FDA Approves Clinical Trial sized With Anti-Tumor Drug PI3K Alpha Inhibitor CYH33

In January 2018, CYH33, a new anti-tumor class 1 drug jointly developed by the Shanghai Institute of Pharmaceutical Research of the Chinese Academy of Sciences and Shanghai Haihe Pharmaceutical Research and Development Co., Ltd., was approved for clinical trials by the General Administration of Food and Drug Administration of the State Food and Drug AdministrationResearchers at Shanghai Drug Institute spent more than 3 years designing, synthesizing and screening thousands of compounds to finalize the candidate drug CYH33, a unique new chemical molecular entity with a unique structure, a highly selective high-activity inhibitor for PI3Ka, which has been patented in China, the United States, Japan and Canadapreclinical studies showed that CYH33's invivity and anti-tumor activity were significantly better than those of similar inhibitors with the leading international progress, especially for Chinese characteristic tumors2018, Shanghai Haihe Biopharmaceutical Co., Ltd("Haihe Bio")," announced that the company developed a class 1 innovative drug CYH33 recently completed the first case of cancer patients administration"We are very pleased that the CYH33 project has completed the first case of cancer patient administration, which is a good start," said DrDong Ruiping, CEO of Haihe BioWe will do our utmost to promote clinical development under the guidance of unique biomarkers, and strive for the early adoption of the new drug through all stages of clinical research, approved to market, benefiting cancer patients in China and the worldCyH333, a phsapholipid inositol 3-kinase (PI3K) alpha inhibitor developed jointly by the Shanghai Pharmaceutical Research InstituteShanghai Pharmaceutical Research Institute and Sea and Biology, has recently obtained a clinical trial implied license (IND) from the U.SFood and Drug Administration (
FDA) for the treatment of advanced solid tumorsPI3K signaling pathway disorder involves the vast majority of human cancers, PIK3CA (codepid PI3K catalytic subunit alpha) is one of the common mutation carcinogenic genes in human tumors, about 2-5% of human solid tumors have mutations in the cancer gene PIK3CA, involving tumor types such asbreast cancer, ovarian cancer , colon cancer, glioblastoma, lung cancer and esophageal cancer CYH33 is a new, high-efficiency, specific PI3K alpha inhibitor developed by Shanghai Drug Institute in conjunction with Sea and Biology, which inhibits the proliferation of tumor cells by inhibiting the signaling pathway of PI3K-mediated, blocking cells in The G1 stage The shanghai drug institute Yang Chunxuan's team used its own development of synthetic methodology, the first time to the drug chemical superior structure of pyridoxa and triazole nucleus into THE study of PI3K inhibitors, through systematic structural relationship research, with ding Jian academician team to work together to find the candidate drug CYH33 Preclinical studies show that CYH33's invivity is better than the listed drug BYL719 The clinical studies carried out by CYH33 show that the compound has good safety and initial clinical efficacy At present, no selective PI3K alpha inhibitors have been approved for market in China Network Source: Network