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On August 10, Fosun Pharma issued an announcement stating that its controlling subsidiary, Fosun Pharmaceutical Industry, received approval from the State Food and Drug Administration for its participation in the development of FH-2001 capsules for advanced malignant solid tumors to carry out clinical trials
.
Fosun Pharmaceutical Industry intends to conduct phase I clinical trials of the new drug in China (excluding Hong Kong, Macao and Taiwan) when the conditions are met
The new drug is a PD-L1/FGFR dual-mechanism small molecule regulator/inhibitor, and it is intended to be mainly used for the treatment of advanced solid tumors; the preclinical research of the new drug is mainly entrusted to carry out, clinical research and subsequent commercialization by Shanghai WuXi AppTec New Drug Development Co.
, Ltd.
It is proposed to be implemented independently by the Group (ie the company and its holding subsidiaries/units)
.
As of the date of this announcement, no small molecule inhibitors targeting PD-L1 have been approved for marketing globally; the small molecule inhibitors of FGFR that have been marketed in China mainly include lenvatinib, regorafenib and pazopanib, etc.
.
According to IQVIA CHPA data, in 2020, the sales of lenvatinib, regorafenib and pazopanib are equivalent to approximately RMB 906.
As of July 2021, the current stage of the Group's accumulated investment in the research and development of this new drug is approximately RMB 42.