Detailed explanation of manufacturer and drug background information of Pitobrutinib/Pirtobrutinib

Pirtobrutinib (also known as LOXO-305) is a new generation of highly selective non-covalent BTK inhibitor, led by Loxo Oncology and developed by Eli Lilly and Company (Eli After the acquisition, Lilly continued to integrate into a unified global R&D and production system. The initial development goal of this drug was to solve the drug resistance problem that occurs after long-term treatment with traditional covalent BTK inhibitors (such as ibrutinib and acalabrutinib), especially when mutations at the C481 site lead to reduced drug efficacy. As a reversibly binding BTK inhibitor, it can maintain inhibitory activity in the presence of drug-resistant mutations. Therefore, it has shown obvious therapeutic advantages in patients with relapsed and refractory lymphoma in clinical trials and is regarded as an important breakthrough drug that fills the gap in the field of BTK drug resistance.

Currently, the global originator manufacturer is Eli Lilly and Company, which is responsible for the raw material synthesis, finished product production, quality control and international supply chain management of drugs. Pitobrutinib is currently supplied in the form of tablets, and there are no officially marketed generic drugs. This is because the drug is a high-threshold small molecule targeted inhibitor with complex process requirements and patent protection is still valid. Eli Lilly maintains stable and consistent drug quality through strict oversight of its production processes, purity standards and global distribution systems. Since the drug is an innovative anti-tumor targeted drug, it is currently only available in regular hospital pharmacies or authorized pharmacies in some countries. The global supply is still relatively tight, especially when demand is growing rapidly in the early stages of marketing.

The research and development background of Pitobrutinib is driven by clinical needs, especially the increasing cases of drug resistance and treatment failure in patients with relapsed and refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Clinical studies have shown that the drug can still maintain a high response rate and show good tolerability in patients who have received multiple lines of treatment in the past, allowing it to be granted breakthrough therapy designation and accelerated approval status by the FDA. This has made it one of the most watched new drugs in the field of BTK inhibitors in recent years, and has also promoted the expansion of research into more related indications, including its potential use in earlier-line treatments and combination regimens.

Since Pitobrutinib is not yet on the market in China and has not been included in the medical insurance catalog, domestic patients usually need to purchase it through cross-border medical or overseas pharmacy channels. Compared to covalent BTK Inhibitor, pitubrutinib is an innovative treatment option designed to target resistance mechanisms, and its long-term safety and cost accessibility are still under continuous evaluation. With the release of more phase III clinical data, expansion of indications, and policy promotion, it is expected to be gradually included in treatment guidelines in more countries and speed up its introduction in the country, so that more patients with hematological tumors can benefit from this new, precisely targeted drug.

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