Jaypirca® Approved in China for New Indication in Chronic Lymphocytic Leukemia

Innovent Biologics has received a new indication approval in China for Jaypirca® (pirtobrutinib) from the National Medical Products Administration (NMPA). The drug is now approved for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) as a monotherapy across all lines of therapy.

This expanded approval allows Jaypirca® to be used in patients regardless of prior treatment with a covalent Bruton tyrosine kinase (BTK) inhibitor. Jaypirca® is a non-covalent BTK inhibitor designed to target the BTK pathway.

The approval is supported by data from the global Phase 3 BRUIN CLL-313 and BRUIN CLL-314 clinical trials. In the BRUIN CLL-313 study, pirtobrutinib demonstrated a statistically significant improvement in progression-free survival compared to bendamustine plus rituximab, showing an 80.1% reduction in the risk of disease progression or death. The BRUIN CLL-314 study met its primary endpoint for overall response rate, showing noninferiority to ibrutinib.

Professor Jianyong Li stated that the approval offers a new treatment option for Chinese patients across all lines of therapy, advancing CLL/SLL management. Dr. Hui Zhou of Innovent highlighted the drug's clinical value and the company's commitment to patient access. Dr. Li Wang from Lilly China noted the approval as a significant milestone for advancing innovation in hematologic malignancies in China.