Innovent Biologics, Inc. (1801) Announces NMPA Approval of Jaypirca for Recurrent CLL/SLL

Bulletin Express02-27

Innovent Biologics, Inc. (1801) announced that Jaypirca (pirtobrutinib), a non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, has gained approval from the National Medical Products Administration of China to treat adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone at least one line of systemic therapy, including a BTK inhibitor.

Jaypirca’s new indication is supported by findings from the international Phase 3 BRUIN CLL-321 study, which involved 238 patients previously treated with a covalent BTK inhibitor. Pirtobrutinib monotherapy significantly extended median progression-free survival (14.00 months versus 8.70 months; hazard ratio = 0.54) compared with either idelalisib plus rituximab or bendamustine plus rituximab. The discontinuation rate due to treatment-related adverse events was lower among patients receiving pirtobrutinib (5.20% compared with 21.10%).

Pirtobrutinib employs a novel non-covalent binding mechanism, which differentiates it from covalent BTK inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib. According to the announcement, Eli Lilly and Company developed pirtobrutinib, and Innovent Biologics, Inc. is responsible for its commercialization in mainland China.

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