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Data show that in 2020, the terminal anti-tumor and immunomodulator market in China's public medical institutions will exceed the 160 billion yuan mark, and this market will grow by more than 15% year-on-year in the first half of 2021
.
I was informed that this year there are 15 listed apply anti-tumor and immunomodulatory agents in a class of drugs in the review and approval, many of whom fourbiomedicine, Jiangsu Hengrui Medicine, Qilu Pharmaceutical and so on
.
Last Thursday, November 25, two domestically produced Class 1 new drugs were approved, which aroused the attention of the market
.
On November 25, the State Food and Drug Administration website showed that the first class innovative drug Orebatinib tablets declared by Guangzhou Shunjian Biopharmaceuticals and Envoli declared by Sichuan Sizhi Kangrui Pharmaceutical were approved with conditions through the priority review and approval procedures.
Monoclonal antibody injection (trade name: Envida) is on the market
.
The third-generation BCR-ABL inhibitor was approved for listing in China.
On November 25, a class 1 innovative drug, olverembatinib (HQP1351) developed by Shunjian Biotech, a wholly-owned subsidiary of Yasheng Pharmaceutical, was approved by the State Food and Drug Administration of China (NMPA) approval
.
This is the first oral third-generation BCR-ABL inhibitor developed by a local Chinese company, and it is also the first innovative drug approved by Ascent Pharmaceuticals since its establishment more than ten years ago
.
This product is used to treat any tyrosine kinase inhibitor resistance, and is diagnosed as an adult patient with T315I mutation in chronic myeloid leukemia in the chronic or accelerated phase using a fully validated detection method
.
Orebatinib has been included in the priority review and breakthrough treatment varieties in China by virtue of its unique advantages
.
Overseas, Orebatinib has successively obtained orphan drug qualification and fast-track review qualifications granted by the US FDA, as well as EU orphan drug qualification
.
It is understood that at present, Yasheng Pharmaceutical has constructed a rich pipeline of 8 new class 1 small molecule drug products entering the clinical stage, including inhibitors that inhibit key proteins in the apoptosis pathway such as Bcl-2, IAP or MDM2-p53; a new generation Targeting inhibitors of kinase mutants that appear in cancer treatment, etc.
, it is an innovative company with clinically developed varieties in the field of key proteins in the apoptosis pathway
.
Subcutaneous injection of PD-L1 antibody was approved for marketing in China On November 25, the National Medical Products Administration (NMPA) conditionally approved the listing of PD-L1 single domain antibody Envida® (Envolimab injection)
.
This drug is jointly developed by Sidi Di Pharmaceutical, Corning Jereh, and Simcere Pharmaceuticals.
It is an anti-PD-L1 monoclonal antibody that can be used for subcutaneous injection
.
Data show that the drug is used for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR) in adult patients with advanced solid tumors, including past fluorouracils, oxali Patients with advanced colorectal cancer who developed disease progression after platinum and irinotecan treatment, and other advanced solid tumor patients who developed disease progression after previous treatment and did not have a satisfactory alternative treatment plan
.
Envolimab has great advantages in terms of safety, convenience and compliance.
It is a very good treatment option for patients who cannot use intravenous injection for various reasons
.
It is understood that Envolimab is a monospecific antibody composed of a single domain antibody (sdAb) and an Fc segment.
Its molecular weight is half the molecular weight of a complete antibody, which gives it enhanced penetration and completeness.
Antigen binding ability
.
In addition, Fc-mediated effector functions are impaired in Envolimab to limit its exposure to the immune system and avoid unexpected unwanted immune responses
.
In addition, Envoli is an anti-PD-L1 monoclonal antibody that can be injected subcutaneously.
Compared with intravenous injection, it is not only faster, but also less likely to have adverse reactions
.
At present, the PD-(L)1 treatment on the market requires frequent intravenous injection, which can not meet the convenience of patients' medication needs, and will also affect patients' compliance with medications
.
With envolimab, the patient can complete the administration process without intravenous injection, which greatly shortens the patient's administration time and can complete the administration within 30 seconds
.
What's more worth mentioning is that Envolimab has the potential of home self-administration, which can effectively improve the quality of life of patients
.
.
I was informed that this year there are 15 listed apply anti-tumor and immunomodulatory agents in a class of drugs in the review and approval, many of whom fourbiomedicine, Jiangsu Hengrui Medicine, Qilu Pharmaceutical and so on
.
Last Thursday, November 25, two domestically produced Class 1 new drugs were approved, which aroused the attention of the market
.
On November 25, the State Food and Drug Administration website showed that the first class innovative drug Orebatinib tablets declared by Guangzhou Shunjian Biopharmaceuticals and Envoli declared by Sichuan Sizhi Kangrui Pharmaceutical were approved with conditions through the priority review and approval procedures.
Monoclonal antibody injection (trade name: Envida) is on the market
.
The third-generation BCR-ABL inhibitor was approved for listing in China.
On November 25, a class 1 innovative drug, olverembatinib (HQP1351) developed by Shunjian Biotech, a wholly-owned subsidiary of Yasheng Pharmaceutical, was approved by the State Food and Drug Administration of China (NMPA) approval
.
This is the first oral third-generation BCR-ABL inhibitor developed by a local Chinese company, and it is also the first innovative drug approved by Ascent Pharmaceuticals since its establishment more than ten years ago
.
This product is used to treat any tyrosine kinase inhibitor resistance, and is diagnosed as an adult patient with T315I mutation in chronic myeloid leukemia in the chronic or accelerated phase using a fully validated detection method
.
Orebatinib has been included in the priority review and breakthrough treatment varieties in China by virtue of its unique advantages
.
Overseas, Orebatinib has successively obtained orphan drug qualification and fast-track review qualifications granted by the US FDA, as well as EU orphan drug qualification
.
It is understood that at present, Yasheng Pharmaceutical has constructed a rich pipeline of 8 new class 1 small molecule drug products entering the clinical stage, including inhibitors that inhibit key proteins in the apoptosis pathway such as Bcl-2, IAP or MDM2-p53; a new generation Targeting inhibitors of kinase mutants that appear in cancer treatment, etc.
, it is an innovative company with clinically developed varieties in the field of key proteins in the apoptosis pathway
.
Subcutaneous injection of PD-L1 antibody was approved for marketing in China On November 25, the National Medical Products Administration (NMPA) conditionally approved the listing of PD-L1 single domain antibody Envida® (Envolimab injection)
.
This drug is jointly developed by Sidi Di Pharmaceutical, Corning Jereh, and Simcere Pharmaceuticals.
It is an anti-PD-L1 monoclonal antibody that can be used for subcutaneous injection
.
Data show that the drug is used for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR) in adult patients with advanced solid tumors, including past fluorouracils, oxali Patients with advanced colorectal cancer who developed disease progression after platinum and irinotecan treatment, and other advanced solid tumor patients who developed disease progression after previous treatment and did not have a satisfactory alternative treatment plan
.
Envolimab has great advantages in terms of safety, convenience and compliance.
It is a very good treatment option for patients who cannot use intravenous injection for various reasons
.
It is understood that Envolimab is a monospecific antibody composed of a single domain antibody (sdAb) and an Fc segment.
Its molecular weight is half the molecular weight of a complete antibody, which gives it enhanced penetration and completeness.
Antigen binding ability
.
In addition, Fc-mediated effector functions are impaired in Envolimab to limit its exposure to the immune system and avoid unexpected unwanted immune responses
.
In addition, Envoli is an anti-PD-L1 monoclonal antibody that can be injected subcutaneously.
Compared with intravenous injection, it is not only faster, but also less likely to have adverse reactions
.
At present, the PD-(L)1 treatment on the market requires frequent intravenous injection, which can not meet the convenience of patients' medication needs, and will also affect patients' compliance with medications
.
With envolimab, the patient can complete the administration process without intravenous injection, which greatly shortens the patient's administration time and can complete the administration within 30 seconds
.
What's more worth mentioning is that Envolimab has the potential of home self-administration, which can effectively improve the quality of life of patients
.
