Will pirtobrutinib be launched in August 2023?

Pirtobrutinib is a new type of non-covalent reversible BTK inhibitor, mainly used to treat hematological malignancies such as relapsed or refractory mantle cell lymphoma (MCL). The drug received accelerated approval from the US FDA in January 2023, becoming the first non-covalent BTK inhibitor. Subsequently, on 2024Year October 29, the National Medical Products Administration (NM PA) approved its marketing in China under the trade name "Jepali" for the treatment of adult patients with relapsed or refractory MCL who have previously received BTK inhibitor treatment.

Although Pitobrutinib has been approved for marketing in China, due to its short time on the market, the domestic market is still in the early stages of promotion, and drug supply and sales channels have not yet been fully established. Patients may face certain difficulties in purchasing domestically. Currently, Innovent is responsible for the commercialization of the drug in mainland China, including import, sales, promotion and distribution.

In overseas markets, the price of the original drug of pitobrutinib is relatively high. The European and American versions are usually priced at around RMB 100,000. The specific price will vary due to exchange rate fluctuations and regional differences. In order to reduce the financial burden on patients, Laos ASEAN Pharmaceutical (TLPH) has launched a generic version of pitobrutinib, with a specification of 50mg*30 tablets and a price of less than 3,000 yuan. The generic drug has been approved for marketing by the Ministry of Health of Laos, providing patients with a more economical treatment option.

In summary, pitobrutinib, as an innovative BTK inhibitor, provides a new treatment option for patients with relapsed or refractory MCL. With its gradual promotion in the Chinese market and the improvement of sales channels, it is expected that patients will have easier access to the drug. At the same time, the emergence of overseas generic drugs has also provided patients with more choices, especially when the financial burden is heavy. When patients choose medication, they should make the most appropriate decision based on their own circumstances and under the guidance of a doctor, weighing the efficacy, price, and accessibility of the drug.

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