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On October 20, Fosun Pharma announced that its controlling subsidiary, Orinove Inc. The small molecule innovation drug ORIN1001 tablets have been approved by the FDA for clinical trials for idynatic pulmonary fibrosis and are scheduled to be clinically phase Ib of the condition in the United States in the near future.
ORIN1001 is an original (First-in-Class) small molecule drug with new enzyme-type targets, new mechanism of action and new chemical structure type developed for Fosun Pharma, which is intended for the treatment of advanced solid tumors and idioblastical pulmonary fibrosis.
Currently, PHASE I clinical use of ORIN1001 for advanced solid tumors is in Phase I clinical in the United States, and adaptations for recurring, re treatable, metastasis breast cancers, including triple-yin breast cancer, have been certified by the FDA Rapid Track Review.
, its clinical application for advanced solid tumors has been approved by NMPA.
as of the announcement date, there is no global market with the same type of new drug.
as of September 2020, Fosun Pharma's cumulative research and development investment in the new drug was approximately RMB11,143.2 million (unaudited).
idiopathic pulmonary fibrosis (IPF) is a major lung disease characterized by the proliferation of fibroblasts and the accumulation of large numbers of extracellular substrates accompanied by inflammatory damage and tissue damage.
the IPF is irreversible and has a very poor prognostosm, with a five-year survival rate of less than 30%.
current treatment can not achieve the goal of cure, can only slow the progression of the disease and improve the quality of life of patients, therefore, the development of new drugs for this is urgent.
original title: Fosun Pharma First-in-class New Drug Approved by FDA for Clinical Use of Iddlya Pulmonary Fibrosis