InnoCare Announces the Grant of US FDA of Orphan-Drug Designation of Orelabrutinib for Treatment of Mantle Cell Lymphoma


Beijing, Dec. 31, 2020 —— InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, announced today the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for treatment of mantle cell lymphoma (MCL).


Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell lymphomas and autoimmune indications. On Dec. 25, orelabrutinib received approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL).


MCL is typically an aggressive form of non-Hodgkin’s lymphoma (NHL) that arises from B-cells originating in the “mantle zone.” InnoCare presented latest clinical data of Orelabrutinib at the 62nd American Society of Hematology (ASH) Annual Meeting, orelabrutinib for treatment of relapsed or refractory MCL demonstrated that ORR was 87.9% and disease control rate was 93.9%. The CR rate, by conventional CT method, reached 34.3%.


Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare said, “I am very proud that, in less than one week after orelabrutinib was approved for two indications in China, it was granted by the US FDA for orphan drug designation. Today is the last day of 2020, I am so happy that we have received such good news, marking a perfect end for 2020. Orelabrutinib has been conducting multi-center and multi-indication clinical trials in China and the United States. In addition to CLL/SLL and MCL, orelabrutinib has been actively exploring other indications in the field of tumors and autoimmune diseases. Except orelabrutinib, more than 10 innovative drugs such as ICP-192 and ICP-723, developed by InnoCare, have also achieved milestones in 2020. Looking forward to 2021, we will continue to uphold the concept of ‘Science drives innovation for the benefit of patients’ to welcome a more brilliance future."


The Orphan Drug Designation from US FDA originates from the Orphan Drug Act which was enacted to encourage the development of innovative drugs to treat orphan diseases with target patient population less than 200,000 in the U.S. Drug candidates with Orphan Drug Designation qualify for seven-year market Orphan Drug Exclusivity (ODE). In addition, US FDA also rewards ODD drugs with comprehensive incentives including tax credit of clinical trial cost, waiver of BLA user fee, subsidies for R&D costs, protocol assistance and expedited regulatory approval pathway.


About InnoCare

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, New Jersey, and Boston.