemotherapy for second-line treatment of patients with advanced or metastatic ESCC
.
The test results have been announced on ASCO 2021
.
In addition, this declaration is also based on the safety data of 1972 patients who received Bazeran® monotherapy in 7 clinical trials
.
.
The test results have been announced on ASCO 2021
.
In addition, this declaration is also based on the safety data of 1972 patients who received Bazeran® monotherapy in 7 clinical trials
.
In addition to the United States, the market application for the indications of Bezian® for the treatment of locally advanced or metastatic ESCC patients who have progressed or become intolerable after receiving first-line standard chemotherapy has been accepted in China and is currently under review
.
.
Esophageal cancer is the most common gastrointestinal malignancy field of tumor one, divided into squamous cell carcinoma and adenocarcinoma
.
At present, both the NCCN and the domestic CSCO guidelines recommend immune regimens for the treatment of esophageal squamous cell carcinoma, which has officially entered the age of immunotherapy
.
.
At present, both the NCCN and the domestic CSCO guidelines recommend immune regimens for the treatment of esophageal squamous cell carcinoma, which has officially entered the age of immunotherapy
.
The RATIONALE 302 study is a randomized, open, multi-center, global phase 3 clinical trial (NCT03430843), which aims to evaluate the effectiveness and safety of Baizian® versus chemotherapy selected by investigators as the second-line treatment for patients with advanced or metastatic ESCC Sex
.
The primary endpoint of the trial is the overall survival (OS) of the intention-to-treat (ITT) population; the key secondary endpoint is the OS of patients with high PD-L1 expression (defined as a visually estimated comprehensive positive score [vCPS] ≥10%).
Key endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and safety
.
.
The primary endpoint of the trial is the overall survival (OS) of the intention-to-treat (ITT) population; the key secondary endpoint is the OS of patients with high PD-L1 expression (defined as a visually estimated comprehensive positive score [vCPS] ≥10%).
Key endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and safety
.
A total of 512 patients from 11 countries or regions in Asia, Europe and North America were enrolled in the trial, and they were randomly assigned to the tislelizumab group or chemotherapy group 1:1
.
According to research PI Professor Lin Lin, due to the huge differences in the distribution of pathological types of esophageal cancer between the East and the West, in order to ensure the high quality and high level of clinical research, and truly produce global representative research results, RATIONALE 302 has made a research design.
After full consideration, the study population fully covers many countries and regions such as Asia, Europe, and the United States, and the proportion of patients enrolled is relatively even.
This is very different from the past global clinical studies where the Chinese population was the main population and the international population was relatively small.
Different
.
.
According to research PI Professor Lin Lin, due to the huge differences in the distribution of pathological types of esophageal cancer between the East and the West, in order to ensure the high quality and high level of clinical research, and truly produce global representative research results, RATIONALE 302 has made a research design.
After full consideration, the study population fully covers many countries and regions such as Asia, Europe, and the United States, and the proportion of patients enrolled is relatively even.
This is very different from the past global clinical studies where the Chinese population was the main population and the international population was relatively small.
Different
.
In addition, in the selection of treatment options for the control group, the researcher team has also fully considered the differences in clinical practice in different countries and regions, and used the chemotherapy drugs selected by the researcher as a control, making the overall research results a high-level cycle applicable to different countries.
Proof of medical evidence
.
Proof of medical evidence
.
At this year's ASCO annual meeting, BeiGene announced the research data of RATIONALE 302
.
The results showed that the primary endpoint of the study, the median overall survival (OS) of the intention-to-treat (ITT) population was 8.
6 months, which reduced the risk of death by more than 30%, and the objective response rate (ORR) reached 20.
3%.
Dazzling
.
.
The results showed that the primary endpoint of the study, the median overall survival (OS) of the intention-to-treat (ITT) population was 8.
6 months, which reduced the risk of death by more than 30%, and the objective response rate (ORR) reached 20.
3%.
Dazzling
.
It is worth noting that RATIONALE 302 is not only the first global study of esophageal squamous cell carcinoma, but also the only phase 3 study that benefits the whole population in the world
.
The results of the study show that tislelizumab is better than chemotherapy in the second-line monotherapy of esophageal squamous cell carcinoma, and it brings good OS benefits to patients
.
The results of this test provide strong support for BeiGene's communication with global regulatory agencies
.
Today, BeiGene submitted a BLA to the FDA based on this clinical trial and was accepted
.
.
The results of the study show that tislelizumab is better than chemotherapy in the second-line monotherapy of esophageal squamous cell carcinoma, and it brings good OS benefits to patients
.
The results of this test provide strong support for BeiGene's communication with global regulatory agencies
.
Today, BeiGene submitted a BLA to the FDA based on this clinical trial and was accepted
.
At present, 4 PD-1 models in China have submitted marketing applications to the FDA
.
The first submission was Junshi’s tereprizumab.
It announced in March this year that it would begin rolling submission of BLA.
Recently, the rolling submission of data has been completed for first-line and third-line treatment of nasopharyngeal cancer; Cinda also announced the letter in May.
Dilimumab's marketing application was accepted by the FDA, and the first-line treatment of non-squamous NSCLC, the PDUFA date is March 2021; in the same month, Kangfang/Tianqing's Paimrizumab also submitted a marketing application to the FDA for the third-line treatment of nasopharynx Cancer, and was selected into the RTOR program
.
.
The first submission was Junshi’s tereprizumab.
It announced in March this year that it would begin rolling submission of BLA.
Recently, the rolling submission of data has been completed for first-line and third-line treatment of nasopharyngeal cancer; Cinda also announced the letter in May.
Dilimumab's marketing application was accepted by the FDA, and the first-line treatment of non-squamous NSCLC, the PDUFA date is March 2021; in the same month, Kangfang/Tianqing's Paimrizumab also submitted a marketing application to the FDA for the third-line treatment of nasopharynx Cancer, and was selected into the RTOR program
.
This time BeiGene's tislelizumab also took an important step towards the sea
.
This product has been authorized by Novartis for US$2.
2 billion.
With the blessing of Novartis, the prospects are promising
.
.
This product has been authorized by Novartis for US$2.
2 billion.
With the blessing of Novartis, the prospects are promising
.
On September 13, BeiGene announced that the U.
S.
Food and Drug Administration (FDA) has accepted its anti-PD-1 antibody drug Bezean® (tislelizumab injection) for a new drug listing application (BLA).
It is used to treat patients with unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic treatment
.
According to the "Prescription Drug User Fees Act" (PDUFA), the target date for the FDA to make a resolution on the marketing application of Bezeran® is July 12, 2022
.
S.
Food and Drug Administration (FDA) has accepted its anti-PD-1 antibody drug Bezean® (tislelizumab injection) for a new drug listing application (BLA).
It is used to treat patients with unresectable, recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic treatment
.
According to the "Prescription Drug User Fees Act" (PDUFA), the target date for the FDA to make a resolution on the marketing application of Bezeran® is July 12, 2022
.
This listing application is a joint application by Baekje and Novartis, based on the results of a randomized, open, multi-center global phase 3 clinical trial RATIONALE 302 (NCT03430843), which aims to evaluate the selection of researchers for the comparison of Bazeran® The effectiveness and safety of advanced chemotherapy for second-line treatment of patients with advanced or metastatic ESCC
.
The test results have been announced on ASCO 2021
.
In addition, this declaration is also based on the safety data of 1972 patients who received Bazeran® monotherapy in 7 clinical trials
.
.
The test results have been announced on ASCO 2021
.
In addition, this declaration is also based on the safety data of 1972 patients who received Bazeran® monotherapy in 7 clinical trials
.
In addition to the United States, the market application for the indications of Bezian® for the treatment of locally advanced or metastatic ESCC patients who have progressed or become intolerable after receiving first-line standard chemotherapy has been accepted in China and is currently under review
.
Standard Standard.
Esophageal cancer is the most common gastrointestinal malignancy field of tumor one, divided into squamous cell carcinoma and adenocarcinoma
.
At present, both the NCCN and the domestic CSCO guidelines recommend immune regimens for the treatment of esophageal squamous cell carcinoma, which has officially entered the age of immunotherapy
.
Tumor tumor.
At present, both the NCCN and the domestic CSCO guidelines recommend immune regimens for the treatment of esophageal squamous cell carcinoma, which has officially entered the age of immunotherapy
.
The RATIONALE 302 study is a randomized, open, multi-center, global phase 3 clinical trial (NCT03430843), which aims to evaluate the effectiveness and safety of Baizian® versus chemotherapy selected by investigators as the second-line treatment for patients with advanced or metastatic ESCC Sex
.
The primary endpoint of the trial is the overall survival (OS) of the intention-to-treat (ITT) population; the key secondary endpoint is the OS of patients with high PD-L1 expression (defined as a visually estimated comprehensive positive score [vCPS] ≥10%).
Key endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and safety
.
.
The primary endpoint of the trial is the overall survival (OS) of the intention-to-treat (ITT) population; the key secondary endpoint is the OS of patients with high PD-L1 expression (defined as a visually estimated comprehensive positive score [vCPS] ≥10%).
Key endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and safety
.
A total of 512 patients from 11 countries or regions in Asia, Europe and North America were enrolled in the trial, and they were randomly assigned to the tislelizumab group or chemotherapy group 1:1
.
According to research PI Professor Lin Lin, due to the huge differences in the distribution of pathological types of esophageal cancer between the East and the West, in order to ensure the high quality and high level of clinical research, and truly produce global representative research results, RATIONALE 302 has made a research design.
After full consideration, the study population fully covers many countries and regions such as Asia, Europe, and the United States, and the proportion of patients enrolled is relatively even.
This is very different from the past global clinical studies where the Chinese population was the main population and the international population was relatively small.
Different
.
.
According to research PI Professor Lin Lin, due to the huge differences in the distribution of pathological types of esophageal cancer between the East and the West, in order to ensure the high quality and high level of clinical research, and truly produce global representative research results, RATIONALE 302 has made a research design.
After full consideration, the study population fully covers many countries and regions such as Asia, Europe, and the United States, and the proportion of patients enrolled is relatively even.
This is very different from the past global clinical studies where the Chinese population was the main population and the international population was relatively small.
Different
.
In addition, in the selection of treatment options for the control group, the researcher team has also fully considered the differences in clinical practice in different countries and regions, and used the chemotherapy drugs selected by the researcher as a control, making the overall research results a high-level cycle applicable to different countries.
Proof of medical evidence
.
Proof of medical evidence
.
At this year's ASCO annual meeting, BeiGene announced the research data of RATIONALE 302
.
The results showed that the primary endpoint of the study, the median overall survival (OS) of the intention-to-treat (ITT) population was 8.
6 months, which reduced the risk of death by more than 30%, and the objective response rate (ORR) reached 20.
3%.
Dazzling
.
.
The results showed that the primary endpoint of the study, the median overall survival (OS) of the intention-to-treat (ITT) population was 8.
6 months, which reduced the risk of death by more than 30%, and the objective response rate (ORR) reached 20.
3%.
Dazzling
.
It is worth noting that RATIONALE 302 is not only the first global study of esophageal squamous cell carcinoma, but also the only phase 3 study that benefits the whole population in the world
.
The results of the study show that tislelizumab is better than chemotherapy in the second-line monotherapy of esophageal squamous cell carcinoma, and it brings good OS benefits to patients
.
The results of this test provide strong support for BeiGene's communication with global regulatory agencies
.
Today, BeiGene submitted a BLA to the FDA based on this clinical trial and was accepted
.
.
The results of the study show that tislelizumab is better than chemotherapy in the second-line monotherapy of esophageal squamous cell carcinoma, and it brings good OS benefits to patients
.
The results of this test provide strong support for BeiGene's communication with global regulatory agencies
.
Today, BeiGene submitted a BLA to the FDA based on this clinical trial and was accepted
.
At present, 4 PD-1 models in China have submitted marketing applications to the FDA
.
The first submission was Junshi’s tereprizumab.
It announced in March this year that it would begin rolling submission of BLA.
Recently, the rolling submission of data has been completed for first-line and third-line treatment of nasopharyngeal cancer; Cinda also announced the letter in May.
Dilimumab's marketing application was accepted by the FDA, and the first-line treatment of non-squamous NSCLC, the PDUFA date is March 2021; in the same month, Kangfang/Tianqing's Paimrizumab also submitted a marketing application to the FDA for the third-line treatment of nasopharynx Cancer, and was selected into the RTOR program
.
.
The first submission was Junshi’s tereprizumab.
It announced in March this year that it would begin rolling submission of BLA.
Recently, the rolling submission of data has been completed for first-line and third-line treatment of nasopharyngeal cancer; Cinda also announced the letter in May.
Dilimumab's marketing application was accepted by the FDA, and the first-line treatment of non-squamous NSCLC, the PDUFA date is March 2021; in the same month, Kangfang/Tianqing's Paimrizumab also submitted a marketing application to the FDA for the third-line treatment of nasopharynx Cancer, and was selected into the RTOR program
.
This time BeiGene's tislelizumab also took an important step towards the sea
.
This product has been authorized by Novartis for US$2.
2 billion.
With the blessing of Novartis, the prospects are promising
.
.
This product has been authorized by Novartis for US$2.
2 billion.
With the blessing of Novartis, the prospects are promising
.
