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Sourced directly from the authorized manufacturer network to ensure authenticity and quality.
Ready to proceed? Start a request for Oritinib 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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Oritinib is a once-a-day tablet for advanced non-small cell lung cancer (NSCLC) with an EGFR mutation. It was discovered and is made in China by Nanjing Sanhome Pharmaceutical, which sells it as 圣瑞沙® (Sanrisso). On the Chinese pack and label its English name is rilertinib mesylate tablets; oritinib is the name used for the same molecule (code SH-1028) in international drug dictionaries and research papers.
China's National Medical Products Administration (NMPA) approved it in June 2024 and added a first-line use in September 2024. It is approved for adults with locally advanced or metastatic NSCLC who have:
It is a prescription cancer medicine and should only be used under an experienced medical oncologist, after the EGFR mutation has been confirmed with an approved test.
In EGFR-mutated lung cancer, a growth switch on the cancer cells is stuck in the "on" position. Oritinib is a third-generation EGFR inhibitor: it locks on to the faulty switch permanently and shuts it down. It acts on the common exon 19 and L858R mutations and on T790M, the change that most often makes older EGFR medicines stop working, while having little effect on normal EGFR. That selectivity is meant to cause fewer skin and gut side effects.
After earlier EGFR treatment (T790M): a phase 2 study published in the Journal of Thoracic Oncology in 2022 treated 227 patients whose cancer had progressed on first- or second-generation EGFR medicines. 60.8% responded, the disease was controlled in 92.5%, and the median time before the cancer grew again was 12.2 months. Responses lasted a median of 13.9 months.
First treatment (SHC013-III-01): in this double-blind phase 3 trial, presented at the 2024 World Conference on Lung Cancer, the cancer was kept under control for a median of 19.3 months with oritinib against 9.8 months with a first-generation EGFR comparison medicine (hazard ratio 0.46). 72.8% of patients responded, and responses lasted a median of 20.7 months.
Your oncologist sets the exact plan using the Chinese prescribing information.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
Muscle enzyme (CPK) rise: the label highlights raised creatine phosphokinase, a sign of muscle strain. If levels go above five times normal, doctors check weekly for muscle pain, tenderness, cramps or weakness, along with kidney function and potassium, and adjust the dose. The risk is higher when taken with some cholesterol medicines (statins) or with strong CYP3A4-blocking drugs, such as certain antibiotics, antifungals and HIV medicines.
Overall: in the clinical trials most side effects were mild or moderate, and blood-related side effects were uncommon. Give your doctor a full list of the medicines and supplements you take, and ask about pregnancy and breastfeeding before starting.
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. You may also find our pages on Lazcluze and Zegfrovy useful, two other EGFR lung cancer medicines we can import.
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 pack holds 20 tablets of 100 mg, which is 10 days of treatment at the usual 200 mg a day, so a month needs three packs. The tablets travel in their sealed original packs and are kept as directed on the pack, under temperature-controlled shipping. 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.
Our New Delhi dispatch point serves the city's major lung cancer centres and patients travelling in from nearby states.
Monthly supplies can go straight to the patient's home or the treating oncologist's hospital.
Oncologists can send the prescription and EGFR report to start a named-patient request, with a quote shared first.
Patients treated in Chennai can plan refills in advance so the daily tablets never run out.
We track the remaining tablet count and send the next packs in good time.
Packs for Kolkata and eastern India travel sealed, with batch and import documents.
The same documented import route applies in Pune, with updates at every stage.
The oncologist's prescription and mutation report are all we need to begin.
Supplies can be delivered to hospitals in Vellore for patients being treated there.
Covers patients from Punjab, Haryana and Himachal Pradesh, with home or hospital delivery.
We arrange delivery to patients and cancer hospitals across Uttar Pradesh.
Patients in Kochi and the rest of Kerala can receive the tablets close to home.
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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