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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Luvometinib on our secure patient portal to submit your prescription, upload documents and track your approval status.
Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.
Manufacturer / Innovator:
China
Regulatory Approval:
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Luvometinib is a once-a-day targeted tablet for two rare conditions: Langerhans cell histiocytosis (LCH) and related histiocytic tumours, and the nerve tumours (plexiform neurofibromas) that grow in children with neurofibromatosis type 1 (NF1). It was developed in China by Fosun Pharma, where it is sold as 复迈宁® (Fumaining), and was known in research as FCN-159.
China's National Medical Products Administration (NMPA) first approved it in May 2025, and added a children's LCH use in June 2026. It is approved for:
It is a prescription rare disease medicine and should only be used under a specialist, such as a haematologist, oncologist or paediatric neurologist with experience of these conditions.
In both LCH and NF1, a growth signal inside the cells, called the MAPK pathway, is stuck in the "on" position. That is what drives the abnormal cells to multiply. Luvometinib selectively blocks two proteins in this chain, MEK1 and MEK2. Switching the signal off slows the growth of the abnormal cells and can make tumours shrink.
Adult LCH and histiocytic neoplasms: in a phase 2 trial, 82.8% of patients responded on PET scans reviewed by an independent committee, and 62.1% had a complete metabolic response, meaning no active disease was seen on the scan. Responses came quickly (median 2.9 months) and lasted: 91.1% of responders were still responding at two years.
Children with NF1 plexiform neurofibromas: in a phase 2 trial of 46 children aged 2 to 17, with a median follow-up of 25.1 months, the tumours shrank meaningfully in 60.5% of the 43 children who could be assessed (44.2% on independent review), and no child's tumour grew. Of 14 children who had tumour pain at the start, 13 (92.9%) had a clear drop in pain.
The doses used in Fosun's clinical trials were:
Tablets come in 1 mg and 4 mg strengths, which allows the dose to be matched to a child's size. The company reports that food does not affect how the tablet is absorbed. The specialist decides the exact dose using the Chinese prescribing information.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
The most detailed public safety figures come from the phase 2 study in 46 children with NF1, reported at ASCO 2025:
The company describes the side effects as in line with other medicines of the MEK inhibitor class. Detailed adult safety data were not included in the public sources we reviewed, so the specialist should go through the full Chinese prescribing information before starting. Tell your doctor about any other medicines you take, and if you are pregnant, planning a pregnancy or breastfeeding.
Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.
Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.
Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.
Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.
Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.
Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.
Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.
The tablets can be imported only in the patient's name, by the patient or a government hospital, in line with India's import regulations for unapproved medicines. You will need:
Once we have received and checked a valid prescription and, where needed, an import permit.
No. It is approved only in China. It has no CDSCO approval, it is not sold in Indian pharmacies, and it has not been approved by the US FDA; we found no approval from the European Medicines Agency either.
Patients can still get it legally through the Named Patient Program (NPP), which allows a medicine not registered in India to be imported for one specific patient on a prescription.
It can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only after receipt of a valid doctor's prescription and an import permit, where applicable.
NamedPatientProgram.com (NPP) sources this medicine through the manufacturer's authorised supply channels in China and arranges supply to patients, doctors, and hospitals under applicable legal provisions. The tablets travel in their sealed original packs under temperature-controlled shipping and should be stored as directed on the pack. Because a child's dose is based on body size, we confirm the mix of 1 mg and 4 mg tablets with the prescribing doctor before ordering. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.
For the current cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.
Patients across India can access this medicine through regulated import pathways, with delivery arranged to the patient or treating hospital on a valid specialist's prescription.
Paediatric and adult specialists in Delhi treat rare histiocytic and NF1 cases referred from across North India, close to our New Delhi dispatch point.
Families in Mumbai can send the specialist's prescription and reports, and the tablets are delivered to the home or hospital as advised.
We share a written quote first, so families can plan for long-term daily treatment.
Chennai's children's hospitals and haematology units can request the medicine for a named patient.
Repeat supplies are planned ahead so a once-daily course is not interrupted.
Orders for Kolkata and the eastern states are tracked from dispatch until they reach the patient.
Patients in Pune can use the same documented import route, with updates at every step.
The treating doctor can send the prescription, diagnosis and the child's height and weight to start the request.
Patients treated at hospitals in Vellore can have their supply sent to the hospital pharmacy or home.
Serves families from Punjab, Haryana and Himachal Pradesh, with delivery to the treating centre.
We coordinate delivery to paediatric and cancer hospitals across Uttar Pradesh, including dose updates as a child grows.
Patients across Kerala can receive the tablets in Kochi and nearby cities, with the import papers handled for them.
Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.
Written By
Nitin GoswamiDeputy Manager – Content & Social Media, Ikris Pharma Network
Sources: NMPA • CDSCO
Last Updated: 19 October 2026
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