Beijing, Dec. 3 - InnoCare Pharma (HKEX: 09969), a commercial-stage biotech company, announced today that its BTK inhibitor orelabrutinib has been included in the updated National Reimbursement Drug List (NRDL) by the China National Healthcare Security Administration (NHSA). Orelabrutinib is an oral, once-daily BTK inhibitor with national Category 1 designation. It is included in the NDRL as the treatment of patients with r/r Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL), and the treatment of patients with r/r Mantle Cell Lymphoma (MCL).
“Lymphoma is one of the malignant tumors with the fastest growth of incidence rate and one of the top ten malignant tumors with the highest mortality rate in China. The inclusion of orelabrutinib in the NRDL could significantly improve access of this innovative drug in China, which can benefit more patients,” said Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare.
“We are grateful that orelabrutinib has been included in the NRDL. We will continue to fulfil our mission -- ‘Science drives innovation for the benefit of patients’, and accelerate exploring more indications for orelabrutinib,” said Dr. Cui.
Orelabrutinib has excellent target selectivity with near 100% BTK occupancy. Orelabrutinib’s once-daily oral administration is convenient for continued treatment.
Orelabrutinib is a small molecule Bruton’s tyrosine kinase inhibitor (BTKi) developed for the treatment of cancer and autoimmune diseases.
Orelabrutinib had received approval on Dec. 25, 2020 from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with r/r Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL), and the treatment of patients with r/r Mantle Cell Lymphoma (MCL). In addition, multi-center, multi-indication clinical trials are underway in the US and China for orelabrutinib as monotherapy or in combination therapies for the treatment of Marginal Zone Lymphoma (MZL), Central Nervous System Lymphoma (CNSL), Waldenstrom’s Macroglobulinemia (WM), Diffuse large B-cell lymphoma (DLBCL), etc.
Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).
Attributed to its excellent selectivity and clinical safety profiles, orelabrutinib is also evaluated in the global phase II studies for the treatment of Multiple Sclerosis (MS), phase II clinical trials for the treatment of Systemic Lupus Erythematosus (SLE) and Primary Immune Thrombocytopenia (ITP) in China.
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on lymphoma, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, New Jersey and Boston.