Beijing, China – December 31, 2020 – InnoCare Pharma, a high-tech biopharmaceutical company, announced that its independently developed Bruton's tyrosine kinase (BTK) inhibitor orelabrutinib has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma (MCL). This marks InnoCare Pharma's first-ever FDA Orphan Drug Designation.
About Orelabrutinib
Orelabrutinib is a Class 1 innovative drug independently developed by InnoCare Pharma. As a novel highly selective BTK inhibitor, it is indicated for the treatment of lymphoma and autoimmune diseases. On December 25, orelabrutinib received marketing approval from China's National Medical Products Administration (NMPA) for two indications, namely the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and patients with relapsed/refractory mantle cell lymphoma (MCL).
About Mantle Cell Lymphoma
Mantle cell lymphoma (MCL) is generally an aggressive form of non-Hodgkin lymphoma (NHL) originating from B cells in the "mantle zone". According to the latest clinical data of orelabrutinib released by InnoCare Pharma at the 62nd American Society of Hematology (ASH) Annual Meeting, a long-term safety and efficacy study of orelabrutinib monotherapy in Chinese patients with relapsed/refractory mantle cell lymphoma enrolled 106 patients, achieving an overall response rate (ORR) of 87.9% and a disease control rate (DCR) of 93.9% among all patients. As assessed by computed tomography (CT) imaging, the complete response (CR) rate reached 34.3%.
About Orphan Drug Designation
The Orphan Drug Designation program was established under the Orphan Drug Act of 1983, which is an initiative by the FDA to encourage the development of innovative drugs for rare diseases affecting fewer than 200,000 people in the United States. Any investigational drug granted Orphan Drug Designation is eligible for a series of supporting policies, including seven years of market exclusivity, tax credits, waivers of biologics license application fees and prescription drug user fees, research grants, protocol assistance, and expedited regulatory review pathways provided by the FDA.
About InnoCare Pharma
InnoCare Pharma is a commercial-stage biopharmaceutical company dedicated to the research and development of Class 1 new drugs for the treatment of malignant tumors and autoimmune diseases. Its drug candidates target various malignancies with high incidence rates among Chinese patients, such as lymphoma, liver cancer, cholangiocarcinoma, and urothelial carcinoma, as well as autoimmune diseases. The company currently has multiple novel drug products in commercialization, clinical, and preclinical development stages. InnoCare Pharma maintains branches in Beijing, Nanjing, Shanghai, Guangzhou, as well as New Jersey and Boston in the United States.
