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Recently, the board of directors of CSPC Group Co.
, Ltd.
announced that the Class 1 new drug "SYHA1908 for injection" ("the product") developed by its subsidiary CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co.
, Ltd.
has been approved by the State Drug Administration of the People's Republic of China.
Approved by the bureau, clinical trials can be carried out in China
.
SYHA1908 (the compound) is a new generation of taxane compounds with high efficacy and low toxicity, acting on the microtubule or tubulin system
.
This product is a drug independently developed by the Group using human albumin as a carrier to achieve effective delivery of a new generation of taxanes in vivo
.
The compound has no cytotoxic effect on normal tissues, but can be converted into active substances by enzymes in the tumor microenvironment to exert anti-tumor effects, so it has a significantly improved safety window.
Compared with the marketed taxane drugs, the safety Increase at least > 100 times, and the effect is comparable
.
Therefore, this compound can improve the clinical limitations of existing taxanes that cannot achieve higher dose administration due to dose-limiting toxicity
.
The clinical indication approved this time is solid tumors.
The preclinical research results show that the product has good anti-tumor activity in a variety of solid tumors, and it is very hopeful that it will show a good anti-tumor effect in clinical trials
.
This product belongs to Category 1 of the registration classification of Chinese chemical drugs, and there is no similar product listed in the world at present
.
The Group will make every effort to promote the clinical trials of the product and strive to launch the product as soon as possible
.
, Ltd.
announced that the Class 1 new drug "SYHA1908 for injection" ("the product") developed by its subsidiary CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co.
, Ltd.
has been approved by the State Drug Administration of the People's Republic of China.
Approved by the bureau, clinical trials can be carried out in China
.
SYHA1908 (the compound) is a new generation of taxane compounds with high efficacy and low toxicity, acting on the microtubule or tubulin system
.
This product is a drug independently developed by the Group using human albumin as a carrier to achieve effective delivery of a new generation of taxanes in vivo
.
The compound has no cytotoxic effect on normal tissues, but can be converted into active substances by enzymes in the tumor microenvironment to exert anti-tumor effects, so it has a significantly improved safety window.
Compared with the marketed taxane drugs, the safety Increase at least > 100 times, and the effect is comparable
.
Therefore, this compound can improve the clinical limitations of existing taxanes that cannot achieve higher dose administration due to dose-limiting toxicity
.
The clinical indication approved this time is solid tumors.
The preclinical research results show that the product has good anti-tumor activity in a variety of solid tumors, and it is very hopeful that it will show a good anti-tumor effect in clinical trials
.
This product belongs to Category 1 of the registration classification of Chinese chemical drugs, and there is no similar product listed in the world at present
.
The Group will make every effort to promote the clinical trials of the product and strive to launch the product as soon as possible
.
