InnoCare Pharma Announces Singapore Approval of Iberukin® (Orelabrutinib) for Relapsed/Refractory Mantle Cell Lymphoma
Beijing, China, November 22, 2022 – InnoCare Pharma Limited (SSE Stock Code: 688428; HKEX Stock Code: 09969), a high-tech biopharmaceutical company, today announced that Yinuokai®(Orelabrutinib) has been approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed/refractory mantle cell lymphoma (R/R MCL).
Dr. Cui Jisong, Co-founder, Chairman, and CEO of InnoCare Pharmastated, “The approval of orelabrutinib for marketing in Singapore marks a significant milestone in InnoCare Pharma’s international commercialization efforts. As a highly selective BTK inhibitor, orelabrutinib has demonstrated favorable efficacy and safety profiles in the treatment of relapsed or refractory mantle cell lymphoma (MCL). With this approval in Singapore, orelabrutinib will provide local MCL patients with an innovative therapeutic option.”
Orelabrutinib was approved in China on December 25, 2020, for two indications: the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and relapsed/refractory mantle cell lymphoma (MCL). It was included in the National Reimbursement Drug List at the end of 2021. In June 2021, orelabrutinib received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory MCL.
Mantle cell lymphoma (MCL) is a distinct subtype of B-cell non-Hodgkin lymphoma (NHL), characterized by its aggressive nature and incurability, with an incidence rate that has been rising year by year.1Mantle cell lymphoma is typically diagnosed at an advanced stage, posing challenges such as limited treatment options and a poor prognosis.2。
Orelabrutinib is a Class 1 new drug developed by InnoCare Pharma, representing a highly selective novel BTK inhibitor designed for the treatment of hematologic malignancies and autoimmune diseases.
Orelabrutinib received conditional approval in China on December 25, 2020, for two indications: the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and relapsed/refractory mantle cell lymphoma (MCL). By the end of 2021, orelabrutinib was included in the National Reimbursement Drug List to benefit a broader patient population.
Marketing Applications for Two New Indications of Orelabrutinib—Relapsed/Refractory Waldenström’s Macroglobulinemia (WM) and Relapsed/Refractory Marginal Zone Lymphoma (MZL)—Have Been Accepted in China
In addition, multicenter, multi-indication clinical trials of orelabrutinib as monotherapy or in combination therapy are being conducted in China and the United States, including for indications such as first-line treatment of the MCD subtype of diffuse large B-cell lymphoma (DLBCL).
Orelabrutinib Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the Treatment of Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL).
The global Phase II clinical trial of orelabrutinib for the treatment of multiple sclerosis (MS), as well as clinical trials in China for systemic lupus erythematosus (SLE), primary immune thrombocytopenia (ITP), and neuromyelitis optica spectrum disorders (NMOSD), are ongoing.
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InnoCare Pharma (SSE Stock Code: 688428; HKEX Stock Code: 09969) is a commercial-stage, high-tech biopharmaceutical company focused on the development of first-in-class novel drugs for the treatment of malignant tumors and autoimmune diseases, with indications covering lymphoma, solid tumors, and autoimmune disorders. The company currently has multiple novel drug candidates at various stages of commercialization, clinical development, and preclinical research. InnoCare Pharma maintains branch offices in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.
1. Medlive
2. 2018 Survey Data from The Lancet