InnoCare Announces Acceptance of NDA for Orelabrutinib (ICP-022) in Patients with Relapsed/Refractory Mantle Cell Lymphoma by NMPA
06 Mar, 2020
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.
13 Jan, 2020
On January 13, 2020, InnoCare announced that the National Drug Administration of China (NMPA) Drug Evaluation Center (CDE) has prioritized the new drug application (NDA) for Orelabrutinib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL). InnoCare co-founder, chairman and CEO Dr. Cui Jisong said: " We are very encouraged by the inclusion of Orelabrutinib in the priority review category.. This fully demonstrates the country's determination to encourage innovation and accelerate the launch of new drugs, so that Chinese patients will have access to international first-in-class new drugs as soon as possible. We will accelerate the market launch of Orelabrutinib and expand its indications to meet the urgent clinical needs of patients world-wide. " Orelabrutinib's NDA for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) was accepted by the NMPA in November 2019. This NDA was submitted 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 chronic lymphoblastic leukemia (CLL)/small lymphoblastic lymphoma (SLL) (Registration No. CTR20180263). A number of global clinical studies on Orelabrutinib are ongoing. The purpose of drug priority review is to accelerate the development and marketing of clinically needed drugs with significant therapeutic advantages. The national drug administration department will prioritize the review and verification of these urgently needed drugs.
20 Nov, 2019
On November 20, 2019, InnoCare announced that the NMPA has accepted the NDA of Orelabrutinib (ICP-022) for the treatment of patients with r/r CLL/SLL.
05 Oct, 2019
InnoCare announced that it will present clinical data on its investigational BTK inhibitor Orelabrutinib (ICP-022) at the 61st ASH Annual Meeting, Dec. 7-10 in USA.
01 Oct, 2019
InnoCare announced that Dr. Xiangyang Chen, who has over 20 years’ experience in biomedical research, was promoted to CTO.