Drugs / Luvometinib
Trials 12
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-09-03 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma’s Self-Developed Innovative Drug Luvometinib Tablets Gains Approval for Adult NF1 Indication, Achieving Full Age-Coverage for NF1 Patients fosunpharma.com ↗
The approval of this new indication marks full age-group coverage in the NF1 indication for this domestically developed innovative drug, providing a new treatment option for Chinese adult NF1-PN patients. |
| 2026-06-15 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma’s Self-Developed Innovative Drug Fumaining® Approved for the First Pediatric LCH Indication in China, Bringing a New Treatment Option for Children with Rare Disease fosunpharma.com ↗
The approval of Fumaining® for the pediatric LCH indication brings a new precise targeted therapy option for this rare and insidious “children killer”. |
| 2025-08-18 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma’s Self-Developed Innovative Drug Luvometinib Tablets Gains Breakthrough Therapy Designation in Saudi Arabia fosunpharma.com ↗
We are delighted that Luvometinib Tablets has gained Breakthrough Therapy Designation from the SFDA for the indication of adult patients with LCH. |
| 2025-06-04 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Results Updated Data of Luvometinib (FCN-159) Treating Pediatric Patients with Neurofibromatosis Type 1 Announced at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting fosunpharma.com ↗ |
| 2025-05-29 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma’s Self-Developed Innovative Drug Luvometinib Tablet Approved in China fosunpharma.com ↗
The approval of Luvometinib Tablets is an important milestone for Fosun Pharma's deep dive into the oncology and rare disease fields. |
| 2025-05-12 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma's Self-Developed Innovative Drug FCN-159 Tablet Granted Breakthrough Therapy Designation for the Treatment of Children with Langerhans Cell Histiocytosis fosunpharma.com ↗
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. |
| 2023-08-08 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma's Self-developed MEK1/2 Inhibitor FCN-159 Tablet Gains Second Breakthrough Therapy Designation fosunpharma.com ↗
This is the second breakthrough therapy designation that FCN-159 tablet has approved, since its indication for histiocytic tumor in April this year. |
All press releases naming this drug 8 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Luvometinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07004075 ↗ |
| Known as | FCN-159 | “Luvometinib (also called FCN-159), a new MAPK inhibitor developed by Fosun Pharma in Shanghai, was approved in 2025 for treating adult LCH.” NCT07371182 ↗ |
| Action | Inhibit | “FCN-159 is a highly active MEK1/2 inhibitor” NCT04954001 ↗ |
| Modality | Small molecule | “Oral selective MEK1/2 inhibitor added to the experimental arm” NCT07431060 ↗ |
| Route | Oral | “FCN-159 is administered orally in once daily schedule for 28 days a cycle.” NCT04954001 ↗ |