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.
02 Jul, 2020
InnoCare Pharmaceuticals (HKEX: 09969), after successfully dosing the first patient in a Phase 2 trial of ICP-192 for urothelial cancer, today announced the first patient dosed in a Phase 2 clinical trial of ICP-192 in patients with cholangiocarcinoma.
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.