InnoCare Announces Acceptance of NDA for Orelabrutinib (ICP-022) in Patients with Relapsed/Refractory Mantle Cell Lymphoma by NMPA


InnoCare announced that the National Medical Products Administration of China (NMPA) has accepted Orelabrutinib (ICP-022) for the new drug application (NDA) for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). Orelabrutinib was independently developed by InnoCare's team and is used to treat a variety of B-cell malignancies, including cancers and autoimmune diseases. It is currently undergoing extensive clinical research in China and the United States.

InnoCare co-founder, chairman and CEO Dr. Cui Jisong said: " This is the second new drug listing application accepted by the NMPA for Orelabrutinib, and is another important milestone achieved in a short period of time after the first NDA of Orelabrutinib was included in the priority review in January this year. Orelabrutinib's international multi-center clinical data has become increasingly abundant, and the company's commercialization team is also under rapid construction. I have full confidence that Orelabrutinib will benefit patients with clinical needs worldwide. "

The NDA is based on data from a clinical trial: A Phase I/II Clinical study to investigate the safety, tolerability and pharmacokinetics/pharmacodynamics of ICP-022 in Chinese patients with relapsed/refractory mantle cell lymphoma (MCL) (Registration No. CTR20180196). Previously, the NDA for Orelabrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) was accepted by the NMPA in November 2019 and included in January 2020 Priority review.

As part of a global development project, a number of clinical studies on Orelabrutinib are currently underway. In addition to the above-mentioned indications for NDA submission, relapse/refractory marginal zone lymphoma (MZL), relapse/refractory central nervous system lymphoma (CNSL), relapse/refractory macroglobulinemia (WM), relapse/refractory CD20 + B-cell lymphoma relapse/refractory diffuse large B-cell lymphoma (DLBCL) and clinical studies of patients with mild to moderate systemic lupus erythematosus (SLE) also conducted in China; in addition to a Phase I trial for B-cell malignancies, which was approved by the U.S. Food and Drug Administration (FDA) in May 2019.


About Orelabrutinib (ICP-022)

Orelabrutinib is a specific and selective BTK inhibitor for the treatment of tumors and autoimmune diseases and has been supported by a national special project for the development of innovative drugs. Orelabrutinib is currently being investigated globally in broad clinical programs including Phase I, Phase II and registration trials as a monotherapy and in combination therapies. Current clinical data have demonstrated robust efficacy with improved safety. Some indications have been declared NDA.