Eli Lilly and Company (NYSE: LLY) announced that the National Medical Products Administration (NMPA) has approved Jaypirca (pirtobrutinib) for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior systemic therapy, including a BTK inhibitor. The non-covalent (reversible) BTK inhibitor, first approved by the FDA in January 2023, becomes the first therapy in China specifically indicated for CLL/SLL after covalent BTK inhibitor progression, addressing resistance and intolerance to ibrutinib, acalabrutinib, zanubrutinib, and orelabrutinib.
Regulatory Milestone
Item
Detail
Company
Eli Lilly and Company (NYSE: LLY); commercialized in China by Innovent Biologics
NRDL negotiation for CLL/SLL indication; leverage MCL approval precedent
2026
Market Positioning
“BTK inhibitor after BTK inhibitor” – unique positioning vs. competitors
Ongoing
Combination Studies
Explore pirtobrutinib + venetoclax or anti-CD20 antibodies
2026+
Expansion
Potential earlier-line use in combination; other B-cell malignancies
Investigational
Forward‑Looking Statements This brief contains forward‑looking statements regarding Jaypirca commercial performance in China, NRDL reimbursement outcomes, and competitive dynamics with zanubrutinib and orelabrutinib in the post-covalent BTK inhibitor setting. Actual results may differ due to pricing pressure from national procurement programs, physician adoption of non-covalent mechanism, and competitive responses from BeiGene and InnoCare.-Fineline Info & Tech
By Fineline Cube 