Domestic new kinase inhibitor! Hehuang pharmaceutical started the phase II clinical trial of solid tumor in China to evaluate the combination therapy of suofantinib and tuoyi!

January 15, 2020 news / Biovalley BIOON / -- and Huang China Pharmaceutical Technology Co., Ltd (hereinafter referred to as "he Huang pharmaceutical" or "Chi Med") recently announced that a phase II clinical trial of suofantinib combined with tuoyi (trepril mAb, the first domestic PD-1 mAb, developed by Junshi Biology) in the treatment of patients with advanced solid tumors has been launched in China This is a further study after the recently completed phase I dose discovery study, and the successful formulation of suofantinib and tuoyi phase II combined drug administration program This phase II clinical trial in China It is part of the global cooperation between HWP and Shanghai Junshi Pharmaceutical Biotechnology Co., Ltd ("Junshi") to evaluate the combination of suofantinib (oral anti angiogenic immune escape kinase inhibitor) and PD-1 monoclonal antibody tuoyi of HWP, and test the combination therapy for multiple cell types and signaling pathways in tumor microenvironment Synergistic antitumor effect Tuoyi was approved for listing by the State Drug Administration of China ("SFDA") in December 2018 This phase II clinical trial will be used in multiple groups of solid tumor patients The primary endpoints were objective response rate (ORR) and safety, and the secondary endpoints included duration of response (DOR), progression free survival (PFS), disease control rate (DCR) and overall survival (OS) This experiment is mainly led by Professor Shen Lin, vice president of Beijing Cancer Hospital For details, please visit clinicaltrials.gov and search nct04169672 Christian Hogg, chief executive of Hewang pharmaceutical, said: "we are pleased to promote the combination of suvantinib and treprizumab to phase II clinical development, and hope to identify patients who can benefit from this innovative treatment." In December 2019, the Chinese new drug market application of sofantini for non pancreatic neuroendocrine tumor was included in the priority review by the drug evaluation center (CDE) of the State Drug Administration In November 2019, the State Food and Drug Administration accepted the listing application of suvantinib for the treatment of non pancreatic neuroendocrine tumor In addition, the U.S Food and Drug Administration (FDA) has also granted sofantini orphan drug qualification for the treatment of pancreatic neuroendocrine tumors Suufatinib (picture source: PubChem) suufatinib (hmpl-012 or sulfatinib) is a new oral tyrosine kinase inhibitor independently developed by Hehuang pharmaceutical, which has dual activities of antiangiogenesis and immunoregulation Sufentanil can block tumor angiogenesis by inhibiting vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), inhibit colony stimulating factor-1 receptor (CSF-1R), and promote immune response to tumor cells by regulating tumor related macrophages Because of its dual mechanism of anti-tumor angiogenesis and immune regulation, suvantinib may be very suitable for combination with other immunotherapies At present, sofantini is carrying out a number of concept validation studies in the United States, and a number of later clinical trials and concept validation studies in China According to Frost & Sullivan, China's market for anti angiogenic vascular endothelial growth factor receptor (VEGF / VEGFR) inhibitors has grown from $500 million in 2015 to more than $1.5 billion in 2019, and is expected to reach $5 billion by 2026 Hehuang pharmaceutical currently has all the rights of sofantini in the world Original source: Hehuang medicine