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Tunlametinib

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Tunlametinib

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Tunlametinib
Generic Name (API): Tunlametinib
Dosage Form & Strength: 3 mg, 6 mg
Route: Oral
Drug Class: MEK1/2 inhibitor (targeted therapy)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Tunlametinib Used For?

Tunlametinib is a targeted cancer capsule for advanced melanoma that carries a change (mutation) in a gene called NRAS. It was discovered and developed in China by Shanghai KeChow Pharma, and is sold there under the brand name Keluping® (科露平®). It is taken by mouth at home, twice a day.

China's National Medical Products Administration (NMPA) approved it in March 2024, on a conditional basis, for patients with:

  • Advanced NRAS-mutant melanoma
  • Whose disease has got worse despite earlier anti-PD-1 or anti-PD-L1 immunotherapy

A tumour test must confirm the NRAS mutation before treatment starts. This is a prescription cancer medicine and should only be used under an oncologist experienced in cancer drugs.

How It Works

Inside a melanoma cell, a faulty NRAS gene keeps a growth signal (the MAPK pathway) switched on all the time. Tunlametinib blocks two proteins further down that chain, MEK1 and MEK2. With the signal cut, the cancer cells stop dividing and many of them die. KeChow describes it as the first targeted medicine approved in China specifically for people with NRAS-mutant melanoma.

What the Trial Showed

Approval rests on a phase 2 study (HL-085-101-II) run across hospitals in China. Of the 64 patients whose melanoma had already been treated with anti-PD-1 or anti-PD-L1 immunotherapy:

  • 40.6% had their tumours shrink by a meaningful amount (objective response rate, checked by independent reviewers)
  • 70.3% had their disease shrink or stay stable
  • Responses lasted a median of 6.3 months; the median time before the disease got worse was 4.1 months, and median overall survival was 12.3 months

Because the approval is based on these early results, the label says the benefit still has to be confirmed in further studies after launch.

Recommended Dosage

  • Usual dose: 12 mg by mouth twice a day, about 12 hours apart, with or without food
  • Swallow the capsules whole; do not chew, dissolve or open them
  • Missed dose: take it only if the next dose is at least 8 hours away; otherwise skip it
  • If side effects build up, the dose can be lowered to 9 mg and then 6 mg twice a day, or paused

Capsules come in 3 mg and 6 mg strengths. Treatment continues for as long as it is helping and side effects are manageable. Your oncologist sets the exact plan.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Warnings and Precautions

In the main trial of 100 patients, side effects were common but mostly mild to moderate. 9% stopped treatment because of them, while 73% needed at least one pause in dosing.

  • Muscle enzyme (CPK) rise: seen in 91% of patients and severe in 38%, usually without symptoms. Blood tests are checked often (weekly is advised when it is severe). Report muscle pain, weakness, chest tightness or chest pain at once.
  • Swelling and diarrhoea: facial swelling (64%), swelling of the legs or feet (62%) and diarrhoea (74%, severe in 4%) were the most frequent problems. Start anti-diarrhoea treatment and fluids early.
  • Skin: rash affected 53% (severe in 5%) and acne-like rash 24%. Treating it early usually keeps it under control.
  • Heart: the heart's pumping strength (LVEF) fell in 8% of patients. A heart scan (echocardiogram) is needed before starting, one month later and then every two months.
  • Eyes: blurred vision occurred in 14%. Rare but serious blockages of the blood vessels in the retina (1% each) mean the medicine must be stopped. Report any sudden change in eyesight straight away.
  • Lungs: inflammation of the lungs (interstitial lung disease) was seen in 3%. New cough, breathlessness or fever needs prompt review.
  • Other: anaemia (39%), tiredness (36%), low albumin (34%) and raised liver enzymes are also common, so regular blood tests are part of treatment.

Pregnancy and breastfeeding: it should not be used in pregnancy. Women who could become pregnant, and men, should use effective contraception during treatment and for 30 days after the last dose, and women should not breastfeed during that time. It is not recommended for anyone under 18. Medicines that strongly block or speed up the liver enzyme CYP2C9 should be avoided, so tell your doctor about everything you take.

How to Access Tunlametinib in India: A 6-Step Process

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.

Documentation & Availability

What documents are required to import Tunlametinib to India?

The capsules 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:

  • A valid prescription from a qualified medical oncologist
  • Diagnostic reports confirming advanced melanoma, the NRAS mutation test result, and details of previous immunotherapy
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

Once we have received and checked a valid prescription and, where needed, an import permit.

Is Tunlametinib available in India?

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. For other melanoma medicines we help import, see our pages on Mektovi and Opdualag.

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.

Sourcing & Delivery

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 capsules are packed in sealed bottles (56 capsules of 3 mg, or 30 capsules of 6 mg) and should be kept below 30°C and away from light, so they travel in their original packs under temperature-controlled shipping. Because the dose can change during treatment, we plan each order around the strength your oncologist prescribes. 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.

Availability Across Major Cities in India

Patients across India can access this medicine through regulated import pathways, with delivery arranged to the patient or treating hospital on a valid oncologist's prescription.

Delhi

Large cancer centres in Delhi see melanoma patients from across North India, and our New Delhi dispatch point means short transit times.

Mumbai

Oncologists in Mumbai can send the prescription and NRAS test report, and the capsules are delivered to the hospital or the patient's address as advised.

Bangalore

Patients in Bangalore receive a written quote before anything is ordered, so the family knows the cost up front.

Chennai

A major referral centre for skin and mucosal cancers in South India, with experience of imported targeted therapies.

Hyderabad

We time repeat orders so that a patient on twice-daily capsules does not run short between supplies.

Kolkata

Supplies to Kolkata and the north-eastern states are tracked from dispatch to delivery.

Pune

Patients in Pune can follow the same documented import route, with updates at every stage.

Ahmedabad

The treating oncologist can share the prescription and earlier treatment records to start the request.

Vellore

Patients treated at hospitals in Vellore can have each month's supply sent directly to them or to the hospital pharmacy.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery arranged to the treating centre.

Lucknow

We coordinate delivery to cancer hospitals across Uttar Pradesh, including follow-up orders after dose changes.

Kochi

Patients across Kerala can receive the capsules in Kochi and nearby cities, with the paperwork handled for them.

Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: NMPA • CDSCO

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 19 October 2026

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