InnoCare Announces Inclusion of Orelabrutinib’s New Indication in China National Reimbursement Drug List 2023

Beijing, Dec.13, 2023 – InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today the inclusion of new indication of BTK inhibitor orelabrutinib in the updated National Reimbursement Drug List (NRDL) 2023, for the treatment of patients with relapsed or refractory (r/r) Marginal Zone Lymphoma (MZL). In the meantime, the updated NRDL continued to include orelabrutinib for the treatment of patients with r/r lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and r/r mantle cell lymphoma (MCL). The updated NRDL will be implemented from January 1, 2024.

In April 2023, orelabrutinib received approval from the China National Medical Products Administration (NMPA) for the treatment of patients with r/r MZL. Orelabrutinib thus became 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.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, “We are grateful that orelabrutinib’s new indication has been included in the updated NRDL. We will continue to work together with the government to improve the market access, bring high-quality innovation drugs to more lymphoma patients.”

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare. As a novel BTK inhibitor, orelabrutinib has high selectivity due to its innovative compound structure, which results in exceptional target occupancy and good efficacy and safety profile. Orelabrutinib’s once-daily oral administration is convenient for continued treatment.

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 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 the National Reimbursement Drug list, allowing it to benefit more lymphoma patients. On Nov. 22, 2022, orelabrutinib was approved for the treatment of R/R MCL in Singapore. On April 20, 2023, orelabrutinib was approved for the treatment r/r MZL in China.

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 for the first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).

Orelabrutinib was granted Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA). Patient enrollment of the phase II registrational trial for R/R MCL was completed in the U.S. The Company expects to submit the NDA to the U.S. Food and Drug Administration (US FDA) in the middle of 2024.

In addition, orelabrutinib is being advanced in other autoimmune trials, worldwide, including: a phase III registrational trial for the treatment of primary immune thrombocytopenia purpura (ITP) ongoing in China, a global phase II study for the treatment of Multiple Sclerosis (MS), a phase II study for the treatment of SLE in China that has achieved proof of concept (PoC), and a phase II study for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) 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.