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.
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.
InnoCare was co-founded by Dr. Jisong Cui, an experienced enterprise manager in the biomedical industry , and Professor Yigong Shi, a world-renowned structural biologist, and. InnoCare focuses on the research and development of first-in-class and best-in-class drugs in the fields of oncology and autoimmune diseases, targeting diseases that are highly prevalent in China such as lymphoma, liver cancer, gastric cancer and autoimmune diseases. The company has three drug candidates and carries out clinical trials in both China and the United States. InnoCare has R&D centers in Beijing and Nanjing, project management centers in Shanghai, a drug manufacturing base in Guangzhou, and branches in New Jersey and Boston for business development and clinical trial management.