InnoCare Announces Orelabrutinib Becomes the First and the Only BTK Inhibitor Approved in China for the Treatment of R/R MZL

April 20, 2023，InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, announced today that its BTK inhibitor orelabrutinib received approval from the China National Medical Products Administration (NMPA) in the treatment of patients with relapsed/refractory (r/r) marginal zone lymphoma (MZL). Orelabrutinib has thus become the first and the only approved BTK inhibitor for the treatment r/r MZL in China, which was also orelabrutinib’s third indication approved in China.

Jun Zhu, Professor of the Peking University Cancer Hospital said, “MZL is considered incurable at the relapsed/refractory stage with limited therapeutic options. Orelabrutinib demonstrated a high response with durable disease remission and was well tolerated in Chinese patients with r/r MZL. The results of this study support the use of orelabrutinib as an effective and tolerable oral treatment option for r/r MZL patients.”

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare said, “MZL is a lymphoma with high incidence rate in China. We would like to thank all the principal investigators and patients who participated in this study, as well as our partners for their strong support and employees for their unremitting efforts. The approval of the third indication of orelabrutinib will not only fill the gap in China, but also benefit more lymphoma patients.”

Marginal zone lymphoma (MZL) is an inert B-cell non-Hodgkin's lymphoma (NHL). It is the second most prevalent lymphoma in China, accounting for 8.3% of all lymphomas. It mainly affects the middle-aged and elderly people. The annual incidence of MZL has increased globally. After first-line treatment, the r/r MZL patients lack effective treatment options.

BTK, as a key target for MZL treatment, has attracted widespread attention, and only orelabrutinib has been approved for the treatment of MZL in China. With high target selectivity and well-tolerated safety profile, orelabrutinib has been approved in China for the treatment of r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and r/r mantle cell lymphoma (MCL).

About Orelabrutinib

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On Dec. 25, 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.

Orelabrutinib’s supplemental New Drug Application (sNDA) was under priority review by the China National Medical Products Administration (NMPA) for the treatment of patients with relapsed or refractory Marginal Zone Lymphoma (R/R MZL).

In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies, such as first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA). Phase II registrational trial for R/R MCL was completed in the U.S.

In addition, orelabrutinib’s global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) achieved proof of concept (PoC), and orelabrutinib’s phase II study for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) is ongoing in China.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.