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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Dirozalkib 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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Dirozalkib is a once-a-day targeted tablet for ALK-positive lung cancer, developed in China by Xuanzhu Biopharmaceutical, part of the Sihuan Pharmaceutical group. It is sold there as 轩菲宁® (Xuan Fei Ning) and was known in research as XZP-3621.
China's National Medical Products Administration (NMPA) approved it in August 2025 for adults with:
It is a prescription cancer medicine and should only be used under a medical oncologist experienced in lung cancer.
In a small share of lung cancers, a gene called ALK becomes fused to another gene. The faulty ALK protein that results keeps telling the cell to grow. Dirozalkib sits in the energy pocket (the ATP-binding site) of the ALK protein and shuts that signal off. In laboratory tests it also blocked several ALK changes that make cancer resistant to older ALK medicines, such as G1202R and I1171N. It crosses into the brain well, which matters because brain spread is common in this type of lung cancer.
The phase 3 DIAMOND-2 trial enrolled 275 people in China with ALK-positive advanced NSCLC who had not had an ALK medicine before. Half took dirozalkib, and half took an older, first-generation ALK tablet used as the comparison medicine. Results presented at the AACR meeting in April 2026 showed:
Your oncologist will set the exact dose from the Chinese prescribing information and may lower it if side effects build up.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Stomach and bowel side effects: these are the main ones. In the interim results of the phase 3 trial, treatment-related diarrhoea affected 97.8% of patients, vomiting 88.3% and nausea 66.4%. Most were mild to moderate, but diarrhoea was severe in 19.0%. Starting anti-diarrhoea and anti-sickness treatment early, and drinking plenty of fluids, helps. Tell your doctor if it does not settle within a day.
Overall: in the interim analysis, severe side effects of any cause occurred in 54.0% of patients on dirozalkib and 65.9% on the comparison medicine. 19.7% needed a lower dose, against 28.3%. Only 0.7% stopped dirozalkib because of side effects at that point (1.5% in the April 2026 update), compared with 6.5% on the comparison 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 lung cancer driven by a different gene change, ROS1, 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. Because the tablet count each day depends on the dose your oncologist chooses, we work out the monthly quantity from the prescription and plan repeat orders ahead of time. 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 treat ALK-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 ALK test report is shared.
Each month's supply can be delivered to the patient at home or to the hospital pharmacy.
A leading centre for lung cancer care in South India, with experience importing targeted tablets for individual patients.
We plan repeat orders ahead so a daily treatment like this is never interrupted.
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 ALK report to start the process.
Oncologists in Ahmedabad can arrange access for newly diagnosed ALK-positive patients, including those with brain spread.
Patients in Rajasthan can receive the tablets close to home, 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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