June 15, 2026 — Fosun Pharma (600196.SH; 02196.HK) announced that its self-developed MEK 1/2 selective inhibitor Luvometinib Tablets (trade name: Fumaining^®) has been officially approved by the National Medical Products Administration (the “NMPA”) for the treatment of pediatric patients 2 years of age and older with relapsed or refractory Langerhans cell histiocytosis (LCH) after systemic therapy. It is currently the only approved therapeutic drug for this indication in China.

Langerhans cell histiocytosis (LCH) is an inflammatory neoplastic disease caused by the clonal expansion of myeloid-derived CD207-positive histiocytes. It is recognized by the World Health Organization as one of the neoplasms of the hematopoietic system and is the most common histiocytic proliferative disorder in children¹. The incidence of pediatric LCH is approximately 2.6 to 8.9 per million, with a median age at diagnosis of only 3 years. The disease can affect bones, skin, lungs, liver, spleen, pituitary gland, and the hematopoietic system. Its clinical manifestations are insidious yet highly heterogeneous, frequently resulting in permanent sequelae such as osteolytic destruction, refractory rash, organ failure, and central diabetes insipidus.

Traditional treatment mainly relies on chemotherapy, which offers limited efficacy and causes significant toxic side effects, leaving approximately 30% to 40% of surviving children with lifelong disabilities. The approval of Fumaining^® for the pediatric LCH indication brings a new precise targeted therapy option for this rare and insidious “children killer”.

In addition to the newly approved indication, as of now, the two approved indications of Fumaining^®—namely the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms, as well as the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection—have both been included in the National Reimbursement Drug List (NRDL), further enhancing the accessibility of medication for patients with rare diseases. The drug is the first and currently the only treatment in China to simultaneously cover dual indications for adult LCH and histiocytic neoplasms, as well as pediatric NF1 with plexiform neurofibromas, filling a critical gap in the domestic treatment field for these rare diseases. With the approval of this additional indication, Fumaining^® has completed a key piece of its puzzle in the LCH therapeutic area, providing targeted treatment options for relapsed/refractory patients across different age groups, from adults to children and adolescents.

Driven by the outstanding clinical value and innovativeness of Luvometinib Tablets, the Center for Drug Evaluation (CDE) of the NMPA has included it in the “Starlight Program,” with indications including pediatric Langerhans cell histiocytosis and low-grade glioma. This reflects the high recognition by the national drug review authority regarding its therapeutic value in the field of rare[i] pediatric tumors. On the international academic stage, the latest data from the Phase II study of Fumaining^® for the treatment of relapsed/refractory pediatric Langerhans cell histiocytosis (LCH) was successfully selected for an oral presentation at the 2026 European Hematology Association (EHA) Annual Congress, earning further international recognition for its clinical value.

The approval of Fumaining^® for the pediatric LCH indication fills the therapeutic gap of having no approved indicated drugs in the pediatric LCH field in China. Armed with four core values—high remission rate, benefit across all subtypes, favorable tolerance, and convenience of administration—it brings new hope for long-term survival and high-quality rehabilitation to patients and their families. This marks the official entry of Chinese pediatric Langerhans cell histiocytosis treatment into a new era where drugs are both available and accessible.