On March 2, Innovent Biologics and Eli Lilly and Company China jointly announced that the non-covalent (reversible) BTK inhibitor Japalli® (pitubrutinib) has been officially approved by the National Medical Products Administration (NMPA) of China for a new indication: the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy including a Bruton's tyrosine kinase (BTK) inhibitor.

Pitobrutinib is a highly selective kinase inhibitor with a novel binding mechanism that can re-establish BTK inhibition in CLL/SLL patients who have previously received covalent BTK inhibitors (including ibrutinib, acomitinib, zanubrutinib, or orelabrutinib), thus prolonging the benefits of targeting the BTK pathway. Pitobrutinib, as a non-covalent (reversible) BTK inhibitor, was approved by the US FDA in January 2023. In October 2024, pitotubactinib was approved in China as monotherapy for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior systemic therapies (including Bruton's tyrosine kinase [BTK] inhibitors). In China , pitotubactinib was developed by Eli Lilly, and Innovent Biologics is responsible for its commercialization in mainland China.

This approval for the new indication is based on the results of the international multicenter, randomized controlled Phase 3 BRUIN CLL-321 study. The study enrolled 238 patients with CLL/SLL who had previously received covalent BTK inhibitor (cBTKi) therapy, aiming to compare the efficacy and safety of pitubrutinib monotherapy with the investigator-selected IdelaR (idelalisib plus rituximab) or BR (bendamustine plus rituximab) regimens. The results showed that pitubrutinib significantly prolonged median progression-free survival (PFS) (14.0 months vs. 8.7 months) and had a lower discontinuation rate due to treatment-related adverse events (5.2% vs. 21.1%), further validating its efficacy and tolerability advantages in patients previously treated with covalent BTK inhibitors.
https://mp.weixin.qq.com/s/OzMj0oLah3npEiSVGhHqew