Beijing, China, April 25, 2025 – InnoCare Pharma, a high-tech biopharmaceutical company, announced that its independently developed novel Bruton's Tyrosine Kinase (BTK) inhibitor, orelabrutinib (trade name: Yinuokai®), has obtained approval from the National Medical Products Administration (NMPA) of China for the first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The approval for first-line CLL/SLL will benefit more lymphoma patients.
About Orelabrutinib
Previously, orelabrutinib had already been approved in China for the treatment of relapsed or refractory (R/R) CLL/SLL, relapsed or refractory mantle cell lymphoma (R/R MCL) and relapsed or refractory marginal zone lymphoma (R/R MZL) in patients who have received at least one prior therapy. All three indications have been included in the National Reimbursement Drug List (NRDL).
As a novel BTK inhibitor with high target selectivity independently developed by InnoCare Pharma, orelabrutinib can avoid off-target-related adverse events, thereby improving safety and efficacy profiles.
CLL/SLL is one of the most common types of leukemia, which is an indolent malignancy of B lymphocytes. Globally, there are 191,000 newly diagnosed CLL cases and 61,000 CLL-related deaths each year[1]. The incidence rate of CLL/SLL in China is on the rise[2].
About InnoCare Pharma
InnoCare Pharma is a commercial-stage high-tech biopharmaceutical company dedicated to the development of Class 1 innovative drugs for the treatment of malignant tumors and autoimmune diseases. The company currently has a portfolio of novel drug products spanning commercialization, clinical development and preclinical research phases. It has established branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong as well as the United States.
