When was Ivosidenib launched in China?

Ivosidenib (Ivosidenib) is an oral targeted inhibitor against IDH1 mutations, developed and registered by CStone Pharmaceuticals in China. According to public information, the National Medical Products Administration of China (NMPA) approved ivosidenib (trade name TIBSOVO) in February of 2022 for the treatment of relapsed or refractory acute myeloid leukemia (R/R) carrying susceptible IDH1 mutations. AML) adult patients.

This approval marks ivonib becoming the first IDH1 inhibitor approved in mainland China, and is expected to fill the gap in this type of precision treatment drugs in China. Prior to this, ivonib had launched China's bridging registration I phase clinical trial in 2019 to evaluate its pharmacokinetics, safety and preliminary efficacy in Chinese AML patients. Later, he participated in the global III phase trial (AGILE study) and completed the first dose in China. Therefore, since it was officially approved in 2022 , ivonib has theoretically been legally qualified to be marketed in China and used for clinical treatment.

However, it should be noted that "approved for marketing" only means that the drug has obtained an approval number. Specifically, whether the hospital has actually introduced it, whether it has been purchased, whether patients can get it in time, and medical insurance coverage may also be affected by multiple factors such as drug supply, hospital procurement decisions, and pricing policies. If you or your doctor are concerned about this drug, you can take the initiative to ask the oncology department or hematology department of your local hospital whether ivonib is on the shelves and whether it is prescribed for patients with IDH1 mutations.

Ivonib is also currently approved overseas for conditions such as cholangiocarcinoma and myelodysplastic syndrome. In summary, ivonib was approved for marketing by China's NMPA in 2022 in February for the treatment of IDH1 mutated R/R AML patients, but specific accessibility needs to be combined with hospital procurement and prescription implementation.

Reference materials: https://www.tibsovo.com/