Biopharmaceutical company InnoCare Pharma (HKEX: 09969) (SSE: 688428) announced on Friday that the China National Medical Products Administration (NMPA) has approved its BTK inhibitor, orelabrutinib, for the first-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This milestone broadens orelabrutinib's therapeutic reach, offering a new, highly effective treatment option to newly diagnosed CLL/SLL patients in China.

Orelabrutinib has previously been approved in China for the treatment of relapsed and refractory (R/R) CLL/SLL, R/R mantle cell lymphoma (MCL), and R/R marginal zone lymphoma (MZL). All of these indications are included in the National Reimbursement Drug List, improving accessibility and affordability for patients.

The first-line treatment approval is supported by compelling clinical data, which demonstrated a complete response rate of 12.1%, underscoring the drug's potential to significantly improve outcomes in hematologic cancers.

A novel, highly selective BTK inhibitor, orelabrutinib was developed by InnoCare with a focus on minimising off-target effects to enhance both safety and efficacy. Its precision mechanism makes it a promising alternative to less targeted therapies currently used in treating CLL/SLL.

CLL/SLL is among the most common types of leukemia globally, characterized by the indolent proliferation of B lymphocytes. Worldwide, the disease accounts for approximately 191,000 new diagnoses and 61,000 deaths annually, with incidence rates rising steadily in China.

InnoCare remains committed to advancing innovative therapies for cancers and autoimmune diseases with significant unmet needs, both in China and internationally. The approval of orelabrutinib for first-line CLL/SLL treatment reinforces the company's leadership in precision oncology and its dedication to improving patient outcomes through cutting-edge science.