Blu-554 (cs3008), FGFR4 inhibitor of cornerstone pharmaceutical, was approved in phase I clinical trial in China

January 29, 2019 / Meitong news agency / -- Cornerstone Pharmaceutical (Suzhou) Co., Ltd (hereinafter referred to as "cornerstone pharmaceutical" or "company") announced that China National Drug Administration (nmpa) recently approved the company's fibroblast growth factor receptor-4 (FGFR4) inhibitor blu-554 (cs3008) to carry out phase I clinical trials in China Blu-554 is developed by the company's partner, blueprint medicine Cornerstone pharmaceutical has the exclusive development and commercialization license of this product in Greater China The approved phase I clinical trial is part of the global phase I clinical trial of blu-554 It aims to evaluate the safety, tolerance, pharmacokinetics, pharmacodynamics and preliminary efficacy of blu-554 in patients with liver cancer (HCC) who are not treated with tyrosine kinase (TKI) activated by FGFR4 Cornerstone pharmaceutical and blueprint medicine are both looking forward to the first patient enrollment in China as soon as possible HCC is the most common type of liver cancer HCC is the third leading cause of cancer death in China, with 466000 new cases and 422000 deaths each year About 30% of HCC patients are caused by FGFR4 activation Most Chinese patients (55%) were not diagnosed until the end of the disease At present, there is no ideal treatment for advanced HCC Blu-554 is a powerful and highly selective small molecule inhibitor of FGFR4 According to the phase I preliminary clinical data published by blueprint medicine at the 2017 ESMO, as of August 18, 2017, of the 38 patients with FGFR4 driven HCC treated with multiple chemotherapy, 6 patients (16%) achieved objective remission, 26 patients (68%) achieved disease control, 18 patients (49%) achieved tumor load reduction, and 5 patients without TKI treatment The initial evidence showed that the period of disease control was prolonged Blu-554 was well tolerated and most of the adverse reactions were grade 1-2 Dr Jiang Ningjun, chairman and CEO of cornerstone pharmaceutical, said: "compared with the current treatment, the data of blu554 shows optimistic tolerance and disease control rate We also plan to launch the phase I trial of blu-554 and cs1001 combined treatment for HCC patients in 2019, hoping to bring more effective treatment options for HCC patients " Blu-554 blu-554 is an oral, highly selective and irreversible FGFR4 inhibitor developed by blueprintmedicines, which can inhibit FGFR4 with high specificity, thus avoiding the effects on FGFR1, FGFR2 and FGFR3 Blueprint medicines is developing blu-554 for the treatment of HCC caused by FGFR4 activation, which is expected to account for about 30% of HCC patients Blu-554 has been granted orphan drug status by the U.S Food and drug administration In June 2018, cornerstone pharmaceutical signed a license agreement with us blueprintmedicine company to obtain the exclusive right to develop and commercialize blu-554 in Greater China Blueprintmedicine reserves the right to develop and commercialize blu-554 outside Greater China About cornerstone pharmaceutical industry, which is born to meet the needs of cancer patients, focuses on the development and commercialization of innovative tumor immunotherapy and molecular targeted drugs Since its establishment 3 years ago, the company has assembled a world-class management team with rich experience in preclinical research, clinical development and commercialization Through the dual innovation sources of internal R & D and external cooperation, the company has built a strong anti-tumor drug pipeline with 14 candidate drugs, including 4 exclusive cooperation and authorized products for blueprint medicine and Agios pharmaceutical, which together with the self-developed pipeline has the significant potential and synergy of single and joint therapy Four of the candidate drugs are in or may be close to the critical test The business model of cornerstone pharmaceutical is driven by clinical research and development, and at the same time, it rapidly establishes commercialization and production capacity The company was supported by well-known investors The financing volume of round a and round B broke the record in the field of biomedicine at that time, with a total of US $412 million in the two rounds With experienced team, potential R & D pipeline, strong business model and sustainable financial support, cornerstone's vision is to become a world-renowned leading Chinese biopharmaceutical company by bringing innovative and differentiated cancer therapy to cancer patients around the world.