(July 9, 2025, Shanghai, China）—On 9 July, 2025, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; Stock Code: 600196.SH, 02196.HK), announced that its self-developed MEK1/2 selective inhibitor Fu Mai Ning (generic name: Luvometinib Tablets; the “Drug”) has entered Phase 3 clinical trial for the treatment of pediatric low-grade glioma (pLGG) in China (excluding Hong Kong SAR, Macau SAR and Taiwan region).

Xingli WANG, Co-President of Fosun Pharma and CEO of Global R&D Center said: “We are pleased to see that Luvometinib Tablets for the treatment of pLGG has entered the pivotal phase 3 clinical stage. This marks not only the first MEK-targeted drug in China to reach Phase 3 clinical trial for this indication, but also another milestone in Fosun Pharma's global R&D efforts. Looking forward, our global R&D team will continue to advance the clinical process so that more patients can benefit from this innovative drug as soon as possible.”

pLGG refers to pediatric and adolescent patients (under 18 years old) diagnosed with low-grade gliomas, as defined in the 2021 World Health Organization (WHO) Classification of Tumors of the Central Nervous System (CNS), which includes entities such as pediatric-type diffuse low-grade glioma and circumscribed astrocytic glioma. pLGG is the most common CNS tumor in children, accounting for approximately 40-50% of all pediatric CNS tumors. In the United States, an estimated 1,000-1,600 new cases were diagnosed in 2015, while the incidence in China has not been clearly reported.

According to data from a multicenter, single-arm Phase II clinical study^[i], the Drug achieved an objective response rate (ORR) of 68.2% and a disease control rate (DCR) of 100% in pLGG patients with BRAF fusion mutations, BRAF V600E mutations, or NF1 positive mutations. No disease progression was observed during the study period, and all patients experienced varying degrees of clinical benefit. These clinical results indicate that the Drug demonstrates good therapeutic efficacy in treating pLGG patients with BRAF fusion, BRAF V600E, or NF1 positive mutations, providing a targeted treatment option for the treatment of pLGG. The Drug is expected to reshape the current treatment landscape of pLGG and benefit more patients.

To date, the Drug has already been approved for marketing in China with two approved indications, including (1) the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms; (2) 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.

The Drug is at the stage of Phase III clinical trial in China for the treatment of adults with neurofibromatosis type 1, children with low-grade glioma, respectively. The Drug is at the stage of Phase II clinical trial in China for the treatment of extracranial arteriovenous malformations, children with Langerhans cell histiocytosis, respectively. The Drug has been granted breakthrough therapy designation by the Center for Drug Evaluation of the National Medical Products Administration for the treatment of two indications of adults with inoperable or post-operative residual/recurrent NF1-associated PNs and children with Langerhans cell histiocytosis.

[i]1.Wenbin Li, Ying Mao, Zhuang Kang, et al. A phase II study to explore the efficacy and safety of FCN-159 in recurrent or progressive pediatric low-grade glioma (pLGG) with MAPK pathway activation. ESMO LBA 2023.