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Becotatug Vedotin

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Becotatug Vedotin

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: Becotatug Vedotin
Generic Name (API): Becotatug Vedotin
Dosage Form & Strength: 50 mg/vial
Route: Intravenous (IV) infusion
Drug Class: EGFR-targeted antibody-drug conjugate (MMAE payload)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Becotatug Vedotin Used For?

Becotatug vedotin is a targeted cancer medicine for nasopharyngeal cancer (cancer of the upper throat, behind the nose) that has come back or spread after other treatments. It was developed in China by Lepu Biopharma and is sold there as 美佑恒® (MEIYOUHENG). Its Chinese generic name is 注射用维贝柯妥塔单抗, and during research it was known as MRG003.

China's National Medical Products Administration (NMPA) granted it marketing approval in October 2025 for adults with:

  • Recurrent or metastatic nasopharyngeal carcinoma
  • Whose cancer has already failed at least two lines of systemic chemotherapy and a PD-1/PD-L1 immunotherapy

It is a prescription cancer medicine and should only be used under a medical oncologist experienced with antibody-drug conjugates.

How It Works

This medicine is an antibody-drug conjugate, or ADC. Think of it as a guided missile: an antibody that seeks out EGFR, a protein found on the surface of many head and neck cancer cells, carrying a strong cell-killing drug called MMAE. Once the antibody latches on, the cancer cell pulls it inside, the link breaks, and MMAE is released where it does the most damage. According to Lepu, EGFR is present in about 89% of advanced nasopharyngeal cancers. It is the first EGFR-targeted ADC approved for marketing in China.

What the Trial Showed

The approval rests on a randomised trial in 173 people whose cancer had come back after a median of three earlier treatments. Results were presented as a late-breaking abstract at the 2025 ASCO Annual Meeting. Compared with standard chemotherapy:

  • Response: the tumour shrank in 30.2% of patients, against 11.5% with chemotherapy
  • Time before the cancer grew: a median of 5.8 months versus 2.8 months, a 37% lower risk of progression
  • Survival: at an interim look, median survival was 17.1 months versus 12.0 months. These figures are not yet final

Recommended Dosage

The Chinese prescribing information (matching the pivotal trial) gives:

  • Dose: 2.3 mg per kg of body weight
  • How: as an intravenous drip over at least 60 minutes (usually 60 to 90 minutes), once every 3 weeks; never as a quick injection
  • Continued until the cancer grows or side effects become too much
  • If side effects need it, the dose is lowered first to 2.0 mg/kg and then to 1.5 mg/kg; if a further cut is needed, treatment is stopped

It comes as a 50 mg vial of powder that the hospital pharmacy dissolves in 12.5 mL of sterile water and then dilutes. As an example, a 60 kg patient would need about 138 mg per dose, which is just under three vials. Your oncologist sets the exact plan.

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

Warnings and Precautions

Overall safety: in the pivotal trial, Lepu reported that side effects occurred at a similar rate in both groups. Severe (grade 3 or higher) treatment-related side effects were reported in 45.3% of patients on becotatug vedotin and 50.6% on chemotherapy, and most were mild to moderate and handled with dose changes or supportive care.

The fuller list of side effects comes from the earlier phase 1 study in 61 people with various solid tumours (JAMA Oncology, 2022). The most common were:

  • Liver enzymes: raised AST (39%) and ALT (30%). Liver blood tests are checked during treatment.
  • Skin: rash (39%) and itching (28%), as expected with medicines that act on EGFR. Report any spreading or blistering rash.
  • Hair loss: 33%.
  • Low blood counts: low white cells (25%) and low neutrophils (20%), which raise the risk of infection. Report fever or chills straight away.
  • General: loss of appetite (31%), muscle pain (23%), fever (21%) and weakness (20%).

In that study, 31% had a severe side effect, most often low sodium (8%), low white cells (7%) and low neutrophils (5%). Two patients had severe febrile neutropenia followed by fatal infection, so blood counts need close watching.

Safety in pregnancy, breastfeeding and children has not been established, and the Chinese approval is for adults only.

How to Access Becotatug Vedotin 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, cold-chain 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 Becotatug Vedotin to India?

The injection 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 recurrent or metastatic nasopharyngeal carcinoma, with details of earlier chemotherapy and immunotherapy
  • 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 Becotatug Vedotin available in India?

No. It is approved only in China (approval number 国药准字S20250057, October 2025). 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. To read about other antibody-drug conjugates we help patients import, see our pages on Datroway and Trodelvy.

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. The vials are stored and shipped exactly as directed on the Chinese pack, using temperature-controlled shipping all the way to the hospital. Because the dose depends on body weight and is given every three weeks, we plan quantities cycle by cycle. 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 treating hospital on a valid oncologist's prescription.

Delhi

Head and neck cancer units in Delhi see patients from across North India, and our New Delhi dispatch point keeps transit time short.

Mumbai

Each cycle's vials can be delivered to the hospital pharmacy before the infusion day.

Bangalore

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

Chennai

A major referral centre for head and neck cancers in South India, with experience handling imported injectable cancer medicines.

Hyderabad

We time deliveries to the three-weekly schedule so each dose is ready on day 1.

Kolkata

Patients from Kolkata and the eastern states can use the same documented import route, with updates at each stage.

Guwahati

For patients in Assam and neighbouring states, we coordinate delivery to the treating cancer hospital.

Pune

Families in Pune are kept informed from the prescription check through to hospital delivery.

Ahmedabad

The treating oncologist can send us the prescription and treatment history to start the import.

Vellore

Patients treated at hospitals in Vellore can have each cycle delivered directly to the hospital.

Lucknow

We arrange delivery to public and private cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive the medicine 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.

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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