Filling the gap in targeted treatment for acute myeloid leukemia, the first IDH1 inhibitor in China was approved

Gaps in precision-targeted therapy for acute myeloid leukemia are being filled.

On February 9, the State Drug Administration approved the marketing application of the first drug of its kind, "Toshowo" (Avonib tablets), the first approved IDH1 inhibitor in China, for the treatment of adult patients with RElapsed or refractory acute myeloid leukemia (R/R AML) with IDH1 susceptible mutations.

Leukemia is a common malignant blood tumor, of which acute myeloid leukemia is the most common type of leukemia in adults, and the disease progresses rapidly, the vast majority of 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 also 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. Traditionally, existing treatments for patients with IDH1 mutations in AML have limited means of survival, with low 5-year survival rates and poor quality of life.

As an IDH1 inhibitor, Toschuvo can exert anti-tumor effects by blocking the activity of idH1 mutant enzymes and promoting the differentiation of AML cells. In 2020, Tuoshua was included in the "List of New Overseas Drugs Urgently Needed for Clinical Use (The Third Batch)" by the Drug Evaluation Center of the State Food and Drug Administration, and obtained the qualification for fast-track review and approval.

Toshovo was originally developed by Agios, and Svea acquired an interest in the product through the acquisition of Agios' oncology business. Subsequently, Svea awarded the Chinese pharmaceutical company 02616.HK for clinical development and commercialization of the product in China and Singapore.

For CStone Pharmaceuticals, Tuosovo is also the company's fourth innovative therapeutic drug approved for listing in the past year, but the company's commercialization capacity building has not started soon, and how to open the sales market of the drug in China still tests the company's promotion ability.

In the early stage, IQVIA China said in the report released that the treatment path and choice of leukemia are important factors affecting medication. At present, in China, whether it is acute or chronic leukemia, chemotherapy is still the most important and basic treatment, but the problem of tolerance and drug resistance is the main reason for the failure of chemotherapy. Doctors' selection of leukemia drugs is first of all the efficacy of the drug, followed by side effects, and finally the price and other factors.