China’s National Medical Products Administration (NMPA) has approved InnoCare Pharma’s Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for use as a first-line treatment for individuals with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
This approval marks the application of the therapy to a wider range of individuals with lymphoma.
Go deeper with GlobalData
The therapy is now approved for three indications: relapsed and refractory (R/R) CLL/SLL, R/R marginal zone lymphoma (R/R MZL) and R/R mantle cell lymphoma (R/R MCL).
These indications have been included in the National Reimbursement Drug List.
The therapy’s high target selectivity helps minimise off-target adverse events and enhances both efficacy and safety.
InnoCare Pharma chairwoman, CEO and co-founder Dr Jasmine Cui stated: “We are delighted to see the approval of orelabrutinib for the first-line treatment of CLL/SLL.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“This marks another important milestone for our company in haematological malignancies. We sincerely thank all the physicians, patients and employees who have worked tirelessly on this study. We look forward to bringing new hope and treatment options to more lymphoma patients.”
CLL/SLL is a slow-growing cancer of B lymphocytes and is a widespread leukaemia with 191,000 new cases of CLL each year and 61,000 mortalities attributed to the condition.
The company is focused on the discovery, development, and commercialisation of treatments for cancer and autoimmune conditions. It operates with branches in several Chinese cities, Hong Kong and the US.
In January 2025, InnoCare Pharma and KeyMed Biosciences’ joint venture entered an exclusive licence agreement with Prolium Bioscience. The agreement relates to developing and commercialising ICP-B02.
