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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Iruplinalkib 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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Iruplinalkib is a once-daily targeted tablet for ALK-positive lung cancer. It was developed in China by Qilu Pharmaceutical and is sold there as 启欣可®. During development it was known as WX-0593.
China's National Medical Products Administration (NMPA) first approved it in June 2023 and widened the approval in 2024. It is now used on its own for adults with:
A tumour test must confirm the ALK rearrangement first. It is a prescription cancer medicine and should only be used under a medical oncologist.
In ALK-positive lung cancer, two genes fuse and produce an abnormal ALK protein that keeps the cancer growing. Iruplinalkib blocks ALK, and also the related ROS1 kinase, which shuts down the growth signals (ERK, STAT5 and AKT) and leads the cancer cells to die. It also reaches the brain, where ALK-positive lung cancer often spreads.
In the phase 3 INSPIRE trial (292 patients, published in the Journal of Thoracic Oncology in 2024), people starting their first ALK treatment were given iruplinalkib or an older first-generation ALK medicine. Iruplinalkib nearly doubled the time before the cancer grew again: a median of 27.7 months against 14.6 months. In the small group with brain metastases, the response rate inside the brain was 90.9%, compared with 60.0% on the comparison medicine.
In the phase 2 INTELLECT study (146 patients whose cancer had progressed on a first-generation ALK inhibitor, BMC Medicine, 2023), 69.9% responded and the median time before progression was 19.8 months by independent review.
In the earliest study, lung inflammation was seen only when the full dose was started without this lower-dose first week. 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.
Liver and muscle enzymes: the most common side effects are blood-test changes rather than symptoms. In the INTELLECT study, AST rose in 43.2% of patients, ALT in 37.0% and the muscle enzyme CPK in 34.9%. Regular blood tests are part of treatment, and the dose can be paused or lowered if levels climb too high.
Overall: in INTELLECT, severe (grade 3–4) treatment-related side effects occurred in 30.8% of patients; 14.4% needed a pause, 11.0% a lower dose and 2.7% stopped. In INSPIRE, severe treatment-related side effects were about as common with iruplinalkib as with the comparison medicine (51.7% vs 49.7%). Safety in pregnancy, breastfeeding and children has not been established.
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 lung cancers driven by the closely related ROS1 gene, see our pages on Augtyro and Ibtrozi.
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 60 mg tablets come in packs of 30 or 90; at the full dose of three tablets a day, a 90-tablet pack lasts about a month. They travel in their sealed original packs under temperature-controlled shipping and are stored sealed at or below 30°C, as the pack directs. 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 treating hospital on a valid specialist's prescription.
Many ALK-positive patients are diagnosed and treated at Delhi's large cancer centres, and our New Delhi dispatch point keeps delivery quick.
The first order can cover the 60 mg starting week and the step up to the full dose, delivered to the hospital or home.
Oncologists in Bangalore can request the tablets for a named patient, with a written quote before anything is ordered.
Patients treated in Chennai receive sealed original packs with batch and import papers.
We plan repeat supplies around the monthly pack so treatment continues without a break.
Shipments reach Kolkata and the eastern states with tracking from dispatch to delivery.
Families in Pune can begin the import once the ALK test report and prescription are ready.
The treating oncologist can send the paperwork to us directly to start the process.
Patients under care in Vellore can collect their supply at the hospital.
Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the treating hospital.
We coordinate deliveries to cancer hospitals throughout Uttar Pradesh.
Patients across Kerala can receive their tablets at hospitals in 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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