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.
03 Jun, 2019
InnoCare, a leading innovator for global biopharmaceutical drugs, is proud to announce the appointment of Shaojing Tong as Chief Financial Officer (CFO). Mr. Tong has been a leading healthcare research analyst for the Asia-market and has extensive knowledge of the industry. Reporting directly to the CEO, Dr. Jasmine Cui, Mr. Tong will be responsible for the financial strategy development, risk management, and investment analysis. Mr. Tong is considered one of Hong Kong’s top research analysts for the entire biopharmaceutical and healthcare sector, repeatedly being ranked in the “Best Analyst Team” of the Asian healthcare industry. Mr. Tong has many years of experience in managing investment analyst teams and has acquired comprehensive knowledge of the industries history, value chains, and developmental trends. Before joining InnoCare, Mr. Tong served as an executive director and industry analyst at UBS China, where he covered medical companies for both the Hong Kong and A-class China markets. Prior to UBS, Mr. Tong was a healthcare research analyst for Bank of America Merrill Lunch (Hong Kong) and Michael Partners (New York). Preceding his financial career, Mr. Tong worked in drug development for CADUS Pharmaceuticals (New York). Mr. Tong received a Bachelor of Science degree in materials science and engineering from the University of Science and Technology of China. He obtained a Master’s degree in chemistry at the University of Pittsburg, and a Master of Business Administration (MBA) from New York University. “We are very pleased to have Mr. Tong onboard,” said Dr. Cui, CEO and Chairman of InnoCare, “His extensive knowledge and unique insight of the biopharmaceutical industry will help cement a strong financial foundation for InnoCare so that we can continuously build towards our goal of becoming a global leader for innovative drugs.” “I am honored to be a member of InnoCare and work with such an outstanding team,” Mr. Tong said, “InnoCare is a leader among Chinese innovative pharmaceutical companies, establishing a wealth of product pipeline in a very short amount of time. I look forward to joining such an experienced and passionate team, and will advance InnoCare’s goal of providing safe, effective, and affordable drugs for patients around the world.”
09 May, 2019
On May 9th of 2019, InnoCare announced the approval of their proprietary BTK inhibitor ICP-022 by the US Food and Drug Administration (FDA) for initiation of clinical investigations. ICP-022 is the first innovative drug candidate from InnoCare to initiate clinical trials in the US. ICP-022 is a highly selective BTK inhibitor targeting both oncology and autoimmune indications. Currently multi-center, multi-indication phase I/II studies are underway in China, with encouraging preliminary results on safety and efficacy. Following the IND approval, InnoCare will soon conduct the clinical trials in the US for ICP-022. InnoCare will also actively seek collaborations with innovative biotech and pharmaceutical companies in related areas. “This is a major milestone for us. We are fully committed to the global development of ICP-022 and looking forward to the expansion of ICP-022 into global markets.” said Dr. Cui Jisong, co-founder, Chairman, and CEO of InnoCare.
InnoCare confirms Mr.James Deng has accepted the invitation to be its Advisory Board Member(ABM) in Sales & Marketing
11 Mar, 2019
March 11, 2019, InnoCare announced that Mr. James Deng has accepted the invitation to be its ABM in Sales & Marketing,providing consultancy on launch strategy and commercial operation. As a member of BD Global Operating Committee, Mr. James Deng is the Senior Vice President of BD and General Manager of Greater China. He is also the founding and elected AdvaMed China Board Chair for four consecutive terms. Prior to BD, Mr. James Deng served as VP Marketing in Novartis Pharma US. Before that, he was the CEO & President for Novartis Pharma China, leading Novartis to be the largest multinational pharmaceutical company with the fastest growing business in China. Under his leadership, the “thick product project” he initiated to optimize the company's infrastructure significantly improved the company's competitiveness. This project was selected as a classic case of Harvard Business School. Mr. James Deng also worked for Johnson & Johnson Pharma in China. He is a graduate of China Europe International Business School (CEIBS) EMBA and General Management Program(GMP) of Harvard Business School. Mr. James Deng now takes active role as Deputy Head of Healthcare Industry Division in China Health Economics Association. “It’s our privilege to have Mr. James Deng to be a key member in InnoCare’s Advisory Board in Sales & Marketing.” Said Dr. Jasmine Cui, Chairman and CEO of InnoCare,” James is a highly respected leader in healthcare industry. His track-record in leading multinational pharma and MedTech companies is resulted from his profound market insights, strong business operation, and global perspective. James’ support will accelerate the pace of InnoCare’s innovative drug products reaching the patients with urgent needs”. “I am truly honored to be a member of InnoCare’s advisory board. As someone who has been working in healthcare for 30years, I have two missions: one is always putting the patient in the center of everything we do, bringing real benefits to them; one is driving true China innovation that can make a global impact. As a leading innovative company in China, InnoCare has done an excellent job in these two aspects. I will contribute as much as I can to support InnoCare become one of the most successful organization in both drug R&D and commercialization. I believe by doing so, together, we will greatly benefit patients in China and worldwide”.