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On November 15, 2021, Beijing time, Junshi Biotech announced that the company’s self-developed anti-PD-1 monoclonal antibody drug teriprizumab for the treatment of esophageal cancer (EC) has obtained the Orphan Drug Qualification (Orphan) from the FDA.
-drug Designation)
.
This is the fourth orphan drug designation obtained by teriprizumab.
Previously, teriprizumab has been designated as an orphan drug by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma and soft tissue sarcoma
.
Orphan-drug, also known as rare disease drugs, refers to drugs used for the prevention, treatment, and diagnosis of rare diseases
.
The orphan drug designation granted by the FDA is applicable to drugs and biological agents for rare diseases with fewer than 200,000 patients in the United States
.
The orphan drug qualification certification issued by the FDA this time will help teriplimumab enjoy certain policy support in the follow-up research and development, registration and commercialization of teriplizumab in the United States, including but not limited to: (1) Clinical trial costs Tax credits; (2) Exemption of new drug application fees; (3) 7 years of market exclusivity after listing and not affected by patents
.
This certification will reduce the investment in new drug research and development to a certain extent, and accelerate the progress of clinical trials and marketing registration
.
Esophageal cancer Esophageal cancer is one of the most common malignant tumors of the digestive tract
.
In China, it is the worst-hit area for esophageal cancer.
According to statistics (2020), esophageal cancer is the seventh most common malignant tumor and the sixth leading cause of cancer death in the world
.
Among them, the number of new cases of esophageal cancer in China is as high as 320,000, accounting for about 50% of the world, and the number of deaths is also as high as 300,000, accounting for about 56% of the world.
.
According to statistics from the American Cancer Society, there are estimated to be 19,000 new cases of esophageal cancer and 15,000 deaths in the United States in 2021
.
The prognosis of patients with advanced esophageal cancer is poor.
With platinum-based first-line treatment, the 5-year overall survival rate is still less than 20%
.
Tereprizumab is the first domestic monoclonal antibody drug targeting PD-1 that has been approved for marketing in China.
It has been launched in China, the United States and other countries covering more than 15 indications.
More than 30 clinical studies
.
As of the disclosure date of this announcement, teriprizumab has been granted 2 breakthrough therapy designations, 1 fast track designation, and 1 priority review designation by the FDA in the fields of mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma and esophageal cancer And 4 certifications for orphan drug qualifications
.
At present, Junshi Biotechnology has carried out 2 phase III registered clinical studies of tereprizumab for esophageal cancer
.
Among them, the JUPITER-06 study (NCT03829969) is a randomized, double-blind, placebo-controlled, multi-center phase III study, which aims to compare teriprizumab combined with paclitaxel/cisplatin (TP chemotherapy) and placebo The effectiveness and safety of TP chemotherapy in the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma
.
In September 2021, the results of the JUPITER-06 study will be announced for the first time at the 2021 European Society of Medical Oncology (ESMO) annual meeting
.
The study reached the composite primary endpoint.
Compared with chemotherapy alone, patients who received teriprizumab combined with chemotherapy achieved statistically significant results in both progression-free survival (PFS) and overall survival (OS).
Significant improvement in clinical significance
.
Based on the JUPITER-06 study, NMPA has accepted the new indications for the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma by NMPA in July 2021.
.
Junshi Biology also plans to submit to the U.
S.
FDA in 2022 a biologics license application (BLA) for terreplimumab combined with platinum-containing chemotherapy for the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma indications
.
Content Source | BioValley Disclaimer The articles reproduced in the "Yaodu" official account are from other official account platforms, and the main purpose is to share industry-related knowledge and deliver the latest information
.
The copyrights of the pictures and articles belong to the original author.
If there is any infringement, please inform us in time.
We will delete the relevant information within 24 hours
.
-drug Designation)
.
This is the fourth orphan drug designation obtained by teriprizumab.
Previously, teriprizumab has been designated as an orphan drug by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma and soft tissue sarcoma
.
Orphan-drug, also known as rare disease drugs, refers to drugs used for the prevention, treatment, and diagnosis of rare diseases
.
The orphan drug designation granted by the FDA is applicable to drugs and biological agents for rare diseases with fewer than 200,000 patients in the United States
.
The orphan drug qualification certification issued by the FDA this time will help teriplimumab enjoy certain policy support in the follow-up research and development, registration and commercialization of teriplizumab in the United States, including but not limited to: (1) Clinical trial costs Tax credits; (2) Exemption of new drug application fees; (3) 7 years of market exclusivity after listing and not affected by patents
.
This certification will reduce the investment in new drug research and development to a certain extent, and accelerate the progress of clinical trials and marketing registration
.
Esophageal cancer Esophageal cancer is one of the most common malignant tumors of the digestive tract
.
In China, it is the worst-hit area for esophageal cancer.
According to statistics (2020), esophageal cancer is the seventh most common malignant tumor and the sixth leading cause of cancer death in the world
.
Among them, the number of new cases of esophageal cancer in China is as high as 320,000, accounting for about 50% of the world, and the number of deaths is also as high as 300,000, accounting for about 56% of the world.
.
According to statistics from the American Cancer Society, there are estimated to be 19,000 new cases of esophageal cancer and 15,000 deaths in the United States in 2021
.
The prognosis of patients with advanced esophageal cancer is poor.
With platinum-based first-line treatment, the 5-year overall survival rate is still less than 20%
.
Tereprizumab is the first domestic monoclonal antibody drug targeting PD-1 that has been approved for marketing in China.
It has been launched in China, the United States and other countries covering more than 15 indications.
More than 30 clinical studies
.
As of the disclosure date of this announcement, teriprizumab has been granted 2 breakthrough therapy designations, 1 fast track designation, and 1 priority review designation by the FDA in the fields of mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma and esophageal cancer And 4 certifications for orphan drug qualifications
.
At present, Junshi Biotechnology has carried out 2 phase III registered clinical studies of tereprizumab for esophageal cancer
.
Among them, the JUPITER-06 study (NCT03829969) is a randomized, double-blind, placebo-controlled, multi-center phase III study, which aims to compare teriprizumab combined with paclitaxel/cisplatin (TP chemotherapy) and placebo The effectiveness and safety of TP chemotherapy in the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma
.
In September 2021, the results of the JUPITER-06 study will be announced for the first time at the 2021 European Society of Medical Oncology (ESMO) annual meeting
.
The study reached the composite primary endpoint.
Compared with chemotherapy alone, patients who received teriprizumab combined with chemotherapy achieved statistically significant results in both progression-free survival (PFS) and overall survival (OS).
Significant improvement in clinical significance
.
Based on the JUPITER-06 study, NMPA has accepted the new indications for the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma by NMPA in July 2021.
.
Junshi Biology also plans to submit to the U.
S.
FDA in 2022 a biologics license application (BLA) for terreplimumab combined with platinum-containing chemotherapy for the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma indications
.
Content Source | BioValley Disclaimer The articles reproduced in the "Yaodu" official account are from other official account platforms, and the main purpose is to share industry-related knowledge and deliver the latest information
.
The copyrights of the pictures and articles belong to the original author.
If there is any infringement, please inform us in time.
We will delete the relevant information within 24 hours
.
