Pitobrutinib/Pirtobrutinib approval status and official approval instructions in China

Pitobrutinib/Pirtobrutinib (pirtobrutinib) has been approved for marketing by the national drug regulatory authorities in China, becoming one of the targeted therapeutic drugs that can be legally used in China. The drug is mainly used to treat specific types of hematological malignancies, such as chronic lymphocytic leukemia and mantle cell lymphoma. The basis for China's approval of its marketing mainly comes from international clinical research data and domestic clinical trial results, which show that its efficacy and safety in these diseases have certain advantages, providing new treatment options for domestic patients.

In the domestic market, the original drug of Pitobrutinib has been officially sold and has been included in the medical insurance. The current specifications for sale are 100 mg 14 tablets and 4 tablets. Each box may be sold for more than 40,000 yuan. When doctors prescribe this drug, they usually make individualized medication recommendations based on the patient's condition and financial ability to ensure the continuity and effectiveness of treatment.

In overseas markets, the original drug of Pitobrutinib is available in two common specifications: European version and American version, respectively 50mg 30 tablets and 100mg 60 tablets. Each box sells for nearly 100,000 yuan, which is expensive. In addition, generic versions of pitobrutinib have appeared overseas, and the ingredients of the drug are basically the same as those of the original drug. For example, each box of 50 mg 30 tablets produced by a Lao pharmaceutical factory sells for more than 2,000 yuan, but the price may be adjusted due to exchange rate fluctuations. The emergence of generic drugs provides overseas patients with an economically viable option and also provides a reference for domestic patients to obtain lower-priced drugs in the future.

For Chinese patients, the approval of pitubrutinib means more diversified treatment options for hematological malignancies. However, patients need to fully evaluate their financial ability and communicate with their doctor about a reasonable treatment plan before use. In addition, it is recommended to purchase through regular hospitals and pharmacies to ensure reliable sources of medicines and avoid using products from informal channels to ensure medication safety and therapeutic effects.

Reference materials:https://pmc.ncbi.nlm.nih.gov/articles/PMC10841293/