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Recently, Junshi Biological released an announcement stating that the company's application for clinical trial of JS001sc injection was accepted by the China Food and Drug Administration
.
According to data, JS001sc is a subcutaneous injection preparation developed by Junshi on the basis of the marketed product Teriprilimab injection (trade name: Tuoyi, product code: JS001)
.
Pre-clinical in vivo pharmacodynamic tests have shown that JS001sc has a significant tumor-inhibiting effect in animal models when administered by subcutaneous injection.
At a dose level of 0.
3 mg/kg, JS001sc administered by subcutaneous injection and Terry administered by intravenous injection The anti-tumor effect of prilimumab was equivalent, and no significant difference was seen
.
In addition, the tolerance of animals to JS001sc is also very good
.
It is understood that among the more than ten PD-(L)1 antibodies currently on the market worldwide, only Envolimab injection (trade name: Envida) is administered by subcutaneous injection, and the rest are intravenous injections.
Administration
.
With the gradual popularization of the concept of "chronic disease management" in tumor immunotherapy, compared with frequent visits to the hospital for several hours of intravenous injection, the shorter time of subcutaneous injection can make immunotherapy more accessible, which helps To further reduce the burden of medical insurance and reduce the direct and indirect medical costs of patients' families and society as a whole, injection drug delivery is being welcomed by more and more patients
.
In this context, the industry believes that if Junshi Bio-JS001sc injection can be successfully listed, it will have huge room for development in the future
.
But it is worth noting that the PD-1 market competition has become increasingly fierce in recent years
.
As of February 2021, there are a total of 154 PD-1 monoclonal antibodies under research worldwide, of which 8 have been marketed, 5 are in the application for marketing stage, and 7 are in the phase III clinical stage
.
It is estimated that there will be more than 20 PD-1 products on the global market in the next 2 to 3 years
.
In this context, the degree of competition in the PD-1 market in the future can be seen
.
In China, the research and development of PD-1 drugs is actually very hot.
Of the 154 PD-1s in the world, 85 are developed or jointly developed by Chinese companies, accounting for 55%.
.
In addition, from the domestic situation of PD-1 monoclonal antibody, there are currently as many as 6 domestically marketed PD-1 models, namely Hengrui’s carrelizumab, BeiGene’s tislelizumab, Cinda Bio's Sintilizumab, Junshi Bio's Tereprizumab, Kangfang Bio's Paimrizumab and Yuheng Bio-Sepalizumab
.
In addition to the 6 products approved for marketing, 3 products are still in the market application stage, and 7 are in the phase III clinical stage
.
According to the current development trend, it is estimated that 15 PD-1 monoclonal antibodies will be marketed in China in the next 2 to 3 years
.
From the above overall point of view, it has become a trend that PD-1 "involution" continues to intensify
.
In this context, the industry believes that in the face of fierce competition in the future, companies need to continue to exert their efforts in two aspects
.
One is indications, and the other is commercialization capabilities
.
It should be noted that, in terms of indications, pharmaceutical companies should try to avoid homogenization.
It is understood that the indications of domestic PD-1 are showing a state of intensive research and development, including lung cancer, gastric cancer, liver cancer, esophageal cancer, etc.
, There are more than 10 research institutes for each indication
.
In addition, in terms of commercialization, domestic pharmaceutical companies should actively promote their products to go overseas, develop overseas rights and interests, and use the partners’ mature overseas sales channels to obtain more business growth when the domestic PD-1 price is falling.
Space
.
.
According to data, JS001sc is a subcutaneous injection preparation developed by Junshi on the basis of the marketed product Teriprilimab injection (trade name: Tuoyi, product code: JS001)
.
Pre-clinical in vivo pharmacodynamic tests have shown that JS001sc has a significant tumor-inhibiting effect in animal models when administered by subcutaneous injection.
At a dose level of 0.
3 mg/kg, JS001sc administered by subcutaneous injection and Terry administered by intravenous injection The anti-tumor effect of prilimumab was equivalent, and no significant difference was seen
.
In addition, the tolerance of animals to JS001sc is also very good
.
It is understood that among the more than ten PD-(L)1 antibodies currently on the market worldwide, only Envolimab injection (trade name: Envida) is administered by subcutaneous injection, and the rest are intravenous injections.
Administration
.
With the gradual popularization of the concept of "chronic disease management" in tumor immunotherapy, compared with frequent visits to the hospital for several hours of intravenous injection, the shorter time of subcutaneous injection can make immunotherapy more accessible, which helps To further reduce the burden of medical insurance and reduce the direct and indirect medical costs of patients' families and society as a whole, injection drug delivery is being welcomed by more and more patients
.
In this context, the industry believes that if Junshi Bio-JS001sc injection can be successfully listed, it will have huge room for development in the future
.
But it is worth noting that the PD-1 market competition has become increasingly fierce in recent years
.
As of February 2021, there are a total of 154 PD-1 monoclonal antibodies under research worldwide, of which 8 have been marketed, 5 are in the application for marketing stage, and 7 are in the phase III clinical stage
.
It is estimated that there will be more than 20 PD-1 products on the global market in the next 2 to 3 years
.
In this context, the degree of competition in the PD-1 market in the future can be seen
.
In China, the research and development of PD-1 drugs is actually very hot.
Of the 154 PD-1s in the world, 85 are developed or jointly developed by Chinese companies, accounting for 55%.
.
In addition, from the domestic situation of PD-1 monoclonal antibody, there are currently as many as 6 domestically marketed PD-1 models, namely Hengrui’s carrelizumab, BeiGene’s tislelizumab, Cinda Bio's Sintilizumab, Junshi Bio's Tereprizumab, Kangfang Bio's Paimrizumab and Yuheng Bio-Sepalizumab
.
In addition to the 6 products approved for marketing, 3 products are still in the market application stage, and 7 are in the phase III clinical stage
.
According to the current development trend, it is estimated that 15 PD-1 monoclonal antibodies will be marketed in China in the next 2 to 3 years
.
From the above overall point of view, it has become a trend that PD-1 "involution" continues to intensify
.
In this context, the industry believes that in the face of fierce competition in the future, companies need to continue to exert their efforts in two aspects
.
One is indications, and the other is commercialization capabilities
.
It should be noted that, in terms of indications, pharmaceutical companies should try to avoid homogenization.
It is understood that the indications of domestic PD-1 are showing a state of intensive research and development, including lung cancer, gastric cancer, liver cancer, esophageal cancer, etc.
, There are more than 10 research institutes for each indication
.
In addition, in terms of commercialization, domestic pharmaceutical companies should actively promote their products to go overseas, develop overseas rights and interests, and use the partners’ mature overseas sales channels to obtain more business growth when the domestic PD-1 price is falling.
Space
.
