On September 8, 2025, Beijing InnoCare Pharma Tech Co., Ltd. (hereinafter referred to as “InnoCare”) announced that Orelabrutinib (brand name: InnoKai^®) has been approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed/refractory marginal zone lymphoma (R/R MZL). This marks the second indication for Orelabrutinib approved in Singapore, representing a solid step forward for the company on its path to internationalization.

Orelabrutinib is a novel BTK inhibitor with high target selectivity, independently developed by InnoCare. It can avoid off-target related adverse events, improve safety and efficacy, and aims to be developed for the treatment of hematological malignancies and autoimmune diseases.

Marginal Zone Lymphoma (MZL) is a type of indolent B-cell Non-Hodgkin’s Lymphoma (NHL) that accounts for 7-10% of all B-cell lymphomas. It primarily affects middle-aged and elderly individuals, and the annual incidence rate is on the rise globally. After first-line treatment, patients with MZL who experience disease progression/recurrence still lack effective treatment options.

In April this year, Orelabrutinib was approved in China for the first-line treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Previously, Orelabrutinib had been approved in China for the treatment of CLL/SLL, Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL), and Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL) in patients who had received at least one previous treatment. All three indications have been included in China’s national medical insurance.

Orelabrutinib is currently only approved for marketing in China and Singapore, and has not yet “gone global” to mainstream markets such as Europe, America, and Japan. Therefore, its “global sales” are essentially equivalent to sales in China (+Singapore). In 2024, Orelabrutinib’s global (actually China) sales amounted to approximately 1 billion yuan, and continued to grow rapidly in Q1 2025. True “global sales” will only be realized after it is approved in mainstream markets such as Europe, America, and Japan.

Currently, as shown in the table below, there is one patent linked to the patent information registration platform for drugs marketed in China for InnoCare’s Orelabrutinib. This indicates that their current patent portfolio is relatively limited. From this, it can be inferred that there may be subsequent attempts by companies to imitate and challenge Orelabrutinib.

References:

1. https://mp.weixin.qq.com/s/AQLhAs2A_VsUSGUl3Kx_Rw

2. https://hk.stockstar.com/IG2025090800004314.shtml