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Highlights
- Revolutionary BTK Inhibitor: Jaypirca® is the first FDA-approved non-covalent BTK inhibitor and a novel treatment for relapsed or refractory MCL patients.
- Strategic Collaboration in China: Innovent will lead Jaypirca®’s commercialization in Mainland China, while Lilly focuses on R&D and clinical development.
- Expanding Access to Innovative Care: The partnership aims to address unmet clinical needs and broaden access to advanced therapies for cancer patients.
Innovent Biologics, Inc. (HKEX: 01801), a leading biopharmaceutical company, and Eli Lilly and Company (NYSE:LLY) have announced a strategic Distribution and Promotion Agreement to bring Jaypirca® (pirtobrutinib) to cancer patients in Mainland China. The agreement marks a significant step in providing advanced treatments for relapsed or refractory mantle cell lymphoma (MCL).
Key Agreement Details
- Innovent’s Role: Innovent will manage the importation, marketing, distribution, and promotion of Jaypirca® in Mainland China.
- Lilly’s Role: Eli Lilly will oversee research and development (R&D) and post-market medical affairs for the drug.
Jaypirca® is a highly selective, non-covalent Bruton's tyrosine kinase (BTK) inhibitor, offering a groundbreaking treatment option for MCL patients who have previously been treated with a covalent BTK inhibitor, such as ibrutinib or zanubrutinib. Its novel reversible binding mechanism re-establishes BTK pathway inhibition, addressing the unmet needs of patients with relapsed or refractory MCL.
The drug was approved by the U.S. Food and Drug Administration (FDA) in January 2023 as the first and only non-covalent BTK inhibitor. In October 2024, China’s National Medical Products Administration (NMPA) approved Jaypirca® as a monotherapy for adult patients with relapsed or refractory MCL after at least two systemic therapies, including a BTK inhibitor.
Ongoing Global Development
Lilly is conducting Phase 3 global clinical trials, including in China, to explore Jaypirca® in various settings, including first-line and relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), as well as BTK inhibitor-naïve relapsed or refractory MCL. These studies aim to evaluate Jaypirca® as a monotherapy and in combination with other therapies to expand its clinical applications.
A Partnership to Broaden Access
Under the agreement, Innovent will exclusively commercialize Jaypirca® in Mainland China. The collaboration leverages Innovent’s strong hematology oncology team and Lilly’s expertise in drug development and scientific innovation, ensuring the drug reaches a broader patient base.
Jaypirca®’s Significance in Cancer Treatment
Jaypirca® represents a new frontier in BTK pathway inhibition by addressing drug resistance observed with covalent BTK inhibitors. It offers renewed hope to MCL patients with limited treatment options, aligning with the shared goal of Innovent and Lilly to improve cancer care and outcomes.
