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BEIJING

InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, announced today that China National Medical Products Administration (NMPA) has approved the clinical trial of Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib in combination with R-CHOP for previously untreated patients with mantle cell lymphoma (MCL).

This is a phase 3 multicenter, randomized trial of orelabrutinib in combination with R-CHOP versus placebo plus R-CHOP in previously untreated MCL patients. The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include overall response rate (ORR), duration of response (DOR), and overall survival (OS). In addition, orelabrutinib combined with R-CHOP will also be used to treat patients with other B-cell malignant lymphomas.

Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell lymphomas and autoimmune indications. On December 25, 2020, orelabrutinib received approval from the 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 MCL. On Dec. 31, 2020, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to orelabrutinib for treatment of MCL.

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

Dr. Jasmine Cui, the co-founder, Chairwoman and CEO of InnoCare said, “Orelabrutinib is the focus of multi-center and multi-indication clinical trials in China and the U.S. In addition to CLL/SLL and MCL, we are actively exploring other tumors and autoimmune disease. It has always been our top priority to target diseases with urgent, unmet needs.”

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.

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