On December 16th, Eli Lilly and Sinovac Biotech jointly announced the launch of Eli Lilly's non covalent (reversible) BTK inhibitor, Jepanil&Co., Ltd; reg; (Pitobutertinib 100mg and 50mg tablets) in Chinese Mainland reached the following cooperation agreement: Cinda Biological will be responsible for GEPALI& reg; Eli Lilly will be responsible for the import, sales, promotion, and distribution of Jepaly&Co; reg; Research and development, as well as post market medical affairs related work.
Pitobutinib was approved by the US FDA in January 2023, becoming the world's first and only approved non covalent (reversible) BTK inhibitor.
In China, Pitobutinib was approved by the National Medical Products Administration (NMPA) in October 2024 as a monotherapy for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two systemic treatments (including BTK inhibitors).
Lilly is conducting multiple Phase 3 clinical trials of Pitibutinib globally (including in China), including initial and relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed/refractory MCL without BTK inhibitor treatment, exploring the potential of monotherapy or combination therapy.