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In the United States, there are about 20,000 new cases each year, and the five-year survival rate of patients is about 29%
Tosuvo® is CStone's fourth innovative drug that has been successfully approved for marketing.
As the first IDH1 inhibitor approved in China, we are pleased to see that Tosuvo® has demonstrated good efficacy and safety in AML patients with IDH1 mutations .
Jianxin Yang, Chief Medical Officer of CStone, said: "We are delighted to see Tosuvo® approved in mainland China for the treatment of R/R AML patients
At the same time, as the first potent and highly selective oral IDH1 inhibitor of its kind in the world, Topsuvo® was selected into the 2020 edition of the "CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies" with its clear clinical advantages
Tosuvo® showed excellent clinical efficacy and good tolerability in the treatment of adult R/R AML Chinese patients with IDH1 susceptibility mutations .
Among 30 evaluable patients, the primary efficacy endpoint of complete remission and complete remission with partial hematologic recovery (CR+CRh) was 36.
Acute myeloid leukemia (AML) is the most common type of leukemia in adults, the disease progresses rapidly, and the vast majority of elderly patients
.
In the United States, there are about 20,000 new cases each year, and the five-year survival rate of patients is about 29%
Dr.
Jiang Ningjun, Chairman and Chief Executive Officer of CStone, said: "This is another important milestone in CStone's development
.
Tosuvo® is CStone's fourth innovative drug that has been successfully approved for marketing.
Professor Wang Jianxiang from the Hospital of Hematology, Chinese Academy of Medical Sciences, the principal investigator of the CS3010-101 bridging study of the Topsuvo® China Registration, said: "The existing treatment options for AML patients with IDH1 mutations have been limited, and the 5-year survival rate is low .
The quality of life of patients is poor
.
As the first IDH1 inhibitor approved in China, we are pleased to see that Tosuvo® has demonstrated good efficacy and safety in AML patients with IDH1 mutations .
Dr.
Jianxin Yang, Chief Medical Officer of CStone, said: "We are delighted to see Tosuvo® approved in mainland China for the treatment of R/R AML patients
In 2020, Topsuvo® was included in the "List of Overseas New Drugs Urgently Needed in Clinical (Third Batch)" by the Center for Drug Evaluation of the State Drug Administration of China, and obtained the qualification for fast-track review and approval
.
At the same time, as the first potent and highly selective oral IDH1 inhibitor of its kind in the world, Topsuvo® was selected into the 2020 edition of the "CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies" with its clear clinical advantages
The approval of Tosuvo® is based on a Chinese registration bridging study CS3010-101, which aims to evaluate the pharmacokinetics, pharmacokinetics, Pharmacodynamic profile, safety and clinical efficacy .
Tosuvo® showed excellent clinical efficacy and good tolerability in the treatment of adult R/R AML Chinese patients with IDH1 susceptibility mutations .
Among 30 evaluable patients, the primary efficacy endpoint of complete remission and complete remission with partial hematologic recovery (CR+CRh) was 36.