Beijing, China, December 27, 2020 – InnoCare Pharma (Hong Kong Stock Exchange: 09969), a high-tech biopharmaceutical company, announced today that its proprietary novel Bruton's Tyrosine Kinase (BTK) inhibitor Yinuokai® (generic name: Orelabrutinib Tablets) has obtained approval from the National Medical Products Administration (NMPA) of China for two indications: the treatment of patients with relapsed/refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) and patients with relapsed/refractory Mantle Cell Lymphoma (MCL). Prior to this, the New Drug Applications (NDAs) for both indications had been included in the priority review program by the Center for Drug Evaluation (CDE) of the NMPA.
About Yinuokai
Yinuokai is a BTK inhibitor independently developed by InnoCare Pharma, indicated for the treatment of malignant tumors and autoimmune diseases. It has been granted support under China's National Major New Drug Creation Program.
About Lymphoma
Lymphoma is a malignant tumor originating from the lymphohematopoietic system. Relevant data shows that lymphoma is one of the malignancies with the fastest growth rate, and also ranks among the top ten cancers with the highest mortality rate in China. Approximately 93,000 new cases of lymphoma are diagnosed each year, and over 50,000 people die from the disease, with both figures on a steady upward trend annually.
BTK is a key kinase in the B-cell receptor signaling pathway, serving as a critical regulatory mechanism for cell proliferation and survival in non-Hodgkin's lymphoma (NHL). BTK inhibitors can block B-cell receptor (BCR)-induced BTK activation and downstream signal transduction, thereby inhibiting tumor cell growth and promoting apoptosis.
As a novel, highly selective BTK inhibitor independently developed by InnoCare Pharma, orelabrutinib is designed to minimize off-target-related adverse events, thus optimizing the safety and efficacy profile of treatment.
