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Rezivertinib

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Rezivertinib

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Rezivertinib
Generic Name (API): Rezivertinib Mesylate
Dosage Form & Strength: 30 mg
Route: Oral
Drug Class: Third-generation irreversible EGFR tyrosine kinase inhibitor (EGFR-TKI)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Rezivertinib Used For?

Rezivertinib is a once-a-day capsule for advanced non-small cell lung cancer (NSCLC) with an EGFR mutation. It was discovered and developed by Beta Pharma (Shanghai), which sells it in China as 瑞必达® (Ruibida). It is a third-generation EGFR medicine, built to work both on the usual EGFR mutations and on T790M, the change that commonly makes older EGFR treatment stop working.

China's National Medical Products Administration (NMPA) approved it on 20 May 2024, and a first-line use followed in late 2024. It is approved for adults with locally advanced or metastatic NSCLC who have:

  • An EGFR exon 19 deletion or exon 21 (L858R) mutation, as the first treatment for advanced disease
  • A confirmed EGFR T790M mutation, after the cancer has grown during or after earlier EGFR tyrosine kinase inhibitor (TKI) treatment

It is a prescription cancer medicine and should only be used under a medical oncologist, after an EGFR mutation test.

How It Works

In EGFR-mutated lung cancer, a growth signal on the cancer cells is switched on all the time. Rezivertinib binds to the faulty EGFR protein and blocks it for good (an irreversible inhibitor), cutting off that signal. NMPA describes it as acting on EGFR mutants such as T790M and L858R. The company reports that it crosses into the brain well, which matters because lung cancer often spreads there.

What the Trials Showed

First treatment (REZOR): this double-blind phase 3 trial, published in The Lancet Respiratory Medicine in 2025, included 369 patients at 50 hospitals in China. The cancer was kept under control for a median of 19.3 months with rezivertinib against 9.6 months with a first-generation EGFR comparison medicine, a 52% lower risk of progression (hazard ratio 0.48). Overall survival data were still immature at the time of publication.

After earlier EGFR treatment (T790M): in the phase 2b study of 226 patients, 64.6% responded, the disease was controlled in 89.8%, and the median time before progression was 12.2 months. Median overall survival was 23.9 months. In the 29 patients with measurable brain tumours, 69.0% saw those tumours shrink.

Recommended Dosage

The capsules come in a 30 mg strength. In the clinical trials the dose was:

  • 180 mg once a day (for example, six 30 mg capsules), the dose chosen for phase 2 and 3 studies
  • Given every day in 21-day cycles until the cancer progresses or side effects become too hard to manage
  • The dose may be paused or reduced if side effects such as low blood counts appear

Your oncologist will confirm the exact dose from 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.

Warnings and Precautions

Blood counts: the most common treatment-related side effects in the first-line trial were drops in white blood cells (40%), platelets (33%), red cells or anaemia (26%) and neutrophils (26%). Most were mild; severe drops were seen in only a few per cent of patients. Regular blood tests are part of treatment, and the dose can be paused or lowered if counts fall.

  • Liver tests: the liver enzymes ALT (28%) and AST (26%) often rose. Few patients needed a dose change for this, and no one had to stop treatment because of liver problems.
  • Skin and stomach: rash and diarrhoea were less common than with the comparison medicine, according to the trial authors.
  • Lung inflammation: one patient in the first-line trial died of pneumonia with interstitial lung disease that was linked to treatment. Report any new cough, breathlessness or fever straight away.
  • Serious side effects: severe (grade 3 or higher) treatment-related side effects occurred in 23% of patients in both groups, and serious treatment-related events were less frequent with rezivertinib (7% vs 11%).
  • Pregnancy and breastfeeding: discuss this with your oncologist before starting, and follow the advice in the Chinese prescribing information.

After earlier EGFR treatment: in the phase 2b study, 83.2% of patients had at least one drug-related side effect, most often low white cells (27.9%), low platelets (23.0%) and anaemia (22.6%), and no interstitial lung disease was reported. Always give your doctor a full list of the medicines and supplements you take.

How to Access Rezivertinib in India: A 6-Step Process

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.

Documentation & Availability

What documents are required to import Rezivertinib to India?

The capsules 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:

  • A valid prescription from a qualified medical oncologist
  • Diagnostic reports confirming NSCLC, with the EGFR mutation report (exon 19 deletion, L858R or T790M) and details of earlier treatment
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

Once we have received and checked a valid prescription and, where needed, an import permit.

Is Rezivertinib available in India?

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. Other EGFR lung cancer medicines we can import are covered on our Lazcluze and Zegfrovy pages.

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.

Sourcing & Delivery

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 bottle holds 30 capsules of 30 mg. At the trial dose of 180 mg a day, one bottle lasts five days, so a month of treatment needs about six bottles, and we plan orders so supplies do not run short. The capsules travel in their sealed original bottles 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.

Availability Across Major Cities in India

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.

Delhi

Patients treated at Delhi's cancer hospitals can receive their capsules quickly from our New Delhi dispatch point.

Mumbai

Bottles are sent to the patient or the hospital pharmacy, with import and batch papers included.

Bangalore

The treating oncologist can request it for a named patient, and we share the quote before ordering.

Chennai

We plan refills ahead for patients in Chennai, since the daily dose uses several capsules.

Hyderabad

Shipments are timed so a new supply arrives before the current bottles run out.

Kolkata

Patients in Kolkata and the north-east can get sealed original packs delivered to their door or hospital.

Pune

The documented import route works the same way in Pune, with updates along the way.

Ahmedabad

Send us the prescription and the EGFR mutation report to begin the request.

Vellore

Supplies can go directly to hospitals in Vellore for patients under treatment there.

Chandigarh

We serve patients from Punjab, Haryana and Himachal Pradesh through Chandigarh.

Lucknow

Delivery is arranged to patients and cancer centres throughout Uttar Pradesh.

Kochi

Patients from across Kerala can receive their capsules in Kochi and nearby cities.

Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: NMPA • CDSCO

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 19 October 2026

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