Is Pitobrutinib/Pitobrutinib launched in China? The latest news is here!

On October 29, 2024, the State Food and Drug Administration officially approved Pirtobrutinib developed by Eli Lilly and Company to be launched in China under the trade name "Jaypirca" (Jaypirca). This drug is the world's first and currently only approved non-covalent (reversible) BTK inhibitor. It is specifically used to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received BTK inhibitor treatment.

The launch of Pitobrutinib has filled the domestic gap in the field ofBTK resistance treatment. Although traditional covalent BTK inhibitors, such as ibrutinib and acotinib, have achieved remarkable results in the treatment of B cell malignancies, some patients will develop drug resistance due to BTK gene mutations (such as C481S), resulting in reduced efficacy. Pitobrutinib binds to BTK through a non-covalent reversible mechanism, which can effectively overcome this type of drug resistance problem and provide patients with a new treatment option.

In terms of commercialization,On December 16, 2024, Innovent Biologics and Eli Lilly reached a cooperation agreement. Innovent Biologics obtained the exclusive commercialization rights of pitubrutinib in mainland China and was responsible for the import, sales, promotion and distribution of the product, while Eli Lilly continued to be responsible for research and development and post-marketing medical affairs.

It is worth noting that as of now, pitubrutinib has not been included in China's national medical insurance directory, so patients may need to bear higher costs when using this drug. However, with further verification of its clinical application and efficacy, it is expected to be included in the medical insurance system in the future to reduce the financial burden on patients.

In general, the launch of pitubrutinib brings new hope to Chinese patients with relapsed or refractory mantle cell lymphoma, especially those who are resistant to traditionalBTK inhibitors. With the accumulation of more clinical data and the improvement of medical insurance policies, pitubrutinib is expected to play a greater role in the treatment of hematological tumors in China.

Reference materials:https://go.drugbank.com/drugs/DB17472