On April 21, 2023 Fosun reported that according to the public announcement made by the Centre for Drug Evaluation of National Medical Products Administration (the "NMPA"), the FCN-159 tablets (the "Investigational New Drug") of Shanghai Fosun Pharmaceutical Industrial Development Company Limited (the "Company" and, together with its subsidiaries/units, the "Group", the same applies below), have been granted breakthrough therapy designation for the treatment of histiocytic tumors (Filing, Fosun, APR 21, 2023, View Source [SID1234633490]).
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II. Basic Information and Research Progress of the Investigational New Drug
The Investigational New Drug is an innovative small molecule chemical drug self-developed by the Group , which is a MEK1/2 selective inhibitor and is intended to be used primarily for the treatment of advanced solid tumors, type I neurofibromas, histiocytic tumors and arteriovenous malformations
As at the date of this announcement, the Investigational New Drug is at the stage of Phase I clinical trial in China (excluding Hong Kong, Macau and Taiwan region for the purpose of this announcement, the same applies below) for the treatment of malignant melanoma; the Investigational New Drug is at the stage of Phase II clinical trials in China, the United States and Europe for the treatment of type I neurofibroma; and the Investigational New Drug is at the stage of Phase II clinical trials in China for the treatment of histiocytic tumors, low-grade glioma and arteriovenous malformations respectively. The application for Phase II clinical trial of the Investigational New Drug for childhood Langerhans cell histiocytosis/Langerhans cell histiocytic hyperplasia has also been approved by the NMPA.
As at the date of this announcement, the MEK1/2 selective inhibitor approved for launch in China include MEGININE (邁吉寧 ) (Trametinib Tablets) of Novartis Europharm Limited. According to the data from IQVIA CHPA (provided by IQVIA, a professional information and strategic consulting service provider for the pharmaceutical and health industry, IQVIA CHPA data represents the drug sales market of hospitals with over 100 beds in China. The actual sales of different drugs may differ from the IQVIA CHPA data to varying degrees due to their different sales distribution channels), the sales of MEK1/2 selective inhibitor in China amounted to approximately RMB98.68 million in 2022. As of March 2023, the Group has invested approximately RMB 311.95 million (unaudited) in total in the research and development ("R&D") of the Investigational New Drug at this stage.
III. Risk Reminder
As required by the relevant laws and regulations in China, the Investigational New Drug is subject to undergo a series of clinical studies and approval by the relevant national drug review department in China before it can be launched. There are certain risks in the R&D of new drugs based on our experience. For example, clinical trials may be terminated due to issues such as safety and/or efficacy.