China's first IDH1 inhibitor Tuosovo was approved by CStone Pharmaceuticals to develop precise treatment of leukemia

On February 9, Hong Kong-listed CStone Pharmaceutical announced that the State Drug Administration (NMPA) has approved a new drug listing application for the first of its kind, Tuosovo (Evenibu tablets). Toskovo is the first approved IDH1 inhibitor in China for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) carrying IDH1 susceptible mutations. The launch of this product will fill the gap in the precision targeted treatment of acute myeloid leukemia and open up a new treatment market for CStone Pharmaceuticals.

It is understood that acute myeloid leukemia is the most common type of leukemia in adults, and the disease progresses rapidly, and the vast majority are elderly patients. In the United States, there are about 20,000 new cases per year, and the five-year survival rate of patients is about 29%. With the aging of the population, the incidence of AML in China is increasing year by year. In China, there are about 75,300 new cases of leukemia each year, of which about 59% are AML patients, and about 6% to 10% of these patients carry IDH1 mutations.

Toskovo is an IDH1 inhibitor that promotes AML cell differentiation by blocking the activity of the IDH1 mutant enzyme, thereby exerting anti-tumor effects. Its approval is based on a Chinese registered bridging study CS3010-101, the study's lead investigator, Professor Wang Jianxiang of the Chinese Academy of Medical Sciences Hematology Hospital, said: "For a long time, the existing treatment methods for AML patients with IDH1 mutations have been limited, the 5-year survival rate is low, and the quality of life of patients is poor. As the first approved IDH1 inhibitor in China, we are pleased to see that Toschuvo has shown good efficacy and safety in AML patients with IDH1 mutations. ”

It is worth mentioning that this is also the fourth innovative drug successfully approved for listing within one year after the approval of two similar first-in-class precision therapeutic drugs, Phuket, Taijihua, and the tumor immunotherapy drug Zejiemei. For the approval of the product, Dr. Jiang Ningjun, Chairman and CEO of CStone, said that this is another important milestone in the development process of CStone. "Toshovo is the fourth innovative drug successfully approved for marketing by CStone Pharmaceuticals, and it took only 6 months from the acceptance of the new drug listing application to the successful approval, which once again reflects the speed of cornerstone." He said.