Eli Lilly Submits New NDA in China for Reversible BTK Inhibitor Pirtobrutinib in CLL/SLL

On June 18, the CDE official website showed,Eli LillyPirtobrutinib TabletsNew indication marketing application accepted. Based on clinical trial progress, InsigHT Database Speculated for TreatmentChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Treated with BTK Inhibitors。

Pirtobrutinib（Pirtobrutinib）It is a highly selective, non-covalent(Reversible)BTK inhibitor, the mostInitially developed by Redx Pharma, it was acquired by Loxo Oncology in July 2017. In January 2019, Eli Lilly and Company spent $8 billion to acquire Loxo Oncology, bringing it under their ownership. 2024In December, Innovent Biologics acquired the rights for the import, sale, promotion, and distribution of Pirtobrutinib in mainland China.

Source: Insight Database

Currently,PirtobrutinibApproved in the United States for 2 indications, respectively: 1) Previously received at least two systemic treatments(Containing BTK Inhibitor)TheRelapsed or Refractory Mantle Cell Lymphoma（MCL）; 2) Have received at least two prior treatments(Including BTK inhibitors, BCL-2 inhibitors)OfChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma。

In October 2024, the product was approved for marketing in China for the first time, intended for third-line treatment of MCL.

Since its launch in 2023,Pirtobrutinib's market performance has been rapidly advancing, with sales reaching $337 million in 2024 and $92 million in the first quarter of 2025.An increase of 84% year-over-year。

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