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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Limertinib 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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Limertinib is a targeted tablet for lung cancer driven by an EGFR mutation, developed in China by Jiangsu Aosaikang Pharmaceutical (ASK Pharm) and sold there as 奥壹新® (Aoyixin®). In mainland China it is brought to patients together with Innovent Biologics.
China's National Medical Products Administration (NMPA) first approved it in January 2025 and widened the approval in April 2025. It is approved for adults with non-small cell lung cancer (NSCLC) in two situations:
It is a prescription cancer medicine and should only be used under a medical oncologist experienced in lung cancer.
A faulty EGFR protein can act like a stuck "grow" switch in lung cancer cells. Limertinib is a third-generation EGFR inhibitor: it binds permanently to the faulty protein and turns that signal off. It acts on the common exon 19 and L858R mutations and also on T790M, the change that often makes cancer stop responding to earlier EGFR tablets, while largely sparing normal EGFR.
As a first treatment: in a phase 3 trial published in The Lancet Respiratory Medicine in 2025, 337 patients in China took limertinib or a first-generation EGFR tablet used as a comparison medicine. The cancer was kept in check for a median of 20.7 months with limertinib against 9.7 months, a 56% lower risk of progression. The benefit was also seen in people whose cancer had spread to the brain.
After earlier EGFR treatment (T790M): in a phase 2b study of 301 patients (Journal of Thoracic Oncology, 2022), 68.8% responded and 92.4% had their disease controlled. Median time without progression was 11.0 months. Among 41 people with measurable brain tumours, 56.1% saw those tumours respond.
Each tablet contains 80 mg. The doses used in the trials were:
Your oncologist will set the exact dose from the Chinese prescribing information and your own test results.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Diarrhoea: this is the main side effect. In the phase 2b study at the higher dose, 81.7% of patients had diarrhoea, and it was severe in 13.0%. Start anti-diarrhoea treatment early, drink plenty of fluids and tell your doctor if it does not settle within a day.
Overall: in the first-line trial, severe treatment-related side effects occurred in 25% of patients on limertinib and 25% on the comparison medicine, and serious treatment-related side effects in 5% and 10%. In the phase 2b study, 24.6% needed a pause in treatment because of side effects but only 2% stopped, and no deaths were linked to the medicine.
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 the US FDA and European Medicines Agency have not approved it 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 EGFR lung cancer situations, see our pages on Lazcluze and Zegfrovy.
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. Each box holds 20 tablets of 80 mg. Because the number of tablets a day depends on the dose your oncologist chooses, we work out the monthly quantity from the prescription. 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.
Patients across India can access this medicine through regulated import pathways, with delivery arranged to the patient or the treating hospital on a valid oncologist's prescription.
Thoracic oncology teams in Delhi see EGFR-positive patients from across North India, and our New Delhi dispatch point keeps delivery times short.
Oncologists in Mumbai can request the tablets for a named patient once the mutation report is shared.
Patients in Bangalore can have each month's boxes delivered to their home or hospital pharmacy.
A leading centre for lung cancer care in South India, with experience in importing targeted tablets for individual patients.
We calculate the number of boxes from the prescribed dose so supply never runs short.
Patients in Kolkata and the eastern states can follow the same documented import route, with updates at each step.
The treating oncologist can send the prescription and EGFR test report to start the process.
Oncologists in Ahmedabad can coordinate access for patients newly diagnosed or whose cancer has developed a T790M mutation.
Patients in Rajasthan can receive the tablets without travelling, as long as the import is in their name.
Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the patient or the treating hospital.
We arrange delivery for patients treated at cancer hospitals across Uttar Pradesh.
Patients across Kerala can have their supply delivered to Kochi and nearby cities.
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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