BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company for the treatment of cancer and autoimmune diseases, announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted a supplemental New Drug Application (sNDA) for Bruton's tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of patients with relapsed or refractory Marginal Zone Lymphoma (R/R MZL).

Professor Jun Zhu of the Beijing Cancer Hospital said, "As the principal investigator, I am happy to see the treatment of R/R MZL patients with orelabrutinib reached the preset primary endpoint and showed sustainable efficacy at the dose of 150 mg QD. Orelabrutinib was well tolerated with a safety profile in the patients with MZL. So far, no BTK inhibitor has ever been approved for treating patients with R/R MZL in China, and we do hope that orelabrutinib can fill the gap in this therapeutic area. "

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said: " MZL is a common type of non-Hodgkin's lymphoma (NHL), accounting for about 7-10% of all NHL¹. The incidence is higher in the elderly population, especially those over 80 years old. Current treatment options for R/R MZL are quite limited. Orelabrutinib is expected to be the first BTK inhibitor to be approved for R/R MZL in China. We hope orelabrutinib will benefit MZL patients who are in urgent need of innovative treatment as soon as possible."

On December 25, 2020, orelabrutinib received approval from 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. In March 2022, the NMPA accepted a supplemental New Drug Application for orelabrutinib for the treatment of patients with relapsed or refractory Waldenstr�m�s Macroglobulinemia.

About Marginal Zone Lymphoma

Marginal zone lymphoma (MZL) is a common B-cell non-Hodgkin's lymphoma (B-NHL), accounting for about 7-10% of all NHLs. Its incidence rate ranked third after diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). According to WHO classification, MZL can be divided into three subtypes: extranodal MZL (EMZL) of mucosa-associated lymphoid tissue (MALT), nodal MZL (NMZL), and splenic MZL (SMZL). Although MZL is an indolent lymphoma, it is still an incurable malignant tumor based on the existing treatment options, and the prognosis of R/R MZL patients is even worse. At present, there is no consensus standard of care in clinical practice, and the therapies for R/R MZL patients are limited. As no effective targeted drug has been approved for the treatment of R/R MZL in China, there is an urgent unmet medical need for patients with R/R MZL.

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.

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.

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).

In addition, orelabrutinib is also being evaluated in global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) 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. We strategically focus on liquid cancer, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong and the United States.

¹ Cerhan JR, Habermann TM. Epidemiology of Marginal Zone Lymphoma. Ann Lymphoma. 2021 Mar;5:1. doi: 10.21037/aol-20-28. Epub 2021 Mar 30. PMID: 33829216; PMCID: PMC8020862.

Thandra KC, Barsouk A, Saginala K, Padala SA, Barsouk A, Rawla P. Epidemiology of Non-Hodgkin's Lymphoma. Med Sci (Basel). 2021 Jan 30;9(1):5. doi: 10.3390/medsci9010005. PMID: 33573146; PMCID: PMC7930980.

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