On 12 May 2025, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) announced that the self-developed innovative drug FCN-159 tablets (Luvometinib tablets, hereinafter the “New Drug”) has been granted breakthrough therapy designation for the treatment of children with Langerhans cell histiocytosis by the National Medical Products Administration (the “NMPA”). Currently, the New Drug is at the stage of Phase II clinical trial in Chinese Mainland.

FCN-159 tablet is a MEK1/2 selective inhibitor and is intended to be used primarily for the treatment of advanced solid tumors, neurofibromatosis type 1, dendritic cell and histiocytic neoplasms and low-grade glioma, etc.

As of now, Luvometinib tablets have been accepted by the NMPA and included in the List of Priority Review for two indications: the treatment of adult dendritic cell and histiocytic neoplasms, and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) -associated plexiform neurofibromas (PN). The New Drug is at the stage of Phase III clinical trial in China (excluding Hong Kong, Macao and Taiwan region for the purpose of this announcement, the same applies below) for the treatment of adults with neurofibromatosis type 1, and the New Drug is at the stage of Phase II clinical trial in China for the treatment of low-grade glioma, extracranial arteriovenous malformations, children with Langerhans cell histiocytosis. The New Drug has been granted breakthrough therapy designation by the Center for Drug Evaluation of the NMPA for the treatment of three indications of histiocytic neoplasms, adults with inoperable or post-operative residual/recurrent NF1-associated PNs, and children with Langerhans cell histiocytosis.

According to the latest data from IQVIA MIDAS™^[1], the sales of MEK1/2 selective inhibitor worldwide amounted to approximately US$2,068 million in 2024, indicating a broad market prospect and clinical value.

In the future, Fosun Pharma will actively explore the development and application of innovative drugs, accelerate the development of rare disease therapies and drugs urgently needed in clinical practice, fill gaps in the treatment of related diseases, and improve the accessibility of innovative therapeutic drugs for rare disease patients.

 [1]Data provided by IQVIA, a provider of professional medical and health information and strategic consultation service in the world.