24 Apr, 2020
On April 24th of 2019, InnoCare announced the approval of their proprietary pan-FGFR inhibitor ICP-192 by the US Food and Drug Administration (FDA) for initiation of clinical investigations. ICP-192 is the second innovative drug candidate from InnoCare approved for initiation of clinical trials in the US. ICP-192 is a highly selective pan-FGFR inhibitor targeting multiple solid tumors with FGFR gene aberrations. Currently phase I/II studies are underway in China, with encouraging preliminary results on safety and tolerability. Following the IND approval, InnoCare will soon initiate clinical studies in the US for ICP-192. InnoCare will also actively explore collaboration opportunities with innovative biotech and pharmaceutical companies in these areas. “In less than one year, another innovative drug candidate from InnoCare has obtained the FDA approval for initiation of clinical investigation. This further demonstrates the profound innovation capability of InnoCare. We will continuously focus our effort on discovering and developing safe and effective therapies for the benefit of patients around the world. " Said Dr. Jasmine Cui, co-founder, Chairman, and CEO of InnoCare.
23 Mar, 2020
On March 23, 2020, InnoCare (Hong Kong Stock Exchange Code: 09969) was officially listed on the main board of The Stock Exchange of Hong Kong Limited (Hong Kong Stock Exchange). InnoCare issued 250, 324,000 shares worldwide at HK $ 8.95 per share, raising approximately HK $ 2.24 billion. The company intends to use raised proceeds primarily for the company's core drug candidates, clinical development of other drug candidates in the pipeline, marketing authorization and external introduction of new projects, etc., and begin the commercialization process and layout of products. InnoCare focuses on two major therapeutic areas, cancers and autoimmune diseases, that have significant market opportunities and synergistic benefits. In less than five years, guided by the global vision of the management team, Innocare has achieved many great milestones, including the discovery and development nine Drug candidates, the submission of 2 NDA applications for core drug candidate ,Orelabrutinib (ICP-022), progressing the second and third drug candidates through Phase I / II clinical trials, and the IND application submission for the fourth drug candidate. These drugs have the potential to meet the huge, unmet, medical needs and benefit patients worldwide. InnoCare has been favored by many well-known investment institutions in the several rounds of financing so far, with its core competitiveness in research and development, balanced drug pipelines, and excellent teams. InnoCare co-founder, chairman and CEO Dr. Cui Jisong said: "Listing on the Hong Kong Stock Exchange marks a new era for InnoCare! In January of this year (2020), InnoCare was happy to report that the NDA for Orelabrutinib was included in the priority review by the NMPA. We are also happy to report that the new indication for Orelabrutinib was also accepted by the NMPA earlier this month. InnoCare was listed on the Hong Kong Stock Exchange today is also the first IPO of a biopharmaceutical company on the HKEX in 2020. This not only reflect the strong cohesion and execution of our team, but also a powerful demonstration of InnoCare's strong commitments. We were honored and heartened to hear the listing bell. Thank you for your recognition, affirmation and support of InnoCare from all walks of life. Starting from this, we will continue to make great strides on the road of innovative research and development, and we are committed to developing and providing innovative therapies for patients around the world, providing growth opportunities for our employees, creating value for shareholders, and shouldering more social responsibilities! "
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.