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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Fanregratinib 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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Fanregratinib is a targeted tablet for a rare form of bile duct cancer that starts inside the liver, called intrahepatic cholangiocarcinoma (ICC). It only helps people whose tumour carries a specific genetic change, an FGFR2 fusion or rearrangement, so a tumour gene test is needed before it can be considered. It was discovered and developed by HUTCHMED in China, where it is sold under the brand name ATLED®.
China's National Medical Products Administration (NMPA) gave it conditional approval in August 2026 for adults with:
It is a prescription cancer medicine and should only be used under a medical oncologist. "Conditional" means the approval rests on a single-arm study, and a larger confirmatory study (the phase IIIb part of the same trial, enrolling since January 2026) is under way.
FGFR proteins sit on the surface of cells and pass on "grow" signals. In about 10 to 15 in every 100 people with ICC, part of the FGFR2 gene is fused with another gene, and the receptor stays switched on all the time, driving the cancer. Fanregratinib is a small-molecule inhibitor that selectively blocks FGFR1, FGFR2 and FGFR3, cutting off that signal.
The approval is based on the registration (phase II) part of a single-arm trial run at 53 hospitals in China (NCT04353375), presented at the ESMO Gastrointestinal Cancers Congress in July 2026. Everyone had FGFR2-altered ICC that had already been treated. An independent review committee found that:
In the registration cohort the dose was:
The tablet strength and the exact label instructions are those printed on the Chinese pack and leaflet. Your oncologist sets the dose and may reduce or pause it if side effects occur.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Overall: in the registration trial, 48.3% of patients had a severe (grade 3 or higher) side effect linked to treatment. Only 2.2% had to stop because of side effects, and no treatment-related deaths were reported.
The full list of side effects with their frequencies has not yet been published outside the Chinese label, so always read the leaflet supplied with the pack and report any new symptom to your oncologist.
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 people whose biliary tract cancer is HER2-positive rather than FGFR2-driven, see our page on Ziihera.
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 are stored as directed on the pack. Because treatment runs in 21-day cycles (two weeks on, one week off), we plan quantities cycle by cycle so there is no gap. 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.
Liver and GI cancer centres here see bile duct cancer patients from across North India, and our New Delhi dispatch point keeps transit short.
Oncologists in Mumbai can send the FGFR2 test report and prescription, and the tablets are delivered to the patient or hospital pharmacy.
We share a written quote for each 21-day cycle before anything is ordered.
A major referral hub for hepatobiliary cancers in South India, with experience handling imported targeted therapies.
Deliveries are timed so the next cycle can start on day 1 without a break.
Patients in Kolkata and the eastern states can use the same documented import route.
We keep patients and their oncologist updated at each stage, from permit to delivery.
The treating oncologist can send us the prescription, gene test and treatment history to start the import.
Patients treated at hospitals in Vellore can have their supply delivered directly to the hospital.
Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to home or hospital.
We coordinate deliveries to public and private cancer hospitals across Uttar Pradesh.
Patients across Kerala can receive the tablets at home or at their hospital 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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