Beijing, China, April 20, 2023 – InnoCare Pharma, a high-tech biopharmaceutical company, announced that its independently developed novel Bruton's Tyrosine Kinase (BTK) inhibitor orelabrutinib (trade name: Yinuokai®) has obtained approval from the National Medical Products Administration (NMPA) of China for the treatment of patients with relapsed/refractory marginal zone lymphoma (MZL). With this approval, orelabrutinib becomes China's first and only BTK inhibitor licensed for the MZL indication, marking its third approved indication in the country.
About Marginal Zone Lymphoma (MZL)
Marginal zone lymphoma (MZL) is a type of indolent B-cell non-Hodgkin lymphoma (NHL). As the second most common lymphoma in China, it accounts for approximately 8.3% of all lymphoma cases, primarily affecting the middle-aged and elderly population. The global annual incidence rate of MZL has been on the rise. For patients with MZL who experience disease progression or relapse after first-line therapy, effective treatment options remain limited.
BTK has attracted extensive attention as a key therapeutic target for MZL. To date, orelabrutinib is the only BTK inhibitor approved for the MZL indication in China. Featuring high target selectivity and favorable safety profile, orelabrutinib had previously received approval in China for the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed/refractory mantle cell lymphoma (MCL).
About Orelabrutinib
Orelabrutinib is a Class 1 Innovative Drug independently developed by InnoCare Pharma. As a novel BTK inhibitor with high selectivity, it is intended for the treatment of hematological malignancies and autoimmune diseases.
In December 25, 2020, orelabrutinib was conditionally approved in China for two indications: relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included in the National Reimbursement Drug List (NRDL) to benefit more patients. On November 22, 2022, orelabrutinib gained approval in Singapore for the treatment of patients with relapsed/refractory mantle cell lymphoma. In April 2023, it secured approval in China for the treatment of relapsed/refractory marginal zone lymphoma (MZL) patients.
In addition, multiple multicenter, multi-indication clinical trials are underway in China and the United States, evaluating orelabrutinib as a monotherapy or in combination with other drugs, including for the first-line treatment of the MCD subtype of diffuse large B-cell lymphoma (DLBCL) and other indications.
Orelabrutinib has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL), and patient enrollment for the relevant trial has been completed.
Proof of Concept (PoC) has been achieved in the global Phase II clinical trial of orelabrutinib for the treatment of multiple sclerosis (MS), as well as in the Phase II studies in China for systemic lupus erythematosus (SLE) and immune thrombocytopenia (ITP). Clinical trials investigating orelabrutinib for neuromyelitis optica spectrum disorder (NMOSD) are currently ongoing.
