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Gumarontinib

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Gumarontinib

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: Gumarontinib
Generic Name (API): Gumarontinib
Dosage Form & Strength: 50 mg
Route: Oral
Drug Class: MET (c-Met) tyrosine kinase inhibitor

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
  • PMDA (Japan)
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What Is Gumarontinib Used For?

Gumarontinib is a once-daily targeted tablet for a specific type of lung cancer driven by a change in the MET gene. It was discovered and developed in China by Shanghai Haihe Biopharma, and is sold there as 海益坦® (Haiyitan®). In earlier papers it was called glumetinib or SCC244.

China's National Medical Products Administration (NMPA) gave it conditional approval in March 2023 for adults with:

  • Locally advanced or metastatic non-small cell lung cancer (NSCLC)
  • Whose tumour carries a MET exon 14 skipping mutation, confirmed by a molecular test

Japan's regulator approved it for the same type of lung cancer in June 2024. It is a prescription cancer medicine and should only be used under a medical oncologist.

How It Works

In MET exon 14 lung cancer, a small piece of the MET receptor that normally acts as its "off switch" is missing, so the receptor stays active and keeps pushing the tumour to grow. Gumarontinib is a highly selective MET inhibitor: it blocks the receptor's activity and the growth signals that follow, which can shrink the tumour.

What the Trial Showed

Approval was based on the phase 2 GLORY study, run at 42 hospitals in China and Japan and published in eClinicalMedicine in 2023. Of 79 patients whose MET mutation was confirmed centrally, 66% had their tumours shrink: 71% of those treated first-line and 60% of those treated before.

After longer follow-up (reported in 2025), the median time before the cancer grew again was 7.7 months and median overall survival was 19.4 months, rising to 25.4 months in people who had not had earlier treatment.

Recommended Dosage

  • Usual dose: 300 mg by mouth once a day (six 50 mg tablets)
  • Take on an empty stomach: food raises the amount of medicine in the blood, so avoid taking it from 1 hour before a meal until 2 hours after
  • Continue every day while it is working and side effects are manageable
  • If side effects occur, the dose can be paused or lowered in steps (250 mg, 200 mg, then 150 mg)

This dosing comes from the official Japanese prescribing information, which matches the GLORY trial. 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

Fluid build-up: swelling (oedema) affected 79.8% of patients in the GLORY study, and low blood albumin 38.1%. Fluid can also collect around the lungs (9.5%) or heart (2.4%). Report sudden weight gain, swelling or breathlessness to your doctor promptly.

  • Lung inflammation (interstitial lung disease): uncommon (1.2%) but serious. New cough, fever or shortness of breath needs urgent review, and treatment is stopped if it is confirmed.
  • Liver: raised bilirubin (27.4%), ALT (26.2%) and AST (21.4%) were common. Liver tests are done before and during treatment.
  • Heart rhythm: QT prolongation on the ECG was seen in 9.5%. ECGs and blood salts are checked regularly.
  • Other common effects: headache and loss of appetite (each 32.1%), nausea (28.6%) and vomiting (23.8%).
  • Medicine interactions: it can raise blood levels of some medicines cleared by the kidneys, including a widely used diabetes tablet, so tell your doctor about everything you take.
  • Pregnancy: animal studies showed harm to the unborn baby. Women who could become pregnant should use contraception during treatment and for 1 week after the last dose, and breastfeeding is not advised.

Overall: severe (grade 3 or higher) treatment-related side effects occurred in 53.6% of patients, and 8.3% stopped treatment because of them. Safety in children has not been studied.

How to Access Gumarontinib 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 Gumarontinib to India?

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:

  • A valid prescription from a qualified medical oncologist
  • Diagnostic reports confirming NSCLC, including the molecular test report showing the MET exon 14 skipping mutation
  • 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 Gumarontinib available in India?

No. It is approved in China and Japan only. It has no CDSCO approval, it is not sold in Indian pharmacies, and the US FDA and European Medicines Agency have not approved it.

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 MET-targeted lung cancer options, see our pages on Tepmetko and Emrelis.

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. Each Chinese box holds 24 tablets of 50 mg, which is four days' supply at the usual 300 mg dose, so about seven to eight boxes cover a month. The tablets travel in their sealed original packs under temperature-controlled shipping and should be stored as directed on the pack. 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 treating hospital on a valid specialist's prescription.

Delhi

Lung cancer specialists in Delhi increasingly test for MET exon 14, and our New Delhi dispatch point means short delivery times.

Mumbai

Monthly supplies can be delivered to the hospital pharmacy or the patient's home on the oncologist's advice.

Bangalore

Oncologists in Bangalore can request the tablets for a named patient, with the full cost shared before ordering.

Chennai

Patients from across Tamil Nadu treated in Chennai can receive sealed original packs with import documents.

Hyderabad

We plan each month's boxes ahead so a once-daily course is never interrupted.

Kolkata

Deliveries reach Kolkata and the north-eastern states with tracking at every stage.

Pune

Patients in Pune can start the import as soon as the prescription and MET report are ready.

Ahmedabad

The treating oncologist can send us the papers directly to begin the process.

Vellore

Patients treated in Vellore can have supply sent to the hospital for collection.

Chandigarh

Covers patients from Punjab, Haryana and Himachal Pradesh, with delivery to the treating hospital.

Lucknow

We arrange deliveries to cancer centres in Lucknow and across Uttar Pradesh.

Kochi

Patients across Kerala can receive their tablets in Kochi or nearby cities.

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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