On 28 November 2019, Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK) announced that its subsidiary Shanghai Fosun Pharmaceutical Development Co., Ltd. has received the U.S. Food and Drug Administration (the “FDA”)’s Orphan Drug Designation for its investigational drug FN-1501. Up until October 2019, Fosun Pharma’s cumulative R&D investment in this investigational drug was RMB72.97 million (unaudited; licensing fees included).
An innovative small molecule chemical drug transferred from China Pharmaceutical University and subsequently self-developed by Fosun Pharma, FN-1501 is mainly indicated for the treatment of leukemia. IND has been by the FDA and China Food and Drug Administration (currently known as the National Medical Products Administration) in October 2017 and December 2017 respectively. Up to 28 November 2019, phase I clinical trials of FN-1501 are still underway for the treatment of leukemia and solid tumors in the US, Australia and mainland China.
Currently, there is still no proprietary medicine with the same target as FN-1501 in China (excluding that of Hong Kong SAR, Macao SAR and Taiwan province). According to the latest data from IQVIA MIDASTM, the global sales of drugs with the same target as FN-1501 totaled approximately US$127.88 million in 2018.
The receiving of Orphan Drug Designation by the FDA will help FN-1501 to secure certain levels of policy support in its subsequent R&D, registration and commercialization for the treatment of acute myeloid leukemia in the US, remarked Fosun Pharma, adding that it will also be helpful in strengthening cooperation and exchanges with the FDA, reducing R&D input for FN-1501 to a certain extent, hastening clinical trials, and shortening market registration time.