The FDA grants fast-track qualification to Fosun Pharma ORIN1001

recently, Fosun Pharma announced that the U.S. Food and Drug Administration (FDA) has recently granted fast-track eligibility for its new drug for the treatment of recurring, incurable, metastasis breast cancer, including triple-yin breast cancer.About ORIN1001 ORIN1001 is a pioneering (First-in-Class) small molecule drug with new enzymatic targets, new action mechanisms and new chemical structure types independently developed by Fosun Pharmaceutical Subsidiary Fosun Hiroshi (Suzhou) Pharmaceutical Technology Co., Ltd. ("Fosun Hiroshi"), which is used to treat advanced solid tumors, and its first exploratory adaptation is relapsed, rectable, metastatic breast cancer.As of May 2019, Fosun Pharma Group has invested approximately RMB45.47 million in research and development of the new drug.founded in July 2017 by a team of Fosun Pharma and overseas scientists,Fosun has established research and development bases in Suzhou and Los Angeles, focusing on anti-cancer drugs related to the metabolism of small molecules and cancer cells.
Fast Track Qualification (FTD) is designed to accelerate drug development and rapid review for serious diseases to address critically unsolved medical needs in key areas. Fast-track eligibility for experimental drugs means that drug companies can meet more frequently with the FDA during the development phase, and are eligible for accelerated approval and priority review, as well as the opportunity for rolling review, if the relevant criteria are met after the application is submitted for listing.review allows pharmaceutical companies to submit the completed portion of their Biologics Licensing Application (BLA) or New Drug Application (NDA) to the FDA without having to wait until each section is complete before reviewing the entire BLA or NDA. (Drug Information Network)