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Befotertinib

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Befotertinib

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: Befotertinib
Generic Name (API): Befotertinib Mesylate
Dosage Form & Strength: 25 mg
Route: Oral
Drug Class: Third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Befotertinib Used For?

Befotertinib is a once-a-day capsule for advanced non-small cell lung cancer (NSCLC) that carries an EGFR mutation. It was discovered by InventisBio and is developed, made and sold in China by Betta Pharmaceuticals under the brand name 赛美纳® (Surmana). It belongs to the third generation of EGFR-targeted tablets and capsules, which were designed to keep working when the cancer becomes resistant to older EGFR treatment.

China's National Medical Products Administration (NMPA) first approved it in May 2023 and added a first-line use in September 2023. 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 or chest physician, after an EGFR mutation test.

How It Works

EGFR is a switch on the surface of lung cells that tells them to grow. In some lung cancers this switch is faulty and stuck in the "on" position. Befotertinib binds to the faulty switch permanently and turns it off. It works on the common exon 19 and L858R faults, and also on T790M, the change that most often makes older EGFR medicines stop working.

What the Trials Showed

First treatment (IBIO-103): this phase 3 trial, published in The Lancet Respiratory Medicine in 2023, enrolled 362 adults at 39 hospitals in China. It compared befotertinib with an older, first-generation EGFR medicine. The cancer was kept under control for a median of 22.1 months with befotertinib against 13.8 months with the comparison medicine, cutting the risk of the disease getting worse by about half (hazard ratio 0.49). In people whose cancer had already spread to the brain, the median was 19.4 months against 13.7 months.

After earlier EGFR treatment (T790M): in the phase 2 registration study, about two in three patients (67.6%) responded, the median time before progression was 16.6 months, and brain tumours shrank in 55.9% of those who had them. In the updated results, people on the 75–100 mg dose lived for a median of 31.5 months.

Recommended Dosage

The capsules come in a 25 mg strength. In the clinical trials the dose was:

  • 75 mg once a day (three 25 mg capsules) for the first 21-day cycle
  • Raised to 100 mg once a day (four capsules) if the first cycle went without serious side effects, low platelets of grade 2 or more, or troublesome headache
  • Kept at 75 mg if those problems appeared
  • Continued every day until the cancer progresses or side effects become too hard to manage

Your oncologist will set the exact dose using the Chinese prescribing information and your blood test results.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Warnings and Precautions

Platelets and blood counts: a fall in platelets (the cells that help blood clot) was the most common side effect in the trials. Your doctor will check your blood counts regularly, and the dose may be kept lower or paused if platelets drop. Tell your doctor about unusual bruising or bleeding.

  • Headache: one of the most common side effects. It is also one of the reasons the dose stays at 75 mg instead of going up to 100 mg.
  • Liver tests: a rise in the liver enzyme ALT was among the most frequent side effects, so liver blood tests are part of routine monitoring.
  • Skin and stomach: the company reports that rash, diarrhoea and mouth sores were clearly less common than with the older comparison medicine in the first-line trial.
  • Serious side effects: in the phase 3 trial, severe (grade 3 or higher) treatment-related side effects occurred in 30% of patients on befotertinib, compared with 8% on the comparison medicine. Serious treatment-related events were reported in 20% against 3%, and 2 patients (1%) died from a treatment-related event, against 1 patient (1%) in the other group.
  • New breathing problems: report any new cough, breathlessness or fever straight away, so your doctor can check the cause.
  • Pregnancy and breastfeeding: discuss this with your oncologist before starting, and follow the advice in the Chinese prescribing information.

Overall: most side effects were mild or moderate and could be managed by monitoring and adjusting the dose. Always give your doctor a full list of the medicines and supplements you take.

How to Access Befotertinib 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 Befotertinib 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 test report (exon 19 deletion, L858R or T790M) and details of any 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 Befotertinib 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. For other EGFR-mutated lung cancer medicines we can import, see our pages on Lazcluze and Zegfrovy.

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 box holds 40 capsules of 25 mg, so at 100 mg a day one box lasts about 10 days, and at 75 mg a day about 13 days. We plan quantities with your oncologist so treatment is not interrupted. The capsules travel in their sealed original packs and are stored as directed on the pack, with temperature-controlled shipping used throughout. 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

Large thoracic oncology departments here see lung cancer patients from all over North India, and our New Delhi dispatch point keeps transit short.

Mumbai

Capsules can be delivered to the patient or the treating cancer centre once the EGFR test report and prescription are checked.

Bangalore

Oncologists in Bangalore can request it for a named patient and receive a written quote before anything is ordered.

Chennai

Patients from across Tamil Nadu who are treated in Chennai can receive monthly supplies without travelling for pickup.

Hyderabad

We time each shipment against the remaining capsule count so the daily dose is never missed.

Kolkata

Supplies for Kolkata and the eastern states are dispatched in sealed original packs with full import papers.

Pune

Patients in Pune follow the same documented import route, with updates at each step.

Ahmedabad

The treating oncologist can share the prescription and mutation report with us to start the request.

Vellore

Patients treated at hospitals in Vellore can have each refill sent directly to the hospital pharmacy.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to home or hospital.

Lucknow

We coordinate delivery to cancer hospitals and patients across Uttar Pradesh.

Kochi

Patients across Kerala can receive the 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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