FDA grants Fosun Pharma ORIN1001 fast-track eligibility for breast cancer treatment
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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recently, FosunMedicines(http://(stock code: 600196SH, 02196.HK) and the announcement that the U.SFood and
Drug(http://Regulatory Authority (
FDA(http://) has recently granted
it a new drug(http://ORIN1001 for the treatment of recurrent, refractory, metastatic breast cancer( including triple-yin breast cancer)about ORIN101
ORIN1001 is fosun pharmaceutical sub-
company (http:// Fosun Hongcheng (Suzhou) Pharmaceutical Technology Co., Ltd ("Fosun Hongcheng" )) independently developed with new enzyme targets, new mechanisms and new chemical structure type of small molecules drug (http:// , used to treat late-stage solid tumors, its first exploration of resocation As of May 2019, Fosun Pharma Group has invested approximately RMB 45.47 million in research and development for the new drug Founded in July 2017 by a team of Fosun Pharma and overseas scientists, Fosun has set up research and development bases in Suzhou and Los Angeles to focus on anti-cancer drugs related to the metabolism of small molecules and cancer cells Fast-track eligibility (FTD) is designed to accelerate drug development and rapid review of serious diseases to address the needs of severely unmet medical (http:// in key areas The fast-track eligibility of experimental drugs means that pharmaceutical companies can meet more frequently with the FDA during the development phase and, if the relevant criteria are met, are eligible for accelerated approval and priority review, as well as opportunities for rolling review rolling review allows pharmaceutical companies to submit completed parts of their Biological Products 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
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