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▎Editor of WuXi AppTec's content team On March 12, the website of China National Medical Products Administration (NMPA) showed that Huahao Zhongtian's Class 1 new drug Utidelone obtained the drug approval number.
In June 2018, the drug's marketing application (CXHS1800005) for the treatment of patients with metastatic or locally advanced breast cancer was included in the priority review by the Center for Drug Evaluation (CDE).
The acceptance number associated with the approval number obtained this time is the same as the registration acceptance number, which means that Utidelon is officially approved in China for the treatment of breast cancer! Extend the survival time, has been recommended by the CSCO guidelines.
It is reported that the new drug listing application of Utidrolone is based on the results of a prospective, multi-center Phase 3 clinical study.
The BG01-1312L study was led by Professor Xu Binghe from the Cancer Hospital of the Chinese Academy of Medical Sciences.
The results of the study were selected for two oral presentations at the ASCO (American Annual Meeting of Clinical Oncology) conferences and published in the internationally renowned oncology journals Lancet Oncology and Annals of Oncology.
Research data shows that for patients with advanced breast cancer who have used anthracyclines and taxanes in the past, the overall survival of Utidrolone combined with capecitabine was significantly prolonged from 15.
7 months compared with capecitabine alone.
By 20.
9 months, the risk of death was reduced by 31%; the progression-free survival period was significantly extended from 4.
11 months to 8.
57 months, and the risk of disease progression was reduced by 54%; the remission rate was increased from 26.
7% to 49.
8%.
Based on the results of the BG01-1312L study, Utidelon has also been recommended by the Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines (2020 Edition) for the rescue chemotherapy of HER2-negative advanced breast cancer that has failed anthracycline and taxane treatments.
Can consider single-drug or combination programs.
The CSCO guidelines point out that in HER2-negative breast cancer, patients who are hormone receptor negative or hormone receptor positive but are resistant to endocrine therapy, or have symptomatic visceral metastases, need to consider the first choice of rescue chemotherapy.
Image source: 123RF provides new options for advanced breast cancer chemotherapy.
According to the 2020 global cancer burden data released by the World Health Organization’s International Agency for Research on Cancer (IARC), the number of new breast cancers reached 2.
26 million, which has replaced lung cancer as the world’s largest cancer .
Moreover, breast cancer is still the number one cancer in women in China.
Among the population of early breast cancer, 30% to 40% will develop into advanced breast cancer and maintain a growing trend.
Data show that the overall median survival time of Chinese patients with advanced breast cancer after diagnosis is 2-3 years, and the 5-year and 10-year overall survival rates are only 27% and 13%, respectively.
There is a huge demand for treatment.
For patients with advanced breast cancer, prolonging survival and improving quality of life are the main treatment goals.
In recent years, despite continuous breakthroughs in targeted therapy and immunotherapy, chemotherapy is still an important basic treatment for advanced breast cancer.
The chemotherapy of breast cancer at this stage is dominated by taxanes and anthracyclines.
Most patients with metastatic breast cancer have used taxanes and anthracyclines in the early stage.
The problems of drug resistance and cumulative toxicity still affect The life of the patient.
The approval of Utidrolone provides new treatment opportunities for advanced breast cancer that has failed anthracyclines and taxanes.
More indications studies Utidelone is a genetically engineered epothilones derivative.
Epothilones are broad-spectrum and highly effective anti-cancer drugs.
Due to their simple structure, they have good chemical modification potential.
, Has always been one of the hot spots in the development of new international anti-tumor drugs.
The approval for listing this time also means that China has ushered in the first epothilone anti-tumor drug.
In addition to being used in chemotherapy for advanced breast cancer, Utidelon has also shown anti-tumor activity against common tumors such as lung cancer, liver cancer, bowel cancer and prostate cancer in previous studies, and is resistant to paclitaxel and many other chemotherapeutic drugs.
Tumors also have good curative effects.
At present, Huahao Zhongtian is carrying out a number of phase 2 clinical trial projects, involving advanced solid tumors such as advanced non-small cell lung cancer, advanced colorectal cancer, gastrointestinal tumors, gynecological tumors, and head and neck tumors.
It is hoped that this drug can bring new treatment options to breast cancer patients, and it is also expected that it can help improve the lives of more patients in the future.
Reference materials [1] Released on March 12, 2021, drug approval documents pending receipt information.
Retrieved 2021-03-12, from https:// html[2] Pin Zhang, et al.
, (2017).
Utidelone plus capecitabine versus capecitabine alone for heavily pretreated metastatic breast cancer refractory to anthracyclines and taxanes: a multicentre, open-label, superiority, phase 3, randomised controlled trial.
The Lancet Oncology, DOI: https://doi.
org/10.
1016/S1470-2045(17)30088-8[3] Xu B, et al.
, (2021).
Efficacy of utidelone plus capecitabine versus capecitabine for heavily pretreated, anthracycline -and taxane-refractory metastatic breast cancer: final analysis of overall survival in a phase III randomised controlled trial.
Ann Oncol, DOI: 10.
1016/j.
annonc.
2020.
10.
600.
Note: This article aims to introduce medical health research progress, not treatment Program recommendation. If you need guidance on treatment plans, please go to a regular hospital for treatment.
In June 2018, the drug's marketing application (CXHS1800005) for the treatment of patients with metastatic or locally advanced breast cancer was included in the priority review by the Center for Drug Evaluation (CDE).
The acceptance number associated with the approval number obtained this time is the same as the registration acceptance number, which means that Utidelon is officially approved in China for the treatment of breast cancer! Extend the survival time, has been recommended by the CSCO guidelines.
It is reported that the new drug listing application of Utidrolone is based on the results of a prospective, multi-center Phase 3 clinical study.
The BG01-1312L study was led by Professor Xu Binghe from the Cancer Hospital of the Chinese Academy of Medical Sciences.
The results of the study were selected for two oral presentations at the ASCO (American Annual Meeting of Clinical Oncology) conferences and published in the internationally renowned oncology journals Lancet Oncology and Annals of Oncology.
Research data shows that for patients with advanced breast cancer who have used anthracyclines and taxanes in the past, the overall survival of Utidrolone combined with capecitabine was significantly prolonged from 15.
7 months compared with capecitabine alone.
By 20.
9 months, the risk of death was reduced by 31%; the progression-free survival period was significantly extended from 4.
11 months to 8.
57 months, and the risk of disease progression was reduced by 54%; the remission rate was increased from 26.
7% to 49.
8%.
Based on the results of the BG01-1312L study, Utidelon has also been recommended by the Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines (2020 Edition) for the rescue chemotherapy of HER2-negative advanced breast cancer that has failed anthracycline and taxane treatments.
Can consider single-drug or combination programs.
The CSCO guidelines point out that in HER2-negative breast cancer, patients who are hormone receptor negative or hormone receptor positive but are resistant to endocrine therapy, or have symptomatic visceral metastases, need to consider the first choice of rescue chemotherapy.
Image source: 123RF provides new options for advanced breast cancer chemotherapy.
According to the 2020 global cancer burden data released by the World Health Organization’s International Agency for Research on Cancer (IARC), the number of new breast cancers reached 2.
26 million, which has replaced lung cancer as the world’s largest cancer .
Moreover, breast cancer is still the number one cancer in women in China.
Among the population of early breast cancer, 30% to 40% will develop into advanced breast cancer and maintain a growing trend.
Data show that the overall median survival time of Chinese patients with advanced breast cancer after diagnosis is 2-3 years, and the 5-year and 10-year overall survival rates are only 27% and 13%, respectively.
There is a huge demand for treatment.
For patients with advanced breast cancer, prolonging survival and improving quality of life are the main treatment goals.
In recent years, despite continuous breakthroughs in targeted therapy and immunotherapy, chemotherapy is still an important basic treatment for advanced breast cancer.
The chemotherapy of breast cancer at this stage is dominated by taxanes and anthracyclines.
Most patients with metastatic breast cancer have used taxanes and anthracyclines in the early stage.
The problems of drug resistance and cumulative toxicity still affect The life of the patient.
The approval of Utidrolone provides new treatment opportunities for advanced breast cancer that has failed anthracyclines and taxanes.
More indications studies Utidelone is a genetically engineered epothilones derivative.
Epothilones are broad-spectrum and highly effective anti-cancer drugs.
Due to their simple structure, they have good chemical modification potential.
, Has always been one of the hot spots in the development of new international anti-tumor drugs.
The approval for listing this time also means that China has ushered in the first epothilone anti-tumor drug.
In addition to being used in chemotherapy for advanced breast cancer, Utidelon has also shown anti-tumor activity against common tumors such as lung cancer, liver cancer, bowel cancer and prostate cancer in previous studies, and is resistant to paclitaxel and many other chemotherapeutic drugs.
Tumors also have good curative effects.
At present, Huahao Zhongtian is carrying out a number of phase 2 clinical trial projects, involving advanced solid tumors such as advanced non-small cell lung cancer, advanced colorectal cancer, gastrointestinal tumors, gynecological tumors, and head and neck tumors.
It is hoped that this drug can bring new treatment options to breast cancer patients, and it is also expected that it can help improve the lives of more patients in the future.
Reference materials [1] Released on March 12, 2021, drug approval documents pending receipt information.
Retrieved 2021-03-12, from https:// html[2] Pin Zhang, et al.
, (2017).
Utidelone plus capecitabine versus capecitabine alone for heavily pretreated metastatic breast cancer refractory to anthracyclines and taxanes: a multicentre, open-label, superiority, phase 3, randomised controlled trial.
The Lancet Oncology, DOI: https://doi.
org/10.
1016/S1470-2045(17)30088-8[3] Xu B, et al.
, (2021).
Efficacy of utidelone plus capecitabine versus capecitabine for heavily pretreated, anthracycline -and taxane-refractory metastatic breast cancer: final analysis of overall survival in a phase III randomised controlled trial.
Ann Oncol, DOI: 10.
1016/j.
annonc.
2020.
10.
600.
Note: This article aims to introduce medical health research progress, not treatment Program recommendation. If you need guidance on treatment plans, please go to a regular hospital for treatment.
