InnoCare Announces Acceptance of NDA for Orelabrutinib (ICP-022) by NMPA


On November 20, 2019, InnoCare announced that the National Medical Products Administration of China (NMPA) has accepted the new drug application (NDA) of Orelabrutinib (ICP-022) for the treatment of patients with relapsed or refractory (r/r) chronic lymphoblastic leukemia (CLL)/small lymphoblastic lymphoma (SLL). Orelabrutinib, which has been independently developed by InnoCare team, is currently being evaluated in a wide range of clinical programs in China and the United States for the treatment of a variety of B-cell malignancies and autoimmune diseases.

Dr. Jasmine Cui, Chairman and CEO of InnoCare, remarked, "I’m very proud of our team. I sincerely thank the clinical investigators and patients as well. Through everyone’s joint efforts, we have achieved Orelabrutinib’s first regulatory filing in such a short time. This is InnoCare’s first NDA and is a major milestone for us. InnoCare is one of the few innovative drug research and development institutions in China that has submitted an NDA application for an independently developed drug. This achievement is the combined result of China’s drug review and approval reforms, improvements in the investment and financing environment, and China’s clinical resource advantages. We expect that Orelabrutinib will be submitted for more NDA applications for other indications and provide more treatment options for patients as early as possible.”

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  chronic lymphoblastic leukemia (CLL)/small lymphoblastic lymphoma (SLL)  (Registration No. CTR20180263). Full data on the effectiveness and safety of Orelabrutinib will be presented at the 61st American Society of Hematology (ASH) Annual Meeting in December 2019.

This NDA is the first in a global development project for Orelabrutinib. Currently, there are a number of clinical studies underway for Orelabrutinib, including several clinical Phase I/II studies in China for  r/r mantle cell lymphoma (MCL), r/r marginal zone lymphoma (MZL), r/r central nervous system lymphoma (CNSL), and r/r Waldenstrom’s Macroglobulinemia (WM), 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 Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
CLL and SLL are non-Hodgkin's lymphomas derived from B lymphocytes (hematopoietic tumors), and they are consistent in cell morphology, immunophenotyping, cytogenetics, clinical manifestations, and treatment. WHO considers the two to be different stages of the same disease and are classified as the same disease, known as CLL/SLL, which is a subtype of mature B-cell lymphoma. [1]

[1] Leukemia & Lymphoma Group, Hematology Branch of the Chinese Medical Association; Hematology and Oncology Professional Committee of the Chinese Anti-Cancer Association; Chinese Chronic Lymphoblastic Leukemia Working Group, 2018; Guidelines for the Diagnosis and Treatment of Chronic Lymphoblastic Leukemia/Small Lymphoblastic Lymphoma in China (2018 Edition).

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  monotherapy and in combination therapies. Current clinical data have demonstrated  robust efficacy with improved safety.

 About InnoCare

InnoCare was co-founded by Professor Yigong Shi, world-renowned structural biologist, and Dr. Jisong Cui, an experienced enterprise manager in the biomedical industry. 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.