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InnoCare Announces Orelabrutinib Becomes the First and the Only BTK Inhibitor Approved in China for the Treatment of R/R MZL

InnoCare Pharma has received approval from the China National Medical Products Administration (NMPA) for its BTK inhibitor orelabrutinib’s use in patients with relapsed/refractory marginal zone lymphoma (MZL). The approval marks orelabrutinib’s third indication approved in China and establishes it as the first and only approved BTK inhibitor for r/r MZL in China. Professor Jun Zhu, of the Peking University Cancer Hospital, said: “Orelabrutinib demonstrated a high response with durable disease remission and was well tolerated in Chinese patients with r/r MZL. The results of this study support the use of orelabrutinib as an effective and tolerable oral treatment option for r/r MZL patients.” InnoCare’s CEO, Dr. Jasmine Cui, thanked partners and patients participating in the study, concluding that orelabrutinib’s approval will “benefit more lymphoma patients.” MZL, an inert B-cell non-Hodgkin’s lymphoma (NHL), is the second most prevalent lymphoma in China and affects mostly middle-aged and elderly people. After first-line treatment, the r/r MZL patients lack effective treatment options. BTK, as a key target for MZL treatment, has recently attracted widespread attention, with only orelabrutinib approved in China for the r/r MZL treatment. Orelabrutinib was also approved in China for the treatment of r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and r/r mantle cell lymphoma (MCL).

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