INNOVENT BIO (01801.HK): Jaypirca approved for CLL/SLL in China

NewTimeSpace News: On 28 September 2026, Innovent Biologics, Inc. (stock code: 01801.HK) said Jaypirca (pirtobrutinib), a marketed non-covalent BTK inhibitor, won China's NMPA approval as monotherapy for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) across all lines of therapy.

The approval was based on two global Phase III studies. In BRUIN CLL-313, the first such study in treatment-naive CLL/SLL patients, pirtobrutinib showed a significant progression-free survival (PFS) benefit versus bendamustine plus rituximab (BR), with a hazard ratio of 0.199 and an 80.1% reduction in progression or death risk. BRUIN CLL-314, the first global Phase III study comparing non-covalent and covalent BTK inhibitors, met its primary endpoint in both the ITT and previously treated populations, with an objective response rate above ibrutinib's and a nominal p-value below 0.05. Eli Lilly developed the drug; Innovent commercializes it in mainland China.

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